Physiotherapy

Physiotherapy
VOLUME 94, NUMBER 2, 2008

Editor
Michele Harms PhD MSc GradDipPhys MCSP Editor The Chartered Society of Physiotherapy London, UK
Editorial Ofce
Physiotherapy Editorial Ofce Elsevier Ltd, The Boulevard Langford Lane Kidlington Oxford OX5 1GB, UK Tel.: +44 (0)1865 843753 Fax: +44 (0)1865 843992 E-mail: physiotherapy@elsevier.com Sheila Payne PhD BA(Hons) RN DipN C. Physchol Lancaster University Lancaster, UK Valerie Pomeroy PhD BA GradDipPhys FCSP University of East Anglia Norwich, UK Gabrielle Rankin PhD MSc GradDipPhys MCSP Chartered Society of Physiotherapy London, UK Patricia Roche PhD MSc BSc(Hons) MCSP Queen Margaret University College Edinburgh, Scotland Sally Singh PhD BSc MCSP Gleneld Hospital Leicester, UK Paul Watson PhD MSc GradDipPhys MCSP BSc(Hons) CertHSM PGCE DipPT University of Leicester Leicester, UK
Associate Editors
Claire Ballinger PhD MSc DipCOT Glasgow Caledonian University Glasgow, UK Richard Bohannon EdD, PT, NCS, FAHA, FAPTA University of Connecticut Connecticut, USA Tracy Bury MSc GradDipPhys MCSP WCPT Secretariat London, UK Vinette Cross PhD MMedEd MCSP DipTP CertEd University of Birmingham Birmingham, UK Mike Hurley PhD GradDipPhys MCSP Kings College London London, UK Sallie Lamb DPhil MSc GradDipPhys MCSP University of Warwick Warwick, UK Gareth Noble PhD BSc(Hons) University of Wales Swansea, Wales
International Advisory Board

D. Bader (London, UK) K. Bo (Oslo, Norway) M. OBrien (Ontario, Canada) C. Cott (Toronto, Canada) R. de Bie (Maastricht, The Netherlands) W. de Weerdt (Heverlee, Belgium) C. Eales (Johannesburg, South Africa) J. Hay Smith (Dunedin, New Zealand) S. Jenkins (Perth, Australia) G. Jensen (Nebraska, USA) R. Ladyshewsky (Perth, Australia) I. Nara (Kobe, Japan) A. Nieuwboer (Heverlee, Belgium) P. Pothongsunun (Chiang Mai, Thailand) G. Wulf (Nevada, USA)
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Physiotherapy 94 (2008) 8990
Editorial
Client-centred rehabilitation: what is it and how do we measure it?
Client centredness has emerged in recent years as an important underlying principle for the delivery of health and rehabilitation services [1]. Increasingly, hospitals are implementing programmes to enhance client centredness of care, but there are few measures to evaluate hospital performance in these areas. In Ontario, the largest province in Canada, indicators of client centredness have been developed at both client and organisational level in order to facilitate the evaluation of programmes in the Hospital report: rehabilitation, a province-wide quality improvement and research initiative that uses a balanced scorecard approach to evaluate the performance of all hospitals with designated rehabilitation beds. A balanced scorecard approach [2] recognises that hospital care is a complicated activity requiring a multitude of skills, experiences and technologies [3]. Performance measurement must therefore include a balanced scorecard of indicators that, when taken together, provide insights into the overall performance of a hospital. The balanced scorecard approach describes performance across four quadrants that are critical to the success of any healthcare organisation: system integration and change (SIC) (the changes and investments that facilities need to make in order to move ahead in the next 35 years); clinical utilisation and outcomes (elements of clinical success); client perspectives (dimensions of care that are most relevant to clients); and nancial performance and condition. The rst step in developing client-centredness indicators for the SIC and client perspectives quadrants required denition of the concept of interest, i.e. client-centred rehabilitation. A review of the literature revealed that there was no commonly used denition of client-centred rehabilitation [4], and that most available denitions focused on acute care, usually from the perspective of various health professionals rather than clients. In order to address these shortcomings, focus groups were conducted with adult rehabilitation clients with chronic physically disabling conditions and rehabilitation professionals in order to identify the important domains of client-centred rehabilitation [5,6]. From these studies, it was concluded that client-centred rehabilitation is a philosophy or approach to the delivery of rehabilitation services that reects the needs
of individuals and groups of clients. Further, client-centred rehabilitation can be thought of at two levels: client (clients are actively involved in managing their care and their rehabilitation in partnership with service providers); and organisation (an approach to care that strives to incorporate client perspectives into the provision of services). Table 1 shows the seven domains of client-centred rehabilitation at client level and the seven domains of client-centred rehabilitation at organisational level identied in the research. These domains formed the basis for the development of indicators at two levels: client and organisation. Creation of a tool to measure client centredness at client level consisted of the development of ve to six questionnaire items for each of the seven domains of client-centred rehabilitation, cognitive interviews with rehabilitation clients to evaluate the clarity and relevance of the items, and testing of the psychometric properties of the tool via a self-administered survey mailed to over 1000 patients discharged from two rehabilitation facilities. The product of this pilot work was a 30-item questionnaire the Client Centred Rehabilitation Questionnaire (CCRQ) which has demonstrated inter-item and testretest reliability and concurrent validity [7]. Subsequently, the CCRQ was embedded within the client perspectives of rehabilitation survey for the Hospital report: rehabilitation. For the 2005 report, it was sent to all clients (n = 11 464) discharged from designated rehabilitation beds within the province of Ontario in 2004. There was a 46% response rate (n = 5274). Further construct validity testing was undertaken by correlating each individual question and each domain score in the CCRQ with a general measure of satisfaction (i.e. Please rate the overall quality of care and services you received) that functioned as a gold standard of client satisfaction [8]. Clients perceived their quality of care to be higher when they felt that: they were involved in determining their progress in rehabilitation; their physical comfort needs were being recognised and handled by staff; they were being treated with respect and dignity; and they had been given the information that they needed to manage their condition in the community. Most important was feeling that they had been treated with respect and dignity, and that they were seen as a person and not just another case.
0031-9406/$ see front matter 2008 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.physio.2008.02.004
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Editorial / Physiotherapy 94 (2008) 8990
Table 1 Domains of client-centred rehabilitation at client and organisational level Domains at client level Client participation in decision-making and goal-setting Client-centred education (information is timely and appropriate) Evaluation of outcomes from the clients perspective, not just from the perspective of the rehabilitation professionals Family involvement and support Coordination and continuity of care (clients often feel isolated and abandoned after discharge from rehabilitation) Emotional support (clients feel they are being listened to and treated with respect and dignity) Physical comfort (recognition and management of pain) Domains at organisational level Client involvement in service planning Evaluation of the programmes and services from the clients perspective Organisational response to client feedback Accessibility Interdisciplinary approach Coordination and continuity with community services Organisational support for client-centred care
Two indicators were used to measure client centredness at organisational level. The rst, evidence of client-centred care, measures the extent to which systems and processes are in place to ensure that the individual care that clients receive during their rehabilitation is client centred. It is derived from seven questions in the SIC questionnaire that parallel the following four components of client-centred rehabilitation: client involvement in decision-making and goal-setting; client-centred and family-centred education; family involvement; and emotional support mechanisms for clients/families and staff. The second organisational level indicator, evidence of organisational client centredness, measures the extent to which hospitals implement a client-centred approach to service delivery at organisational level. The indicator is constructed from four questions in the SIC questionnaire that address: the extent to which hospitals are collecting client/family feedback, including evidence that client perspectives are incorporated into service planning; strategies that hospitals utilise to disseminate client and family feedback results; and the existence of specic staff roles that facilitate client-centred care (e.g. patient advocate/ombudsman, designated contact person assigned to each client and family, or designated staff who addresses equity issues). More detailed denitions of the two indicators, including weighting of each question, are available in the rehabilitation technical summary at http://www.hospitalreport.ca/. Preliminary examination of the inter-relationships between the client perspectives indicators and the two client-centredness SIC indicators found that hospitals which actively involve clients and families within the organisation are perceived by clients to provide care of higher quality, to recognise and manage physical comfort needs, and to actively involve clients in evaluating their rehabilitation outcomes. These results represent trends that could provide direction for hospitals with respect to quality improvement efforts. In conclusion, client centredness is an important component of any rehabilitation programme. It is important for
organisations to utilise measures of client centredness that can be used for discriminative and evaluative purposes so that quality of care can be monitored within and between programmes. In Ontario, measures of client centredness at both client and organisational level have been developed and are being used as part of a province-wide quality improvement initiative. Although developed in Canada, these measures are in the public domain and have the potential to be utilised in other rehabilitation service delivery systems. Conict of interest: None. References
[1] Picker Institute. Eye on patient: a report by Picker Institute for the American Hospital Association. Boston, MA: Picker Institute Inc.; 2000. p. 114. [2] Kaplan RB, Norton DP. The balanced scorecard measures that drive performance. Harvard Bus Rev 1992;70:719. [3] Baker GR, Pink GH. A balanced scorecard for Canadian hospitals. Healthcare Manage Forum 1995;8:713. [4] Cott CA, Boyle J, Fay J, Sutton D, Bowring J, Lineker S. Client-centred rehabilitation. Working Report 157. Toronto: Arthritis Community Research and Evaluation Unit; 2001. [5] Cott CA. Client-centred rehabilitation: client perspectives. Dis Rehabil 2004;26:141122. [6] Soever L, Cott CA, Boyle J. Client centred rehabilitation II: health care professionals perspectives. Working Report 160. Toronto: Arthritis Community Research and Evaluation Unit; 2003. [7] Cott CA, Teare G, McGilton KS, Lineker S. Development and pilot testing of the client-centred rehabilitation questionnaire. Dis Rehabil 2006;28:138797. [8] Tyas J, Soever L, MacKay C, Cott CA. Client perspectives technical summary. Hospital report 2005: rehabilitation. Toronto: Hospital Report Research Collaborative, University of Toronto; 2005.
Cheryl A. Cott Department of Physical Therapy, Faculty of Medicine, University of Toronto, 160500 University Avenue, Toronto, Ontario M5G 1V7, Canada Tel.: +1 416 978 0301; fax: +1 416 946 8562. E-mail address: cheryl.cott@utoronto.ca
Available online at www.sciencedirect.com
Incidence and effect of leg length discrepancy following total hip arthroplasty
D.J. Beard a, , J. Palan a , J.G. Andrew b , J. Nolan c , D.W. Murray a , EPOS Study Group
a
Nufeld Department of Orthopaedic Surgery, University of Oxford, Nufeld Orthopaedic Centre, Oxford OX3 7LD, UK b Ysbyty Gwynedd District Hospital, Penrhosgarnedd, Bangor, UK c Norfolk and Norwich University Hospital, Norwich, UK
Abstract Objectives The clinical importance of a leg length discrepancy (LLD) following total hip arthroplasty (THA) remains controversial. This study was undertaken to determine the effects of LLD on clinical outcomes at up to 3 years follow-up. Design and setting Prospective, multicentre study. Participants Nine hundred and eighty-seven cases of primary THA, categorised into two main groups: the NoLLD group (LLD of less than 10 mm) and the LLD group (LLD of 10 mm or more). Main outcome measures The primary outcome measure was the change in Oxford Hip Score ( OHS) at up to 3 years follow-up. Secondary outcome measures were length of operating time and hospital stay, and revision and dislocation rates. Potential predisposing factors for LLD, including body mass index, age and type of anaesthesia employed, were examined. Results At 3 years, the LLD group had a signicantly worse OHS [22.0; 95% condence interval (CI) 20.5 to 23.5] compared with the NoLLD group (23.8; 95% CI 23.1 to 24.5) (P = 0.034). There were no signicant differences in revision (P = 0.389) or dislocation (P = 0.220) rates between the two groups. Use of an epidural was associated with a decreased incidence of developing an LLD of 10 mm (P = 0.004). Conclusion A postoperative LLD of 10 mm or more leads to poorer functional outcomes. Further studies are needed to assess the impact of an LLD on clinical outcomes in the longer term. 2008 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Keywords: Leg length discrepancy; Arthroplasty, hip; Dislocation; Revision; Oxford Hip Score
Introduction Leg length discrepancy (LLD) has been well described as a common complication following total hip arthroplasty (THA) [1,2]. The presence of LLD has been associated with back pain [3,4], increased risk of nerve injury [5] and dislocation [6], poor patient satisfaction [7] and the need for revision surgery [8]. It has been cited as a major cause of litigation following THA [9]. In the literature, there is continuing debate about the importance of LLD and its clinical effect.
Corresponding author. Tel.: +44 1865 227454; fax: +44 1865 227671. E-mail address: david.beard@orthopaedic-surgery.oxford.ac.uk (D.J. Beard).
A recent paper by Konyves and Bannister [10] concluded that patients with an LLD (longer leg length on operated side) had a worse functional outcome compared with patients who did not have an LLD. However, a study by White and Dougall [11] showed no statistical association between LLD and patient satisfaction and outcome. However, in both of these studies, the cohort size was small and single centred.
Objectives The aim of this study was to determine the clinical effects of LLD following THA using the change in the Oxford Hip Score ( OHS) as a primary outcome measure.
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Design and setting This was a prospective non-randomised multicentre study involving seven centres.
Participants In total, 987 THAs were examined in this study, involving consultant and non-consultant surgeons and utilising two different surgical approaches (anterolateral and posterior). The diagnosis in every case was that of primary osteoarthritis and all were unilateral hips. None of the patients had undergone previous surgery to the hip. In all cases, a cemented Exeter femoral stem (Stryker Howmedica Osteonics, Mahwah, New Jersey, USA) was used with various acetabular components. The true leg length was measured in millimetres (mm) using a direct tape measure method, with the patient in a supine position, from the anterior superior iliac spine to the medial malleolus of the operated side and non-operated side [1214]. The LLD was calculated as the difference between the two measurements. The patients were categorised into two main groups: the NoLLD group, with an LLD of less than 10 mm (n = 794); and the LLD group, with an LLD of 10 mm or more (n = 193). A subgroup analysis was also performed on a small number of patients (n = 55) who had a severe LLD of 20 mm of more. The mean LLD was 0.7 mm [standard deviation (SD) 1.8] and 14.9 mm (SD 7.4) in the NoLLD group and the LLD group, respectively. In the subgroup of patients with an LLD of 20 mm or more, the mean LLD was 24.7 mm (SD 2.1). The overall mean LLD in the series was 3.5 mm. The LLD was assessed to determine whether the effect of the discrepancy was to lengthen or shorten the affected leg. In the NoLLD group, 417 patients had equal leg lengths. Within this group, there were 110 patients with a minor LLD of less than 10 mm, of which 49 patients (45%) had a shortening of the operated leg and 61 patients (56%) had a lengthening of the operated leg. In the LLD group, 75 cases of LLD of 10 mm or more (39%) were shorter and 118 cases (61%) were longer (P < 0.001, Chi-squared test). Within the LLD
Table 1 Demographics and preoperative data for the two study groups Total no. of total hip arthroplasties Gender (total) Men Women Mean age at operation (years) +1 SD Mean body mass index (kg/m2 ) +1 SD Charnley category A B C 983 n 791
group, the mean length of leg shortening was 13.9 mm and the mean length of leg lengthening was +15.6 mm. Patient demographics are shown in Table 1. There were 293 men and 498 women in the NoLLD group, and 69 men and 123 women in the LLD group. Patients in the NoLLD group were younger than those in the LLD group (P = 0.014). There was no signicant difference in the mean body mass index of the two groups (P = 0.135). The Charnley categories for each group of patients were not signicantly different (P = 0.865). Category A describes unilateral hip disease, Category B describes bilateral hip disease and Category C describes multiple joint involvement which limits walking ability [15] (Table 1).
Main outcome measures The OHS was used as a well-validated method [16,17] of assessing clinical outcomes on a patient-centred basis. The OHS is scored from 12 (best) to 60 (worst) and consists of 12 questions, each marked from one (best) to ve (worst). Pre- and postoperative OHSs were collected and the change in OHS ( OHS) was calculated at 3 months, 1 year and 3 years. The OHS was also analysed as separate question components to identify if there were particular functional activities or symptoms which affected those patients with an LLD. Secondary outcome measures included the mean length of operating time and hospital stay, and revision and dislocation rates for each of the LLD groups. The type of anaesthetic used for each patient was recorded to assess if there was an association between the type of anaesthetic used and LLD. This was either a general anaesthetic, spinal anaesthesia or an epidural. Statistics For the outcome measures, analysis of variance and Tukeys Post Hoc test were used to compare differences in data between the groups. Categorical and frequency data were analysed using Chi-squared and Fishers Exact tests, and the -level of signicance was dened as less than 5% (P 0.05).
NoLLD group (LLD of less than 10 mm) 293 498
n 192
LLD group (LLD of 10 mm or more) 69 123
P-value 0.803
985 936 939
792 752 754
69.4 8.5 27.6 5.0 502 141 111
193 184 185
71.1 8.5 27.0 4.3 122 33 30
0.014 0.135 0.865
LLD, leg length discrepancy; SD, standard deviation.
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Data from Questions 1 and 9 of the OHS were analysed using the non-parametric KruskalWallis test. Statistical Package for the Social Sciences Version 12.0.1 (SPSS Inc, Chicago, IL, USA) was employed for statistical analysis of the data.
Results Primary outcome measure There was no difference in the preoperative OHS between the NoLLD group and the LLD group (P = 0.885). The mean preoperative OHS was 43.4 in the NoLLD group (LLD of less than 10 mm) and 43.3 in the LLD group (LLD of 10 mm or more). The outcomes did not differ between the two groups until 3 years. The clinical benet of surgery as determined by the OHS was not signicantly different between the groups at 3 months (P = 0.537) or 1 year (P = 0.086) after surgery (Table 2). However, at 3 years following THA, a statistically signicant difference in the OHS between the groups was seen, with the NoLLD group showing the greater improvement in OHS (P = 0.034) (Fig. 1). The absolute OHS (Table 2) at 3 years was also signicantly different between the groups: 19.3 for the NoLLD group and 21.1 for the LLD group (P = 0.022). A subgroup analysis of the LLD group was performed whereby patients with an LLD of 20 mm or more were also assessed in terms of their OHS and OHS. This minority group of patients had a signicantly higher preoperative OHS (45.6) compared with patients in the LLD group with an LLD of 10 to <20 mm (OHS = 42.3) (P = 0.017), indicating worse pain and functional symptoms prior to surgery. At 3 years, this group of patients achieved a considerable benet from surgery as evidenced by their OHS of 24.6. The effect of shortening and lengthening of the operated leg side was evaluated within the LLD group. There was no difference in OHS at 3 months (P = 0.568), 1 year
Fig. 1. Change in Oxford Hip Score (OHS) at 3, 12 and 36 months follow-up in the two study groups. Error bars represent standard deviation (+1SD).
(P = 0.591) or 3 years (P = 0.498) when comparing a shorter LLD with a longer LLD (Table 3). The individual components of the OHS questionnaire were analysed. In particular, emphasis was placed on Questions 1 and 9 which dealt specically with pain and limping, respectively. Questions 1 and 9 were scored from one to ve points (one point being the best score, ve points being the worst score). Patients with an LLD of 20 mm or more scored highest (worst) preoperatively for Question 1 compared with the other patients (P = 0.03), indicating that patients who had a severe postoperative LLD had signicantly more pain associated with their arthritic hip prior to their operation. After surgery, this difference in pain was no longer signicant (P = 0.654). With regards to limping, there were no signicant differences in the scoring for Question 9 preoperatively between the NoLLD group and the LLD group, including the subgroup of patients with an LLD of 20 mm or more (P = 0.584). However, differences emerged after surgery, with the LLD group, especially the patients with an LLD
Table 2 Mean absolute pre- and postoperative Oxford Hip Scores (OHSs) and change in OHS ( OHS) in the two study groups at up to 3 years follow-up Total no. of total hip arthroplasties Preoperative OHS Mean absolute OHSa 3 months 1 year 3 years Mean OHSb 3 months 1 year 3 years 987 861 946 814 861 946 814 NoLLD group (LLD of less than 10 mm) n 794 691 758 661 691 758 661 Mean 43.4 24.7 19.4 19.3 18.6 23.8 23.8 95% CI 42.8 to 43.9 24.1 to 25.2 18.9 to 20.0 18.7 to 19.9 17.9 to 19.4 23.2 to 24.5 23.1 to 24.5 LLD group (LLD of 10 mm or more) n 193 170 188 153 170 188 153 Mean 43.3 25.2 20.8 21.1 18.1 22.5 22.0 95% CI 42.2 to 44.3 24.1 to 26.2 19.6 to 21.9 19.6 to 22.5 16.7 to 19.5 21.2 to 23.9 20.5 to 23.5 0.885 0.423 0.041 0.022 0.537 0.086 0.034 P-valuec
LLD, leg length discrepancy; CI, condence intervals. a Absolute OHS: 12 (best) to 60 (worst). b OHS: 0 (worst) to 48 (best). c P-value calculated using analysis of variance.
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Table 3 Mean change in Oxford Hip Score ( OHS) in the leg length discrepancy (LLD) group, at up to 3 years follow-up, comparing a shorter and longer LLD Total no. of total hip arthroplasties Mean 3 months 1 year 3 years OHSa 170 188 153 68 73 57 18.6 22.1 21.4 16.3 to 20.9 19.9 to 24.3 18.9 to 23.9 102 115 96 17.8 22.8 22.4 16.0 to 19.6 21.3 to 24.5 20.5 to 24.3 0.568 0.591 0.498 Shorter LLD n Mean 95% CI n Longer LLD Mean 95% CI P-valueb
CI, condence intervals. a OHS: 0 (worst) to 48 (best). b P-value calculated using analysis of variance.
of 20 mm or more, scoring worse for Question 9 compared with the NoLLD group (P = 0.001). Secondary outcome measures The percentage of patients in each of the three groups needing revision surgery was analysed. In the NoLLD group, six of 794 cases [relative frequency (RF) = 1%] needed revision, and in the LLD group, three of 193 cases were revised (RF = 2%; P = 0.389). There was no signicant difference in dislocation rate between the groups (NoLLD group: RF = 2%, 16/794 cases; LLD group: RF = 1%, 1/193 cases; P = 0.220). The mean length of operating time for the two groups was signicantly different (P = 0.038), as was the length of hospital stay (P = 0.006). The NoLLD group had a longer mean operating time (89.9 minutes) and a shorter length of hospital stay (9.0 days) compared with the LLD group (mean operating time 84.9 minutes, length of hospital stay 10.6 days). Use of an epidural was associated with a decreased incidence of having an LLD greater than 10 mm (P = 0.004). A higher percentage of patients in the NoLLD group (29%, 229/793 cases) received an epidural and had an LLD of less than 10 mm, whereas in the LLD group, the percentage was 19% (36/193 cases). No signicant differences were associated with a general (P = 0.307) or spinal (P = 0.225) anaesthetic and an LLD of 10 mm or more.
Discussion LLD has been reported in the literature as being a common nding following primary THA, although there is a lack of consensus about what constitutes a clinically signicant postoperative inequality [18]. The vast majority of these patients have an LLD of less than 10 mm; in one series, 97% of patients undergoing THA had an LLD of less than 10 mm, with a mean LLD of 1 mm [19]. In another study, Turula et al. [14] found that LLD varied from 20 (shortened leg) to +15 mm (lengthened leg) with a mean of 2.8 mm. In a consecutive series of 100 patients, Ranawat and Rodriguez [20] demonstrated that the mean LLD was 3.4 mm (range 10 to 18 mm). In the present series, the relative frequency of patients with an LLD of less than 10 mm was 80%, with an overall mean LLD of 3.5 mm. The incidence of an LLD of
20 mm or more was 6% (55/987 cases). Such a pronounced discrepancy has been described in the literature as being poorly tolerated by patients [21]. This study has demonstrated that having an LLD of 10 mm or more is associated with having a signicantly poorer outcome in terms of the clinical benet of surgery ( OHS) compared with patients who either have equal leg lengths or an LLD of less than 10 mm. Whether such a difference in OHS is clinically important is more difcult to assess. Murray et al. have described a two-point change in OHS as being the minimum clinical change perceived by patients as meaningful and which may lead to changes in clinical practice [22]. There was no difference in OHS at 3 years when a shorter LLD was compared with a longer LLD. It is surprising to note that those patients in the LLD group who had an LLD of 20 mm or more still gained a considerable benet from having a THA and had a greater OHS at 3 years compared with patients who had an LLD of 10 to <20 mm. The reason for this is unclear. It may be because such patients had particularly severe pain symptoms from their diseased hip, and therefore the benet of surgery is especially pronounced in terms of improved OHS outcomes and the reduction of pain. Patients with an LLD of 20 mm or more had a signicantly higher score preoperatively for Question 1 of the OHS questionnaire (indicating worse pain symptoms) compared with the other groups, yet achieved a comparable score to the other groups at 3 years follow-up. This suggests that surgery alleviated their pain to such an extent that even with an LLD of 20 mm or more, the analgesic effect of surgery was such as to offset the symptoms of signicant LLD. It should also be remembered that the sample size in this group was small and that this may affect the meaning of statistical tests of signicance [23]. A power analysis was performed in this subgroup of patients and the sample size was insufcient to detect a two-point difference in OHS. As such, some caution is advised when interpreting the signicance of the results in this select group of patients. Limping appeared to be more of a problem in patients with an LLD of 10 mm or more. Preoperatively, patients in all three groups had a similar incidence of limping; however, 3 years after surgery, patients with an LLD of 10 mm or more had twice the incidence of limping compared with patients with an LLD of less than 10 mm. Clearly, the presence of an LLD
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of 10 mm of more is, perhaps not surprisingly, associated with the presence of a limp. The use of an epidural was associated with a decreased risk of having an LLD of 10 mm or more. It is postulated that the reasoning for this relates to the degree of motor blockade achieved using an epidural compared with the other anaesthetic techniques. LLD is thought to be related to myofascial tension, which may be difcult to assess during surgery, under a general anaesthetic, as the muscles are fully relaxed [6]. An epidural provides a less potent muscle relaxant effect compared with a spinal or general anaesthetic [24], and the patients muscles are in a more physiologically normal state. In turn, this may lead to greater accuracy in assessing intra-operative leg lengths and hence minimise the risk of developing a substantial LLD [25]. This study did not demonstrate any signicant differences in revision or dislocation rates between the groups. In terms of dislocation, this nding is supported by experimental evidence examining the potential dislocating forces around the hip joint. Gait analysis work by Brand and Yack [26], on the effects of an LLD on the forces at the hip joint, concluded that there are no substantial changes in hip forces for most types of LLD seen after THA. The present results contradict those of other studies which have demonstrated an association between LLD and dislocation rates [27,28], which is thought to be due to changes in the myofascial tension affecting the stability of the hip prosthesis [29]. It is important to differentiate between an apparent and a true LLD as the success of various treatment options will be different. An apparent or functional LLD can occur as a result of a xed spinal deformity (lumbosacral scoliosis), contractures of periarticular hip muscles including tensor fascia lata, gluteus minimus and medius, and the presence of pelvic obliquity [20]. An apparent LLD can be treated with aggressive physiotherapy in the form of stretching exercises, manual massage and soft tissue mobilisation techniques occasionally supplemented with steroid or Botox injections [30]. Most cases of an apparent LLD following THA resolve with time and physiotherapy, although a small subset of patients may require a shoe lift, heel lift or, as a last resort, surgical soft tissue releases or revision arthroplasty [20]. A true LLD is an anatomical decit and occurs as a result of component malpositioning following THA. Either the acetabular cup is implanted too distally (shifting the centre of the hip joint and causing the leg to migrate distally) or too long a femoral component is used [13]. In such cases, physiotherapy has a much more limited role as no amount of rehabilitation will correct the discrepancy. By and large, the majority of treatments remain non-operative and involve the use of shoe or heel lifts to the shorter leg. Shoe lifts have been used in patients with an LLD of less than 10 mm, and are noninvasive, inexpensive and can be prepared and adjusted by trained physiotherapists [31]. Occasionally, because of persistent pain and impaired function, failure of non-operative therapy or if there is gross instability of the hip replacement, revision surgery is required [13].
There are some potential limitations to this study. Firstly, the measurement of leg length was performed by clinical measurement and not radiological measurements. Such imaging techniques, although considered the gold standard in measuring LLD accurately, are limited by their costs, time consumption and patient exposure to radiation [32], and clinical methods involving the tape measure method of determining LLD have been shown to be valid in the clinical setting [12,25]. Secondly, although this is a large and prospective study by design, it did have some incomplete data and there is always the potential that those patients lost to follow-up may have different characteristics. However, demographic data suggest that such patients had no particular differences and the number was small. In conclusion, an LLD of more than 10 mm does appear to diminish the benets of THA signicantly in terms of OHS. Whether this difference in OHS is clinically important, from a patients perspective, remains less clear. Care should therefore be taken to minimise LLD intra-operatively in order to maximise the clinical benets of THA for the patient. Further studies are needed into the longer-term effects of an LLD following hip arthroplasty.
Acknowledgements The authors wish to thank Ms. Kate Honeybill and Dr. Polly Winter (Clinical Research Associates, Stryker Howmedica Osteonics, Newbury, UK) for their help in collating the EPOS data. The following are principal investigators of the EPOS group: Mr. P. Gibson, Mr. J. Nolan, Mr. A. Hamer, Mr. M. Fordyce and Mr. K. Tuson. The following are study co-ordinators for the EPOS group: A. Potter, A. McGovern, K. Reilly, C. Jenkins, A. Cooper, C. Darrah, L. Cawton, P. Inaparthy and C. Pitchfork. Ethical approval: Salford and Trafford Research Ethics Committee, Project Number 98105 MREC 98/8/20 UK Multi-centre Exeter Primary Outcome Study (EPOS). Conict of interest: This study was supported by Stryker Howmedica Osteonics, Newbury, UK.
References
[1] Williams O, Fitzpatrick R, Hajat S, Reeves BC, Stimpson A, Morris RW, et al. Mortality, morbidity, and 1-year outcomes of primary elective total hip arthroplasty. J Arthroplasty 2002;17:16571. [2] Williamson JA, Reckling FW. Limb length discrepancy and related problems following total hip joint replacement. Clin Orthop Relat Res 1978:1358. [3] Friberg O. Clinical symptoms and biomechanics of lumbar spine and hip joint in leg length inequality. Spine 1983;8:64351. [4] Giles LG, Taylor JR. Low-back pain associated with leg length inequality. Spine 1981;6:51021. [5] Pritchett JW. Nerve injury and limb lengthening after hip replacement: treatment by shortening. Clin Orthop Relat Res 2004:168 71.
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D.J. Beard et al. / Physiotherapy 94 (2008) 9196 [19] Woolson ST, Hartford JM, Sawyer A. Results of a method of leg-length equalization for patients undergoing primary total hip replacement. J Arthroplasty 1999;14:15964. [20] Ranawat CS, Rodriguez JA. Functional leg-length inequality following total hip arthroplasty. J Arthroplasty 1997;12:35964. [21] Gross RH. Leg length discrepancy: how much is too much? Orthopedics 1978;1:30710. [22] Murray DW, Fitzpatrick R, Rogers K, Pandit H, Beard DJ, Carr AJ, et al. The use of the Oxford hip and knee scores. J Bone Joint Surg Br 2007;89:10104. [23] Royall RM. The effect of sample size on the meaning of signicance tests. Am Statist 1986;40:3135. [24] Holmstrom B, Laugaland K, Rawal N, Hallberg S. Combined spinal epidural block versus spinal and epidural block for orthopaedic surgery. Can J Anaesth 1993;40:6016. [25] Jasty M, Webster W, Harris W. Management of limb length inequality during total hip replacement. Clin Orthop Relat Res 1996;333:16571. [26] Brand RA, Yack HJ. Effects of leg length discrepancies on the forces at the hip joint. Clin Orthop Relat Res 1996;333:17280. [27] Callaghan JJ, Heithoff BE, Goetz DD, Sullivan PM, Pedersen DR, Johnston RC. Prevention of dislocation after hip arthroplasty: lessons from long-term followup. Clin Orthop Relat Res 2001;393:15762. [28] Coventry MB. Late dislocations in patients with Charnley total hip arthroplasty. J Bone Joint Surg Am 1985;67:83241. [29] Padgett DE, Warashina H. The unstable total hip replacement. Clin Orthop Relat Res 2004;420:729. [30] Bhave A, Mont M, Tennis S, Nickey M, Starr R, Etienne G. Functional problems and treatment solutions after total hip and knee joint arthroplasty. J Bone Joint Surg Am 2005;87(Suppl. 2):921. [31] Defrin R, Ben Benyamin S, Aldubi RD, Pick CG. Conservative correction of leg-length discrepancies of 10 mm or less for the relief of chronic low back pain. Arch Phys Med Rehabil 2005;86:2075 80. [32] Gurney B. Leg length discrepancy. Gait Posture 2002;15:195206.
[6] Woo RY, Morrey BF. Dislocations after total hip arthroplasty. J Bone Joint Surg Am 1982;64:1295306. [7] Maloney WJ, Keeney JA. Leg length discrepancy after total hip arthroplasty. J Arthroplasty 2004;19(Suppl. 1):10810. [8] Austin MS, Hozack WJ, Sharkey PF, Rothman RH. Stability and leg length equality in total hip arthroplasty. J Arthroplasty 2003;18(Suppl. 1):8890. [9] Attarian DE, Vail TP. Medicolegal aspects of hip and knee arthroplasty. Clin Orthop Relat Res 2005:726. [10] Konyves A, Bannister GC. The importance of leg length discrepancy after total hip arthroplasty. J Bone Joint Surg Br 2005;87:1557. [11] White TO, Dougall TW. Arthroplasty of the hip. Leg length is not important. J Bone Joint Surg Br 2002;84:3358. [12] Beattie P, Isaacson K, Riddle DL, Rothstein JM. Validity of derived measurements of leg-length differences obtained by use of a tape measure. Phys Ther 1990;70:1507. [13] Parvizi J, Sharkey PF, Bissett GA, Rothman RH, Hozack WJ. Surgical treatment of limb-length discrepancy following total hip arthroplasty. J Bone Joint Surg Am 2003;85-A:23107. [14] Turula KB, Friberg O, Lindholm TS, Tallroth K, Vankka E. Leg length inequality after total hip arthroplasty. Clin Orthop Relat Res 1986:1638. [15] Garellick G, Malchau H, Herberts P. Specic or general health outcome measures in the evaluation of total hip replacement. A comparison between the Harris hip score and the Nottingham Health Prole. J Bone Joint Surg Br 1998;80:6006. [16] Dawson J, Fitzpatrick R, Carr A, Murray D. Questionnaire on the perceptions of patients about total hip replacement. J Bone Joint Surg Br 1996;78:18590. [17] Dawson J, Fitzpatrick R, Murray D, Carr A. Comparison of measures to assess outcomes in total hip replacement surgery. Qual Health Care 1996;5:818. [18] Abraham WD, Dimon III JH. Leg length discrepancy in total hip arthroplasty. Orthop Clin North Am 1992;23:2019.
Systematic review
Assessing the effect of sample size, methodological quality and statistical rigour on outcomes of randomised controlled trials on mobilisation, manipulation and massage for low back pain of at least 6 weeks duration
Dries M. Hettinga a , Deirdre A. Hurley b , Anne Jackson a, , Stephen May c , Chris Mercer d , Lisa Roberts e
Research and Development, Chartered Society of Physiotherapy, 14 Bedford Row, London WC1R 4ED, UK School of Physiotherapy and Performance Science, University College Dublin, Beleld, Dublin 4, Ireland c Faculty for Health and Wellbeing, Shefeld Hallam University, Shefeld S10 2BP, UK d Physiotherapy Department, Worthing and Southlands Hospitals NHS Trust, Upper Shoreham, Shoreham-by-Sea BN43 6TQ, UK e School of Health Professions and Rehabilitation Sciences, University of Southampton, Higheld, Southampton SO17 1BJ, UK
b a
Abstract Objectives To assess the effect of sample size, methodological quality and statistical rigour on outcomes of randomised controlled trials (RCTs) on manual therapy (i.e. manipulation, mobilisation and/or massage) for non-specic low back pain (LBP) of at least 6 weeks duration, and to report results from RCTs with adequate sample size, methodological quality and statistical rigour. Data sources MedLine, EMBASE, CINAHL, AMED, Cochrane, PEDro and the library collection of the Chartered Society of Physiotherapy. Review methods RCTs were identied that compared manual therapy with a control or alternative intervention in adults with non-specic LBP of at least 6 weeks duration. The sample size, methodological quality (adapted 10-point van Tulder scale) and statistical rigour were then assessed. RCTs were regarded as higher quality if they fullled the following three criteria: (a) >40 subjects in the manual therapy group; (b) scoring >5/10 on the Van Tulder scale; and (c) reporting statistical tests that compared the change in the intervention group with the change in the control group. Results Ten RCTs were included in the review but only two qualied as higher quality RCTs. Results from smaller trials and lower quality RCTs showed more variation in differences between the intervention and control groups than larger or higher quality trials. Evidence from large, high-quality RCTs with adequate statistical analyses showed that, for improvement in pain and function, a mobilisation/manipulation package is an effective intervention [compared with general practitioner (GP) care], whilst manipulation used in isolation showed no real benets over sham manipulation or an alternative intervention. No higher quality evidence considering massage was identied. Conclusions Many RCTs in the area of manual therapy for LBP have shortcomings in sample size, methodological quality and/or statistical rigour, but there remains evidence from higher quality RCTs to support the use of a manual therapy package, compared with GP care, for non-specic LBP of at least 6 weeks duration. 2007 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Keywords: Low back pain; Massage; Manipulation; Manual therapy; Systematic review
Introduction Manual therapy, dened as massage, mobilisation and/or manipulation in this review, is commonly used by physiotherapists to treat patients with low back pain (LBP) [1,2]. However, within manual therapy, different approaches to
Corresponding author. Tel.: +44 1903 212116; fax: +44 208 306 6653. E-mail address: jacksona@csp.org.uk (A. Jackson).
treatment exist, ranging from massage and mobilisation to manipulation. Unfortunately, the literature does not always distinguish between mobilisation and manipulation [3]. Consequently, results of randomised controlled trials (RCTs) in this area are often difcult to interpret, thereby limiting their value in academic and clinical practice. Moreover, RCTs in the area of back pain often score low on methodological quality scales and include small sample sizes [4,5], which means that their ndings should be interpreted with caution.
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These shortcomings in the evidence for manual therapy for LBP are problematic when developing guidance for clinical practice. The European clinical guidelines for the treatment of chronic LBP do not recommend the use of massage, while a short course of manipulation/mobilisation is recommended [6]. Some systematic reviews on massage for LBP, however, whilst acknowledging the low quality of most RCTs, conclude that massage might be benecial for patients with LBP [710]. In contrast, some reviews on spinal manipulation, including the latest Cochrane review, conclude that there is insufcient evidence to recommend manipulation [11,12]. This shows that the evidence for manual therapy is still hotly debated, and a denitive statement on its effectiveness is not yet available. In order to facilitate this debate, it is desirable to focus on high-quality research. Assendelft et al. (1995) showed that although the quality of most reviews on spinal manipulation for LBP was low, those with the highest quality scores generally supported the use of spinal manipulation [13]. This gives some insight into how methodological quality may impact upon outcome. A similar approach may be possible at RCT level, especially since the quality of RCTs in back pain is often reported to be impaired [4,5]. A good understanding of how the quality, including sample size, methodological quality and statistical rigour, of RCTs may affect the reported outcome is essential if research is to inform clinical practice. Inadequate sample sizes in RCTs can result in unreliable results. Some systematic reviews, in particular those from the Cochrane Collaboration, visualise this by using forest plots [8]. Adequate statistical power (i.e. sample size) is especially difcult to achieve in studies on LBP due to its natural history of resolution. Furthermore, the heterogeneity of the LBP population may hinder the clinician when applying the research ndings to clinical practice. Only appropriately powered RCTs will detect statistically signicant differences [5]. Moreover, research in other areas has shown that conclusions from reviews on multiple smaller RCTs can conict with the results from one larger RCT [14,15], which illustrates the need for large RCTs. Secondly, low methodological quality can impair the validity of the results from RCTs. Systematic reviews attempt to control for this using various quality checklists or scales to assess the quality of the individual RCTs. Again, this is of particular importance to LBP trials as their methodological quality is often impaired [4]. Thirdly, the effectiveness of an intervention for LBP should be tested by analysing differences in changes between two or more intervention groups. Since a large proportion of patients with LBP are reported to recover spontaneously [16,17], within-group analysis will not distinguish the natural course of LBP from the interventionspecic effect. Moreover, excluding those with acute LBP (<6 weeks) will reduce, although not eliminate entirely, the group of patients who recover spontaneously from acute LBP. Therefore, in this review, persistent LBP was dened as pain persisting for 6 weeks or more.
The aim of this systematic review was to assess the effect of sample size, methodological quality and statistical rigour on outcomes of RCTs on manual therapy for LBP of at least 6 weeks duration. Once this effect is known, the best available evidence can be used to inform clinical practice. Best available evidence in this context was dened as evidence from RCTs that full the following three criteria: (a) high methodological quality; (b) a large sample size (as an estimate for statistical power); and (c) used adequate statistical analyses to directly compare the change achieved using manual therapy with the change in the control or alternative intervention group. Denitions of these criteria are given below.
Methods This review was part of a project aimed at developing physiotherapy-specic guidelines for the treatment of persistent LBP, published by the Chartered Society of Physiotherapy (CSP). Literature search An extensive literature search was conducted to identify systematic reviews and RCTs on physiotherapy interventions for the treatment of LBP, published since the start of each database until June 2003. This search in MedLine, EMBASE, CINAHL, AMED, Cochrane, PEDro and the library collection of the CSP resulted in 5065 articles. In June 2005, an updated search was conducted using the same databases to identify any new systematic reviews or RCTs published between 2003 and 1 June 2005. This search resulted in an additional 2660 articles. Systematic reviews were used to identify relevant RCTs, while the search on RCTs aimed to nd RCTs that were not included in the systematic reviews or which were published after the last search date of the systematic reviews. RCTs were included if they met the following criteria: Patients aged >18 years with non-specic LBP of at least 6 weeks duration. A description of subacute or chronic patients was not sufcient; the actual duration of pain was needed. Either massage, mobilisation and/or manipulation was used as the single intervention for at least one group in the trial. RCTs were not excluded if these manual therapies were combined with other non-physiotherapy interventions, such as general practitioner (GP) care or medication. The effectiveness of manual therapies was tested in at least one of the following areas: pain; function; psychological status; or return to work/sick leave. The methodological quality of the included trials was assessed by two reviewers using an adapted version of the van Tulder criteria [18]. The original scale consists of 24 criteria, and 10 were identied as the most relevant for this review.
Table 1 Characteristics of randomised controlled trials (RCTs)

RCT Cherkin 2001 [21] Descarreux 2004 [29] Interventions Massage vs Chinese medical acupuncture vs self-care Manual therapy (intensive chiropractic care 12 treatments in 1 month) vs manual therapy (intensive chiropractic care same as above) + follow-up sessions (once every 3 weeks for 9 months) Manual therapy (manipulation) vs untreated controls Manual therapy (osteopathic manipulation) vs short-wave diathermy vs placebo (detuned short-wave diathermy) One manipulation per week vs two manipulations per week vs three manipulations per week vs four manipulations per week. Half of each group received additional physical modalities, therefore eight treatment arms in total Massage vs relaxation therapy Manual therapy (chiropractic manipulation) vs medication vs back school vs placebo (anti-oedema gel) Manipulation vs sham manipulation vs education programme Methodological quality score (criteria)a 7 (B, D, E, G, H, I, J) 5 (A, B, E, H, I) n in manual therapy group (total n) 78 (262) 15/15 (30) Statistical test to compare changes? No No Outcome measures included in this review Pain: 110 scale for bothersomeness Function: modied Roland Disability Scale Pain: VAS
Evans 1978 [22] Gibson 1985 [23] Haas 2004 [30]
5 (B, E, G, H, I) 4 (D, G, H, I) 4 (A, H, I, J)
32 (32) cross-over design 41 (109) 6 (72)
No No Yes
Function: modied Oswestry Questionnaire Pain: four-point scale Pain: VAS
Pain: modied Von Korff pain scale
Hernandez-Reif 2001 [24] Postachini 1988 [25]
3 (B, E, I) 1 (I)
12 (24) 52 (398)
Yes Yes
Triano 1995 [26]
7 (A, B, D, E, G, H, I)
47 (209)
Yes
Function: modied Von Korff disability scale Pain: short-form McGill Pain Questionnaire, VAS This trial presented a combined pain and function score, which has not been included in this review Pain: VAS Function: Oswestry Low Back Pain Disability Questionnaire Psychological status: modied Zung Depression Index Pain: Von Korff Pain Scale
UK BEAM 2004 [27]
Mobilisation + manipulation + GP care vs exercise + GP care vs mobilisation + manipulation + exercise + GP care vs GP care
6 (A, B, D, H, I, J)
353 (1334)
Yes
Waagen 1986 [28]
Manual therapy (chiropractic manipulation) vs sham manipulation
4 (B, D, G, I)
11 (29)
No
Function: Roland-Morris Disability Questionnaire Psychological status: Fear-avoidance Behaviour Questionnaire Pain: VAS
VAS, visual analogue scale; GP, general practitioner. The RCTs in bold have been regarded as best evidence, i.e. fullled the three criteria on sample size, methodological quality and statistical rigour. Interventions have been described as massage (n = 2), manipulation (n = 2) and mobilisation + manipulation (n = 1) based on the description in the original articles; however, in many cases, these descriptions were inadequate; consequently, these interventions are called manual therapy (n = 5) in this table. a Methodological quality criteria: (A) Treatment allocation: was the treatment allocation concealed? (B) Were the groups similar at baseline regarding the most important prognostic indicators? (e.g. age, duration of complaints, value of main outcome measures) (C) Was the care provider blinded to the intervention? (D) Were co-interventions avoided or comparable? (E) Was the compliance rate in each group unlikely to cause bias? (F) Was the patient blinded to the intervention? (G) Was the outcome assessor blinded to the intervention? (H) Was the withdrawal/drop-out rate unlikely to cause bias? (I) Was the timing of the outcome assessments in both groups comparable? (J) Did the analysis include an intention-to-treat analysis? These criteria are derived from van Tulder et al. Spine 1997;22:232330 [18]. 99
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Nine of the criteria addressed internal validity of the RCT, and one criterion addressed similarities of main baseline characteristics/predictors (see Table 1 for a list of all criteria). The other criteria from the original 24-item van Tulder list that were not used to calculate the score in this review were either included in the scope of this review (e.g. eligibility criteria, description of interventions) or qualitatively assessed (e.g. statistical criteria). Sample size was considered separately as this is not included in the van Tulder criteria. Instead of using the total number of subjects in the RCTs, the number of subjects in the manual therapy group was used as an indication of sample size. This controls for RCTs with a relatively large sample size but multiple subgroups. The smallest RCTs (15 subjects in the manual therapy group) that also scored very low on the methodological quality scale (2 out of 10) were excluded from this review. Quantitative analysis Most of the RCTs monitored pain and function before and after intervention, and therefore these two outcomes were analysed quantitatively. Any outcome measure for pain and function was included in this analysis. For every RCT, the change in pain and function after any follow-up period was calculated as a percentage of the baseline score of that group [(post-score baseline score)/baseline score 100%]. An improvement in outcome was expressed as a positive value, while any worsening in symptoms was expressed as a negative value. These percentage changes were plotted so that the change in the manual therapy group was displayed on the x-axis, and the control or alternative intervention group was displayed on the y-axis (Figs. 1 and 2). Some RCTs reported P-values for this difference in change, while the statistical
Fig. 2. The change in function as a percentage of the baseline value for the intervention group compared with the same parameter of the comparator group. All points are taken from larger randomised controlled trials (40 subjects in manual therapy group) with a quality score of 5 or more. The line y = x represents the line of no difference between the change in the manual therapy group and the control group.
signicance of this value was unknown in other cases. These LAbbe plots give a clear picture of all the data in the RCTs and facilitate identication of possible outliers [19]. Points towards the bottom-right corner of the plots indicate that the manual therapy intervention was better, while points towards the top-left corner favour the control interventions. Points along the line y = x indicate that the effectiveness of the manual therapy intervention was similar to that of the control intervention. To assess the effect of sample size and methodological quality, the difference in change (percentage change in the manual therapy group minus percentage change in the control/alternative intervention) was plotted against the quality score of the trial (Fig. 3) and the number of subjects in the manual therapy group (Fig. 4).
Fig. 1. The change in pain as a percentage of the baseline value for the intervention group compared with the same parameter of the comparator group. Black points represent results from larger randomised controlled trials (40 subjects in manual therapy group) with a quality score of 5 or more. Open points represent results from smaller and/or lower quality trials. The line y = x represents the line of no difference between the change in the manual therapy group and the control group.
Fig. 3. The difference in change (percentage change in manual therapy group minus percentage change in the control group) presented in the randomised controlled trials and the methodological quality score of the corresponding trial.
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statistical tests were used to recommend specic manual therapy interventions for chronic non-specic LBP.
Results Ten RCTs fullled all inclusion criteria for this review (Table 1); eight of these compared manual therapy with a control or alternative intervention [2128], and two compared various forms of manual therapy [29,30]. The methodological quality of the RCTs ranged from 1/10 to 7/10 and the median score was 5/10. The sample size of the RCTs ranged widely from 24 to 1334, and the number of subjects in the manual therapy group ranged from nine to 353. Five of the 10 RCTs were classied as larger (40 subjects in manual therapy group) [21,23,2527]. Only three RCTs were both large and of higher methodological quality [21,26,27]. However, only two of these three trials reported sufcient statistical analyses to meet the inclusion criteria for the qualitative analysis [26,27]. Quantitative analysis For the quantitative analysis, eight RCTs were considered since two trials compared different manual therapy interventions with one another. Of these eight RCTs, six trials reported pain values that could be used to calculate a percentage change score [21,23,24,2628], and three trials reported function scores that could be used to calculate a percentage change score [21,26,27]. Fig. 1 gives the percentage change in pain for the manual therapy group and the corresponding control group; 16 of the 27 points came from larger, higher quality RCTs, and two of these points were statistically signicant. Fig. 2 gives the same information for function; all these points came from larger higher quality trials and three points were statistically signicant at the 5% level. Based on the percentage change in the manual therapy group and the control/alternative intervention group (shown in Figs. 1 and 2), the difference in change between manual therapy and control/alternative intervention was calculated. This difference in change was plotted against the methodological quality score of the RCT (Fig. 3) and the number of subjects in the manual therapy group (Fig. 4). From the limited number of observations shown in Figs. 3 and 4, it can be seen that the smaller RCTs and those of lower quality tend to show more variation in the difference in change than the larger and higher quality RCTs. Qualitative analysis Based on the criteria of sample size, methodological quality and statistical rigour, there is evidence from higher quality RCTs that states: manipulation in combination with mobilisation is more effective than GP care for pain relief and function improvement [27];
Fig. 4. The difference in change (percentage change in the manual therapy group minus the percentage change in the control group) presented in the randomised controlled trials and the number of subjects in the manual therapy group of the corresponding trial.
Qualitative analysis Since small sample size, low methodological quality and inadequate statistical testing can distort the results of RCTs, only results from large, high-quality RCTs with adequate statistical tests comparing the difference in change between intervention groups were considered for the qualitative analysis. To distinguish larger from smaller trials and low quality from higher quality trials, arbitrary cut-off points were agreed by expert panel consensus. Methodological quality was assessed on a 10-point scale and RCTs were considered to be of lower methodological quality if they scored less than the median score on the 10-point quality score. Consequently, RCTs scoring the median score or higher were considered to be of higher methodological quality. Although a power analysis should determine adequate sample size, a pragmatic approach was used in this review due to limitations in the available data. An RCT with 40 subjects in the manual therapy group was dened as large. This cut-off point was adapted from work by Moore et al. on the effect of chance on variability in patients response to pain relief interventions [20]. The third criterion for best available evidence in this review was adequate statistical testing to determine the level of statistical signicance for the difference in change between the manual therapy group and the control/alternative intervention group. Given that LBP is reported to improve in many patients over time [16,17], comparing pre- and post-scores within one group is not sufcient to test the effectiveness of an intervention. This review only considered the difference in change between the manual therapy group and the comparator group, and the level of statistical signicance for that difference in change. Although all RCTs that fullled the three inclusion criteria were included in the quantitative analysis, except the very small RCTs that also scored low on the quality scale, only RCTs that were large, high-quality and employed adequate
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manipulation in combination with mobilisation is as effective as GP care for reduction in fear-avoidance behaviour [27]; and manipulation is as effective as sham manipulation or an education programme for pain relief and improvement in function and psychological status (relief of depression) [26].
Discussion The aim of this review was to assess the extent to which methodological quality, sample size and statistical rigour affected the conclusions from RCTs on mobilisation, manipulation and/or massage for persistent LBP. The authors proposed that only evidence from RCTs that scored high on these three criteria should be used to guide clinical practice. The results showed that the smaller and lower quality studies displayed more variation in outcome, and therefore the results of these studies should be interpreted with caution. It should be noted that this conclusion is based on a limited number of observations (see Table 1), although the ndings on impaired sample size and methodological quality in LBP trials have been reported previously [4,5]. Moreover, similar analyses on exercise interventions for LBP suggest that sample size and methodological quality can indeed result in misinterpretation of RCTs [31]. Evidence from RCTs that fullled the study criteria on methodological quality, sample size and statistical rigour suggested that mobilisation, in combination with manipulation, was a useful and effective additional therapy to standard GP care for pain and function [27]. Manipulation used in isolation appeared to be less effective, since there was high-quality evidence that such an intervention was of equal benet to sham manipulation or an education programme [26]. No clear evidence statement could be made for massage interventions as no large, high-quality RCT with adequate statistical analysis was identied. The justication for only considering RCTs that fullled all three criteria came from the quantitative analyses. Fig. 3 shows that there is a tendency for more variance in difference in change in the lower quality RCTs. A similar tendency was evident for the smaller RCTs (Fig. 4). Moreover, the smaller RCTs tended to result more often in positive results for the manual therapy group; in Fig. 4, more points are located above the line y = 0. This may have been caused by publication bias as smaller trials with negative results are less likely to be published. Differences in subject characteristics could also have played a role since larger trials have to recruit from a larger pool of subjects, which may be more generalisable than more selective recruitment from smaller trials. It is widely reported that LBP improves over time for many [16,17], and this is evident from Figs. 1 and 2. It therefore seems reasonable to expect additional improvement from effective treatments, and this requires comparison with a second group that either receives a control or alternative
intervention. Analysing change scores within one group or comparing post-scores of two groups seems inadequate to detect the true effectiveness of an intervention. Most other systematic reviews on manual therapy for LBP report effect sizes when comparing and summarising RCTs. However, this was not done in the present review because: (a) a measure of variation and the mean are needed to calculate effect size and it has been reported previously that this is not always reported in RCTs on manual therapy for LBP [12]; (b) an effect size may be more difcult for clinicians to interpret, especially towards their patients, whereas a percentage is a more intuitive parameter; and (c) pooling effect sizes in systematic reviews can be useful but does not reect the diversity in the treatments studied, especially in manual therapy where the same terms have been used to describe different interventions [3]. The use of percentages in the current review also has some limitations. It does not take into consideration any variance present in the subject groups, nor does it indicate a clinically and statistically important difference. Nevertheless, it is of interest to analyse original data in various ways, and the methodology used here may reveal new insights or strengthen existing views on trials in the area of manual therapy for LBP. In addition to the statistical limitations, this review also raises some methodological issues. Firstly, the strict inclusion criteria used to identify relevant RCTs facilitated comparison, and also resulted in the inclusion of only 10 RCTs. Secondly, systematic reviews are only as good as the component studies and this was reected in the quantitative analysis. Thirdly, the validity and reliability of the outcome measures for pain and function were not formally assessed, although most RCTs used standard outcome measures such as visual analogue scales for pain and the Roland-Morris Disability Questionnaire for function. Furthermore, the study denition of higher quality trials, i.e. 40 subjects in the manual therapy group, 5 out of 10 on the adapted van Tulder scale, and statistical analyses testing the difference in change between interventions, is based on consensus from the authors and the wider Guideline Development Group involved in this project (see Acknowledgements). Ideally, a power calculation should reveal the appropriate sample size, but conducting a power analysis for all RCTs retrospectively was beyond the capacity of this study. An arbitrary cut-off point was therefore agreed, although some evidence has been identied to support this cut-off point [20], and this value has been used in a similar review on exercise [31]. Whilst the use of the cut-off point in methodological quality score (i.e. the median value) was arbitrary, it does distinguish the higher from the lower quality studies. The use of a total score implies that shortcomings in certain methodological aspects can be compensated for by fullling other criteria. However, this is a restriction of all methodological quality scores. Nevertheless, such scores, due to their simplicity, are now commonly used in reviews. All scores from the RCTs included in this review are displayed in Table 1. Finally, grouping changes in pain or
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function at any follow-up time was justied by the fact that no correlation was found between follow-up time and difference in change (not displayed in gures). This does not, however, suggest that there were no differences in effectiveness between follow-up points within trials; it merely justies pooling all follow-up points in the gures presented in this review. Similar results were found in a review on exercise for LBP [31]. To ensure that future RCTs can be used to inform clinical practice, the following points should be kept in mind in the design and analysis of RCTs: description of the interventions and precise use of terms for the various elements of the intervention should be explicit and consistent; an adequate sample size must be determined in advance to ensure detection of statistically signicant and clinically relevant effects, and a power calculation is essential; highest methodological quality must be aimed for in the design and reporting of the trial; relevant and valid outcome measures should be used, for example the suggestions made by the Cochrane Collaboration to use at least outcome measures for pain, function, global measure of improvement and return to work [18]; the change achieved with the primary intervention should be compared with the change achieved with a control or alternative intervention, since such an analysis can reveal the true value of an intervention; and identication of the characteristics of subgroups for whom specic treatments, such as manual therapy, may be most effective. In conclusion, this systematic review shows that limitations in sample size, methodological quality and statistical rigour could have impaired the validity of the results from RCTs in the eld of manual therapy for LBP of at least 6 weeks duration. Nevertheless, the ndings from the most robust RCTs supported the use of a comprehensive manual therapy package consisting of mobilisation and manipulation over GP care. At this point in time, manipulation used in isolation cannot be recommended. Likewise, no recommendations can be made for massage interventions due to the lack of RCTs fullling all criteria for best available evidence. There is a need for further high-quality research into the use of manual therapy in the management of persistent LBP. Moreover, it would be benecial to identify the characteristics of subgroups in non-specic LBP who would benet most from manual therapy. For manipulation, clinical prediction rules have been suggested [32]. However, a reliable set of criteria for subclassication of LBP has yet to be established; movement pattern, sensory, neuromuscular and/or psychological parameters have all been suggested [33]. There is a need for more thorough research into the effectiveness of various physiotherapy interventions to ensure that physiotherapists can continue to play a key role in evidence-based medicine and practice.
Acknowledgements The authors would like to thank the people who assisted with conducting this review (Dr. Katherine Deane, Jo Jordan, Jenni Hall and Sharlene Ting), the library staff at the CSP (Samantha Molloy, Linda Grifths, Andrea Peace, Anna Sewarniak and Alison Jinks), other staff at the CSP (Alex Warne, Helen Whittaker and Susan Williams), and all members of the Guideline Development Group (in addition to the authors, Dr. Panos Barlos, Sarah Ferguson, Susan Greenhalgh, Dr. Vicki Harding, Prof. Jennifer Klaber-Moffett, Dr. Denis Martin, Jude Monteath, Nia Taylor and Dr. Steve Woby). Funding: CSP and the CSPs Charitable Trust, UK. Conict of interest: None.
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Narrative review
Constraint-induced movement therapy: a narrative review

Anna Tuke
School of Psychology, University of Nottingham, Nottingham NG7 2RD, UK
Abstract Objectives To identify factors relevant to implementing constraint-induced movement therapy (CIMT) within the clinical setting. Data sources AMED (1995January 2007), CINHAL (1982January 2007), Medline (1996January 2007) and EMBASE (1996January 2007) were searched to identify relevant studies. Review methods Criteria for inclusion of trials in this study were that trial participants were over 18 years of age, had had a stroke, and CIMT or modied CIMT was compared with either no intervention, modied CIMT or alternative treatment. Modied CIMT had to include both constraint and training components. The study design was either a quasi-randomised controlled trial or a randomised controlled trial. Trials had to be published in English and score 4 or more on the PEDro scale. Results Twelve eligible studies were identied. The quality of the studies varied, although there was evidence that this improved with more recent studies achieving higher PEDro scores. Patient selection criteria and the components related to the delivery of CIMT were identied as relevant factors. Thirteen different patient selection criteria were identied: age; length of time post stroke; specied side of hemiplegia; hand dominance; spasticity; pain; balance and mobility; hand function; range of active and passive movement; cognitive impairment; perception; sensation; and communication. Ten components were identied as being relevant to the actual delivery of CIMT: type of CIMT; type of constraint; constraint wear time; excluded activities; shaping; shaping dosage; group versus individual treatment; environment; potential harms of CIMT; and compliance. A third relevant consideration was the selection of outcome measures. Signicant variability was identied in many aspects of CIMT, although there was evidence of greater standardisation in more recent studies. Conclusion The development of CIMT for stroke patients has provided clinicians with a treatment technique for a dened patient group that is now supported by a considerable evidence base. CIMT is a complex intervention and the optimum intensity and length of treatment remains unknown. Transferring CIMT into the clinical environment has been hampered by the lack of standardisation in many aspects of the intervention. However, there is evidence that this is improving. Implementation and evaluation in the clinical environment would strengthen the evidence base. 2007 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Keywords: Constraint-induced movement therapy; Stroke; Clinical application
Introduction Constraint-induced movement therapy (CIMT), a new treatment for the upper limb following stroke, has emerged from the concept of learnt misuse and has been cited as one of the few neurorehabilitation techniques developed from a scientic and theoretical foundation [1]. Early investigations on the effect of somatosensory deafferentation in monkeys suggested that during a period of diaschisis, repeated unsuc Present address: Inpatient Physiotherapy Department, Babington Hospital (Derbyshire County Primary Care Trust), Belper, Derby Road, Derbyshire DE56 1WX, UK. Fax: +44 1773 525086. E-mail address: anna tuke@yahoo.com.
cessful attempts to use the paretic upper limb resulted in the monkey learning not to use that limb. This phenomenon, termed learned non-use, continued after the diaschisis had passed and the limb was potentially functional. However, the application of training techniques and/or constraint increased the spontaneous use of the paretic limb. It was later hypothesised that learned non-use could occur in humans after stroke, and that the application of appropriate training regimes could reduce learned non-use and increase spontaneous use of the paretic limb [2]. The technique consists of two components: constraint of the non-paretic upper limb; and shaping incremental repetitive task practise [3]. The combination of these is thought to cause extinction of the learned non-use, resulting in signicant improvements in speed of task performance,
106 Table 1 Criteria for inclusion of trials in this study
A. Tuke / Physiotherapy 94 (2008) 105114
Results In total, 16 studies were identied. Twelve studies scored 4 or more on the PEDro scale (Table 3). Eight of the studies were small scale, with less than 20 participants [3,1218], and three studies recruited 66, 23 and 69 participants [4,19,20]. The largest trial recruited 222 stroke patients [8].
Trial participants were over 18 years of age and had had a stroke CIMT or modied CIMT was compared with either no intervention, modied CIMT or alternative treatment Modied CIMT had to comprise both constraint and training components Randomised controlled trial or a quasi-randomised controlled trial Published in the English language in a journal CIMT, constraint-induced movement therapy.
functional ability and increased use of the paretic upper limb [35]. A systematic review of randomised controlled trials of CIMT in stroke concluded that CIMT may improve upper limb function following stroke for some patients when compared to alternative or no treatment [6]. This conclusion was subsequently supported following a meta-analysis of the effectiveness of CIMT [7]. The completion of a large randomised controlled trial conrmed that CIMT produces statistically signicant changes in upper limb function, which were maintained at 1 year [8]. The National Clinical Guidelines for Stroke recommended the use of CIMT in patients with at least 10 degrees of active wrist and nger extension, who are more than 1 year post stroke and who can walk independently without an aid [9]. There is some evidence that therapists are sceptical about the use of CIMT within a clinical environment. Page et al. (2002) investigated therapist opinions about CIMT through a self-reported questionnaire, and found that the principal concerns were patient adherence and safety [10]. At present, there is no reference to the practical application of CIMT within any of the published literature. Therefore, the aim of this paper is to identify and review the issues relevant to clinicians considering the development of a CIMT programme.
Selection criteria In total, 24 selection criteria were identied (Table 4); these have been condensed into 13 categories relevant to clinicians. The number included for each study ranged from 2 [18] to 15 [8,15]. The most frequently used criteria were the requirement to have more than 20 degrees of active extension at the wrist and a dened level of cognitive impairment. Hand dominance and its relationship to the hemiplegic side was the least used criterion. Length of time post stroke CIMT has been applied to chronic, subacute and acute stroke patients. The studies recruited participants at the following times post stroke: more than 12 months [3,4,13,14,20]; between 3 and 9 months [8,16]; more than 6 months [17]; between 1 and 6 months [10]; less than 4 months [15]; and less than 14 days [18,19]. Age Six out of the 12 studies did not specify an upper age limit [8,13,1619]. In the remaining six studies, the upper age limit ranged from 75 to 95 years (Table 4). One study reported that age did not inuence the results and therefore should not be used to exclude participants [8]. Specied side of hemiplegia and hand dominance Two studies excluded participants on the basis of hand dominance and its relationship to side of stroke [3,4]. The former reported that this was for ease of test administration and the latter did not specify a reason. Another study reported that there was a small, but not clinically relevant, difference in treatment gains between participants with paresis of their pre-stroke dominant side compared with those with paresis of their pre-stroke non-dominant side [8]. Spasticity Of the ve studies that reported excessive spasticity as an exclusion criterion, three reported using the Modied Ashworth Scale [10,14,15] and one reported using the Motor Assessment Scale [19]. One study listed excessive spasticity as an exclusion criterion but did not report how it was
Method A computerised search of relevant bibliographic databases was undertaken to identify all randomised control trials. The inclusion criteria are listed in Table 1 and the search history is given in Table 2. The reference lists of all included trials were searched manually. The methodological quality of the studies was assessed using the PEDro scale [11]. As blinding of therapists and subjects is not possible with CIMT, the maximum score was 8/10. Trials scoring 3 or less were not included.
Table 2 Search history Database AMED CINHAL Medline Medline EMBASE Years 1985January 2007 1982January 2007 1996January 2007 1996January 2007 1996January 2007 Search terms No. of hits No. selected Constraint Constraint Constraint CIMT Constraint 159 328 2108 108 106 8 3 0 5 0
CIMT, constraint-induced movement therapy.
Table 3 PEDro scores Author Taub 1993 [3] Van der Lee 1999 [4] Dromerick 2000 [19] Page 2002 [12] Wittenberg 2003 [13] Page 2004 [14] Page 2005 [15] Alberts 2004 [16] Suputtitada 2004 [20] Brogardh 2006 [17] Ro 2006 [18] Wolf 2006 [8] Random allocation Y N Y Y Y Y Y Y Y Y Y Y Concealed allocation N Y N N N Y N N N Y N Y Baseline comparability Y N Y N Y Y Y Y Y N Y Y Blind subjects N N N N N N N N N N N N Blind therapist N N N N N N N N N N N N Blind assessors Y Y Y Y Y Y Y N Y Y Y Y One key outcome from 85% of subjects Y Y Y Y Y Y Y Y Y N Y Y Intention-to-treat analysis N Y N N N N Y Y N Y Y Y Between-group comparisons Y Y Y Y Y Y Y Y Y Y Y Y Point estimates and variability N Y Y N N Y Y Y N Y Y Y Total score (out of 10) 5 6 6 4 5 7 7 6 5 6 7 8
Table 4 Inclusion criteria

Taub 1993 [3] Time post stroke Age limit (years) Specied side of hemiplegia Serious medical condition Not participating in any trials Not in active rehabilitation No haemorrhagic lesions Hand dominance Extension at the wrist (degrees) Extension at the ngers (degrees) Extension at the metacarpophalangeal joints (degrees) Extension at the interphalangeal joints (degrees) Passive range of movement Movement at the thumb (degrees) Minimum/maximum hand function Balance Mobility Cognition Perception Sensation Communication Spasticity Pain >12 months <75 + + + >20 >10 >10 + + + + + + + Van der Lee 1999 [4] >12 months 1880 + >20 >10 + + + + + + + Dromerick 2000 [19] <14 days + + + + + + Page 2002 [12] 16 months 95 + + + >20 >10 >10 + + + Wittenberg 2003 [13] >12 months >20 >10 + Page 2004 [14] >12 months 1895 + + + >20 >10 >10 + + + Alberts 2004 [16] 39 months + + + >20 >10 >10 + >10 + + + + + Suputtitada 2004 [20] >12 months 1880 >20 >10 + + + + + + Page 2005 [15] <4 months 1895 + + >20 >10 >10 + + + + Brogardh 2006 Ro 2006 [17] [18] >6 months + >20 >10 >10 + + + + + <14 days >10 + Wolf 2006 [8] 39 months + + + >10/20 >10 >10 + >10 + + + + +
107
, not listed as a criterion; +, listed as a criterion.
108
assessed [3]. None of these studies documented which joints were assessed. Pain Five studies reported using excessive pain as an exclusion criterion [8,10,1416]. All of these studies reported using a visual analogue scale. Two studies did not report a maximum score, but excluded patients if they had excessive pain in any joint of the paretic extremity [8,16]. Page et al., (2002), (2004) and (2005) excluded participants scoring 4 or more on a 10 point visual analog pain scale. Balance and mobility In the six studies that stipulated balance and mobility as criteria, participants were at the following times post stroke: more than 12 months [3,4,20]; between 3 and 9 months [8,16]; and more than 6 months [17]. None of these studies reported using a standardised measure of balance and/or mobility. The inclusion criteria for the six studies were: able to mobilise without an assistive device at all times [3,20]; able to walk inside without a stick [4]; independent toilet transfers, independent 2-minute stand and independent sitstand [8,16]; and able to mobilise 20 metres in 40 seconds [17]. Out of the six studies that did not stipulate balance and mobility as criteria, participants were at the following times post stroke: more than 12 months [13,14]; between 1 and 6 months [15]; less than 4 months [10]; and less than 14 days [18,19]. Hand function Only one study did not specify hand function as an inclusion criterion [3]. Of the 11 studies that did specify hand function as an inclusion criterion, six used the Motor Activity Log (MAL), excluding participants if they scored more than 2.5 [8,10,1416] or 2.7 [13]. Two studies excluded participants if they scored more than 51 on the Action Research Arm (ARA) Test (maximum score 57) [4,20]. Two studies reported using the National Institute of Health Stroke Scale (NIHSS), although the exclusion scores were different [18,19]. Another study recruited participants scoring less than 65 on the Sollermans Hand Function Test (maximum score 80) [17]. Range of active and passive movement
of extension in two additional digits [8]. There is evidence that these lower function patients also beneted from CIMT [8]. Two studies specied the passive range of movement at the shoulder (90 degrees of abduction and exion, 45 degrees of external rotation), elbow (no less than 30 degrees of elbow extension, 45 degrees of forearm supination and pronation from neutral), wrist (extension to neutral) and metacarpophalangeal joint (no contracture greater than 30 degrees) [8,16]. Cognitive impairment A minimum level of cognitive function was reported as an exclusion criterion in all papers except two [13,18]. The MiniMental State Examination (MMSE) was reported in four studies [3,4,8,16]. The minimum scores used were 26, 22, 24 and 24 respectively out of a total score of 30. One study used the NIHSS to assess cognitive function, requiring participants to score 0 or 1 on the consciousness, communication and neglect items [19]. Three studies stipulated that participants had to score more than 70 on the modied MMSE [12,14,15]. One study stated cognitive impairment as an exclusion criterion but did not report how it was measured [20]. Perception Three studies assessed perception [3,4,19] using the following range of tests: test of visual neglect [3]; letter cancellation test [3,4]; line bisection test [4]; and the NIHSS [19]. The effect of CIMT on perceptual impairments is currently unknown. Sensation One study reported impaired sensation as an exclusion criterion [20]; however, its measurement was not dened. Two studies rated sensation using the Abbreviated SensoryPerceptual Examination [3] and a dichotomous scale [4], although neither specied impaired sensation as an exclusion criterion. The latter reported that patients with sensory disorders receiving CIMT exceeded the mean improvement in the ARA Test compared with patients with sensory disorders who received bimanual training [4]. This exceeded the minimal clinically important difference and was maintained at 1-year follow-up. Communication
Most studies specied 20 degrees of active wrist extension and 10 degrees of active nger extension (Table 4). However, the operational details of testing these movements were only reported by two studies, both of which specied the range of movement and the number of repetitions required at each joint [8,16]. One of these studies included lower functioning participants who had only 10 degrees of wrist extension, 10 degrees of thumb extension/abduction and at least 10 degrees
Six studies reported impaired communication as an inclusion criterion. Of these, one study did not mention the measure used [20]. Another study reported that patients with a level of aphasia that prevented the completion of the outcome measures were excluded [18]. The remaining four studies used the following outcome measures: Token test [3,17]; Stichting Afasie Netherlands [3]; and the NIHSS [19].
109
Outcome measures Table 5 illustrates the outcome measures used to assess change in upper limb function following CIMT. In total, 12 different measures were identied, and the MAL, Wolf Motor Function Test (WMFT), Fugl Meyer Test and ARA Test were used most commonly. A number of different versions of the MAL exist and a clear description of the scoring system is not reported.
tional CIMT programme did not enhance the treatment effect [17]. The studies investigating modied CIMT reported that the mitt should be worn for more than 6 hours per day [19], or for 5 hours on week days that were identied as a period of frequent hand use [10,14,15]. One study requested that participants should aim to wear the mitt for 90% of waking hours [18]. Activities excluded
Intervention Ten relevant factors were identied in the delivery of CIMT: type of CIMT; type of constraint; length of time the constraint was worn (wear time); excluded activities; shaping; shaping dosage; group versus individual treatment; environment; potential harms of CIMT; and compliance. Type of CIMT CIMT can be classied into the traditional format and a modied format. Seven studies reported using the traditional format [3,4,8,13,16,17,20]. Studies investigating the traditional format recruited participants who were 3 months [16], 6 months [17], between 3 and 9 months [8], or more than 12 months post stroke [3,4,13,20] Five studies reported using a modied format [10,14,15,18,19], although a number of different variations exist. The modied format was applied to participants who were less than 14 days [18,19], between 1 and 4 months [10], more than 12 months [14], or less than 4 months [15] post stroke. None of the 12 studies reviewed demonstrated that any one of these formats was superior. Type of constraint The type of constraint varied between studies (Table 6). Three studies reported using a resting splint and sling [3,4,13]. Three other studies reported using mesh, polystyrene-lled mitts and a sling [12,14,15]. The remaining studies reported using either a mitt [8,1619] or a glove [20]. There does not appear to be a relationship between the type of constraint, the type of CIMT or the length of time post stroke. None of the 12 studies reviewed compared one type of constraint with another. Wear time In the studies investigating traditional CIMT, four studies requested participants to wear the constraint for 90% of their waking hours [3,8,16,17], and two studies did not report the length of time that participants were requested to wear the constraint [4,20]. One study reported a wear time of 6 hours during week days and 4 hours at weekends [13]. Extending the mitt-wearing regime following a tradi-
Four studies reported activities for which the constraint should not be worn (Table 6). These ranged from activities where balance or safety would have been compromised [3,18] to travelling, sleeping, dressing [4] and toileting [3,17]. The other studies did not report any activities for which the constraint should not be worn. Compliance Six studies assessed compliance with the constraintwearing regime (Table 6). Five studies reported issuing participants with a log book [4,10,14,15,17], and two studies reported using informal patient/therapist interviews [12,15]. One study included a behavioural contract, a caregivers contract, mitt compliance device and daily schedule to increase levels of compliance [8]. Another study provided oral and written instructions to carers for those discharged prior to the end of treatment [18]. Four studies provided comments about the level of compliance [3,10,15,17]; these were predominantly positive. One study reported that the mitt compliance device consisted of a physical sensor and timer [8]. On the few occasions that the self-reports did not match the output from the device, participants were informed of the discrepancy and accurate reports occurred thereafter. Shaping Shaping is the therapy component of CIMT and is reported as being crucial to its success [3]. Signicant variation exists in interpretation of the therapy component of CIMT (Table 7). Six studies did not mention the term shaping [3,4,10,13,14,19], but the term was used in ve studies [8,1518]. One study described the intervention as forced use treatment [20]. Three studies provided a more detailed account, referring to shaping or adaptive task practise and repetitive task practise [8,16,17]. None of the studies provided the detailed information required to replicate the treatment. Shaping dosage Shaping dosage is dened as the number of hours spent shaping per day, the total number of days and the length of time over which it is administered. There was little variation in the shaping dosage in studies investigating traditional CIMT. All seven studies reported 6 hours of shaping over
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Table 5 Hand function measures Taub Van der Lee 1993 [3] 1999 [4] Hand function (inclusion criteria) Action Research Arm Test Motor Activity Log Sollermans Hand Function Test National Institutes of Health Stroke Scale Hand function (outcome measure) Emory Motor Function Test Arm Motor Ability Test Motor Assessment Scale Motor Activity Log Wolf Motor Function Test Fuyl Meyer Assessment Action Research Arm Test Grip strength Pinch strength Two-point Discrimination Test Sollermans Hand Function Test Peg Board Test <51 <2.5 12 <2.7 <2.5 <2.5 Dromerick 2000 [19] Page Wittenberg 2003 Page Alberts 2004 Suputtitada 2002 [12] [13] 2004 [14] [16] 2004 [20] <51 <2.5 65 13 <2.5 A. Tuke / Physiotherapy 94 (2008) 105114 Page Brogardh 2005 [15] 2006 [17] Ro 2006 [18] Wolf 2006 [8]
Participants had to achieve a minimum score >51 on the Action Research Arm Test (maximum score 58), maximum scores <2.5/<2.7 on the Motor Activity Log (maximum score not reported), and a maximum score of 65 on the Sollermans Hand Function Test (maximum score 80) to be eligible for the study. National Institutes of Health Stroke Scale, the Motor Arm Scores correspond to normal (0), drift of the outstretched upper extremity (1), inability to hold arm up against gravity (23) and no movement (4). , listed as an outcome measure.
Table 6 Constraint wear time and assessment of compliance Author Taub 1993 [3] Environment/patient Type of constraint type Outpatient/chronic (>12 months) Resting splint and enclosed sling Wear time 90% of waking hours Number of days 14 Activities excluded Activities where balance would be compromised (toileting) Assessment of compliance Nil Comments on compliance 3 participants worn it all the time and 1 participant worn it for 70% of the time. All participants reported that they enjoyed wearing the constraint, and one of them wanted to keep it after the study Nil
Van der Lee 1999 [4] Dromerick 2000 [19] Page 2002 [12] Wittenberg 2003 [13] Page 2004 [14] Alberts 2004 [16] Suputtitada 2004 [20] Page 2005 [15] Brogardh 2006 [17]
Outpatient/chronic (>12 months)
Inpatient/acute (<14 days) Outpatient/subacute Mesh, polystyrene-lled mitts (14 months) and sling Inpatient/chronic (>12 months) Outpatient/chronic (>12 months) Subacute and chronic/outpatient (39 months) Outpatient/chronic (>12 months) Inpatient/acute (<4 months) Chronic/outpatient (>6 months) Hand splint and sling Mesh, polystyrene-lled mitts and sling Mitt
Resting splint at home and enclosed sling during treatment Padded mitten
Not listed
12
6 hours per day 5 hours on week days identied as a period of frequent hand use 6 hours on week days/4 hours on weekends 5 hours on week days identied as a period of frequent hand use 90% of waking hours during intervention Not listed 5 hour of, week days identied as a period of frequent hand use 90% of waking hours
14 Week days for 10 weeks
Travelling, sleeping, dressing, toileting None None reported
Log book
Nil Log book
Nil None reported A. Tuke / Physiotherapy 94 (2008) 105114
10 continuous inpatient days Week days for 10 weeks
None reported None reported
None reported Log book
12
None reported
None
None
Glove Mesh, polystyrene-lled mitts and sling Mitt
10 Week days for 10 weeks
None reported Log books, patient/therapist interviews Log book
None reported High satisfaction
12 days and every other day for 2 weeks over a 3-month period, = 12 + 21 days
Toileting
Ro 2006 [18]
Inpatient/subacute (<14 days)
Mitten
Target of 90% of waking hours
14
Wolf 2006 [8]
Outpatient/39 months
Mitten with monitoring device
Target of 90% of waking hours
14
Activities in which safety would have been jeopardised None reported
Oral/written instructions to those discharged before 14 days Monitoring device in mitten, patient diary, behavioural contract, caregiver contract and daily schedule
Participants reported that the mitt was good at increasing awareness of the hand. 8/16 reported achieving 90% wear time. 7/16 reported achieving 8085% wear time. 1/16 reported achieving 50% wear time None reported
Adherence to mitt use while participants were in the research laboratory was usually very high
111
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Table 7 Description of therapy intervention Author Taub 1993 [3] Van der Lee 1999 [4] Form of CIMT Traditional Traditional Patient type/environment Chronic/outpatient (>12 months) Chronic/outpatient (>12 months) Description of therapy for the experimental group Practicing eating with a fork and spoon, throwing ball, dominoes, writing, pushing a broom Practice aimed at functional goals selected on the basis of patients residual sensorimotor capacity Individual/ group Not specied Group Duration 10 days 10 days Intensity 6 hours per day on week days 6 hours per day on week days Additional therapy None reported Group activities, exercises and therapist attention Routine interdisciplinary stroke rehabilitation None reported
Dromerick 2000 [19]
Modied
Acute/inpatient (<14 days)
Intervention that directed subject attention and effort towards hemiparetic arm. Circuit training encouraged use of the paretic arm with a variety of functional tasks Occupational therapy concentrated on functional tasks with same wrist/arm strengthening. Participants identied two to three tasks and practiced using shaping techniques. Physiotherapy concentrated on postural control activities Therapy involved progressively improving motor task performance by a successive approximation procedure combining physical/occupational and recreational therapy 25 minutes of occupational therapy concentrated on affected upper limb usage in functional tasks chosen by the patient. 5 minutes spent on strengthening and compensatory techniques using the unaffected limb. Shaping techniques were used for two to three upper limb activities chosen by the patients. Physiotherapy concentrated on postural control activities Shaping or adaptive task practice and repetitive task practice were used during the training sessions. Typical activitiesstacking checkers, ipping cards, picking up marbles Forced use treatment Shaping techniques for three tasks such as brushing hair, writing, typing, picking up a cup and drinking from it. 5 minutes completing range of movement for paretic arm Shaping, task practice such as moving objects from one shelf to another, throwing balls in buckets. Fine motor practice such as fastening nuts on bolts, putting pegs in a board. Muscle strength training through lifting weights. Activity training such as laying the table, cleaning a window Shaping of the desired movements using the techniques of successive approximations Shaping (adaptive task practice) and standard task practice
Not specied
10 days
2 hours per day on week days
Page 2002 [12]
Modied
Subacute/outpatient (14 months)
Individual
10 weeks
30 minutes occupational therapy and physiotherapy three times per week 6 hours on week days and 4 hours on weekends 30 minutes three times per week of occupational therapy and physiotherapy
Wittenberg 2003 [13] Page 2004 [14]
Traditional
Modied
Chronic/location unclear (>12 months) Chronic/outpatient (>12 months)
Not specied Individual
10 days
None reported
10 weeks
None reported
Alberts 2004 [16]
Traditional
Subacute/outpatient (39 months post stroke) Chronic/outpatient (>12 months) Acute/inpatient and outpatient (<4 months) Chronic/outpatient (>6 months)
Individual
2 weeks
Up to 6 hours per day
None
Suputtitada 2004 [20] Page 2005 [15]
Traditional Modied
Groups of 34 Individual
10 days 10 weeks
6 hours per day 30 minutes three times per week
Brogardh 2006 [17]
Modied and traditional
Groups of 23
2 weeks
6 hours per day
None reported
Ro 2006 [18] Wolf 2006 [8]
Modied Traditional
Subacute (<14 days) 39 months post stroke
Individual Not specied
12 days 10 days
3 hours per day 6 hours per day
None reported None specied
CIMT, constraint-induced movement therapy.
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a 10-day period [3,4,8,13,16,17,20]. However, there was greater variation in studies using the modied format. One study reported 2 hours of shaping each day for 10 days [19]. Three studies reported 30 minutes of physiotherapy and occupational therapy three times a week for 10 weeks [12,14,15]. Another study reported 3 hours of shaping each day for 12 days (Table 7) [18]. Group versus individual treatment The delivery of the shaping component of CIMT also varied (Table 7), being delivered in a group session [4,17,20] or through individual sessions [10,1416,18,19]. Other studies did not specify the format [3,8,13]. One study evaluated the effect of delivering the 6 hours of training within a group setting and reported a signicant difference on the Motor Assessment Score, Sollermans Hand Function Test and the MAL [17]. The absence of a control group, in which shaping was delivered on an individual basis, makes it difcult to draw rm conclusions regarding which approach is superior. The lack of standardised outcome measures makes comparisons with studies using an individual approach difcult. However, there is some indication that participants value the opportunity to interact within a group environment [4,17]. At present, it is unknown whether or not this interaction has an impact on patient compliance with the CIMT programme. Environment Eight studies conducted CIMT within an outpatient environment [3,4,8,10,14,16,17,20]. All of these patients were at least 3 months post stroke. One study delivered CIMT to inpatients who were less than 14 days post stroke [19], and two studies delivered CIMT to inpatients and outpatients who were less than 4 months [15] or 14 days [18] post stroke. Another study did not state the environment in which the treatment was delivered [13]. None of the studies compared inpatient treatment with outpatient treatment. Potential harms of CIMT and adverse events One study reported that three out of four patients in the constraint group experienced muscle soreness half way through the CIMT protocol [3]. Another study reported three adverse events that affected three different participants [4]. Two of these were second-degree burns, one of which occurred in the constraint group and one in the control group. In the rst case, the burns happened when the affected hand was used to operate the throttle of a scooter. The second case occurred whilst ironing. The third event was a minor skin lesion that occurred when one of the participants in the control group was shaving with the affected hand. The authors reported that these adverse effects were the result of imprudent actions of the patients or overestimation of their own capabilities [4]. There were no reports of an increase in lesion size in any of the studies investigating CIMT. Another study
investigated serious adverse events in both a control group and an intervention group, and found no statistical difference between the groups [8].
Discussion This review has identied a number of factors that require consideration in the development of CIMT. Many aspects of CIMT are varied, although there is some evidence that a standardised approach is emerging [8,16,21]. One study standardised the inclusion/exclusion criteria, and clearly described the measures or procedures used to assess range of movement, cognition, balance and mobility [21]. This study also provided a clear description of the contracts used to encourage compliance, identify constraint wear time and involve carers in CIMT. A variety of different outcome measures have been used to assess change following CIMT. The WMFT and the MAL were reported as primary outcome measures in one study [21]. The WMFT has a high level of reliability and validity [23]. A number of different versions of the MAL exist and it is currently unclear which is the agreed format. A clear description of the 14-item version has been published [22], although uncertainty remains about whether it is appropriate for clinical use [24]. The use of acclerometry and the Actual Amount of Use Test as secondary measures [21] may be appropriate within the research community, but are likely to be too time/resource consuming for use within the clinical environment. An agreed set of outcome measures, which are accessible and usable by clinicians, would facilitate the transfer of CIMT into the clinical environment. Studies were selected to include those that had both constraint and shaping components. The variation in constraint wear time and shaping dosage means that, unlike the traditional format, there was little standardisation in the modied CIMT protocol. The optimum level of CIMT input, its distribution and application post stroke is unknown. There is some evidence that the length of time post stroke (between 3 and 9 months compared with more than 12 months) is not a predictor of motor improvement following CIMT. However, chronicity appears to be associated with greater pain and fatigue [25]. Therefore, a standardised modied CIMT protocol for patients, in both the acute and subacute phases, may be particularly important, strengthening the potential for the clinical use of CIMT. The interpretation of shaping varied substantially, although the similarity in the descriptions increased in more recent studies. A clearer description of shaping is available [22], although publication of the battery of tasks would further clarify the content. The optimal training frequency and duration is not known. Safety and adherence have been highlighted as major issues in the application of CIMT [10]. However, in the studies reviewed, no signicant problems were found. In the 12 studies reviewed, adverse events were not more likely to
114
A. Tuke / Physiotherapy 94 (2008) 105114 [6] Hakkennes S, Keating J. Constraint-induced movement therapy following stroke: a systematic review of randomised controlled trials. Aust J Physiother 2005;51:22131. [7] Bjorklund A, Fecht A. The effectiveness of constraint induced therapy as a stroke intervention. Occup Ther Health Care 2006;20:3149. [8] Wolf S, Winstein C, Miller P, Taub E, Uswatte G, Morris D, et al. Effect of constraint-induced movement therapy on upper extremity function 39 months after stroke. JAMA 2006;296:2095104. [9] Intercollegiate Stroke Working Party. The national clinical guidelines for stroke. 2nd ed. London: RCP; 2004. [10] Page S, Levine P, Sisto S, Bond Q, Johnston MV. Stroke patients and therapist opinion of constraint induced movement therapy. Clin Rehabil 2002;16:5560. [11] Maher C, Sherrington C, Herbert R, Moseley A, Elkins M. Reliability of the PEDro scale for rating quality of randomised controlled trials. Phys Ther 2003;83:71321. [12] Page S, Sisto S, Johnston MV, Levine P. Modied constraint-induced therapy after subacute stroke: a preliminary study. Am Soc Neurorehabil 2002;16:2905. [13] Wittenberg GF, Chen R, Ishii K, Bushara KO, Taub E, Gerber LH. Constraint induced movement therapy in stroke: magneticstimulation motor maps and cerebral activation. Neurorehabil Repair 2003;17:4857. [14] Page SJ, Sisto S, Levine P, McGrath RE. Efcacy of modied constraint induced movement therapy in chronic stroke: a single blinded randomized controlled trial. Arch Phys Med Rehabil 2004;85:148. [15] Page SJ, Levine P, Leonard AC. Modied constraint-induced therapy in acute stroke: a randomised controlled pilot study. Neurorehabil Neural Repair 2005;19:2732. [16] Alberts JL, Bulter AJ, Wolf SL. The effects of constraint induced therapy on precision grip: a preliminary study. Neurorehabil Neural Repair 2004;18:2508. [17] Brogardh C, Sjolund B. Constraint induced movement therapy patients with stroke; a pilot study on effects of small groups training and of extended mitt use. Clin Rehabil 2006;20:21827. [18] Ro T, Noser E, Boake C, Johnson R, Gaber M, Speroni A, et al. Functional reorganization and recovery after constraint induced movement therapy in subacute stroke: case reports. Neurocase 2006;12:5060. [19] Dromerick A, Edwards D, Hahm M. Does the application of constraintinduced movement therapy during acute rehabilitation reduce arm impairment after ischemic stroke? Stroke 2000;31:29848. [20] Suputtitada A, Suwanwela NC, Tumvitee PT. Effectiveness of constraint induced movement therapy in chronic stroke patients. J Med Assoc Thailand 2004;87:148290. [21] Winstein CJ, Miller P, Blanton S, Taub E, Uswatte G, Morris D, et al. Methods for a multisite randomized trial to investigate the effect of constraint induced movement therapy in improving upper extremity function among adults recovering from a cerebrovascular stroke. Neurorehabil Neural Repair 2003;17:13752. [22] Taub E, Uswatte G, King DK, Morris D, Crago J, Chatterjee A. A placebo controlled trial of constraint induced movement therapy for upper extremity after stroke. http://stroke.ahajournals.org/ cgi/content/full/37/4/1045. [23] Wolf SL, Catlin PA, Ellis M, Archer AL, Morgan B, Piacentino A. Assessing Wolf motor function test as outcome measure for research in patients after stroke. Stroke 2001;32:16359. [24] Van der Lee JH, Beckerman H, Knol DL, de Vet HCW, Bouter LM. Clinimetric properties of the motor activity log for the assessment of arm use in hemiparetic patients. Stroke 2004;35:14104. [25] Underwood J, Clark P, Blanton S, Aycock DM, Wolf SL. Pain, fatigue, and intensity of practise in people with stroke who are receiving constraint induced movement therapy. Phys Ther 2006;86:124150.
occur in the experimental group compared with the control group [4,8]. Compliance with CIMT is reported to be predominantly positive (Table 6). Recent studies have emphasised the use of techniques such as behavioural contracts, caregiver contracts and daily schedules to increase compliance and safety. This approach should be applied rigorously within the clinical environment, and the occurrence of adverse events should be monitored and disseminated. This review has attempted to identify the issues relevant to clinicians considering the development of CIMT. However, errors or bias may have occurred due to the following factors. Firstly, a signicant number of studies identied were not randomised controlled trials and their inclusion may have affected the results. Secondly, only studies published in English were included and the majority of these were conducted within the American healthcare environment. Finally, the lack of a second reviewer could have increased the likelihood of errors and bias; however, the systematic approach to the review aimed to reduce this possibility.
Conclusion The development of CIMT for stroke patients has provided clinicians with a treatment technique for a dened patient group. However, transferring CIMT into the clinical environment has been hampered by its complexity and lack of standardisation. There is increasing evidence to support the use of CIMT, and recent publications have attempted to standardise the intervention. This should facilitate the implementation of CIMT within the clinical environment and ensure its continued evaluation. Conicts of interest: None.
References
[1] Wolf S, Blanton S, Baer H, Breshears J, Bulter A. Repetitive task practise: a critical review of constraint induced movement therapy in stroke. Neurologist 2002;8:32538. [2] Sunderland A, Tuke A. Neuroplasticity, learning and recovery after stroke: a critical evaluation of constraint-induced therapy. Neuropsychol Rehabil 2005;15(2):8196. [3] Taub EMN, Novack T, Cook E, Flemming WC, Nepomuceno MD, et al. Technique to improve chronic motor decit after stroke. Arch Phys Med Rehabil 1993;74:34754. [4] Van der Lee JWR, Lankhorst GF, Vogelaar TW, Deville WL, Bouter LM. Forced use of the upper extremity in chronic stroke patients. Results from a single-blind randomised clinical trial. Stroke 1999;30:236975. [5] Kundel A, Kopp B, Muller G, Villringer K, Villringer A, Taub E, Herta Flor. Constraint induced movement therapy for motor recovery in chronic stroke patients. Arch Phys Med Rehabil 1999;80: 6249.
Outcome following a physiotherapist-led intervention for chronic low back pain: the important role of cognitive processes
Steve R. Woby a,b, , Neil K. Roach c , Martin Urmston a,b , Paul J. Watson d
a
Department of Physiotherapy, North Manchester General Hospital, Delaunays Road, Crumpsall, Manchester M8 5RB, UK b Centre for Rehabilitation Science, Division of Epidemiology and Health Sciences, University of Manchester, Manchester, UK c Department of Exercise and Sport Science, Manchester Metropolitan University (MMU Cheshire), Alsager, UK d Department of Health Sciences, University of Leicester, Leicester, UK
Abstract Objectives To examine whether patients with chronic low back pain exhibit changes in cognitive factors following Interactive Behavioural Modication Therapy (IBMT), delivered by physiotherapists; and to examine the association between pre- to post-treatment changes in cognitive factors (cognitive processes) and pre- to post-treatment changes in pain, disability and depression. Design Observational beforeafter study. Setting Outpatient physiotherapy department. Participants One hundred and thirty-seven patients with chronic low back pain. Interventions IBMT: Work Back to Life rehabilitation programme. Main outcome measures Pre- to post-treatment changes in pain, disability and a range of cognitive factors. Results Patients demonstrated signicant favourable changes for a range of cognitive factors. Furthermore, pre- to post-treatment changes in these cognitive factors explained an additional 22%, 17% and 15% of the variance in changes in pain, disability and depression, respectively, after controlling for other important factors. Conclusions Changes that emerge in cognitive factors are strongly related to treatment outcome within a physiotherapy treatment context. Specically, reductions in fear of movement and catastrophising, and increases in functional self-efcacy appear to be particularly important. Modifying these cognitive factors should be seen as a priority when treating patients with chronic low back pain. 2007 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Keywords: Low back pain; Fear; Psychology; Self-efcacy; Treatment outcome; Physiotherapy
Introduction A cognitive process refers to a pre- to post-treatment change that occurs in a cognitive factor. In chronic low back pain (CLBP), it has been shown that treatment outcome is strongly inuenced by cognitive processes [13] and these processes may be of greater importance than physical and/or behavioural processes [4,5]. Consequently, the successful modication of certain cognitive factors during physiotherapy treatment would appear to be a priority. Signicant changes in certain cognitive factors have been shown
Corresponding author. Tel.: +44 161 720 2423; fax: +44 161 720 2490. E-mail address: steve.woby@pat.nhs.uk (S.R. Woby).
to occur following cognitive-behavioural therapy and multidisciplinary treatment [6,7]. However, these interventions are unlikely to be the panacea to the huge social and economic problems associated with back pain, because they are typically expensive to deliver [8] and are inaccessible for many patients. On this basis, it would seem useful to determine the extent to which a physiotherapist-led intervention for CLBP can bring about changes in important cognitive factors. This form of intervention is less expensive and potentially far more accessible for patients than cognitive-behavioural therapy or multidisciplinary treatment. It has been reported that a physiotherapist-led exercise programme (Back to Fitness programme) that employed cognitive-behavioural principles was more effective than
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routine management from a general practitioner in terms of reducing disability and improving clinical status [9]. In a subsequent study, the aforementioned intervention brought about signicant reductions in disability at 3 but not 12 months post intervention. In contrast, a spinal manipulation intervention brought about signicant reductions in disability at both 3 and 12 months post intervention [10]. These two studies provide some support for the clinical effectiveness of a cognitive-behavioural-based intervention delivered by physiotherapists. However, it is unclear whether this mode of intervention provides any additional clinical benets beyond those afforded by other forms of physiotherapy treatment. A study conducted in primary care compared the effectiveness of a brief pain management programme with manual therapy for patients with subacute low back pain [11]. Both interventions were delivered by physiotherapists and the primary outcome was reduction in disability at 12 months post treatment. The pain management programme attempted to inuence a number of cognitive factors such as coping style use, psychological distress and fear of movement/(re)injury. The study found no signicant differences between the two interventions at 12 months post treatment, which suggests that a physiotherapist-led back pain intervention that targets cognitive factors may be no more effective, in respect of clinical outcome, than an intervention that does not target cognitive factors explicitly. It should be noted that although the pain management programme attempted to inuence cognitive factors, levels of depression did not appear to change as a result of the programme, and fear of movement/(re)injury [Tampa Scale for Kinesiophobia (TSK)] seemed to increase. The fact that the pain management programme did not bring about notable changes in important cognitive factors could potentially explain why this intervention was no more effective than the manual therapy intervention. Based on the available evidence, it appears that physiotherapist-led interventions that target cognitive factors may be no more effective than routine physiotherapy. However, this may be because current physiotherapistled interventions fail to bring about notable changes in cognitive factors. Alternatively, it is possible that cognitive processes exert less inuence on treatment outcome in those patients who present to physiotherapy. Indeed, although previous physiotherapist-led interventions have attempted to inuence cognitive factors, the extent to which changes in these factors underpin treatment outcome in a physiotherapy treatment context is unclear. This study aimed to examine whether CLBP patients exhibit changes in cognitive factors following Interactive Behavioural Modication Therapy (IBMT), which is a physiotherapist-led intervention underpinned by cognitivebehavioural principles; and to determine the association between cognitive processes and changes in pain, disability and depression in the aforementioned treatment context.
Methods Study population Data were collected from 166 CLBP patients who had been referred to the Work Back to Life rehabilitation programme. In order to be referred to this intervention, patients had to exhibit psychosocial risk factors (yellow ags), such as fear of movement/(re)injury, catastrophising, avoidance behaviour etc. [12]. Exclusion criteria were nerve root compression, central nervous system impairment, progressive motor decit, sphincter impairment from neurological cause, and presence of red ags (e.g. unexplained weight loss, recent urinary tract infection, history of intravenous drug use). Patient characteristics are presented in Tables 1 and 2. IBMT: Work Back to Life rehabilitation programme IBMT is a type of intervention that was developed by the chronic pain physiotherapy team based at North Manchester General Hospital. The Work Back to Life rehabilitation programme is a condition-specic form of IBMT developed for patients with CLBP. The intervention is highly interactive and is delivered to groups of approximately seven patients, usually by two physiotherapists. A total of six physiotherTable 1 Demographics and background information of patients who completed the intervention compared with patients who dropped out Variable Age (years) Male Nature of onset (gradual/sudden) Gradual Duration of back pain >1 year Employment status Employed and currently working Employed but currently on sick leave Unemployed because of back pain Unemployed but not due to health Housewife/househusband Student Retired Other Receiving wage compensation Pursuing medicolegal compensation Disabled/retired because of back pain Disabled but not because of back pain Previous history of back pain First episode One previous episode Two or more previous episodes Previous surgery for back pain Completed (n = 137) 44.4 (11.8) 40 49 56 37 21 19 2 4 3 3 11 37 15 3 3 39 17 44 5 Dropped out (n = 29) 42.5 (11.8) 57* 65* 70* 33 14 22 13** 8 2 4 4 37 17 4 0 43 11 46 4
Values expressed as mean + standard deviation or percentage. * P < 0.05. ** P < 0.01.
S.R. Woby et al. / Physiotherapy 94 (2008) 115124 Table 2 Baseline characteristics of patients who completed the intervention compared with patients who dropped out Variable Disability (RDQ) Pain intensity (VAS) Depression (HADS) Fear of movement/(re)injury (TSK) Functional self-efcacy (CPSS-PF) Catastrophising (CSQ) Control over pain (CSQ) Ability to decrease pain (CSQ) Completed (n = 137) 11.6 (5.7) 39 (22.5) 7.4 (4.1) 39.5 (6.5) 38.7 (16.1) 13.5 (7.9) 3 (1.1) 2.8 (1.2) Dropped out (n = 29) 12.2 (6.4) 44 (22.2) 7.7 (3.8) 41 (7.4) 40.4 (17.4) 12.6 (7.3) 3.1 (1.3) 2.8 (1.2)
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Measures Patients completed a series of self-report measures before and after the intervention. Change scores (post-treatment score minus pre-treatment score) were calculated for each of the measures. Outcome measures (in regression analyses) Disability The Roland Disability Questionnaire [13] is a 24-item selfreport measure that assesses disability due to back pain. Total scores range from 0 to 24, with higher scores reecting greater disability. The measure has excellent reliability, validity and responsiveness [1315]. Pain intensity A 100-mm horizontal pain visual analogue scale (VAS) with endpoints labelled no pain and worst possible pain was employed to assess current pain intensity. Scores range from 0 to 100, with higher scores indicating greater pain intensity. The VAS has been widely used in pain research and demonstrates good reliability, validity and responsiveness [16,17]. Depression The depression subscale of the Hospital Anxiety and Depression Scale [18] was used to assess depression. This does not assess severe psychopathology and is therefore considered to be more acceptable to chronic pain patients [19]. All items are scored on a four-point scale from 0 to 3. Scores can range from 0 to 21, with higher scores reecting greater levels of depression. The depression subscale has established validity and reliability [20,21]. Cognitive processes (predictors in regression analyses) Fear of movement/(re)injury Fear of movement/(re)injury (also known as kinesiophobia) has been dened as an irritational and debilitating fear of physical movement resulting from a feeling of vulnerability to painful injury or reinjury [22]. The TSK [23] requires patients to rate 17-items on a four-point Likert scale with scoring alternatives ranging from strongly disagree to strongly agree. Items 4, 8, 12 and 16 are inversely scored. Total scores range from 17 to 68, with higher scores reecting greater fear of movement/(re)injury. The English version of the TSK possesses good psychometric properties [24]. Catastrophising Catastrophising has been operationalised as an exaggerated negative orientation toward pain stimuli and pain experience [25,26]. The catastrophising subscale of the Coping Strategies Questionnaire (CSQ) [27] requires patients to rate the frequency with which they engage in catastrophic thoughts about their pain. Total scores range from 0 to 36,
Values expressed as mean standard deviation. RDQ, Roland Disability Questionnaire; VAS, visual analogue scale; HADS, Hospital Anxiety and Depression Scale; TSK, Tampa Scale for Kinesiophobia; CPSS-PF, Physical Functioning Subscale of the Chronic Pain Self-efcacy Scale; CSQ, Coping Strategies Questionnaire.
apists (each trained in IBMT) were involved in delivering the intervention throughout the duration of this study. The intervention is underpinned by cognitive-behavioural principles but is not cognitive-behaviour therapy. The primary aims of the intervention are to reduce fear of movement and catastrophising, and to enhance self-efcacy by gradually exposing patients (via exercise and goal setting) to activities that they perceive as harmful and/or threatening. Specically, the intervention involves ve treatment sessions, each of 3.5 hours duration, spanning a period of 6 weeks. The initial four sessions are held on consecutive weeks, and the nal session takes place 2 weeks after the fourth session. The intervention comprises an exercise programme, education, problem solving and progressive goal setting. The exercise programme consists of specic stretching and strengthening exercises that aim to improve patients range of motion, muscular endurance, general strength and cardiorespiratory tness. Twisting, bending and light impact exercises (e.g. star jumps) are included in the exercise programme. These exercises are included because it is believed that back pain patients are often fearful of activities of this nature. Therefore, it was felt that exposing patients to these types of activities gradually would help to reduce pain-related fear and enhance functional self-efcacy. Specic topics are covered during the interactive educational sessions. These include: common medical terms used to describe back pain; the chronic pain cycle; the multifactorial nature of chronic pain with specic emphasis on the inuential role of emotions, thoughts and beliefs; postural advice; activity pacing; returning to personally valued activities; methods of pain control; management of a areup; and relapse prevention. Patients also agree long-term behavioural goals that can realistically be achieved by the end of the programme. These goals have to involve re-engaging in activities that patients have stopped doing because of their back pain. The goals are negotiated between practitioners and patients, thus ensuring that the goals are acceptable to patients. In addition to long-term goals, patients also agree short-term behavioural goals that are reviewed on a weekly basis.
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with higher scores denoting greater catastrophic thinking. The catastrophising subscale possesses good internal consistency [27,28] and high testretest reliability [28]. Functional self-efcacy Functional self-efcacy refers to the condence that a person has in their ability to accomplish certain functional activities successfully (e.g. household activities, social activities, family activities). The functional subscale of the Chronic Pain Self-efcacy Scale (CPSS-PF) [29] was used to measure functional self-efcacy. The original CPSSPF is scored on a 10-point Likert scale, and is anchored with endpoints of 10 (very uncertain) and 100 (very certain). However, a nine-point Likert scale was employed in this study because it provided patients with a mid-point option. The written descriptors used were 0 (totally uncondent), 4 (moderately condent) and 8 (totally condent). Scores range from 0 to 72, with higher scores indicating greater functional self-efcacy. The psychometric properties of this scale were assessed in a group of CLBP patients (n = 111). The scale possessed excellent internal consistency ( = 0.88) and testretest reliability over a 3-day period (intraclass correlation coefcient 0.88, condence interval 0.80 0.93). Control over and ability to decrease pain The two single-item scales from the CSQ [28] were employed. Patients have to rate the extent to which they can control, and decrease, their pain on seven-point scales. The two scales possess acceptable testretest reliability over a 14-day period [1]. Statistical analyses Data were analysed in four stages. Firstly, a series of tests were performed to explore whether the baseline characteristics of patients who completed the intervention differed from those who dropped out. Chi-square and Fishers exact tests were used to explore differences in categorical measures, and Mann Whitney U-tests were calculated to explore differences in continuous variables. Secondly, Wilcoxon signed ranks tests were computed to determine whether pre- to post-treatment changes occurred in the cognitive measures. Wilcoxon signed ranks tests were used because KolmogorovSmirnov tests indicated that baseline scores on a number of the self-report measures were not normally distributed, and therefore parametric analysis could not be performed. Effect sizes were also calculated to provide an indication of the size of any change that emerged on a variable of interest. Cohen [30] dened effect sizes (ES) of 0.20, 0.50 and 0.80 or more as small, moderate or large, respectively. Kolmogorov-Smirnov tests indicated that the change scores that emerged on each of the self-report measures were normally distributed. Consequently, parametric analyses could be used when analysing change scores. Therefore, Pearsons product-moment correlation coefcients were computed to
show the inter-relations that existed between the changes that emerged in the cognitive factors. Finally, hierarchical multiple regression analyses were performed to determine whether change scores on the cognitive factors were associated with changes in pain intensity, disability and depression. Multiple regression analysis determines the extent to which a series of predictor variables are related to an outcome of interest. Using a hierarchical approach enabled predictor variables to be entered in a specic order, which enabled determination of the extent to which the cognitive processes contributed to the outcome of interest after controlling for other potentially important variables. When change in pain intensity was the outcome, age and sex (demographics) were entered in Step 1 of the analysis, followed by the change scores in the cognitive factors in Step 2. When change in disability was the outcome, demographics were entered in Step 1, change scores in pain intensity were entered in Step 2, and change scores in the cognitive factors were entered in Step 3. When change in depression was the outcome, demographics were entered in Step 1, changes in pain and disability were entered in Step 2, and changes in the cognitive factors were entered in Step 3. Change scores in the cognitive factors were entered in the nal step to determine the extent to which they contributed to changes in pain intensity, disability and depression beyond those variables entered in earlier steps of the analysis.
Results Patient characteristics Seventy-ve percent of patients (n = 137) completed the intervention. Physiotherapists checked the self-report measures after they had been completed, and patients were required to answer any questions that they had missed. This ensured that complete pre- and post-treatment data were available from all 137 patients. Tables 1 and 2 show that patients who dropped out of the intervention were more likely to have been male, to have experienced a gradual onset of back pain, to have had back pain for >1 year, and to be unemployed but not for health reasons. Aside from these differences, there were no other signicant baseline differences between those patients who completed the programme and those who dropped out. Of those patients who completed the intervention, 6% attended three sessions, 25% attended four sessions and 69% attended all ve sessions. Sixty percent of the sample was female, 56% had reported back pain symptoms for >1 year and the mean age was approximately 44 years. The majority of patients were not currently working, and 19% perceived that they were not working because of their back pain. Thirty-seven percent were receiving wage compensation and 15% were pursuing medicolegal compensation. The sample reported moderate levels of pain [31] and disability [13,15], and relatively high levels of fear of movement [32,33].
S.R. Woby et al. / Physiotherapy 94 (2008) 115124 Table 3 Pre- to post-treatment changes that occurred in each of the measures (n = 137) Variable Disability (RDQ) Pain intensity (VAS) Depression (HADS) Fear of movement/(re)injury (TSK) Functional self-efcacy (CPSS-PF) Catastrophising (CSQ) Control over pain (CSQ) Ability to decrease pain (CSQ) Pre-treatment 11.6 (5.7) 39 (22.5) 7.4 (4.1) 39.5 (6.5) Post-treatment 8.4 37.9 (27.6) 6.5 (4.7)* 34.9 (8.5)*** (6.1)*** Effect size 0.56 0.04 0.22 0.71
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cant change occurred in pain intensity. Moderate effect sizes were evident on the measures for disability, fear of movement/(re)injury, and functional self-efcacy. Correlations Table 4 shows that signicant associations were evident between the change scores that emerged for each of the measures. None of the correlation coefcients exceeded 0.90, which means that the change scores that emerged for the cognitive factors could be entered as separate predictor variables in the regression analyses [34]. Multiple regression analyses Pain intensity as the outcome As shown in Table 5, age and sex were not signicantly associated with changes in pain intensity. After controlling for these two variables, the changes that occurred in the cognitive factors accounted for an additional 22% of the variance in changes in pain intensity. Examination of the weights revealed that an increase in functional self-efcacy was the cognitive process most strongly related to a reduction in pain intensity ( = 0.23; P < 0.05). Disability as the outcome Table 6 shows the results of the regression analysis when change in disability was the outcome. Changes in pain intensity explained an additional 22% of the variance in changes in disability beyond that accounted for by age and sex, which
38.7 (16.1) 13.5 (7.9) 3 (1.1) 2.8 (1.2)
47.3 (18.2)*** 10 (8.3)*** 3.5 (1.4)*** 3.2 (1.4)**
0.53 0.44 0.45 0.33
Values expressed as mean standard deviation. RDQ, Roland Disability Questionnaire; VAS, visual analogue scale; HADS, Hospital Anxiety and Depression Scale; TSK, Tampa Scale for Kinesiophobia; CPSS-PF, Physical Functioning Subscale of the Chronic Pain Self-efcacy Scale; CSQ, Coping Strategies Questionnaire. * P < 0.01. ** P < 0.001. *** P < 0.0001.
Pre- to post-treatment changes in the self-report measures The pre- to post-treatment changes that occurred for each of the measures are shown in Table 3. Signicant reductions were observed in disability, fear of movement/(re)injury, catastrophising and depression. Signicant increases emerged in functional self-efcacy, perceptions of control over pain, and ability to decrease pain. No signiTable 4 Correlations between the changes ( ) that occurred in the measures (n = 137) 1 1 2 3 4 5 6 7 8
* P < 0.05
2 0.54*** 0.44*** 0.49*** 0.39*** 0.28*** 0.38*** (two-tailed).
Pain intensity Disability Depression Fear of movement Self-efcacy Catastrophising Decrease pain Control over pain (two-tailed),
** P < 0.01
0.50*** 0.31*** 0.21* 0.32*** 0.29*** 0.29*** 0.32*** (two-tailed),
0.50*** 0.59*** 0.54*** 0.43*** 0.49***
0.46*** 0.49*** 0.37*** 0.36***
0.41*** 0.37*** 0.40***
0.31*** 0.39***
0.55***
*** P < 0.001
Table 5 Hierarchical regression analysis with change ( ) in pain intensity as the outcome and Step 1 Variable Demographics Age Sex Cognitive factors Fear of movement/(re)injury Functional self-efcacy Catastrophising Ability to decrease pain Control over pain
a * ***
in cognitive factors as predictor variables (n = 137) F change 0.00 0.94 0.13 1.14 1.47 0.12 2.31* 1.57 1.01 1.82 a t
R2 0.00
R2 change 0.00
0.22
0.22
6.66*** 0.01 0.23 0.15 0.10 0.19
Standardised regression coefcient. P < 0.05. P < 0.001.
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Table 6 Hierarchical regression analysis with change ( ) in disability as the outcome and Step 1 Variable Demographics Age Sex Pain intensity Cognitive factors Fear of movement/(re)injury Functional self-efcacy Catastrophising Ability to decrease pain Control over pain
a * ** ***
in cognitive factors as predictor variables (n = 137) R2 change 0.02 F change 1.36 0.03 0.05 0.39 0.68 3.6*** 2.33* 3.08** 0.97 0.91 1.53 a t
R2 0.02
2 3
0.24 0.42
0.22 0.17
36.54*** 6.95***
0.29 0.20 0.27 0.08 0.08 0.14
Standardised regression coefcient. P < 0.05. P < 0.01. P < 0.001.
Table 7 Hierarchical regression analysis with change ( ) in depression as the outcome and Step 1 Variable Demographics Age Sex Pain and disability Pain intensity Disability Cognitive factors Fear of movement/(re)injury Functional self-efcacy Catastrophising Ability to decrease pain Control over pain
a * ** ***
in cognitive factors as predictor variables (n = 137) F change 7.24*** 0.02 0.15 0.23 2.18* 0.35 3.08** 0.74 3.04** 2.79** 1.29 1.25 a t
R2 0.11
R2 change 0.11
0.39
0.28
28.32*** 0.03 0.25
0.54
0.15
7.47*** 0.01 0.24 0.22 0.10 0.10
Standardised regression coefcient. P < 0.05. P < 0.01. P < 0.001.
accounted for a non-signicant 2% of the variance. After adjusting for age, sex and changes in pain intensity, the cognitive processes explained a further 17% of the variance in outcome. According to the weights, the cognitive processes most strongly related to outcome were reductions in fear of movement ( = 0.20; P < 0.05) and increases in functional self-efcacy ( = 0.27; P < 0.01). The nal model explained 42% of the total variance in changes in disability. Depression as the outcome The results of the regression analysis when change in depression was the outcome are shown in Table 7. Demographics contributed signicantly to the prediction of outcome, accounting for 11% of the variance. Examination of the weights revealed that sex, but not age, was related to outcome. Specically, females were more likely to exhibit a reduction in depression ( = 0.15; P < 0.05). Together, the changes that emerged in pain intensity and
disability accounted for an extra 28% of the variance in outcome beyond demographics. Examination of the weights revealed that reductions in disability were strongly related to reductions in depression ( = 0.25; P < 0.01), whereas changes in pain intensity were not ( = 0.03; P > 0.05). Changes that occurred in the cognitive factors accounted for an additional 15% of the variance in outcome, beyond demographics and changes in pain intensity and disability. Increases in functional self-efcacy ( = 0.24; P < 0.01) and reductions in catastrophising ( = 0.22; P < 0.01) were both predictive of reductions in depression. The nal model was able to explain 54% of the variance in outcome.
Discussion This study aimed to determine whether CLBP patients exhibited changes in cognitive factors following IBMT; and
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to examine the association between pre- to post-treatment changes in cognitive factors (cognitive processes) and pre- to post-treatment changes in pain, disability and depression. Pre- to post-treatment changes in cognitive factors Patients who completed the intervention demonstrated signicant reductions in fear of movement/(re)injury, catastrophising and depression, and signicant increases in functional self-efcacy, perceptions of control over pain, and perceptions of their ability to decrease pain. These ndings intimate that IBMT may be an effective way of bringing about changes in cognitive factors in CLBP patients. It should be noted that although highly signicant favourable changes occurred in the cognitive factors, the effect sizes were only small to moderate. This suggests that IBMT may only be able to bring about modest changes in important cognitive factors. These ndings partly support those of the UK BEAM trial [10], which found that a physiotherapistled exercise programme that employed cognitive-behavioural principles brought about changes in fear-avoidance beliefs and general back pain beliefs (3 months post intervention). Whilst in partial agreement with ndings from the UK BEAM trial [10], the present ndings were in direct contrast to those reported by Hay et al. [11]. In their study, a brief pain management programme delivered by physiotherapists on a one-to-one basis did not appear to bring about notable changes in cognitive factors, and factors such as fear of movement actually appeared to increase as a result of the intervention. A number of reasons could potentially explain the difference between these studies. Firstly, in the study by Hay et al. [11], patients randomised to the pain management programme received a median of three, 20-minute sessions of treatment. However, the majority of patients (94%) in the present study received between 14 and 17.5 hours of treatment. This suggests that physiotherapists may need to deliver fairly comprehensive interventions, such as IBMT, in order to bring about changes in cognitive factors. Hay et al. [11] also examined long-term (12 months post intervention) changes in cognitive factors, whereas the present study only explored short-term changes. It is feasible that a physiotherapist-led intervention may be capable of bringing about short-term, but not long-term, changes in cognitive factors. In further support of this, the UK BEAM trial [10] found that a physiotherapistled exercise programme that employed cognitive-behavioural principles did not bring about long-term changes in cognitive factors. Further work is required to determine the extent to which IBMT brings about long-term changes in cognitive factors. Relationship between cognitive processes and changes in pain intensity Cognitive processes explained an additional 22% of the variance in pain intensity, after adjusting for age and sex,
which failed to explain a signicant proportion of the variance. This is considerably more than the variance explained in previous back pain studies, which demonstrated that cognitive processes typically explain between 0 and 16.5% of the variance in pain intensity [1,5,35,36]. It is noteworthy that previous studies have only explored a relatively small number of cognitive processes within the same study. The fact that the present study explored a larger number of cognitive processes could explain, in part, why a much larger proportion of the variance was explained. Increases in functional self-efcacy were strongly related to reductions in pain intensity. Patients with lower functional self-efcacy are less likely to engage in certain activities, thus limiting their exposure to painful experiences [37,38]. This means that patients have less opportunity to compare the pain they expect to experience during a particular activity with the pain they actually experience during that activity [39]. With prolonged avoidance of activity, the lack of disconrmatory experiences could potentially lead to a gradual increase in pain perception. It is therefore possible that the increases in self-efcacy that emerged in this study led patients to engage in previously avoided activities, as evidenced by the signicant reduction in disability. This would have provided patients with an increased number of disconrmatory experiences that may have led to an overall decrease in pain perception. Relationship between cognitive processes and changes in disability After controlling for age, sex and changes in pain intensity, the cognitive processes explained a further 17% of the variance in reductions in disability. The nding that such a large proportion of additional variance was explained highlights the important role that cognitive processes play in bringing about reductions in disability within a physiotherapy context. Previous studies have also shown that cognitive processes are strongly related to changes in disability after controlling for changes in pain intensity [1,4]. Interestingly, in the study conducted by Mannion et al. [4], cognitive processes explained only 7.8% of the variance in disability. However, in the present study and in the study by Woby et al. [1], cognitive processes explained an additional 17% and 22% of the variance, respectively, after controlling for age, sex and changes in pain intensity. None of the interventions employed in the study by Mannion et al. [4] attempted to inuence cognitive factors directly, whereas the intervention employed in this study, and the study by Woby et al. [1], attempted to modify certain cognitive factors explicitly. The fact that cognitive factors were not targeted in the study by Mannion et al. [4] may explain why these factors only explained a relatively small proportion of the variance. In addition, individuals in the study by Mannion et al. [4] were recruited via advertisements in the local media and not directly from clinical practice. Individuals who volunteer to participate in an exercise-based intervention may not be representative of
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those individuals typically seen within clinical practice. For instance, individuals seen in clinical practice often exhibit an elevated fear of movement and low self-efcacy, whereas individuals who volunteer to participate in an exercise programme are probably less likely to exhibit an elevated fear of movement and/or low self-efcacy. Both reductions in fear of movement and increases in functional self-efcacy were strongly related to reductions in disability. This supports fear-avoidance models which postulate that reducing fear of movement will lead to a reduction in disability [39,40]. The present ndings also provide partial support for a recently proposed modied version of the fear-avoidance model, which implies that the interaction between fear of movement and functional self-efcacy is a key factor underpinning levels of disability in CLBP patients [41]. Relationship between cognitive processes and changes in depression Together, changes in pain and disability explained a large proportion of the variance in changes in depression. Interestingly, although changes in disability were strongly related to changes in depression, this was not the case for changes in pain intensity. This appears to support the notion that pain intensity is not directly related to depressive symptoms, but is indirectly related to depression via the mediating role of interference with activities [42,43]. After adjusting for changes in pain and disability, the cognitive processes explained an additional 15% of the variance in changes in depression. This demonstrates the important role that cognitive processes play in bringing about reductions in depression, even after controlling for factors such as changes in pain and disability. Increases in functional selfefcacy and reductions in catastrophising were both strongly related to reductions in depression. Anecdotally, physiotherapists often suggest that tackling the depression exhibited by CLBP patients falls outside their clinical remit. The authors agree that severe cases of depression, or depression that is not the direct consequence of loss of function or loss of valued activities, require onward referral to an appropriately trained specialist. However, when the consequences of having back pain are the primary cause of a patients depression, the authors believe that physiotherapists are ideally placed to tackle this problem. Indeed, the ndings of this study clearly demonstrate that many of the factors that lead to a reduction in depression (reduced disability, reduced catastrophising and increased self-efcacy) are amenable to a physiotherapistbased intervention. Limitations Due to dropout, data were only obtained from 75% of patients who were originally referred to the intervention, which potentially threatens the generalisability of the ndings. Those patients who dropped out from the intervention
were more likely to have been male, to have experienced a gradual onset of back pain, to have had back pain for >1 year, and to be unemployed but not for health reasons. However, aside from the aforementioned differences, no other signicant baseline differences were evident between those patients who completed the programme and those who dropped out. This indicates that data for this study were derived from patients who were representative of the original sample, suggesting that the results have good generalisability. In determining the extent to which IBMT brought about changes in cognitive factors, it should be noted that no control or comparison group was used. Therefore, it is possible that the changes that emerged in the cognitive factors may have occurred as a result of natural history or regression to the mean, rather than as a result of the intervention per se. However, given the protracted duration of symptoms experienced by the patients in this study (>50% had reported symptoms >1 year), it is unlikely that the changes in cognitive factors were solely the result of natural history or regression to the mean. Nevertheless, future randomised controlled trials are required to determine the extent to which IBMT brings about changes in cognitive factors relative to other interventions. In order to establish whether cognitive processes were related to treatment outcome, the study employed a correlational design, which precludes any causal inferences from being made. A further limitation relates to the fact that the study only investigated the relationship between short-term changes in cognitive factors and short-term changes in clinical outcomes. Future studies should explore the extent to which long-term changes in cognitive factors correspond to long-term changes in pain, disability and depression. It is also important to establish whether a physiotherapist-led intervention, such as IBMT, can bring about long-term changes in cognitive factors. Finally, it should be noted that data for this study were derived from patients who exhibited psychosocial risk factors, such as pain-related fear, catastrophising, avoidance behaviour etc. [12]. This potentially means that the importance of cognitive processes may have been more pronounced within the sample, thus limiting the generalisability of the ndings. An interesting area for future research would be to examine the degree to which cognitive processes are related to treatment outcome in different cohorts of CLBP patients who manifest contrasting psychosocial proles.
Conclusions This study showed that cognitive processes were strongly related to treatment outcome within a physiotherapy treatment context. Specically, reductions in fear of movement and catastrophising, and increases in functional self-efcacy emerged as strong predictors of treatment outcome. It is therefore imperative to target these cognitive factors when treating CLBP patients. Importantly, these ndings suggest that these cognitive factors can be modied following IBMT,
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which is a physiotherapist-led intervention underpinned by cognitive-behavioural principles.

[13]
Acknowledgements The authors wish to thank the staff at the Physiotherapy Department of North Manchester General Hospital for their help with data collection, and particularly Stuart Heron. Ethical approval: 02/NM/313). North Manchester LREC (Ref:
[14]
[15] [16] [17]
Funding: Pennine Acute NHS Trust. Conict of interest: None.
[18] [19]
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A survey of outcome measurement of balance, walking and gait amongst physiotherapists working in neurology in the UK
L. Samantha Yoward , Patrick Doherty, Chris Boyes
Faculty of Health and Life Sciences, York St John University, Lord Mayors Walk, York YO31 7EX, UK
Abstract Objective To explore the current practice of measurement of balance, walking and gait amongst UK physiotherapists who work in neurology. Design Survey by postal questionnaire. Participants Members of a random sample of regions of the Association of Chartered Physiotherapists Interested in Neurology (ACPIN). Results Questionnaires were sent to 347 members of the ACPIN, and 269 completed questionnaires were returned (response rate 78%). All respondents were working at a senior level and the median number of years qualied was 10 [interquartile range (IQR) 618]. Respondents reported spending a median of 80% (IQR 7090) of their working time clinically. Ninety-one percent of respondents (245/269) reported that they measure the outcome of their interventions with a standardised measure, and the majority of respondents reported measuring balance, walking and gait: 84% (227/269), 76% (204/269) and 61% (165/269), respectively. The four outcome measures used most commonly for balance, walking and gait were: the 10-metre (or other distance) walk test; the Berg Balance Scale; the Get Up and Go/Timed Up and Go Test; and the Functional Reach Test. Conclusion The majority of ACPIN members reported that they measure the outcome of intervention. Many different methods are used clinically to measure balance, walking and gait, but only four methods were used by at least 50% of the study respondents. 2007 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Keywords: Outcome measure; Balance; Neurology; Physiotherapy
Introduction The measurement of outcome of intervention is a requirement of all physiotherapists working in the UK according to the core standards of practice [1]. However, outcome measurement does not always take place. A project aimed to increase awareness amongst members of the Association of Chartered Physiotherapists Interested in Neurology (ACPIN) of the need to measure motor performance revealed that few therapists were routinely using standardised measures [2]. A survey of 247 therapists in Scotland revealed that 39% of therapy departments reported using outcome measures [3]. When these departments were resurveyed, only 10 were found to use standardised measures exclusively, and seven departments were using a combination of standardised and non-standardised measures. Together, these represented 9%
Corresponding author. Tel.: +44 1904 876331; fax: +44 1904 716801. E-mail address: l.yoward@yorksj.ac.uk (L.S. Yoward).
of the initial sample of departments that were using standardised measures [3]. Therapists are not the only group failing to measure the outcome of interventions. A survey of rehabilitation centres in the UK found that 23% of the centres did not collect standardised measures as part of routine clinical practice [4]. Although it is likely that the use of outcome measurement is increasing over time, data on who uses what and when is lacking. The UK Clearing House for Information on the Assessment of Health Services Outcomes found that, following a request for information about planned outcome measures projects, more than half of studies were using locally developed measures as opposed to published and standardised measures [5]. It has been suggested that clinicians should not develop their own measures locally but should focus on the evaluation of existing standardised measures [6]. Johnson [7] contradicts this and recommends that, until the most appropriate outcome indicators have been identied, service
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providers should be able to use local measures if they seem more appropriate than measures that are already available. As well as being a professional standard to measure outcome [1], there are numerous practical reasons why physiotherapists should measure; for example, for baseline information, to aid planning treatment and for feedback to patients [8]. External pressures on clinicians to demonstrate the benets of their interventions for the purposes of commissioning of services and benchmarking also suggest a need to engage more actively in outcome measurement. In view of the benets and the professional requirement to measure, investigating the current practice of measurement amongst physiotherapists is worthwhile. In addition, with the implementation of the UK Comprehensive Research Network [9], designed to support research in the National Health Service (NHS), it may also be important to establish the measurement tools that are currently being used to contribute to knowledge of minimum data set requirements. People with balance difculties constitute a large proportion of all neurological, rehabilitation and elderly care caseloads [10,11]. A study examining the main areas for evaluation and treatment in physiotherapy for patients with Parkinsons disease found that there were four core areas, including gait and balance [12], and mobility has been highlighted as the most important activity of daily living amongst a patient group [13]. Balance and mobility were, therefore, judged to be important areas for measurement in the eld of neurorehabilitation. The following questions have been formulated: Do physiotherapists who work in neurology measure the outcome of their interventions with standardised measurement tools? Which measurement tools are used by the majority of neurophysiotherapists for balance, gait and walking? The overall aim of this study was to explore the current practice of measurement of balance, walking and gait amongst UK physiotherapists who work in neurology.
The sample was obtained by selecting half of the 18 ACPIN regions at random, and surveying all available members in the nine regions selected. Survey The study intended to use a pre-existing survey tool, if possible, to enhance the validity of the measure. In order to identify previous studies that have explored the measurement of balance, walking and gait by physiotherapists, a literature search was conducted using Medline (19652005), CINAHL (19822005) and AMED (19852005) databases. Combinations of the keywords outcome, measur* and physi* were used, where the asterisk indicates alternatives for the word; for example, measures, measuring and measurement. This search revealed no published studies on the specic topic, leading the authors to conclude that there is no published survey to determine the current practice of physiotherapists for the outcome measurement of balance, gait and walking. However, some studies [4,16] had used questionnaires relating to the collection of outcome measurement data, and some questions were therefore adapted for use in this questionnaire to enhance overall validity; for example, when asking about the collection of standardised outcome measures in the course of routine clinical practice [4] and when asking about the frequency of use [16]. The initial stage of development of the questionnaire comprised a consultation with senior clinicians in neurophysiotherapy, and was designed to highlight the issues of concern or interest in the eld of balance measurement [17]. The themes from this discussion were used to construct a questionnaire that was piloted using a member of the original panel, a lay member for comments on language use, and two further physiotherapists with a special interest in neurology. These steps in the questionnaire design enhanced the content validity. The nal questionnaire comprised eight sides of A4 paper and was estimated to take no more than 15 minutes to complete. It was presented in three parts: the rst part established demographic details and whether or not respondents measured outcome using standardised tools; the second part explored the specic measurement of certain items including gait, walking and balance, and the reasons for nonmeasurement if appropriate; and the third part explored the tools used (as well as other items, such as rating scales, that are beyond the scope of this paper). Copies of the questionnaire are available, on request, from the corresponding author. The nal questionnaire was sent to all members (whose details were provided by the ACPIN) of the nine selected regions. These members had already indicated to the ACPIN, when joining the Association, that they would be willing to participate in research. Thus, a level of participant consent was inherent in the researcher receiving their details. A pre-printed and stamped postcard was included with a
Methods Participants The target population of this study was physiotherapists in the UK who work with patients who have a neurological impairment. Members of the ACPIN were chosen as the study population for convenience. It has been assumed that they are representative of all physiotherapists who work in neurology, and have been described as market-leaders and opinion-leaders [14]. In addition, a previous survey of ACPIN members revealed that 90% (234/261) of respondents worked in the NHS, suggesting that the largest employer of physiotherapists in the UK employed a signicant number of ACPIN members [15].
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request that respondents return the postcard at the same time as the questionnaire, but separately, to trace those who had responded without losing anonymity of the questionnaires. This alerted the research administrator to those members of the sample who had returned the questionnaire and those who had not, ensuring that reminder letters were only sent to the appropriate people [18]. A reminder letter and further questionnaire was sent to those who had not responded by the allotted time. All postcards and completed questionnaires were returned to the research administrator. Ethical approval for the study was obtained from York St John University College. Consent was assumed from the return of the completed questionnaire [19]. All data were analysed using Statistical Package for the Social Sciences software.
Results At the time of the study, the total membership of the ACPIN who were willing to receive questionnaires was 957. The random sample of half of the regions contained 36% of this population. In total, 347 questionnaires were sent and 269 completed questionnaires were returned; a response rate of 78%. Two questionnaires were undelivered and nine were returned uncompleted. The non-completions were due to: being on a career break (n = 2); no longer working clinically (n = 5); retired (n = 1); and no longer working in neurology (n = 1). Table 1 shows the grade reported by the respondents. It can be seen that all respondents were working at a senior level. Respondents were asked to indicate the number of years that they had been qualied. This ranged from 2 to 38 years with a mean of 12.6 years [standard deviation (SD) 8]. Given that the responses did not form a normal distribution, the
median number of years qualied was 10 with an interquartile range (IQR) of 618 years. The respondents spent an average of 79% (SD 18) of their working time clinically. Again, the responses were not normally distributed; the median percentage of working time spent clinically was 80% with an IQR of 7090% and a range of 0100%. The respondents worked with patients who had a wide variety of conditions. As this was expected, they were asked to report the percentage of time spent with each condition treated. Only those who spent more than 5% of their time with patients with a specic condition were documented. Eighty-seven percent (237/269) worked with people who had had a stroke, 46% (125/269) with patients with multiple sclerosis, 29% (78/269) with patients with a traumatic brain injury, 26% (70/269) with patients with Parkinsons disease, 13% (34/269) with patients with a spinal cord injury and 12% (32/269) with patients with a tumour of the central nervous system. Other conditions were seen by less than 10% of respondents. Response by ACPIN region The questionnaires returned by region were: Northern Ireland (86%, 24/28); Scotland (80%, 48/60); Merseyside (79%, 34/43); Surrey (78%, 31/40); Yorkshire (72%, 43/60); Kent (69% 18/26); North Trent (62%, 21/34); Northampton (60%, 9/15); and Northern (56%, 23/41). Seven percent (18/269) of returned questionnaires either reported a different region or failed to complete the question. All the respondents were included in the analysis of the questionnaires. General outcome measurement collection Respondents were asked: Do you collect at least one standardised outcome measure in the course of routine clinical practice, i.e. a test or scale that has been shown to measure a particular attribute? Please circle as appropriate:
Yes No
Table 1 Grade of respondents Number (%) of respondents Senior I Senior II Superintendent III Clinical specialist Private practitioner Split role Team leader Superintendent II Superintendent IV Consultant Extended scope practitioner Lecturer Reader in rehabilitation Researcher Total 130 (48) 58 (22) 21 (8) 21 (8) 12 (5) 12 (5) 4 (2) 3 (1) 2 (<1) 2 (<1) 1 (<1) 1 (<1) 1 (<1) 1 (<1) 269
Percentages do not add up to 100% due to rounding.
The questionnaire was structured such that a negative response to this question indicated that a reason should be given for the non-collection of measures, and that the rest of the questionnaire did not require completion. Two respondents did not complete this question. Of these, one went on to answer the rest of the questionnaire, so it was assumed that this person did collect outcome measures. The second provided a reason for non-collection, so a negative response to this question was assumed. A further 23 respondents reported that they do not collect outcome measures and 244 reported that they do collect outcome measures. Taking into account the assumptions from the non-completed responses, 91% (245/269) of respondents collected outcome measures.
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Table 2 Reasons reported for non-measurement of outcome of treatment using a standardised tool Reason for non-measurement of treatment I do use a measure but it is not standardised There are no suitable tests available for my needs I know how to but I do not have the time The level of impairment of my patients is too severe Someone else does I would rather spend time on treatment itself I do not know how to A team measure is useda We have never got round to agreeing what we should measurea Preparing to implement outcome measuresa I do not always believe that very specic measures actually benet patientsa Piloting MDT measuresa It is not important to measure I know how to but I do not have the equipment I am not allowed to The level of impairment of my patients is too mild Number of respondents 10 9 8 7 5 4 3 1 1 1 1 1 0 0 0 0
by the respondents. In order to complete the question, operational denitions of balance, gait and walking were provided in the questionnaire. Balance was dened as the ability to maintain postural stability without falling, walking was dened as mobility using both lower limbs for support and propulsion, and gait was dened as the style of walking. The majority of respondents measured balance, walking and gait. Those who did not measure balance, walking or gait did not need to complete further items on the questionnaire. Measurement of balance in patients with a balance difculty Eighty percent (188/236) of the respondents indicated that they always or almost always measure balance in patients with a balance difculty; n = 89 and n = 99, respectively. Only 4% (10/236) of respondents reported that they occasionally or hardly ever measure balance. Four respondents did not complete the question. Measurement of gait in patients with a gait difculty Sixty-ve percent (151/231) of the respondents indicated that they always or almost always measure gait in patients with a gait difculty, whereas 17% (39/231) of respondents reported that they hardly ever or occasionally measure gait. Nine respondents did not complete the question. Measurement of walking in patients with a walking difculty Seventy-ve percent (174/232) of the respondents indicated that they always or almost always measure walking in patients with a walking difculty. Seven percent (16/232) of the respondents reported that they hardly ever or occasionally measure walking. Eight respondents did not complete the question. Therefore, the questionnaire found that the majority of respondents measure balance, walking and gait, and always or almost always perform measures where the patient demonstrates difculty. Outcome measures used by respondents
MDT = Multidisciplinary Team. a Reasons offered as other by respondents. These are presented as the wording/abbreviations chosen by respondents.
Reasons for non-measurement of treatment using standardised tools Respondents were asked for their reasons for noncollection of standardised measures in the course of routine clinical practice. A table of possible responses was provided, including space for respondents to provide an alternative reason. Table 2 shows the reasons given by those respondents who did not measure the outcome of treatment with a standardised tool. Some respondents provided more than one reason. Items measured Respondents were asked to underline the items that they measured, and Table 3 shows the frequency of items reported
Table 3 Items measured by respondents Item measured Balance Walking Range of movement Strength Gait Tone Co-ordination Sensory systems Alignment Sitting balance Other Number (%) of respondents 227 (84) 204 (76) 183 (68) 174 (65) 165 (61) 137 (51) 113 (42) 112 (42) 76 (28) 1 (<1) 1 (<1)
A list of 14 measures was provided in alphabetical order for respondents to indicate which measures they use (the question and possible responses are shown in Appendix A). As it was anticipated that the measures listed would not cover the entire range of those used by the sample, a space was left for respondents to include other measures. Some respondents completed the other section with measures that were not directly relevant to the topic of balance, walking and gait, such as the Nine Hole Peg Test, whereas others included measures that were partially relevant such as global disability measures. There was a wide variety in the measures used; in total, 89 measures were recorded. A number of respondents (13%,
L.S. Yoward et al. / Physiotherapy 94 (2008) 125132 Table 4 Measures used by respondents Measure used by respondents 10-metre (or other distance) walk test Berg Balance Scale Get Up and Go/Timed Up and Go Functional Reach Timed Standing (incorporating Timed Unsupported Standing/TUSS) Rivermead Mobility Index Rivermead Mobility Index incorporating modied Rivermead Mobility Index POAM/Tinetti/modied Tinettia 6-minute (or other time) walk test Postural Sway Motor Assessment Scale Elderly Mobility Scale Turn tests combined (180 and 360 ) Number (%) of respondents 201 (75) 191 (71) 143 (53) 140 (52) 129 (48) 76 (28) 88 (33) 46 (17) 39 (14) 23 (9) 23 (9) 17 (6) 15 (11 and 4, respectively) (4 and 2, respectively)
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To be included, at least 5% of respondents had to report using the measure. Percentages are of whole sample. a Performance Oriented Assessment of Mobility (POAM) was developed by Tinetti and was included as a possible response on the list provided. The respondents who use this have been added to those who reported using Tinetti or modied Tinetti.
34/369) reported using Tinetti or modied Tinetti. This option had not been provided on the list, although the Performance Oriented Assessment of Mobility (POAM) was provided and was developed by Tinetti [20]. It is unclear whether those who reported using Tinetti or modied Tinetti were referring to the POAM, but this has been assumed in the results table by summing the frequency for both. Measures used by more than 5% of all respondents are shown in Table 4.
Discussion A very high number of physiotherapists from this sample reported that they measure the outcome of their interventions with standardised tests and scales. A previous study investigating the use of outcome measures amongst therapists in Scotland found that only 44% (38/86) of physiotherapy respondents reported that their departments were using outcome measures, although there was a wide range of responses amongst therapists generally (1765%), depending on the area of the country in which they worked [3]. A second survey of the same respondents who had reported using outcome measures revealed that the majority were using non-standardised measures. This is mirrored by the UK Clearing House for Information on the Assessment of Health Services Outcomes, who also found that the majority of studies reported were using locally developed measures [5]. The current questionnaire specically asked respondents to state whether they use at least one standardised outcome measure . . . so the response of 91% is extremely high compared with previous reports. It is possible that social desirability bias resulted in over-reporting of use [21]. Also,
the difference may be accounted for by the fact that the samples used in the studies were very different. For example, the sample from the current study only included individuals from a special interest group, who are potentially highly motivated to maintain professional standards in their eld. In addition, the sample from the present study had all given their consent to the special interest group administrators that they may be contacted for the purposes of research. This suggests that these individuals value research and are perhaps more comfortable with the idea of being questioned about their own data collection. In addition, the present study sample only contained senior physiotherapists and it is likely that junior physiotherapists also work in neurology. Whilst this sample represents the ACPIN, it may not be representative of all physiotherapists who work in neurology. A sample of all grades of staff who work in neurology would be required to conrm this assumption. A further difference is the time lapse between the two studies. In the last 10 years, the concept of outcome measurement is more frequently publicised, and standardised outcome measures are more easily available; for example, the Chartered Society of Physiotherapy has a database of over 200 outcome measures on their website [22]. In addition, changes in healthcare provision have resulted in competition in the workplace with commissioning for services. This places more pressure on healthcare professionals to be able to demonstrate the positive outcomes of their work, and a requirement from managers and commissioners to access these objective outcomes. These external pressures have resulted in the need for more widespread gathering of clinical information [7]. Also, pressures from within the profession enforce the collection of outcome measures [1]. As a result of external and internal inuences, it may be that more physiotherapists are genuinely collecting standardised outcome measures than was the case a decade ago. A survey of Australian private physiotherapy practitioners revealed that more than 90% endorsed statements that health professionals should monitor patient progress using reliable and valid tools [21], and a further survey of physiotherapists in Australia and New Zealand conrmed that reliability and validity of outcome measures inuenced usage [23]. A survey of a general population of physiotherapists in the UK would be useful to conrm the current status. Only a very small number (1%, 3/269) of respondents reported not knowing how to measure. It is unclear from this survey why the respondents did not know how to measure; for example, it may be that respondents are unfamiliar with the concept of measurement per se or simply that they are not aware of an appropriate measure for their clinical need. Interviews with these respondents would have been benecial to explore this further, but this was not possible because of the anonymity of the questionnaires. Given the very small number, it can be assumed that the vast majority of physiotherapists who are ACPIN members do know how to measure using a standardised tool; this is reassuring as it is a core standard of practice [1].
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Balance, walking and gait were all measured by at least half of the respondents. Balance was measured by more respondents than the other items (84%), closely followed by walking (76%). This may reect the value placed on these abilities or may be representative of the type of measures that are available. Further study is required to nd out why these items, in particular, are highly favoured for measurement. Certainly balance impairment frequently presents in patients with neurological impairment [10,24]. As many factors contribute to the ability to balance, such as strength, vision and proprioception, it seems likely that many patients who experience neurological impairment have the potential to develop problems with their balance. Likewise, walking is an activity that also requires contribution from other systems for it to be efcient, so patients with any impairment of balance, range of motion, strength, vision, proprioception and coordination, amongst others, may be predisposed to problems with walking. It may be assumed that balance is a prerequisite for normal walking given that the body is unstable during walking, with approximately 80% of the cycle spent in single limb support [25]. In addition, it has been suggested that any motor skill depends to an extent on the ability to control posture and balance [26], hence the importance attributed to its restoration in neurological physiotherapy [10,27]. As the majority of respondents indicated that they measure balance, walking and gait always or almost always when their patients present with difculty, it can be assumed that these are considered important to measure. However, it is not known how frequently the measurements take place for each individual item, or whether the tools chosen for this measurement were standardised tools. This could have been explored further by interview but was beyond the scope of this study. The measures used by at least half of the respondents were: the 10-metre walk test; the Berg Balance Scale; the Timed Up and Go Test; and the Functional Reach Test. The Berg Balance Scale was initially developed for elderly individuals [28,29], but has since been tested amongst other populations with neurological conditions such as stroke [30], Parkinsons disease [31], brain injury [32] and multiple sclerosis [33]. The Functional Reach Test was originally developed as a balance measure and specically excluded those with neurological impairment during its development [34]. It has since been tested in older people [35] and in neurological conditions, including Parkinsons disease [36], children with spasticity [37] and in a modied form for people who have a spinal cord injury [38]. The 10-metre walk test is widely used clinically and in research, and a version of it has been presented as a suggested standardisation for patients with neurological impairment [39]. It has been widely tested for reliability and validity for measurement of mobility amongst patients with neurological impairments [4042]. The Get Up and Go Test was originally developed for testing balance in elderly people [43], and was later modied to the Timed Up and Go Test that was used for testing mobility in the elderly [44].
What remains unclear is the extent to which the measures are being used appropriately. Although the top four measures have all been tested to some degree, it cannot be stated that they have all been tested for reliability and validity in all populations of neurological conditions. It is possible that the measures may be used clinically for a population of patients in which testing has not yet taken place, and conclusions drawn from the collection of that data are therefore limited. A systematic review of the literature for the psychometric properties of these tests in varying neurological conditions is warranted so that clinicians are able to choose an appropriate outcome measure for individual patients. Limitations of the study The sample, whilst argued to be representative of physiotherapists working in neurology in the UK, may not be so. These results suggest that, in contrast to previous studies, a high percentage of physiotherapists measure the outcome of intervention. This may be because they are a group of individuals sufciently motivated to join a special interest group, and therefore potentially motivated enough to ensure that they work to the professional standards set. Terms related to outcome measurement may be understood in different ways by different respondents [3,45]. To alleviate the potential for this occurrence, attempts were made to clarify terms used by operationally dening key words and terms such as balance, walking, gait and standardised outcome measure. However, it is possible that there may still have been misunderstandings or alternative interpretations over the meaning of these words, including the concept of outcome measurement. Recommendations for further study The next series of studies from the authors research group will investigate the use of specic measures in particular patient populations in terms of validity and reliability.
Conclusion This study found that the majority of physiotherapists who are members of the ACPIN do measure the outcome of their interventions, and specically measure outcomes related to balance, walking and gait. This suggests that these aspects of care are considered important by this group of professionals, and reects the issues of importance in patient groups. However, almost 10% of members of the ACPIN do not measure the outcome of their interventions, in spite of this being core to the professional standards. The most widely used outcome measures for balance, walking and gait are the 10-metre walk test, the Berg Balance Scale, the Get Up and Go/Timed Up and Go Test and the Functional Reach Test. This information could be used to inform minimum data set requirements for further research.
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Acknowledgements The authors wish to thank the physiotherapists from Barnsley Primary Care Trust for their expertise in formulating the questionnaire objectives, especially Kerry Anderson for piloting the questionnaire; Ed Kirby for his support, proof reading and excellent administration of the project; Toni Power and Judy Purton for piloting the questionnaire; and all the ACPIN physiotherapists who kindly completed and returned the questionnaires. Ethical approval: York St John College. Funding: Faculty of Health and Life Sciences, York St John University. Conict of interest: The rst author is a member of the ACPIN and a member of one of the regions selected randomly for the sample.
Appendix A Which of the following measures do you use (underline all that apply)? Berg Balance Scale Brunel Balance Assessment Clinical Gait and Balance Scale Clinical Test of Sensory Integration and Balance Falls Efcacy Scale Functional Reach Test Gait Laboratory Get Up and Go Test/Timed Up and Go Test Performance Oriented Assessment of Mobility Postural Sway Rivermead Mobility Index Timed Standing 10-metre walk test or other timed distance (state distance) 6-minute walk test or other time (state time) Other
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Relationship between low back pain and life-stressing events among Nigerian and Caucasian patients
Michael O. Egwu a,b, , Vincent C.B. Nwuga c,d
a
Department of Medical Rehabilitation, Faculty of Basic Medical Sciences, College of Health Sciences, Obafemi Awolowo University, Ile-Ife, Nigeria b EMO Physiotherapy Clinic, Ile-Ife, Nigeria c Bodija Physiotherapy Clinic, Bodija, Ibadan, Nigeria d Department of Physiotherapy, Faculty of Basic Medical Sciences, College of Health Sciences, Obafemi Awolowo University, Ile-Ife, Nigeria
Abstract Objectives Socio-economic status and life-stressing events have been shown to have ethnic and racial differences that exert a strong inuence on care-seeking habits and recovery from low back pain (LBP). This study examined the relationship between life-stressing events and sensory and psychological attributes among Nigerian and Caucasian patients with LBP, and the inuence of socio-economic status on this relationship. Design Stratied, single cohort questionnaire study. Setting Three outpatient physiotherapy clinics in Nigeria. Participants One hundred and sixty-ve patients, including 107 Black Nigerians (age range 2665 years, mean 52 years) and 58 Caucasians (age range 2562 years, mean 41 years), with LBP of at least 6 weeks duration were recruited over a 9-year period. Main outcome measures The Low Back Pain Questionnaire, Social Re-adjustment Rating Scale, State-Trait Anxiety Inventory and Multiple Affect Adjective Check List. Socio-economic status and pain levels, on a 0100 numerical rating scale, were also recorded. Questionnaires were administered within 5 days of the patient reporting at the clinic. Results Recorded pain intensity was similar in Nigerian [mean pain score 78, 95% condence interval (CI) 73.4 to 83.4] and Caucasian (mean pain score 79, 95% CI 74.8 to 84.8) patients. Subjects who recorded higher numbers of life-stressing events on the Social Re-adjustment Rating Scale also recorded higher scores on a number of LBP attributes including hot, burning, bright, throbbing and pressure qualities. Pain intensity and state anxiety correlated signicantly with life-stressing event scores among Caucasian patients, who were mainly of high socio-economic status. State and trait anxiety and emotional discomfort scores correlated signicantly with life-stressing event scores among Nigerian patients, who were mainly of low to medium socio-economic status. Conclusion Most patients had experienced a number of life-stressing events, particularly those classied as being of low socio-economic status. Low socio-economic status patients who had experienced a high number of life-stressing events were more likely to show emotional and psychological symptoms, which may have inuenced the reporting of the characteristics and history of their LBP. There is a need to assess these issues when managing LBP patients. Further research is required to determine how the outcome of treatment may be inuenced by these factors. 2007 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Keywords: Back pain; Stressful events; Socioeconomic status; Racial stocks; Caucasian race; Negroid race
Introduction Pain is known to create immediate awareness of actual or threatening injury and has sensory, affective, cognitive and emotional components [14]. Due to recognition of the fact that painful conditions such as low back pain (LBP) result from the interaction between biological, psychological
Correspondence: Department of Medical Rehabilitation, Faculty of Basic Medical Sciences, College of Health Sciences, Obafemi Awolowo University, Ile-Ife, Nigeria. Tel.: +2348033739499. E-mail address: egwumo@yahoo.com (M.O. Egwu).
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and social factors, the current trend is to view pain as a biopsychosocial experience [1,5,6]. However, it is widely believed that the perception and response to pain vary with ethnicity and race [710]. Over the years, people of different races (common descent) have been distinguished by skin colour, facial type, cranial prole and amount, texture and colour of hair [1012]. On the basis of these criteria, races such as the Mongoloid, Negroid and Caucosoid were identied, but efforts to establish a genetic base for these phenotypic differences remain equivocal [1113]. Nevertheless, current reports suggest that the various responses to a painful experience within and between races are shaped by culture, literacy level and socioeconomic status, which are largely environmental factors [79]. Green et al. [8] observed that Caucasians report their pain promptly while African Americans with chronic pain report later and have more pain, depression, post-traumatic stress disorders and impairment in their physical, emotional and social health. They concluded that perceptions of the health system, attitudes towards pain itself, socio-economic disparities and cultural norms about expressing pain may be important factors in the observed racial differences. Moreover, the delay in reporting pain observed among Australian aborigines and African Americans was associated with signicant decreases in quality of life and psychological distress, and increased life stresses [8,9]. This suggests that there is a relationship between LBP and life-stressing events that may have racial and socio-economic differences. However, the exact nature of this relationship is not clearly understood. Studies of Australian aborigines [9], Black Nigerians [7] and Senegalese [14] indicate that ruralurban variations also exist in the perception and reaction to pain. These ruralurban differences reect discrepancies in social (access to healthcare personnel and facilities, level of awareness, literacy level, nancial status etc.) and cultural (beliefs, religion, family size and nature of job) variables that shape the aetiology and response to LBP, including care-seeking habits, in different human settlements. Furthermore, over the years, it has been noted that back pain is prevalent in the bereaved, divorced, widows and in people who change jobs frequently [6,15,16], and poor marital, social and sexual adjustments have also been associated with LBP [1517]. Studies from industrial workplaces show that job satisfaction, personality and social denials were predictors of who complained of LBP [17,18]. The above ndings suggest that mood and other psychosocial states may be crucial factors in determining which individuals complain of LBP. However, the pain-coping strategy of individuals with similar psychosocial or mood states experiencing LBP may differ [5,6,1922]. The pain-coping response of LBP patients may be in the form of confrontation or avoidance [1922]. The avoidance approach normally leads to the maintenance and exacerbation of fear, while the confrontation approach may lead to a reduction of fear and/or suppression of pain [21,22]. Lethem et al. [21] highlighted that there is a contin-
uum between extreme avoidance and extreme confrontation of pain, and noted that an individuals position along the continuum is determined by the psychosocial context in which the initial LBP occurs. The psychosocial context reects components of anxiety (an uncomfortable feeling of nervousness or worry about something that is happening or may happen in the future) that may be measured by pain-coping strategies, previous pain history, personality traits and life-stressing events [6,19,20]. The characteristics of LBP and life-stressing events have been measured for several decades using tools including: the Modied Somatic Perception Questionnaire [23]; the Affect Adjective Check List [24]; the Multiple Affect Adjective Check List [25]; the Minnesota Multiphasic Personality Inventory [26]; the State-Trait Anxiety Inventory [27]; the Social Re-adjustment Rating Scale [28]; and the Low Back Pain Questionnaire [29]. Nwuga [30] used some of these tools to study the relationship between LBP and life-stressing events among Nigerian patients, and found that life-stressing events related to some sensory and psychological attributes of LBP but not to emotional state. Globalisation of workplaces and industries and increased movement/resettlement of people across the globe have created major changes in the mix of cultures in some countries and major cities of the world. There is a need for physiotherapy managers to recognise the different emerging experiences and attitudes of people towards LBP, and to adopt appropriate strategies that are effective in meeting their needs. The purpose of this investigation was to examine the relationship between sensory and psychological attributes of LBP and life-stressing events among Nigerian and Caucasian patients, and the effect of socio-economic status on this relationship.
Methods Subjects One hundred and sixty-ve LBP patients (93 males, 72 females) participated in the study. Of these, 107 were Black Nigerians (age range 2665 years, mean 52 years) and 58 were Caucasians (age range 2562 years, mean 41 years). Patients were diagnosed with LBP of mechanical origin and referred to the participating institutions (Bodija Physiotherapy Clinic; Physiotherapy Department, Obafemi Awolowo University Teaching Hospital Complex; and EMO Physiotherapy Clinic in Ibadan and Ile-Ife, South-West Nigeria) between February 1996 and September 2004. The nature of the study was explained and patients who gave their consent to take part received the questionnaire. Patients who did not wish to participate in the study were treated normally. Inclusion criteria Inclusion criteria were: LBP of at least 6 weeks duration; and pain reproduced by at least one direction of trunk move-
135
ment (mechanical activity). Racial classications were based on skin colour and type of hair because previous reports indicated that the Caucasoid race has white skin and straight hair while the Negroid race has brown to brown-black or dark brown skin and curly black hair [1013]. Therefore, Caucasian subjects were white-skinned expatriates or their dependants with straight hair, while Nigerian subjects were brown-black skinned with curly black hair. The age range for the subjects was 25 to 65 years, with a mean of 46.5 years. Classication of socio-economic status Criteria for classication into groups of socio-economic status were based on a questionnaire adapted from Olusi et al. [31], as modied by Balogun et al. [32]. Specically, information was collected on: the highest educational attainment of the subjects; their land and property; the type of housing estate; the number of rooms and people in the household; and household utensils and appliances such as stereo, gas cooker, refrigerator, dishwasher, washing machine etc. Scores were assigned to each item in the questionnaire based on their status symbol in Nigerian society. For example, completion of a doctoral degree was rated 7 and formal education below the level of rst school leaving certicate was rated 1. Ownership of a house and a car were each rated 1. Household utensils and appliances were each assigned 0.5 points. Crowding indices (dened as the ratio of the number of rooms to the number of people in the house) lower and greater than 0.5 were assigned 0.5 points and 1 point, respectively. For each patient, the scores were summed to obtain a value representative of the total socio-economic status. Subsequently, the total score was used to classify the subjects into groups of different socio-economic status. The minimum and maximum possible scores on the questionnaire were 0 and 26 points, respectively. Subjects with scores lower than 9 were classied as being of low socio-economic status; those with scores between 9 and 17 were classied as being of medium socio-economic status; and those with scores above 17 were classied as being of high socio-economic status. Sensory and psychological factors The Low Back Pain Questionnaire was administered and scored as described in the text manual [29] after taking a brief pain history. This questionnaire has a cluster of seven patterns with the following factors: Factor I, severe emotional discomfort; Factor II, mild pressure sensation; Factor III, moderate bright pressure sensation; Factor IV, mild skin pressure sensation; Factor V, moderate constant burning sensation; Factor VI, moderate intermittent hot sensation; and Factor VII, severe throbbing pressure sensation. The Social Re-adjustment Rating Scale containing 43 lifestressing items was used to assess life-stressing events. The
questionnaire, listing the life-stressing items on a single sheet, was presented to each subject to mark the relevant items. The items were then weighted, scored and added together to obtain a life-stressing event score for the patient. This score shows the signicant change in life events in the preceding year for the patient. Similarly, the State-Trait Anxiety Inventory was used to measure anxiety. From the 40 self-evaluative inventories, patients rated the statements in the order of their accuracy in describing the patient at that moment. The Multiple Affect Adjective Check List was used to measure depression and hostility, while pain intensity was measured using a 0100 scale where 0 indicates no pain and 100 indicates maximum pain. Patients were also asked to score their average pain on this scale. Questionnaires were translated into the local language for those who could not read English, and the subjects were tested with these instruments within 5 days of reporting at the clinic. The Anderson-Darling test [33] was used to check the data for normality, and the data were found to be normally distributed. Mean pain scores and 95% condence intervals for patients in the groups of high, medium and low socio-economic status were computed, and pain scores were subjected to analysis of variance to determine differences in group socio-economic status. Students t-tests were used to check for differences in reported pain, life-stressing events and socio-economic status scores between Nigerian and Caucasian patients. In order to determine the relationship between life-stressing events and the sensory and psychological attributes of LBP, Pearsons product-moment correlation coefcient (r) was calculated. Fishers Z transformation was used to check the distribution of differences in the size of the correlation coefcient between the two groups and three levels of socio-economic status [34]. Statistical Package for the Social Sciences Version 11 (SPSS Inc., Chicago, IL, USA) was used for data analysis.
Results One hundred and ninety-two patients gave their consent to participate in this study; however, 27 of them were excluded during data analysis due to incomplete responses (n = 15) and inability to give appropriate responses even after interpretation and explanation (n = 12). Therefore, 165 valid responses were analysed. Table 1 shows that the average pain scores of Nigerian and Caucasian patients were similar regardless of socio-economic status. However, life-stressing event scores were signicantly higher and socio-economic status scores were signicantly lower for Nigerian patients than their Caucasian counterparts (Table 2). Fishers Z transformation demonstrated that the linear relationship between the Caucasian and Nigerian patients was similar and their correlation coefcients were equal. The majority of the subjects (44%, 74/165) were of high socio-
136
Table 1 Low back pain intensity of Nigerian and Caucasian subjects grouped by socio-economic status Nigerians n Socio-economic status High 22 Medium 53 Low 32 All 107 CI, condence intervals. Mean pain intensity (95% CI) 80 (73.8 to 86.3) 78 (75.2 to 80.8) 81 (77.9 to 84.1) 78 (73.4 to 83.4) Caucasians n 52 6 58 Mean pain intensity (95% CI) 80 (77.3 to 82.7) 78 (70.2 to 85.8) 79 (74.8 to 84.8) All n 74 59 32 165 Mean pain intensity (95% CI) 80 (77.2 to 82.8) 78 (75.8 to 80.2) 80 (77.9 to 84.1) 79 (74.6 to 84.6)
economic status; of these, 70% (52/74) were Caucasians. Ninety percent (52/58) of the Caucasian patients were of high socio-economic status. All of the subjects classied as being of low socio-economic status (19%, 32/165) were Nigerian, and most subjects of medium socio-economic status were also Nigerian (90%, 53/59). Relationship between sensory and psychological attributes of LBP and life-stressing events Eight of the 12 sensory and psychological attributes of LBP correlated with life-stressing events in the entire sample (Table 3): severe throbbing pressure sensation (P < 0.001); moderate bright pressure sensation (P < 0.001); moderate constant burning sensation (P < 0.01); moderate intermittent hot sensation (P < 0.01); trait anxiety (P < 0.01); state anxiety (P < 0.01); mild pressure sensation (P < 0.01); and severe emotional discomfort (P < 0.05). Among the Caucasian patients, the following attributes correlated with the number of life-stressing events: severe throbbing pressure sensation (P < 0.001); moderate bright pressure sensation (P < 0.001); moderate constant burning sensation (P < 0.001); moderate intermittent hot sensation (P < 0.001); mild pressure sensation (P < 0.01); pain intensity (P < 0.01); and trait anxiety (P < 0.05). Other variables, including severe emotional discomfort, were not linearly related to life-stressing events in the Caucasian patients. However, among the Nigerian patients, the following attributes correlated with the number of life-stressing events: trait anxiety (P < 0.001); state anxiety (P < 0.001); severe emotional discomfort (P < 0.001); moderate bright pressure sensation (P < 0.01); severe throbbing pressure sensation (P < 0.01); moderate intermittent hot sensation (P < 0.05);
Table 2 Socio-economic status, life-stressing events and pain scores in Nigerian and Caucasian patients [mean (standard deviation)] Nigerians Socio-economic status Life-stressing events (Social Re-adjustment Rating Scale) Pain intensity (numerical rating scale 0100) 16 (4.1) 279 (6.2) Caucasians 21 (2.6) 172 (3.1) P-value <0.001 <0.001
and moderate constant burning sensation (P < 0.05). The data did not suggest a relationship between depression and lifestressing events. Socio-economic status The effects of socio-economic status on the correlations between life-stressing events and the sensory and psychological attributes of LBP are presented in Table 4. Some of the coefcients will have been affected by the small numbers in the subgroups, particularly the group of Caucasian patients of medium socio-economic status. However, some trends are apparent: depression, hostility and moderate skin pressure sensation demonstrated low coefcients. In the Nigerian patients, low socio-economic status was related to higher severe emotional discomfort and signs of state and trait anxiety. In the Caucasian patients, socio-economic status appeared to have little effect on these relationships, although this will have been affected by small numbers. When the results of all the subjects were combined, low socio-economic status was related to higher severe emotional discomfort and state and trait anxiety. The linear relationships between moderate bright pressure sensation, severe throbbing pressure sensation and life-stressing event scores were not affected by socio-economic status. However, it should be noted that the r2 statistics for most of these variables are relatively small, suggesting that, despite their statistical signicance, their individual contribution to the variability in the outcome variable may be relatively small.
Discussion Classication of the duration of back pain into chronic and acute pain is controversial [1,2,35,36]. Merskey and Bogduk [2] classied chronic pain as that which persists beyond the normal time of healing of 1 to 6 months, and recommended 3 months as a convenient point of demarcation between acute and chronic pain. However, others have considered LBP of more than 6 weeks duration as chronic [35,37]. As most LBP patients who attend physiotherapy clinics are chronic episodic back pain sufferers experiencing a are-up, the authors considered that 6 weeks was an appropriate cut-off for the acute phase of LBP [37]. Subjects
78 (6.4)
79 (4.0)
0.991
Table 3 Pearsons product-moment correlation coefcient between life-stressing events and sensory and psychological attributes of low back pain patients Group Low back pain factors Severe emotional discomfort Life-stressing events Nigerians (n = 107) Caucasians (n = 58) All subjects (n = 165) Mild pressure sensation Moderate bright pressure sensation 0.42b 0.60c 0.51c Moderate skin pressure sensation 0.15 0.18 0.17 Moderate constant burning sensation 0.23a 0.54c 0.39b Moderate intermittent hot sensation 0.27a 0.48c 0.38b Severe throbbing pressure sensation 0.42b 0.63c 0.53c Psychological factors Trait anxiety State pressure Hostility Depression Pain intensity
0.46b 0.10 0.28a
0.17 0.42b 0.30b
0.53c 0.19 0.37b
0.51c 0.21a 0.35b
0.15 0.11 0.13
0.17 0.08 0.13
0.18 0.30b 0.19
a P < 0.05; b P < 0.01; c P < 0.001.
Table 4 Effect of socio-economic status on Pearsons product-moment correlation coefcient between life-stressing events and sensory and psychological attributes of low back pain patients Low back pain factors Severe emotional discomfort Life-stressing events Nigerians (n = 107) High (n = 22) Medium (n = 53) Low (n = 32) Caucasians (n = 58) High (n = 52) Medium (n = 6) Low (n = 6) All subjects (n = 165) High (n = 68) Medium (n = 65) Low (n = 32) Mild pressure sensation Moderate bright pressure sensation Moderate skin pressure sensation Moderate constant burning sensation Moderate intermittent hot sensation Severe throbbing pressure sensation Psychological factors Trait anxiety State anxiety Hostility Depression Pain intensity
0.16 0.32b 0.55c 0.09 0.11 0.18 0.22a 0.54c
0.19 0.29a 0.17 0.45b 0.08 0.34b 0.19 0.14
0.44b 0.37b 0.46b 0.58c 0.61c 0.51c 0.49c 0.46b
0.18 0.15 0.11 0.20a 0.16 0.19 0.16 0.11
0.32b 0.24a 0.12 0.55c 0.52c 0.44b 0.38b 0.12
0.41b 0.26a 0.13 0.49c 0.46b 0.45b 0.36b 0.13
0.41b 0.39b 0.45b 0.64c 0.62c 0.52c 0.51c 0.45b
0.50c 0.52c 0.58c 0.16 0.14 0.39b 0.33b 0.58c
0.44b 0.48c 0.62c 0.38b 0.26a 0.33b 0.32b 0.62c
0.19 0.11 0.15 0.09 0.12 0.14 0.12 0.15
0.09 0.12 0.14 0.06 0.09 0.08 0.11 0.14
0.15 0.16 0.12 0.56c 0.34b 0.41 0.25a 0.12 137
a P < 0.05; b P < 0.01; c P < 0.001.
138
were accordingly dened as patients with chronic LBP of mechanical origin. One hundred and sixty-ve patients were studied over a 9-year period. The results reveal that severe throbbing, moderate bright and mild pressure sensations, moderate constant burning, intermittent hot sensations and anxiety correlated signicantly with life-stressing events in this group of patients. Hostility, depression and mild pressure sensation were not linearly related to life-stressing event scores. The reason why life-stressing events relate to some but not all sensory and psychological attributes of LBP is open to speculation. The results of previous studies show that life-stressing events have an exacerbatory effect on physical illness [30,38]. Nwuga [30] suggested that life-stressing events have a selective effect on the sensory attributes of LBP. Leavitt et al. [39] noted that life-stressing events exacerbate certain types of pain and that the types of pain exacerbated differ in people with and without organic disease. The ndings in the present study agree with these hypotheses to some extent. Further analysis of data revealed that severe emotional discomfort and trait anxiety were related to life-stressing events in Nigerian patients but not in Caucasian patients. Conversely, pain intensity only correlated with the lifestressing event scores in Caucasian patients. Based on the model which suggests that pain has sensory, affective, cognitive and emotional components, these ndings can be interpreted to mean that life-stressing events exacerbate the sensory components of LBP in Caucasian patients whereas the affective emotional components of LBP are related to life-stressing events in Nigerian patients. It does appear that the latency periods for the sensory and affective-emotional components of pain differ, because the average time between onset of pain and time of reporting was shorter for the Caucasian patients (8 weeks) than the Nigerian patients (17 weeks). This implies that apart from ruralurban variations, there may be racial and/or socio-economic differences in the variables that shape the aetiology and response to LBP, including care-seeking habits, even in the same geographical location. The reason for the differences in the relationship between life-stressing events and some sensory and psychological attributes of LBP between Caucasian and Nigerian patients reporting a similar intensity of pain (Table 2) is unclear. It is even more difcult to ascertain whether these differences reect socio-economic or racial variations in perception. However, Zola [40] suggested that people seeking help for a symptom for the rst time do so because they are unable to tolerate it any longer; however, individual tolerances vary. Thus an exacerbating symptom that becomes intolerable for a Nigerian patient may differ from that of a Caucasian patient. This observation is supported by Budd [41] who characterised suffering as occurring when we assess ourselves in a situation and dont like where we are, where we have been, or where we are going and we can take no actions to close the gap.
Also, these data suggest that the lower the socio-economic status, the greater the number of life-stressing events and the greater the psychological symptoms for a given intensity of perceived pain. This may be due to discrepancies in the nature of the patients life events, level of education and information processing. The fact that sensory and affective attributes are often differentiated during the experience of pain has long been known [16,42]. Sensory attributes have been more closely associated with tissue damage and affective attributes with mood, and the two are products of information processing concerning sensory experiences. Fordyce [17] explained that perception of the nature and meaning of incoming sensory information, how the body responds physiologically and what actions are taken, as well as anticipation of what the future holds, are inextricably intertwined, and emotional states inuence whether and how an aversive stimulus such as pain is perceived. Emotional states also inuence physiological processes (e.g. heart rate, blood pressure, muscle tension etc.), which then feedback to colour the perception of what is happening, the meanings assigned to it, the consequences inferred to follow, and the actions taken in response. These factors appear to respond to socio-economic dynamics inuenced by the number and types of life-stressing events, reecting the psychosocial context in which the initial LBP occurred. Furthermore, there is evidence that life-stressing events inuence pain reporting and pain unpleasantness. In the study by Zelman et al. [43], reading elative statements improved mood and pain tolerance, whereas reading depressive statements worsened mood and reduced pain tolerance. Pain intensity rating, which reects the sensory aspect of pain, was not affected by mood, which implies that emotional manipulations by intensity of life stresses alter pain unpleasantness more than pain sensation, while attention alters both pain sensation and unpleasantness. Therefore, Nigerian patients of medium to low socio-economic status having experienced a high number of life-stressing events may have focused more attention on socio-economic, nancial and emotional problems, inuencing their care-seeking behaviour and potentially leading to delays in reporting for treatment [7,18,41,43]. In addition, LBP is culturally interpreted by most Nigerian patients as a harmless experience that accompanies ageing, and expression of pain is seen as a sign of weakness [7]. On the other hand, Caucasian and Nigerian patients of high socio-economic status who have experienced fewer life-stressing events and pressures may have focused more attention on the possible harmful effects of the intensity and spread of the hot, burning, pressure or throbbing qualities of LBP, compelling them to report more quickly for treatment [8,41,42]. It is therefore important to ascertain the socio-economic status and number of life-stressing events that a LBP patient has experienced before and after the onset of pain, as these may be crucial factors in a patients response to therapy.
139
Conclusion Pain intensity reported by this cohort of patients was not affected by either race or socio-economic status. Eighty percent of the Nigerian patients were of low to medium socioeconomic status, whereas 90% of the Caucasian patients were of high socio-economic status. Life-stressing events and socio-economic factors may inuence the reporting of pain characteristics and pain history in patients with LBP. The results suggest that patients with LBP who have experienced a high number of life-stressing events may have an altered perception of their condition, and these effects may be exacerbated in patients of low socio-economic status. These factors should be taken into account in the management of LBP patients, although further research is needed to determine the effect of these factors on outcome following treatment.
[10]
[11]
[12]
[13] [14]
[15]
[16]
Acknowledgments
[17]
The technical, logistic and secretarial support provided by Professor M.O.B. Olaogun, Dean, Faculty of Basic Medical Sciences; Mr P.A. Oyinlola, Secretary, Department of Medical Rehabilitation; and Mr C.U. Uwasomba, Lecturer, Department of English Language and Literature are gratefully acknowledged. Ethical approval: Ethics and Research Committee of the Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria. Conict of interest: None declared.
[18] [19]
[20]
[21] [22]
[23]
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Self-referral, access and physiotherapy: patients knowledge and attitudesresults of a national trial
Valerie S. Webster a, , Lesley K. Holdsworth b , Angus K. McFadyen a , Helen Little a , The Scottish Physiotherapy Self Referral Study Group
a
School of Health and Social Care, Glasgow Caledonian University, Glasgow G4 0BA, UK b NHS Quality Improvement Scotland, Glasgow, G1 2NP
Abstract Objectives To identify service users views and attitudes to access, physiotherapy and patient-autonomous health-seeking behaviours. Study design Mixed qualitative and quantitative questionnaire. Setting Twenty-six locations representing a range of socio-economic and geographical settings throughout Scotland. Participants Three thousand and ten patients over 16 years of age. Methods Postal questionnaires containing a mix of open and closed questions, attitude statements and free text for comments were sent to all consenting patients 4 weeks after discharge from physiotherapy. Responses were analysed by referral group: self-referred patients; patients referred by their general practitioner (GP); and patients referred at the suggestion of their GP. Results A response rate of 72% (2177/3010) was achieved. Males, females and all age groups were represented. Strong support for the effectiveness of physiotherapy was reported by all groups (>90%). Despite more than 80% of respondents claiming that they were able to condently predict when they needed physiotherapy, less than 23% reported being knowledgeable or very knowledgeable about physiotherapy, with no signicant association between level of knowledge and referral group (P = 0.129). Self-referred patients were more satised (P < 0.001), more supportive of being able to self-refer (83% vs 69% of GP-referred patients and 71% of patients referred at the suggestion of their GP), and more supportive of physiotherapists making decisions about their tness for work or activities (59% vs 53% of GP-referred patients and 53% of patients referred at the suggestion of their GP). Conclusions Physiotherapy was regarded positively by all referral groups, particularly by self-referred patients, despite there being a distinct lack of knowledge about the profession. There is a clear need to raise awareness and knowledge of physiotherapy if autonomous health-seeking behaviours are to be encouraged and self-referral schemes progressed appropriately. 2008 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Keywords: Self-Referral; Physiotherapy; Patents Views; National Trial; Questionnaire
Introduction Throughout the UK, there has been growing interest in the concept of patient self-referral to a range of services provided by the National Health Service, including physiotherapy. This interest has developed, not least, because of the signicant drivers for change contained within Government policies which, since 1997, have consistently emphasised the need
Corresponding author. Tel.: +44 141 331 8118; fax: +44 141 331 8112. E-mail address: v.webster@gcal.ac.uk (V.S. Webster).
for a patient-centred National Health Service with improved access to services [15]. Whilst healthcare practitioners, professional bodies and policy makers consider the introduction of self-referral as facilitating the empowerment of service users, evidence relating to their actual views and/or level of support for such systems is limited [68]. The current Patient Focused Public Involvement agenda of UK Government health policies makes clear the need to actively seek and respond to the views of service users when developing or redesigning services [9].
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V.S. Webster et al. / Physiotherapy 94 (2008) 141149
Patient satisfaction Within the National Health Service, consumer satisfaction is often viewed as an indicator of quality, and remains an important part of the consumer perspective on healthcare systems [10]. Although self-referral to physiotherapy appears to be feasible, appropriate and cost-effective [1113], at the time of conducting this study, the only published UK evidence relating to service users views about systems of self-referral consisted of two small-scale satisfaction studies (n = 133, n = 58) [8,14]. Both reported high levels of satisfaction with self-referral but did not explore respondents views or attitudes further. Although important indicators, surveys of satisfaction are known to elicit positive ratings which may not be sensitive to specic problems [15], nor do they provide any indication of underlying inuencing attitudes, values or perceptions. It must also be recognised that studies undertaken within local settings by clinical delivery teams may result in a favourable bias, due to respondents feeling constrained in their ability to respond honestly for fear of having to use the service again. Existing knowledge of physiotherapy A recent poll in the UK revealed that 88% of respondents were supportive of being able to refer themselves to physiotherapy [16]. However, what is not known is whether they were expressing their support for the concept of patients being able to refer, or whether they actually had existing knowledge from which to make an informed decision. Very little is known about how knowledgeable the public and service users are about physiotherapy or their associated perceptions. Additionally, the only studies that have attempted to explore some of these issues were conducted overseas [1723]. Each reported a lack of public awareness of physiotherapy, and consistently recommended the need for wider marketing of the profession [18,19,21]. As recently as 2004, the annual report of the American Physical Therapy Association emphasised a number of strategies being used to highlight physiotherapy to the American public [24]. Autonomous behaviours If self-referral systems are to be accessed appropriately, patients have to have knowledge of physiotherapy, condence in its potential effectiveness and adopt autonomous healthseeking behaviours. In a study of patients experiences of an open access (self-referral) system for the ongoing management of inammatory bowel disease, the authors found that preference for self-referral was based on whether patients exhibited a desire to take control of their health and its management. It also reported that some patients were not condent with this approach and still preferred the doctor to take control of their management options [25]. It has to be accepted, therefore, that a proportion of patients, irrespec-
tive of their level of knowledge, may still prefer healthcare professionals to make decisions on their behalf. Chicken or egg or both? In the only published large-scale UK study investigating the efcacy of self-referral to physiotherapy, a 22% (648/3010) self-referral rate was reported [8]. The reason for this relatively low gure is unknown but it may have been as a consequence of any or all of the following: a lack of knowledge of physiotherapy; a lack of condence; being unaware of the self-referral facility; and/or a reticence to adopt autonomous health-seeking behaviours. Only by engaging with service users will some of these questions be answered. This paper reports the results of a follow-up study to the recently reported Scottish national trial [1113], and aims to provide information to add to the emerging evidence base about the acceptability of patient self-referral to physiotherapy.
Aim The aim of this study was to identify the views and perceptions of physiotherapy service users about access and their physiotherapy experience, including any differences reported by referral group; i.e. self-referred patients, patients referred by their general practitioner (GP), and patients referred at the suggestion of their GP.
Methods Participants The full methodology of the main study has been reported previously [11]. Prior to their initial physiotherapy contact, a full explanation of the trial was provided to patients. All patients referred to physiotherapy were asked for their consent to participate in the follow-up study, which would involve completing and returning a postal questionnaire. They were assured that there was no obligation to take part in the follow-up phase, even if they agreed to take part in the initial study. They were also free not to return the questionnaire if they wished to withdraw at a later time. Study design A postal questionnaire was designed to illicit the views and perceptions of patients about physiotherapy. Postal questionnaires are an appropriate and cost-effective way of engaging signicant numbers of individuals to gather broad-based information, particularly from widespread geographical areas. This method allowed patients to complete the questionnaire in the privacy of their own homes [26,27].
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Box 1: Key question themes Demographics: gender, age group, post code Type of problem that physiotherapist was consulted about Awareness of ability to self-refer Source of awareness (if appropriate) Perceived level of knowledge of physiotherapy Satisfaction with physiotherapy intervention Current symptom status Other healthcare practitioners consulted Attitude statements in relation to aspects of: access to physiotherapy effectiveness of physiotherapy condence with autonomous behaviours physiotherapy roles free comments
sisting of an attitude item pool of individual statements, and a box for comments. The item pool consisted of nine attitude statements, and respondents were asked to indicate the extent to which they agreed or disagreed with each statement using a ve-point Likert scale. Information about gender, age group and primary condition for which they had attended physiotherapy was also collected. Data collection Questionnaires were bar coded to ensure that the three referral groups were easily identiable. A questionnaire, explanatory letter and freepost envelope were sent to all consenting patients 4 weeks after discharge from physiotherapy. No direct patient-identiable information was collected, and each patient was only categorised by their referral group and location so that individual results could be returned to each location on an aggregated basis.
Respondents were asked to complete the questionnaire within 1 week and return it via a supplied freepost envelope to the study centre. Freepost envelopes were used to minimise the associated nancial costs and to encourage return rates. Return to the study centre rather than the local physiotherapy service was chosen to encourage open and honest responses, not constrained by a fear that any future involvement with the local service could be compromised. Principles of questionnaire design The questionnaire was developed and processed using PinPoint Questionnaire Software (Longman, Longtron, 1997); a computer-based programme designed specically to produce and analyse questionnaires. A statistician was consulted at all stages of development. The questionnaire was developed and rened in line with the principles advocated by Oppenheim [26] and Chesson [27]. The questions included were designed to capture respondents views relating to the key themes outlined in Box 1 . The multiple choice answers were predominantly those rigorously developed and subsequently used in a previously published study (n = 485) [28]. Further verication of their applicability was ascertained prior to nalisation of the questionnaire. The nal version consisted of a series of closed questions with a choice of predetermined answers, including other, please state to capture alternative views, one open question, a semantic differential section conTable 1 Questionnaire response rates Questionnaire returns GP referral GP-suggested referral Self-referral Number of questionnaires issued GP, general practitioner. Questionnaires issued 1795 542 648 3010
Data analysis The data from all the questionnaires were analysed using PinPoint Questionnaire Software. Frequency distributions were reported in percentages with the differences between the groups studied by means of non-parametric tests. Chisquared test and extended Chi-squared test were used to examine the association between the groups of nominal data. Ordinal and continuous data were examined using the Mann Whitney test. The level of signicance was set at 5% and condence levels at 95%. All comments were transcribed verbatim and listed under the appropriate referral mode, then reviewed to identify themes and subthemes. The themes were then veried by two independent observers.
Results A response rate of 72% (2177/3010) was achieved (Table 1). Demographics and condition breakdown by referral group are presented in Table 2. Awareness of self-referral facility Respondents were questioned about whether they were aware that they could refer themselves to physiotherapy
Proportion of questionnaires returned by referral group 1271 (71%) 364 (67%) 542 (84%) 2177 (72%)
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Table 2 Summary of descriptive data relating to respondents GP referral Gender Missing data 47 Age (years) Male Female 1620 2130 3140 4150 5164 6574 >75 LBP Neck Lower limb Shoulder Knee Upper limb Multiple Other 463 (37%) 782 (63%) 26 (2%) 65 (5%) 169 (13%) 213 (17%) 438 (35%) 224 (18%) 130 (10%) 203 (16%) 89 (7%) 86 (7%) 171 (14%) 161 (13%) 123 (10%) 290 (23%) 138 (10%) GP-suggested referral 134 (37%) 224 (63%) 5 (1%) 19 (5%) 51 (14%) 60 (17%) 135 (37%) 67 (18%) 27 (8%) 64 (18%) 30 (8%) 32 (9%) 36 (10%) 36 (10%) 30 (9%) 106 (29%) 26 (7%) Self-referral 181 (34%) 346 (66%) 9 (2%) 44 (8%) 61 (11%) 105 (19%) 178 (33%) 100 (19%) 42 (8%) 104 (20%) 32 (6%) 59 (11%) 63 (12%) 70 (13%) 43 (8%) 111 (21%) 49 (9%) Signicance P = 0.486
P = 0.210
Missing data 9 Condition category
P = 0.006
Missing data 25 GP, general practitioner; LBP, low back pain.
(Fig. 1), and if so, the source of this knowledge. All self-referred patients reported being aware, compared with 26% (330/1271) of patients referred by their GP and 34% (124/364) of patients referred at the suggestion of their GP. The majority of self-referred patients stated that they had been made aware of the facility through the local press or word of mouth (63%, 342/542). Not surprisingly, patients referred by their GP citied their GP as the most common source of information (37%, 122/330), followed by poster displays (31%, 102/330). Reported level of knowledge of physiotherapy Most respondents classied themselves as having limited knowledge of physiotherapy (Fig. 2), with no signicant association between knowledge and referral group (P = 0.129). Less than 5% of all respondents in all groups considered themselves to be very knowledgeable.
Satisfaction Despite there being a signicant association between satisfaction and referral group (P < 0.001), the majority of all respondents were either satised or very satised with their physiotherapy intervention: 79% of self-referred patients; 73% of patients referred at the suggestion of their GP; and 74% of patients referred by their GP) (Fig. 3). Less than 3% of all respondents reported that they were not satised. Current symptoms One month after discharge, over 70% (1536/2128) of respondents reported continued symptoms, although the majority stated that their symptoms were improving. Approximately one-fth of respondents reported that they had consulted a healthcare professional specically about the problem for which they had attended physiotherapy since
Fig. 1. Awareness of ability to self-refer.
Fig. 2. Perceived knowledge of physiotherapy.
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apy could offer and to whom; greater collaboration between physiotherapists and GPs; timing of service delivery; and providing a help desk/telephone advice line to provide and/or clarify information/advice.
Discussion The emerging and growing evidence about the clinical effectiveness and cost-effectiveness of patient self-referral [8,1113] assumes that this mode of access is also supported by patients who are comfortable, able and willing to initiate access to physiotherapy themselves. Since 2003, the Chartered Society of Physiotherapy has been actively campaigning for self-referral to be a real choice for primary care patients by 2007 [4]. Government policy published in 2006 also included the intention to introduce and evaluate patient self-referral to physiotherapy in locations throughout England [1]. Interest has been voiced increasingly by the physiotherapy profession, healthcare managers, professional bodies, GPs, politicians, and even patients and the wider public [2932]. In some respects, this emphasis is somewhat surprising considering that the only UK evidence about service users views on physiotherapy relates to a limited number of patient satisfaction studies [8,14]. Patient satisfaction It has been stated that the concept of self-referral is well supported by the public [16], but on what is this support based? Whilst not decrying the use of patient satisfaction as an indicator, little evidence exists to provide any indication of what patients or the public actually know about physiotherapy. In line with the previously published satisfaction surveys [8,14], the patients in this study reported high levels of satisfaction with physiotherapy; the method used to elicit their views and, in particular, the method of returning completed questionnaires to an independent study centre enhances the reliability of these ndings. Knowledge of physiotherapy Forty-six percent (1002/2177) of respondents provided additional comments which were grouped into four themes (Box 2). The vast majority were very positive, with many arguing for continuance of the schemes. There were also issues highlighted where it was felt that improvements could be made to the service. Some patients reported that their physiotherapy intervention time was rushed. Others highlighted the constraints of a system that only operated during ofce hours. Some were concerned that introducing self-referral without a parallel public education/awareness campaign would result in inappropriate presentations and longer waiting lists. Suggestions for improvement included: increased level of physiotherapy provision; what physiotherSince the 1960s, theoretical models have emerged that aim to demonstrate the concept of patient access to healthcare services. One of the most established, the Anderson model [33,34], suggests that a person initiating access to health care is dependent on a number of factors such as enabling, predisposing and a need for care. These factors include not only age, gender and race, but also factors such as access, knowledge, and individual attitudes and beliefs. The majority of all respondents, irrespective of referral group, claimed to have limited knowledge of physiotherapy (Fig. 2), despite a recent experience. This nding is perhaps understandable as the respondents were seen within phys-
Fig. 3. Perceived levels of satisfaction.
being discharged, with GPs being most frequently cited by all referral groups: 17% (93/534) of self-referred patients; 22% (79/358) of patients referred at the suggestion of their GP; and 19% (236/1244) of patients referred by their GP (P = 0.219). Attitudes The levels of agreement/disagreement with the nine attitude statements are detailed in Table 3. There were signicant differences between the referral groups in views relating to access to physiotherapy, autonomous behaviours and future use of physiotherapy. Self-referred patients were more likely to be strongly supportive of being able to self-refer, agreeing that self-referral could save them time and they would use the service again in the future. The vast majority of all respondents agreed or strongly agreed that physiotherapy was effective (92%, 2008/2149). Self-referred patients were least likely to lack condence in their ability to determine when physiotherapy was appropriate, and most supportive of physiotherapists making decisions about patients tness for work or normal activities (Table 3). Respondents comments
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Table 3 Summary of opinion data relating to general practitioner (GP) referrals, GP-suggested referrals and self-referrals Questions Only GPs should be able to refer patients to physiotherapy Responses Strongly disagree Disagree No opinion Agree Strongly agree GP referral 199 (16%) 665 (53%) 150 (12%) 190 (15%) 45 (4%) GP-suggested referral 53 (15%) 204 (56%) 35 (10%) 50 (14%) 18 (5%) Self-referral 135 (25%) 307(58%) 39 (7%) 44 (8%) 8 (2%) Signicance
P < 0.0001
Missing data 35 Self-referral to physiotherapy could save a lot of time Strongly disagree Disagree No opinion Agree Strongly agree 25 (2%) 73 (6%) 43 (3%) 665 (53%) 455 (36%) 10 (3%) 20 (6%) 7 (2%) 176 (49%) 144 (40%) 6 (1%) 17 (3%) 11 (2%) 237 (44%) 266 (50%)
P < 0.0001
Missing data 22 Physiotherapists offer effective treatment for conditions such as back and neck, joint or soft tissue problems Strongly disagree Disagree No opinion Agree Strongly agree Missing data 26 I am not happy for physiotherapists to make decisions about whether I am t for work or normal activities Strongly disagree Disagree No opinion Agree Strongly agree Missing data 84 I am condent I know myself when I need to consult a physiotherapist Strongly disagree Disagree No opinion Agree Strongly agree Missing data 32 Patients can learn a lot about how to help to manage their health problems themselves Strongly disagree Disagree No opinion Agree Strongly agree Missing data 35 I would feel happier consulting both my GP and the physiotherapist Strongly disagree Disagree No opinion Agree Strongly agree Missing data 52 I would use the service again Strongly disagree Disagree No opinion Agree Strongly agree 12 (1%) 12 (1%) 15 (1%) 665 (53%) 548 (44%) 3 (1%) 3 (1%) 2 (1%) 155 (42%) 199 (55%) 4 (1%) 4 (1%) 4 (1%) 223 (41%) 301 (56%) 25 (2%) 263 (21%) 233 (19%) 602 (49%) 117 (9%) 7 (2%) 59 (17%) 45 (13%) 186 (52%) 58 (16%) 18 (3%) 151 (28%) 133 (25%) 205 (39%) 23 (4%) P < 0.001 10 (1%) 85 (7%) 86 (7%) 808 (64%) 263 (21%) 7 (2%) 20 (6%) 16 (4%) 223 (62%) 93 (26%) 12 (2%) 23 (4%) 29 (6%) 330 (62%) 1370 (26%) P < 0.011 19 (1%) 154 (12%) 76 (6%) 774 (62%) 232 (19%) 3 (1%) 43 (12%) 9 (3%) 223 (62%) 80 (22%) 6 (1%) 38 (7%) 28 (5%) 344 (65%) 116 (22%) P < 0.007 138 (11%) 511 (42%) 331 (27%) 191 (15%) 58 (5%) 39 (11%) 145 (42%) 88 (26%) 56 (16%) 17 (5%) 70 (14%) 234 (45%) 130 (25%) 67 (13%) 18 (3%) P = 0.545 13 (1%) 28 (2%) 57 (4%) 702 (56%) 461 (37%) 2 (1%) 7 (2%) 12 (3%) 175 (49%) 161 (45%) 3 (1%) 6 (1%) 15 (3%) 275 (52%) 234 (44%) P = 0.023
P < 0.001
Missing data 27
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Box 2: Examples of comments made by respondents

Positive Access and location Pleased I was able to choose, excellent idea please keep it Access easier, less hassle, speedier recovery Should encourage self-referral, excellent innovation I know what to do in the future if symptoms recur Able to get clear understanding of condition and what affects it I have quality of life now Gave condence, cope much better now Gave me control over pain which previously was intolerable If you self-refer, YOU are taking responsibility, shows desire to get better Reassurance that what you are doing is right, priceless General practitioner time Saved general practitioner time, should be done for other clinics, e.g. warts Waste of time seeing general practitioner for painkillers/back pain, better to see physiotherapist Doctors time not taken up by patients who they just refer on My general practitioner gave me no encouragement or support and without your schemes, I might still be talking to her which was no use Excellent, very happy with treatment Thank you for this way of getting physiotherapy Very pleased with self-referral and treatment Self-referral much more effective, saves a lot of time and pain Self-referral, thank you, hope it gets lots of support, rst class, undervalued Would not hesitate to go back First time been able to access in 30 years and has transformed my life Courteous and knowledgeable, very good at explaining A physiotherapist might not have experience on your condition that your general practitioner does have Any opinion on tness for work would have to be in liaison with a doctor. There might be other medical problems Negative Waiting times too long Not well publicised Appointment times could be improved, only during working hours difcult Want to be able to see my general practitioner General practitioner should refer Danger patients will refer with minor problems so waiting would increase
Empowered patients
Physiotherapy service
More treatment sessions needed Treatment sessions too short (20 minutes) Found initial appointment difcult Physiotherapists only look at the problem you present with, not whole person Better if see same physiotherapist throughout In my experience, good physiotherapists are rare and cannot be effective in health centres Assessment of priority patients based on those working or not is awed System could be open to abuse with patients who genuinely need to see a physiotherapist having to wait longer due to non-genuine complaints Did not seem too interested As physiotherapist had other clients on the go at the same time, she could not fully attend to my needs and I feel everything was a bit rushed
Godsend for the older patient Exercises/advice have improved intervals between attacks considerably Referred me to occupational therapist for specialist help, very positive Got exercises should have had 12 years ago
iotherapy outpatient clinics, predominately requiring one physiotherapy episode of care for an average number of four contacts [11,35]. It is not therefore unreasonable to surmise that respondents were only exposed to specic aspects of physiotherapy, and that would not be sufcient to inform an overall increased knowledge. It should also be noted that respondents understanding of their own condition was at variance with that of the physiotherapists. In the main study, less than 2% (39/3010) of subjects were identied as being referred with multiple problems, but in this follow-up study, over 20% of patients referred
by their GP (290/1271) and self-referred patients (83/542), and nearly 30% (107/364) of patients referred at the suggestion of their GP stated that they had attended with multiple problems. Joint understanding and decision making are key elements of current healthcare practice, but these results suggest that physiotherapy has some way to go before this is a reality for all. If, as proposed by other authors, a key factor inuencing initiation of contact is knowledge, then a lack of knowledge will inhibit autonomous behaviours [33,34,36]. These ndings support the recommendation made by other authors that
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there is a need to raise public awareness and knowledge of physiotherapy, and sets a challenge as to how this can be achieved [18,19,21,24]. Attitudes and beliefs The stronger attitudes of self-referred patients about a number of issues support other published evidence [33,34,36] that attitudes and beliefs are also key predisposing factors to access. Over 90% (2008/2177) of all respondents reported strong support for the effectiveness of physiotherapy, although selfreferred respondents were more strongly supportive of using the service again (Table 3). As well as being more satised, self-referred patients had a greater overall condence in the effectiveness of physiotherapy, even with limited knowledge. Possibly not so surprising was the fact that self-referred patients had stronger supportive attitudes about the advantages of adopting autonomous behaviours. Interestingly, one-quarter of all respondents, irrespective of referral group, expressed no opinion about who should make decisions about their tness for work or activities. This does not necessarily indicate that respondents were ambivalent about these issues. Perhaps they did not feel strongly about who actually made these decisions, and were accepting of the appropriateness of either physiotherapists or doctors undertaking these roles. Limitations This study represents an attempt to quantify the views of physiotherapy patients in relation to self-referral as a viable mode of access. Although these views are representative of a large physiotherapy population, they only relate to Scottish physiotherapy patients and may not represent the views of the rest of the UK. In this study, the methods used to advertise the self-referral facility were, for the most part, provided through practice newsletters, posters, word of mouth and via healthcare professionals. Although appropriate in this case, this method of marketing relies heavily on people having some contact with other healthcare services to gain information. Members of the general public who rarely visit their local general practice or have contact with other healthcare providers may be unaware of the facility.
are to be encouraged, it will be vital to ensure that the public are more aware of the potential role of professions. In line with other evidence, it is essential that the physiotherapy profession uses effective modern marketing strategies to enhance the publics awareness and condence in physiotherapy-led services, and to publicise how access to these services can be achieved. This study also identied that self-referred patients appear to have more condence in their own autonomous behaviours and more positive attitudes to physiotherapy than patients referred from other sources. A number of specic issues were highlighted about the local arrangements for access, communication and information/knowledge. As a responsible profession, it is imperative that physiotherapy regularly identies and responds to feedback from service users and the public using these ndings to meaningfully inform policy and service level development.
Acknowledgements The authors would like to acknowledge the Scottish Physiotherapy Self Referral Study Group. Ethical approval: Multi-centred Research Ethics Committee (Scotland), Ref no. MREC/02/0/37. Funding: Glasgow Caledonian University, Forth Valley NHS and participating sites. Conict of interests: None declared.
References
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Conclusions The high response rate and large proportion of additional comments suggest that the public are keen to contribute to discussions about patient access in general and physiotherapy specically. There were high levels of support for the value of and wider access to physiotherapy, although the lack of knowledge about the profession and how it can assist in managing health was rather concerning. If systems of self-referral
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[24] American Physical Therapy Association. Annual report 2004. Alexandria: American Physical Therapy Association; 2004. [25] Rogers A, Kennedy A, Nelson E, Robinson A. Patients experiences of an open access follow up arrangement in managing inammatory bowel disease. Quality Safety Health Care 2004;13:3748. [26] Oppenheim AN. Questionnaire design, interviewing and attitude measurement. London: Continuum International Publishing Group; 1992. [27] Chesson R. How to design a questionnaire a ten stage strategy. Physiotherapy 1993;79:7113. [28] Holdsworth LK, Webster VS. Direct access to physiotherapy in primary care: now and into the future. Physiotherapy 2004;90:6472. [29] Chartered Society of Physiotherapy. Widening access: improving patient care. Frontline Supplement. London: The Chartered Society of Physiotherapy; 2005. [30] Chartered Society Physiotherapy. Brieng paper: self referral to physiotherapy services. London: Chartered Society of Physiotherapy; 2004. [31] Boyce R. Direct access in Australia. Physiotherapy 2005;91:61 2. [32] Wigmore-Welsh J. Referral system controls entry to NHS physiotherapy. Frontline 2001;January 17:23. [33] Andersen RM. Revising the behavioural model and access to medical care: does it matter? J Health Soc Behav 1995;36:110. [34] Anderson RM 1968 cited in Akinci F, Sinay T. Perceived access in a managed care environment: determinants of satisfaction. Health Serv Manag Res 2003; 16:8595. [35] Minns C, Bithell C. Musculoskeletal physiotherapy in general practice fundholding practices. Physiotherapy 1998;84:8492. [36] Kula-Glasgow I, Delnoij D, de Bakker D. Self-referral in a gatekeeping system: patients reasons for skipping the general-practitioner. Health Pol 1998;45:22138.
Goals of physiotherapy interventions can be described using the International Classication of Functioning, Disability and Health
Rene Mittrach a , Eva Grill a , Monika Walchner-Bonjean a , Monika Scheuringer a , Christine Boldt a , Erika Omega Huber b , Gerold Stucki a,c,d,
a
ICF Research Branch, WHO FIC Collaborating Center (DIMDI), IHRS, Ludwig-Maximilians-University, Munich, Germany b Department of Rheumatology and Institute for Physical Medicine, University Hospital Zurich, Switzerland c Department of Physical Medicine and Rehabilitation, Ludwig-Maximilians-University, Munich, Germany d Swiss Paraplegic Research, Nottwil, Switzerland
Abstract Objective To provide an example of how goals of physiotherapy interventions and their typical patterns can be described using the International Classication of Functioning, Disability and Health (ICF). Design Cross-sectional study. Setting Acute hospital. Participants One hundred patients with neurological, musculoskeletal or cardiopulmonary conditions requiring physiotherapy interventions in University Hospital Zurich between January 2003 and October 2003. Main outcome measures The case record form consisted of two parts: a standardised questionnaire for functioning and health of the patient; and a standardised record form for physiotherapy interventions. Both parts were based on the ICF. Results The mean age of the subjects was 58.2 years (standard deviation 15.9), the median age was 60.5 years and 44% were female. The most frequent intervention goals in patients with neurological conditions were: muscle power functions; muscle tone functions; control of voluntary movement functions; changing basic body position; maintaining a body position; and transferring oneself. The most frequent intervention goals for cardiopulmonary patients were: functions of the cardiovascular system; and respiration functions. The most frequent intervention goals in patients with musculoskeletal conditions were: sensation of pain; stability of joint functions; muscle power functions; muscle tone functions; and muscle endurance functions. Conclusion By using the ICF as a framework and linguistic support, intervention goals can serve as standardised documentation for physiotherapy interventions, their evaluation and planning. 2007 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Keywords: Physical therapy (speciality); Documentation; Rehabilitation; Treatment outcome; Goals; ICF
Introduction The outcome of an acute illness or injury depends not only on appropriate medical and surgical care, but also on the recognition of patients needs during rehabilitation. In the acute setting, rehabilitation relates mainly to interventions by nurses and physiotherapists that accompany the
Correspondence: Department of Physical Medicine and Rehabilitation, Ludwig Maximilians University Munich, Marchioninistr. 15, 81377 Munich, Germany. Tel.: +49 89 7095 4050; fax: +49 89 7095 8836. E-mail address: gerold.stucki@med.uni-muenchen.de (G. Stucki).
course of acute medical care [1]. The goals of physiotherapy interventions in the acute setting are to maintain and restore functioning and to prevent functional decline. Typical goals depend on individual patient characteristics such as age, psychosocial factors, health condition and environmental factors. An early onset of interventions and their appropriate management has been demonstrated to improve functional outcome and to prevent the need for long-term care [29]. Physiotherapy interventions are integrated into a continuous and cyclic process. This process involves the identication of problems and needs, the relation of the problems to relevant factors of the person, denition of goals,
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planning of interventions, and assessment of the effects [10]. Goal setting and re-evaluation allows measurement of the result of any intervention. However, one major barrier to the appropriate evaluation of treatment effects is the challenge of describing interventions, namely physiotherapy interventions, in a standardised way. At present, there is no commonly understood terminology that qualies for the description of interventions [11,12]. One approach to classify and standardise physiotherapy interventions is to relate them to their individual goals [13]. The International Classication of Functioning, Disability and Health (ICF) [14] may provide a framework and classication for such a standardised documentation. The ICF provides a model of functioning and a classication to describe and classify functioning, health and disability. While the medical model sees disability as a problem of the individual, caused by injury or disease, the social model denes disability as lack of integration of individuals into society. The ICF unies these two models by looking at functioning not only in association with morbidity, but also in the interaction with personal factors and the environment. Simultaneously, one of the key objectives of the ICF is to provide a universal language for all health professionals. It is likely that the ICF, with its components Body functions and structures, Activities and participation and Contextual factors, will become a universal framework in medicine and, particularly, in rehabilitation. The objective of this study was to describe goals of physiotherapy interventions and their typical patterns using the ICF. Specic objectives were: (1) to identify and quantify the goals of physiotherapy interventions in the acute setting using ICF categories; (2) to describe their most frequent combinations; and (3) to examine the association between limitations and impairment in functioning, expressed as ICF categories, and the corresponding physiotherapy intervention goals.
Methods Study design and study population This cross-sectional study on physiotherapy interventions was part of a larger multicentre, cross-sectional study that has been described in detail elsewhere [15]. In brief, the study population consisted of all patients with neurological, musculoskeletal or cardiopulmonary conditions requiring physiotherapy interventions at University Hospital Zurich between January 2003 and October 2003 who gave informed consent. Patients were recruited from predened acute and intensive care wards. Measures The case record form used in this study consisted of two parts: a standardised questionnaire for functioning and health of the patient; and a standardised record form for physiother-
apy intervention goals. Both parts are based on the ICF and its notation. The ICF describes the human within his/her physical, social and psychological environment. By including all these factors, the ICF complements the International Classication of Disease-10 [16] which provides a classication system for diagnoses and causes of death. The ICF consists of four components. The rst component refers to body functions and body structures as physiological functions, such as mobility of joints and anatomical parts such as tendons. The second component is about activity and participation, and refers to task execution by individuals. Activity is the execution of a task, e.g. using a telephone, and participation describes the involvement of individuals in real-life situations, e.g. in the community, at home or at the workplace. The third component is about environmental factors and describes external inuences on functioning, e.g. food, devices, policies, or ora and fauna. The fourth component, personal factors, describes internal inuences on functioning, e.g. gender, age or lifestyle, but is not yet classied. The ICF has two parts, each containing two separate components. Part 1 covers functioning and disability, and includes the components Body functions (b), Body structures (s) and Activities and participation (d). Part 2 covers contextual factors and includes the components Environmental factors (e) and Personal factors (Fig. 1). In the ICF classication, the letters b, s, d and e, which refer to the components of the classication, are followed by a numeric code starting with the chapter number (one digit) followed by the second level (two digits), and the third and fourth level (one digit each). ICF categories are nested [14] so that ICF chapters are dened to include the more detailed second-level ICF categories (Box 1 ). Twenty-six ICF second-level categories, included in all three condition-specic acute ICF core sets, were used to document functioning and health of the patients [1719]. These core sets are selections of second-level ICF categories that have been developed in a comprehensive consensus process [20], and which are the most relevant components of functioning for patients in the acute setting. Interviewers were advised to record limitations or impairments as present or absent due to the condition that had been the reason for hospitalisation.
Fig. 1. International Classication of Functioning, Disability and Health model.
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Box 1: Example for the International Classication of Functioning, Disability and Health hierarchy: muscle power function b7 Neuromusculoskeletal and movement-related functions b730 Muscle power functions b7300 Power of isolated muscles and muscle groups b7301 Power of muscles of one limb b7302 Power of muscles of one side of the body b7303 Power of muscles in lower half of the body b7304 Power of muscles of all limbs b7305 Power of muscles of the trunk b7306 Power of all muscles of the body b7308 Muscle power functions, other specied b7309 Muscle power functions, unspecied A standardised case record form based on the ICF categories was developed by four experienced therapists (physical therapist, occupational therapist, nutritionist, speech therapist) from University Hospital Zurich to record the goals of physiotherapy interventions. Based on the average number of prescribed physiotherapy interventions over the last 6 months, the most frequent and common interventions were identied. An ICF category was included as an intervention goal if there was a specic intervention aimed at prevention or therapy of this specic category, e.g. respiratory therapy with its many therapeutic possibilities all aiming at respiration functions. The nal questionnaire comprised 73 intervention goals, expressed as second-level ICF categories. All intervention goals could be found within the ICF framework, and all were ICF categories of the components Body functions and Activities and participation. Data collection and quality assurance The interviews were held and the patients were treated by health professionals trained in the application and principles of the ICF. Interviewers were trained during a structured 1-day meeting and provided with a manual. Before each interview started, the medical record sheet was checked. If information was not obtainable from the patient, health professionals of the relevant wards or relatives were asked. Each interviewer was asked to check the data-collection form immediately after the interview to correct unclear statements and to add comments. All data forms were checked by a second person for completeness and plausibility. Data analysis Absolute and relative frequencies were reported to quantify the goals of physiotherapy interventions. Absolute frequency is the observed number of goals for the sample, and relative frequency is the observed proportion of goals among all goals.
In order to analyse the association between perceived impairments and limitations in functioning and the prevalence of intervention goals, the absolute and relative frequencies of patients reporting an impairment or a limitation in the 26 ICF categories, and receiving or not receiving an intervention aimed at these categories, was calculated. Likewise, the absolute and relative frequencies of patients not reporting an impairment but receiving an intervention aimed at these categories were also calculated. Only those intervention goals that had a relative frequency of 50% or more were taken into account to describe the most frequent combinations.
Results One hundred patients were included; 50 with neurological conditions, 20 with cardiopulmonary conditions and 30 with musculoskeletal conditions. The mean age was 58.2 years (standard deviation (SD) 15.9), the median age was 60.5 years, and 44% were female. For the neurological conditions, the mean age was 55.3 years (SD 16.9), the median age was 58.0 years, and 36% were female. For musculoskeletal conditions, the mean age was 57.1 years (SD 14.9), the median age was 58.5 years, and 63% were female. For cardiopulmonary conditions, the mean age was 65.1 years (SD 13.2), the median age was 68.5 years, and 35% were female. The mean number of days since the event was 19.8 (SD 23.9). Leading diagnoses are shown in Table 1. Physiotherapy interventions Ninety-seven percent of the patients received physiotherapy. Patients with neurological conditions had a higher
Table 1 Most frequent diagnoses responsible for inpatient stay (International Classication of Disease-10) (n = 100) Condition responsible Neurological (n = 50) Diagnosis Cerebrovascular disease (I60I69) Malignant neoplasms (C00C97) Cerebral palsy and other paralytic syndromes (G80G83) Injuries to the head and unspecied multiple injuries (S00S09, T07) Diseases of the circulatory system (I10I59, I70I99) Diseases of the musculoskeletal system and connective tissue (M00M99) Injuries (exclusive injuries to the head) and unspecied multiple injuries (S10S99, T07) Patients (%) 41 25 10
10
Cardiopulmonary (n = 20)
88
Musculoskeletal (n = 30)
70
26
R. Mittrach et al. / Physiotherapy 94 (2008) 150157 Table 2 Median of intervention goals per patient Neurological conditions (n = 50) Body functions (min., max.) Activities and participation (min., max.) Total (min., max.) 11 (0, 28) 7 (0, 15) 18 (0, 43) Cardiopulmonary conditions (n = 20) 8.5 (3, 30) 3.5 (0, 9) 12.5 (4, 36)
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Musculoskeletal conditions (n = 30) 7 (3, 17) 3 (0, 5) 10 (3, 22)
Table 3 Therapeutic intervention goals expressed as International Classication of Functioning, Disability and Health (ICF) categories (body functions): relative frequency of patients receiving physiotherapy interventions aimed at the corresponding ICF category ICF code b114 b130 b140 b144 b152 b156 b160 b167 b172 b176 b210b229 b230b249 b250b279 b280 b310 b320 b330 b340 b410b429 b440 b445 b450 b460 b510 b515 b525 b530 b535 b540 b620 b630 b710 b715 b720 b730 b735 b740 b750 b755 b760 b765 b770 b780 b810b849 b850b869 ICF code description Orientation functions Energy and drive functions Attention functions Memory functions Emotional functions Perceptual functions Thought functions Mental functions of language Calculation functions Mental function of sequencing complex movements Seeing and related functions Hearing functions Additional sensory functions Sensation of pain Voice functions Articulation functions Fluency and rhythm of speech functions Alternative vocalisation functions Functions of the cardiovascular system Respiration functions Respiratory muscle functions Additional respiratory functions Sensations associated with cardiovascular and respiratory functions Ingestion functions Digestive functions Defaecation functions Weight maintenance functions Sensations associated with the digestive system General metabolic functions Urinary functions Sensations associated with urinary functions Mobility of joint functions Stability of joint functions Mobility of bone functions Muscle power functions Muscle tone functions Muscle endurance functions Motor reex functions Involuntary movement reaction functions Control of voluntary movement functions Involuntary movement functions Gait pattern functions Sensations related to muscles and movement functions Functions of the skin Functions of the hair and nails Neurological conditions n = 50 (%) 38 28 46 10 8 72 8 16 40 22 32 52 16 10 8 4 4 14 26 16 16 4 12 2 2 8 2 2 2 26 70 8 80 82 64 8 56 84 38 60 44 12 2 Cardiopulmonary conditions n = 20 (%) 30 10 15 5 20 10 5 15 15 5 15 85 80 65 60 65 5 5 5 10 5 15 45 35 30 55 45 55 15 15 10 10 30 15 10 5 Musculoskeletal conditions n = 30 (%) 7 7 37 13 17 80 10 17 7 3 10 70 83 13 77 77 77 3 3 37 3 50 50 3 3
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Table 4 Therapeutic intervention goals expressed as International Classication of Functioning, Disability and Health (ICF) categories (activity and participation): relative frequency of patients receiving physiotherapy interventions aimed at the corresponding ICF category ICF code d310 d315 d320 d325 d330 d335 d340 d345 d350 d355 d360 d410 d415 d420 d430 d435 d440 d445 d450 d455 d460 d465 d510 d520 d530 d540 d550 d560 ICF code description Communicating with receiving spoken messages Communicating with receiving non-verbal messages Communicating with receiving formal sign language messages Communicating with receiving written messages Speaking Producing non-verbal messages Producing messages in formal sign language Writing messages Conversation Discussion Using communication devices and techniques Changing basic body position Maintaining a body position Transferring oneself Lifting and carrying objects Moving objects with lower extremities Fine hand use (picking up, grasping) Hand and arm use Walking Moving around Moving around in different locations Moving around using equipment Washing oneself Caring for body parts Toileting Dressing Eating Drinking Neurological conditions n = 50 (%) 36 22 22 6 4 16 8 2 80 78 78 20 18 28 64 60 14 30 18 6 6 8 24 6 10 Cardiopulmonary conditions n = 20 (%) 25 20 5 10 15 10 35 30 20 15 10 20 55 30 5 5 5 Musculoskeletal conditions n = 30 (%) 60 63 47 10 7 17 43 10 7 3
number of different intervention goals (n = 18) than patients with cardiopulmonary (n = 12.5) or musculoskeletal (n = 10) conditions (Table 2). Thirteen of 73 intervention goals were prevalent in the three health conditions in more than 75% of the patients. The
most frequent intervention goals in patients with neurological conditions were: muscle power functions; muscle tone functions; control of voluntary movement functions; changing basic body position; maintaining a body position; and transferring oneself. The most frequent intervention goals for
Fig. 2. Two main combinations of International Classication of Functioning, Disability and Health intervention goals and other frequent combinations.
Table 5 Association between limitations and impairment in functioning and the corresponding physiotherapy intervention goals
ICF category Content n n impaired (% of impaired receiving intervention for this category) Neurological b114 b156 b280 b410 b440 b445 b460 Orientation functions Perceptual functions Sensation of pain Heart functions Respiration functions Respiratory muscle functions Sensations associated with cardiovascular and respiratory functions Defaecation functions Mobility of joint functions Muscle power functions Muscle tone functions Muscle endurance functions Sensations related to muscles and movement functions Changing basic body position Maintaining a body position Transferring oneself Lifting and carrying objects Fine hand use (picking up, grasping) Hand and arm use Walking Washing oneself Caring for body parts Toileting Dressing Eating Drinking 91 91 99 99 100 99 89 16 (56%) 31 (29%) 8 (100%) 7 (0%) 13 (77%) 8 (63%) 1 (100%) Cardiopulmonary 6 (33%) 2 (0%) 3 (100%) 17 (88%) 16 (75%) 13 (77%) 12 (92%) Musculoskeletal 11 (0%) 24 (96%) 3 (67%) 5 (40%) 2 (100%) n not impaired (% of not impaired receiving intervention for this category) Neurological 27 (19%) 12 (25%) 41 (39%) 42 (12%) 37 (8%) 41 (10%) 41 (17%) Cardiopulmonary 13 (8%) 16 (25%) 17 (65%) 3 (100%) 4 (50%) 7 (0%) 6 (100%) Musculoskeletal 29 (3%) 19 (21%) 6 (67%) 27 (4%) 25 (16%) 28 (14%) 29 (14%)
b525 b710 b730 b735 b740 b780 d410 d415 d420 d430 d440 d445 d450 d510 d520 d530 d540 d550 d560
100 100 100 100 98 91 100 100 100 96 100 69 97 100 100 100 100 100 100
1 (0%) 23 (70%) 40 (98%) 41 (100%) 32 (94%) 17 (65%) 40 (78%) 39 (74%) 38 (82%) 10 (60%) 14 (86%) 23 (48%) 30 (83%) 3 (100%) 3 (33%) 4 (100%) 12 (100%) 3 (100%) 5 (80%)
1 (100%) 9 (44%) 11 (73%) 9 (56%) 10 (90%) 3 (33%) 7 (43%) 6 (0%) 4 (75%) 3 (67%) 2 (50%) 10 (20%) 1 (100%) 1 (100%)
21 (100%) 23 (100%) 23 (96%) 23 (87%) 15 (67%) 18 (100%) 19 (95%) 14 (86%) 3 (100%) 4 (25%) 13 (92%) 1 (100%)
49 (49%) 27 (19%) 10 (60%) 9 (56%) 18 (83%) 25 (36%) 10 (20%) 11 (27%) 12 (25%) 40 (72%) 36 (69%) 15 (53%) 20 (85%) 47 (70%) 47 (68%) 46 (70%) 38 (66%) 47 (51%) 45 (29%)
19 (32%) 11 (18%) 9 (67%) 11 (18%) 8 (100%) 16 (44%) 13 (38%) 14 (43%) 16 (37%) 16 (50%) 18 (28%) 4 (0%) 8 (75%) 19 (42%) 20 (30%) 20 (30%) 19 (37%) 20 (30%) 20 (25%)
30 (40%) 9 (100%) 7 (86%) 7 (86%) 7 (71%) 15 (80%) 12 (100%) 11 (91%) 16 (87%) 24 (92%) 30 (23%) 23 (9%) 16 (94%) 30 (53%) 30 (30%) 30 (33%) 29 (76%) 30 (20%) 30 (10%)
This reads as follows: 16 neurological patients reported impairment in orientation functions, and of those, 56% received physiotherapeutic intervention aiming at this impairment; 27 neurological patients were not impaired in orientation functions, and of those, 19% received physiotherapeutic intervention aiming at this impairment.
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cardiopulmonary patients were: functions of the cardiovascular system; and respiration functions. The most frequent intervention goals in patients with musculoskeletal conditions were: sensation of pain; stability of joint functions; muscle power functions; muscle tone functions; and muscle endurance functions (see Tables 3 and 4). The two most frequent combinations of intervention goals were: stability of joint functions/muscle power functions with muscle tone functions; and changing basic body position/maintaining a body position with transferring oneself. These two combinations were also associated with several other intervention goals. Fig. 2 shows the combinations along with their frequencies and further associated intervention goals. The association between limitations and impairment in functioning, expressed as ICF categories, and the corresponding physiotherapy intervention goals is shown in Table 5. Activities of daily living, such as washing oneself, toileting, dressing and eating, and the body functions, sensation of pain, muscle power functions and muscle endurance functions, were most frequently addressed by interventions when limited or impaired. There were, however, some patients who received interventions aimed at unimpaired categories such as muscle power, transfer and mobility issues.
Discussion This study provides an example of how physiotherapy intervention goals in the acute setting and their typical patterns can be identied, quantied and analysed using ICF categories. A range of intervention goals plausible for patients in the acute setting was found. Neuromusculoskeletal and movement-related functions and activities are the rst goals of early interventions for all patients in the acute setting because these functions are the rst to suffer from immobilisation. A Delphi process among physiotherapists gave similar results [13]. At the same time, these functions are preconditions for self-care activities. Additionally, most patients with neurological conditions received interventions aimed at mental functions such as attention and perceptual functions. This is in line with the complex effects of physiotherapy interventions described previously [2123]. Two major patterns of intervention goals could be detected. One dealt with power and stability of muscles and joints, and the other dealt with postural control and transfer. Both are sound descriptions of physiotherapy packages. In combination with further typical goals, such as muscle endurance or control of voluntary movement functions, they give a good impression of patterns and the purpose of physiotherapy in the acute setting [24,25]. Most patients reporting a specic problem did receive the corresponding physiotherapy intervention. To give an example, in more than 90% of the neurological patients, functions of muscle power, muscle endurance, muscle tone and the
sensation of pain were reported intervention goals if these functions were a problem. Patients reporting problems in multifaceted issues such as walking or lifting/carrying objects but not receiving the corresponding intervention may have been too frail or still in a very acute stage of disease. A moderate proportion of patients received interventions aimed at goals that were not reported as problems. Muscle power and muscle endurance functions are most likely to be treated to prevent further damage or loss in functioning, even without a prevalent problem [2527]. It is of great importance to keep track of functions at risk and of preventive interventions. Thus, physiotherapeutic records are vital to acknowledge not only the impairment but also the potential for loss of functioning. Additionally, some intervention goals may be secondary effects inseparable from the main goal. To give an example, an exercise such as improving hip and knee mobility with the help of the hands will also strengthen the arm muscles. Clinical stereotypes and routines in prescribing physiotherapy interventions can serve as another explanation for interventions. Several limitations of this study need to be considered. Interviewer bias may have been an issue, since evaluation of goals and functioning is subject to error. Appropriate training and supervision of interviewers, however, was provided before and during the study, so the authors are condent that this source of bias was minimised. Pretests showed that reliability of ICF category coding is good. Interviewers reported intervention goals, not interventions. Different therapists performing the same intervention, however, may have different goals in mind [11]. Translation of physiotherapy interventions into a common standardised language still remains a major challenge. However, this study demonstrated that goals of physiotherapy interventions can be documented plausibly with the help of ICF categories. This study may have captured intervention goals without the necessary precision. The second-level categories of the ICF, used throughout this study, may not be sufciently detailed for daily and profession-specic documentation. With the use of the third and fourth levels of the ICF categories, however, a more detailed and specic documentation is possible. To give an example, the combination of the two ICF codes b7100.3 (mobility of a single joint severe impairment) and s75011.371 (structure of the knee joint severe impairment qualitative changes in structure right side) can describe a severe mobility impairment of the right knee exactly. With the code b28016.1 (pain in joints mild impairment), information about pain is added. Routine use, however, of the deeper levels of the ICF is not possible in clinical settings and should be reserved for situations where the most detailed description is actually warranted.
Conclusion Focusing on intervention goals to classify physiotherapeutic interventions and using the ICF as a classication tool
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has several advantages. First, if an intervention is inseparable from its goals, there may be several interventions with the same goal, and every health professional will choose the most appropriate intervention depending on the goal to be achieved. Second, a commonly understood taxonomy of intervention goals can be a start for improved goal setting and communication between health professionals in the acute setting. Third, detailed documentation of intervention goals helps to unravel the black box of physiotherapy [11] and improve evidence-based clinical practice. By using the ICF as a framework and linguistic support, intervention goals can serve as standardised documentation for interventions, their evaluation and planning. Simultaneously, because of the universality of the ICF as a commonly accepted classication, intervention goals can also be communicated to all health professionals working in the acute setting. Ethical approval: None required. Conict of interest: None.
References
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Nasal inspiratory pressure as an indirect measurement of respiratory muscle strength measured during SNIP and Psn methods in healthy subjects and subjects with motor neurone disease
S. McNally b,c, , P. Brennan a , M. Hussey b , P. Goodman b , R.W. Costello c
b a Department of Neurology, Beaumont Hospital, Dublin 9, Ireland School of Physics, Dublin Institute of Technology, Kevin Street, Dublin 7, Ireland c Department of Medicine, Beaumont Hospital, Dublin 9, Ireland
Abstract Objective To investigate the difference in nasal inspiratory pressure as an indirect measurement of inspiratory muscle strength when the established sniff nasal inspiratory method (SNIP) is compared with a novel method of SNIP application known as Psn. Design A prospective, correlational design using two different techniques in random order at the same session. Setting Multidisciplinary clinic in a regional hospital. Participants Fifty-two normal healthy individuals from hospital staff and family members, as controls, and a group of 25 subjects with motor neurone disease (MND) recruited from a specialised MND clinic. Interventions In both SNIP and Psn, a measuring nasal bung is placed in one nostril. In SNIP, the contralateral nostril is unoccluded, and in Psn, the contralateral nostril is occluded. Main outcome measures Inspiratory nasal pressure (cmH2 O). Six consecutive measurements of SNIP and Psn were carried out on each subject through both the right and left nostrils, each conducted by the same operator. Results Data were analysed from 52 control subjects and 25 subjects with MND. Five patients were unable to produce acceptable and reproducible SNIP data, and one control subject was unable to perform Psn. Bland and Altman plots were used to determine the level of agreement between the two sets of measurements. The two methods of nasal inspiratory testing showed a relatively good level of agreement; the inspiratory pressure measured using SNIP was lower than that measured using Psn [mean difference: control subjects 12.3 cmH2 O (limits of agreement 9.2 to 32.9); subjects with MND 20.3 cmH2 O (limits of agreement 4.6 to 45.1)]. These results suggest that both methods of application are useful in the detection of respiratory muscle strength. However, Psn yielded signicantly higher values. Conclusion Psn may be used to complement SNIP in the evaluation of respiratory muscle testing of patients, particularly in those patients who have signicant bulbar weakness throughout disease progression. Thus, Psn may be more informative in advanced disease. However, the lack of published reference values to date for Psn may limit its utility as a diagnostic or serial measurement tool in the short term. 2007 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Keywords: Respiratory muscle strength; Sniff nasal inspiratory pressure; Motor neurone disease
Introduction Sniff nasal inspiratory pressure (SNIP) has become increasingly popular for the measurement of inspiratory muscle strength in both neuromuscular and skeletal disorders. Snifng through a nostril using a volitional manoeuvre elim Corresponding author at: School of Health Sciences, The Robert Gordon University, Aberdeen AB10 7QG, UK. Fax: +44 1224 263000. E-mail address: 0609775@rgu.ac.uk (S. McNally).
inates the use of orofacial muscles, and is easily performed by most patients in a clinical setting. In one of the earlier studies detailing SNIP measurement, the authors used a method where a nasal bung was placed in one nostril and the contralateral nostril remained unoccluded [1]. Subjects then proceeded to exhale to functional residual capacity followed by a short sharp maximal sniff, thus producing a measurable peak pressure. SNIP has signicantly increased the diagnostic abilities in this area of respiratory assessment. Measurement of SNIP
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has gained importance due to its simplicity and utility in the laboratory and in clinical and bedside settings to assess the strength of the respiratory muscles [27]. However, in clinical practice, this method may have limitations with disease progression, especially in patients with pronounced orofacial or bulbar muscle weakness where coordination of muscle activation may be reduced. When using the method with the contralateral nostril unoccluded, many patients tend to open their mouth during maximal SNIP. This is increasingly evident in the bulbar population. In contrast, where both nostrils are occluded, in the method known as Psn, results seem to be more reproducible and less problematic in obtaining dependable measurements. A previous study highlighted the use of an occluded nasal sniff and compared this with phrenic nerve stimulation. It concluded that the results were similar [8]. Phrenic nerve stimulation is an important measure of respiratory muscle strength, but it is invasive. In addition, with disease progression, the coordination of muscle activation required to achieve SNIP becomes more important. Previous authors have documented that in severe disease, a more sustained manoeuvre may achieve a greater pattern of inspiratory muscle activation [9]. The guidelines for respiratory muscle testing suggest that sniffs can be achieved only when one or both nostrils are unoccluded, to allow the passage of air [10]. Furthermore, the guidelines suggest an occluded sniff may be called a gasp, and is more difcult for subjects to perform reproducibility. The primary aim of the present study was to determine the levels of agreement between both methods of testing SNIP in normal subjects. The secondary aim was to determine any measurable difference between the two techniques in a group of subjects with motor neurone disease (MND). The problems encountered with disease progression, especially in the latter stages of MND where subjects may have signicant orofacial and bulbar weakness, may reduce the effectiveness of SNIP. Thus, many important interventions such as the accurate timing of non-invasive ventilation may be delayed. A more equal pattern of respiratory muscle activation may aid the overall prognostic information required for the appropriate clinical management of subjects with MND.
from a specialised multidisciplinary MND clinic. None of these 25 subjects had performed either SNIP or Psn before the study commenced. Subjects were at different stages of disease progression. Seventeen of the 25 patients who participated in the study were diagnosed as bulbar MND and the remaining eight as limb MND. All tests were performed by the same experienced operator, and tests were conducted in a random order. Sniff nasal inspiratory pressure Both SNIP and Psn were measured from functional residual capacity in subjects in a sitting position, connected to a Micromedical manometer. However, where SNIP consisted of a rapid generation of pressure (less than 1 second), Psn was more sustained and prolonged (more than 1 second and less than 2 seconds). During all manoeuvres, subjects were provided with both visual and audible feedback [11]. For each measurement, six acceptable and reproducible manoeuvres were performed with a 1-minute rest between tests. Acceptable and reproducible measurements consisted of performance from functional residual capacity where a rapid sharp SNIP was performed to total lung capacity for maximal values to be obtained. Six efforts were performed to achieve replication of test results, and the highest value of the six efforts with a maximum of 5% variability was documented. A learning effect of both testing methods had been observed previously, so prior to testing, subjects were familiarised with both techniques by performing four additional trials to eradicate a potential bias of testing. In addition, depending on the results obtained during the familiarisation of trials, testing was conducted in one nostril (right or left) where the greatest pressure was obtained in conjunction with patient/subject preference to minimise the effects or inuence of the nasal cycle on the results obtained. Thus, in total, 12 tests were performed for the purposes of the study; six using the SNIP method and six using the Psn method. Statistical analysis Data were averaged and expressed as mean and standard deviation (S.D.) for all measurements conducted (i.e. six measurements for SNIP and six measurements for Psn). The statistical test by Bland and Altman [12] was utilised for assessing agreement between the more established SNIP and the alternative method of Psn was performed, using the mean of each measurement separately. All statistical analyses were performed using MedCalc for Windows, Version 9.2.0.0 (MedCalc Software, Mariakerke, Belgium).
Materials and methods Population Fifty-two normal control subjects were included in the current study. Subjects were recruited over a 2-month period, until a general age spread from 18 to 80 years was established. Exclusion criteria for the normal control subjects included neuromuscular disease, cardiopulmonary disease, less than 18 years of age or any chronic disease. Data on gender, height and method of sniff nasal pressure measurement were recorded. Testing of subjects with MND with variable disease progression was also performed in 25 subjects recruited
Results Measurements were made on 52 normal control subjects and 25 subjects with MND (Table 1). All participants agreed to perform two sets of measurements in their dominant nostril.
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Table 1 Summary statistics of control subjects and patients with motor neurone disease Variables Control subjects Men (n = 24) Mean Age (years) Height (cm) SNIP (cmH2 O) Psn (cmH2 O) 45.4 176.9 112.4 126.6 S.D. 15.1 8.4 25.3 27.0 Women (n = 28) Mean 42.5 160.7 91.9 101.7 S.D. 12.4 7.4 15.3 14.3 Subjects with MND Men (n = 11) Mean 60.7 176.6 66.3 84.6 S.D. 11.0 3.2 28.5 24.2 Women (n = 14) Mean 62.3 164.2 35.5 59.1 S.D. 8.4 5.2 16.8 16.9
MND, motor neurone disease; SNIP, sniff nasal inspiratory pressure; Psn, sniff nasal pressure; S.D., standard deviation.
Comparison of SNIP and Psn in control subjects In the control subjects, the mean (S.D.) age for men and women was 45.4 (15.1) years and 42.5 (12.4) years, respectively. Mean SNIP was 101.4 cmH2 O [95% condence interval (CI): 95.0 to 107.7] and mean Psn was 113.7 cmH2 O (95% CI: 106.5 to 120.9). In males, mean SNIP was 112.4 cmH2 O (25.3) and mean Psn was 126.6 cmH2 O (27.0). In females, mean SNIP was 91.9 cmH2 O (15.3) and mean Psn was 101.7 cmH2 O (14.3). Limits of agreement between SNIP and Psn were measured using Bland and Altman plots, and results show a relatively good level of agreement. Fig. 1 is a Bland and Altman plot which suggests that, in healthy subjects, measurements using Psn will be, on average, 12.3 (10.9) cmH2 O higher than when taken using SNIP, and on 95% of occasions, the measurements using Psn will lie between 9.2 cmH2 O lower and 32.9 cmH2 O higher than those taken using SNIP. Comparison of SNIP and Psn in subjects with MND In subjects with MND patients, the mean (S.D.) age for men and women was 60.7 (11.0) years and 62.3 (8.4) years, respectively. Mean SNIP was 51 cmH2 O (95% CI: 40.2 to 61.7) and mean Psn was 70.52 cmH2 O (95% CI: 60.6 to 80.3). In males, mean SNIP was 66.3 cmH2 O (28.5) and mean Psn was 84.6 cmH2 O (24.2). In females, mean SNIP was 35.5 cmH2 O (16.8) and mean Psn was 59.1 cmH2 O (16.9).
Fig. 2. BlandAltman plot: difference between sniff nasal inspiratory pressure (SNIP) and sniff nasal pressure (Psn) plotted against the mean of these two variables (subjects with motor neurone disease patients, n = 25).
Fig. 2 is a Bland and Altman plot which shows that, in subjects with MND, measurements using Psn will be, on average, 20.3 (12.7) cmH2 O higher than when taken using SNIP, and on 95% of occasions, the measurements using Psn will lie between 4.6 cmH2 O lower and 45.1 cmH2 O higher than those taken using SNIP. These results suggest a poor level of agreement between the two methods in MND patients.
Discussion This study was designed to establish the compatibility of two methods of measuring inspiratory muscle strength in both normal subjects and a group of subjects with MND with variable extents of disease progression. The main ndings can be summarised as follows: rstly, in control subjects, the variation coefcients for SNIP and Psn were similar, and the level of agreement between both tests was relatively good, suggesting that Psn may be used for respiratory muscle strength assessment in patients free from neuromuscular disease; and secondly, although there was a positive correlation between SNIP and Psn in subjects with MND there was relatively poor agreement. This study represents the rst assessment of an alternative method of application for its feasibility and usefulness in both a normal healthy group of subjects and a small group of subjects with MND. To accomplish this, both the absolute values obtained in each method and the agreements of these values with consecutive measurements were com-
Fig. 1. BlandAltman plot: difference between sniff nasal inspiratory pressure (SNIP) and sniff nasal pressure (Psn) plotted against the mean of these two variables (control subjects, n = 52).
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pared from one visit. This study demonstrated that the Psn method of testing is a valid and easy method to measure respiratory muscle strength in normal healthy subjects. Recently, a study concluded that having multiple tests of respiratory muscle function available both increases diagnostic precision, and makes assessment possible in a range of clinical circumstances [13]. Comparison of the conventional method of testing which involves placing a nasal bung in one nostril with the contralateral nostril unoccluded showed positive correlation and relatively good agreement. These data suggest that Psn is as useful as SNIP in monitoring respiratory muscle strength in both normal subjects and subjects with MND. However, without additional published reference values for Psn, its suitability for testing subjects with MND remains unclear. The reasons for this lack of agreement are unknown. It could be that the ability of the eustachian tube to equalise negative pressure, together with the intentional leak of the device during the more sustained method, reduces the apparent overestimation shown previously while performing a occluded rapid sniff or gasp over shorter periods. Pressure equalisation of positive pressure is usually done without much effort by either passive pressure opening or active muscular opening of the tube. Negative pressure is more difcult to equalise and requires active dilation of the tube by muscular contraction, which occurs while performing the occluded Psn method. Comparing the present study with other published articles [17], it is important to raise some methodological considerations. Firstly, the method of application while performing the Psn test departed from standard practice. Although the guidelines state that in an occluded inspiratory effort, the pressure measured in the upper airways often exceeds the simultaneous intrathoracic pressure and thereby overestimates inspiratory muscle strength, this was not evident in the present study and thus requires further comparison studies to establish this effect [10]. Many subjects with MND produced spuriously low values while performing the SNIP method, and results did not correlate well with patient symptoms. A previous study reported that many factors contributing to low values in bulbar patients include upper airway collapse and discoordinated/dyspractic contraction of the various respiratory muscles during the tests, both of which would mainly affect the dynamic manoeuvres such as the sniff test [14]. Discoordination of orofacial musculature in particular while performing the SNIP test was observed in both bulbar and non-bulbar patients in this study. This weakness in advanced disease has the potential to lead to air leaks through air being sucked through the mouth, which results in poor performance and lower values. In comparison, the occluded method allows for a more controlled evaluation using a closed circuit, thus eliminating the air sucking that usually occurs with the standard SNIP method through orofacial muscle weakness and disease progression in MND. However, it is important to document any proposed changes from standard practice which may, in the future, aid the testing of patients with respiratory muscle weakness.
SNIP performed through one nostril with the contralateral nostril unoccluded is generated during a ballistic manoeuvre where the inspiratory muscles shorten to a greater extent and at a higher speed than during the proposed alternative method, which is probably a more sustained isometric task, similar to the established Muller manoeuvre. In addition, although a similar method to maximal inspiratory pressure, the use of Psn avoids all possibility of using the cheeks. Thus, A more sustained manoeuvre may achieve a greater pattern of inspiratory muscle activation in severely affected patients [9]. The authors believe that this explains why a large proportion of bulbar patients were able to perform the technique in a previous study [7]. Since there is no airow present using Psn compared with SNIP, Psn is a static measurement and requires an intentional leak to prevent glottic closure. In addition, the guidelines state that respiratory muscle strength performed through one nostril with the contralateral nostril occluded, such as Psn, is not a reproducible method of obtaining indirect measurements of respiratory muscle strength [10]. However, this was not apparent in the present study, where the replications of tests performed were similar to SNIP. To use the results obtained in this study clinically, all measurements of Psn would need to be repeated six times in either nostril and averaged to achieve information similar to that presented.
Conclusion Sniff nasal inspiratory testing remains one of the most widely used techniques to assess functional capacity and conrm a diagnosis of respiratory muscle weakness. As patients with advanced disease tend to make poor efforts using SNIP and often need encouragement, it was noted that occlusion of the contralateral nostril permitted detection of nasal alae contraction, and thus permitted encouragement of maximal inspiratory efforts without sucking air through the mouth. This study found that both techniques provide essential information in the assessment of respiratory muscle weakness in MND when administered and supervised by trained and qualied personnel. Both manoeuvres, SNIP and Psn, generate a pressure that is a reection of complex interactions between several muscle groups, since the efforts produce different mechanisms of activity. Thus, when comparing measurements of SNIP and Psn, a 12 cmH2 O mean difference in normal control subjects and 20 cmH2 O mean difference in subjects with MND is likely to occur, with Psn achieving the higher values. Using the limits of agreement, on 95% of occasions, measurements of Psn will be between 9.2 cmH2 O lower and 32.9 cmH2 O higher than SNIP in healthy subjects, and Psn will be between 4.6 cmH2 O lower and 45.1 cmH2 O higher than SNIP in subjects with MND. What are acceptable limits of agreement when comparisons are made with a test to measure respiratory muscle function? Many researchers in this eld have found this question difcult. However, it is
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a question that needs to be addressed if future publications on validating the use of respiratory tests are to be of true scientic worth. According to Bland and Altman, We want to know by how much the new method is likely to differ from the old: if this is not enough to cause problems in clinical interpretation we can replace the old method by the new or use the two interchangeably. In addition, using the Bland and Altman analogy, if the SNIP and Psn method were unlikely to give readings that differed by more than, say, 10 cmH2 O, SNIP could be replaced by Psn because such a small difference would not affect decisions on patient management. On the other hand, if the methods differed by 30 cmH2 O, Psn would be unlikely to be satisfactory. How far apart measurements can be without causing difculties will be a question of judgment; moreover, although the results suggest that the two methods are not interchangeable, Psn is a well-tolerated and valuable procedure, and should be included in the overall non-invasive evaluation of respiratory muscle weakness. In addition, it is important that the different application of pressures generated in this study be clearly understood and utilised in a similar fashion. Without reference values, there is a reduction in the utility of the Psn measurement as a diagnostic or discriminatory tool. In conclusion, further studies are required to determine reference values to enable the use of Psn as a serial measurement in the overall assessment of subjects with MND. Ethical approval: Dublin Institute of Technology Ethics Committee. Funding: None. Conict of interest: None.
References
[1] Heritier F, Perret C, Fitting JW. Esophageal and mouth pressure during sniffs with and without nasal occlusion. Respir Physiol 1991;86:30513. [2] Stefanutti D, Benoist MR, Scheinmann P, Chaussain M, Fitting JW. Usefulness of sniff nasal pressure in patients with neuromuscular or skeletal disorders. Am J Respir Crit Care Med 2000;162:150711. [3] Stefanutti D, Fitting JW. Sniff nasal inspiratory pressure. Reference values in Caucasian children. Am J Respir Crit Care Med 1999;159:10711. [4] Fitting JW. Sniff nasal inspiratory pressure: simple or too simple? Eur Respir J 2006;27:8813. [5] Fitting JW. Some methodological considerations pertaining to sniff nasal inspiratory pressure (SNIP). Am J Respir Crit Care Med 2005;172:9323 [author reply 933]. [6] Fitting JW, Paillex R, Hirt L, Aebischer P, Schluep M. Sniff nasal pressure: a sensitive respiratory test to assess progression of amyotrophic lateral sclerosis. Ann Neurol 1999;46:88793. [7] Morgan RK, McNally S, Alexander M, Conroy R, Hardiman O, Costello RW. Use of sniff nasal-inspiratory force to predict survival in amyotrophic lateral sclerosis. Am J Respir Crit Care Med 2005;171:26974. [8] Esau SA, Bye PT, Pardy RL. Changes in rate of relaxation of sniffs with diaphragmatic fatigue in humans. J Appl Physiol 1983;55:7315. [9] Hart N, Polkey MI, Sharshar T, Falaize L, Fauroux B, Raphael JC, et al. Limitations of sniff nasal pressure in patients with severe neuromuscular weakness. J Neurol Neurosurg Psychiatry 2003;74:16857. [10] American Thoracic Society/European Respiratory Society. ATS/ERS statement on respiratory muscle testing. Am J Respir Crit Care Med 2002;166:518624. [11] Laporta D, Grassino A. Assessment of transdiaphragmatic pressure in humans. J Appl Physiol 1985;58:146976. [12] Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:30710. [13] Steier J, Kaul S, Seymour J, Jolley C, Rafferty GF, Man WD, et al. The value of multiple tests of respiratory muscle strength. Thorax 2007;62:97580. [14] Uldry C, Janssens JP, de Muralt B, Fitting JW. Sniff nasal inspiratory pressure in patients with chronic obstructive pulmonary disease. Eur Respir J 1997;10:12926.
Effect of spectators on the performance of a physiotherapy exercise

Jeremy Walsh , Geraldine Gill
Discipline of Physiotherapy, Trinity College Dublin, Trinity Centre, St. Jamess Hospital, Dublin 8, Ireland
Abstract Objective To investigate the effect of spectators on the performance of a physiotherapy exercise. Design Observational study. Setting Research laboratory, Trinity College Dublin. Participants Forty adult volunteer subjects (36 females, four males). As there were only four males, these were excluded from the analysis. Interventions Subjects were observed and timed while performing single leg stance in two conditions 48 hours apart; once with the investigator present (investigator condition) and once with the investigator and three spectators present (spectator condition). Main outcome measure Duration of single leg stance in seconds. Results The mean duration of single leg stance, for females, under the investigator condition was 173 seconds [95% condence interval (CI) 131 to 214], while that of the spectator condition was 168 seconds (95%CI 128 to 208). The mean difference between the two conditions was 5 seconds (95%CI 21 to 31). This was not statistically signicant using a paired t-test (P = 0.686). Conclusions Female performance of a straightforward exercise such as single leg stance was not affected by the presence of three spectators. 2007 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Keywords: Spectators; Performance; Single leg stance
Introduction Physiotherapy assessments, treatments and exercises are performed in a variety of settings, and other people are often present. These may be other patients, relatives or staff members and are known as spectators, observers or an audience in the literature. The term spectators will be used predominantly in this article. A number of theories exist about why the presence of spectators may have an effect on performance [1]. The non-specic drive theory states that the mere presence of others will increase the drive and activation level of the performer in such a way that dominant reactions will be enhanced [2]. In other words, the performance of expert or skilled performers and the accomplishment of simple tasks will improve in the presence of spectators, while the performance of unskilled or novice performers and the execution of complex/difcult tasks will decline under this condition. The distraction-conict hypothesis [3] concurs with the non-specic drive theory, stating that the perfor
Corresponding author. Tel.: +353 86 1713077; fax: +353 1 4531915. E-mail address: walshj2@tcd.ie (J. Walsh).
mance of difcult tasks will decline when spectators are present due to the distracting effect of spectators. In contrast, the theory of objective self-awareness [4] assumes that people direct attention on themselves when they feel that they are being observed by others. A state of self-awareness emphasises the weaknesses between actual behaviour and an ideal or expected behaviour; as a result, the performer tries to reduce these weaknesses. The self-presentation theory [5] infers that if a task is deemed to be easy, the performer will be able to demonstrate ability and appear competent to spectators, which will further improve performance. On the other hand, if a performer believes a task is difcult and fears appearing incompetent, performance will be impaired. Finally, the choking approach [6] advocates that spectator pressure adds to self-consciousness, which will disturb prociency in executing a task, i.e. the performer will choke under pressure. Choking is more likely to occur during skilful activities, especially those that demand accuracy and speed. The effect of spectators on the performance of physiotherapy activities is unknown. Much of the research in the literature pertaining to the effect of spectators on performance
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has concentrated on sporting activities [711]. Research has also been conducted to determine the effect of spectators on the performance of non-sporting activities, such as driving [12], playing video games [13] and learning [14]. Studies in relation to the effect of spectators on sports performance have produced conicting ndings. Bell and Yee [11] showed that the presence of spectators had no effect on the performance of karate kicks by skilled subjects, although unskilled subjects showed reduced accuracy. Also, Chevrette [8] found that the presence of spectators had no effect on girls performance of a number of physical exercise activities. However, Chevrette [8] found that the running performance of boys improved when they were observed by mixed or opposite sex spectators, while Rhea et al. [7], who studied the consequences of spectator presence and competition on maximal weight-lifting performance, concluded that competition and audience presence have a positive effect on power and strength performance. In contrast, Forgas et al. [10] demonstrated that squash players performance deteriorated in the presence of two spectators. The authors speculated that instead of trying to outdo the opponent, a player matches his competitor in order to provide a better spectacle for the audience. Moore and Brylinsky [9] investigated the effect of spectators on basketball performance. Due to a measles epidemic, two basketball teams played 11 games with spectators and 11 without spectators during one season. On analysis of ofcial basketball score sheets incorporating details of offensive and defensive team performance and individual player information, the investigators found that both teams played better when there were no spectators present. Thus, there is conicting evidence in relation to the effects of spectators on sporting performance. Similarly, there are conicting ndings in the literature concerning the effects of spectators on the performance of non-sporting activities. Baxter and Manstead [12] investigated the inuence that a passenger may have on driver behaviour. Older female passengers had a signicant inuence, causing all categories of motorist to drive more slowly. Overall, driver compliance with the speed limit increased with passenger presence; the one exception was that drivers with younger male passengers exceeded the speed limit. Kimble and Rezabek [13] found that video-game performance deteriorated under an audience condition, while Sawyer and Noel [14] studied the effects of spectators on the learning of a motor task and concluded that the presence of an audience has a negative effect on initial learning of a motor task but has no effect on further learning or retention of the exercise. It must also be borne in mind that the presence of spectators may have different effects depending on the personality type of the performer. Graydon and Murphy [15] found that extroverts performed better at table tennis before an audience, whereas introverts performed better without an audience. The type of audience may also inuence performance. In the clinical setting (e.g. a hospital ward), there may be people present who are not focusing on the sub-
ject but who still have an effect on the subject. This is known as the mere presence effect. It has been demonstrated that mere presence is enough to affect behaviour and performance [16]. Butler and Baumeister [17] devised different experiments to study the effects that can be created by a supportive audience. The authors provided a background into the benecial (emotional boost, positive reactions from friends/family despite a poor performance) and damaging (high expectations from supporters, increased pressure to maintain appearance) effects of a supportive audience. It was found that there is a greater tendency towards performance inadequacy under this condition. In the rst experiment, a difcult mental arithmetic task was performed before a neutral stranger and again before a friend. Fewer correct calculations were made with a friend watching, despite the fact that the performer perceived this condition to be less stressful and less distracting. In a second experiment, both speed and accuracy while completing a video game were found to worsen with a supportive audience, despite subjects reporting reduced feelings of pressure compared with the neutral condition. These ndings reveal that a combination of factors and traits modify an individuals performance in the presence of spectators. These factors should be recognised and considered in the clinical setting so that the optimal environment for the performance of the task is tailored to each patients individual needs. Furthermore, it is worth noting that a socalled supportive audience may actually be a hindrance to the patient. Although people generally prefer supportive attention, their true capabilities may not be facilitated in such circumstances. This may be particularly signicant in a physiotherapy setting, where the therapist will try to instil positive feelings in the patient while performing tasks that challenge their abilities. However, there is a lack of evidence regarding the effect that spectators may have on the performance of physiotherapy activities. Considering the conicting ndings, outlined above, in relation to the effect of spectators on the performance of non-physiotherapy activities, research is warranted to determine whether spectators affect the performance of physiotherapy activities positively, negatively or not at all. Such information could be used to determine the optimal environment (in relation to the presence or absence of spectators) for the performance of physiotherapy activities. The aim of this study was to investigate whether the presence of spectators has any effect on the performance of a physiotherapy exercise.
Methods Physiotherapy exercise Single leg stance was chosen as the physiotherapy exercise as it is commonly used in assessment and rehabilitation, and as an outcome measure across a wide variety of disciplines
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[1820]. This can be made more challenging as a means of assessment or rehabilitation by providing a less stable surface [21] in appropriate cases. As the subjects in this study were healthy (and therefore more akin to the type of patient that would require a more challenging exercise), a pillow was used to provide a less stable surface to render the single leg stance more challenging. Recruitment Healthy volunteers from staff and students at Trinity College Dublin were recruited via noticeboard advertisements in December 2005. An induction session was held for those who responded to the advertisements to explain and demonstrate the procedure. Inclusion and exclusion criteria Subjects who declared themselves able to perform a single leg stance, to comprehend English and who gave informed consent were included. Exclusion criteria were inability to perform the exercise for any reason, and the presence or history of any condition that may impair balance. Sample Forty-eight volunteers responded to the advertisement but eight of these failed to present for testing. Therefore, 40 subjects (36 females, four males) participated in the study. Procedure Half of the subjects initially performed the task under the investigator condition, and the other half did so under the spectator condition to negate any learning effect between tests. Under the investigator condition, only the investigator was present, while under the spectator condition, the investigator and three spectators (unknown to the subject) were present. The spectators were instructed to sit (approximately 3 metres away from the subject) and direct their attention on the subject, but not to speak or offer any vocal encouragement to the subject while performing the task. Subjects were instructed to remove socks and shoes and to ensure that both feet were visible in order to accurately time when the suspended foot touched the surface again. They were asked to stand on their non-dominant leg on a pillow, with the dominant leg off the surface (but not suspended against the non-dominant leg), and were told that they would be timed. They were instructed to try and maintain that position for as long as possible, but that they could stop whenever they wanted to or if they felt any pain or discomfort. Subjects were timed until their dominant foot touched the surface again. The investigator timed each subject with a stopwatch, and the duration of each single leg stance was recorded in seconds. Forty-eight hours later, the subjects returned to repeat the test under the other condition.
Data analysis Data were analysed using Microsoft Excel and Statistical Package for the Social Sciences, Version 14.0. As the data were normally distributed, a paired t-test was used to compare times under the two conditions. As only four males were recruited, these were excluded from the analysis.
Results The mean (standard deviation) age of the female subjects was 19.3 (1.5) years with a range of 1725 years. The mean duration of single leg stance, for females, under the investigator condition was 173 seconds [95% condence interval (CI) 131 to 214], while that of the spectator condition was 168 seconds (95%CI 128 to 208), as illustrated in Fig. 1. The mean difference between the two conditions, for females, was 5 seconds (95%CI 21 to 31).
Discussion This study found that the presence of three spectators had no effect on the performance of a single leg stance physiotherapy exercise by females. Therefore, the presence or absence of spectators should not play a major role in inuencing the location of the performance of such a physiotherapy exercise by a female. As stated previously, there is conicting evidence in the literature about the effects of spectators on performance. Some studies have found that the presence of spectators has a positive effect on performance [7,8,12], others have demonstrated a negative effect on performance [9,10,1214], and others, including the present study, have reported that spectators have no effect on performance [8,11]. However, these studies concentrated on sporting and nonsporting rather than physiotherapy activities, and so are not directly comparable.
Fig. 1. Mean and 95% condence intervals for duration of single leg stance, for females, under each condition.
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This study had a number of limitations. Due to a lack of volunteers and time constraints, an insufcient number of males was recruited for worthwhile statistical analysis. Also, although it has been shown that subject personality type [15] and spectator characteristics [16] can inuence performance, these were not determined in this study. For the purposes of this study, it was decided to determine the effect of focused spectators rather than that of mere presence on performance. However, it would be worthwhile investigating the effect of mere presence on the performance of physiotherapy activities. Although the subject faced the spectators during the test, the majority of subjects tended to focus their attention on a point on the wall or on their own foot rather than look directly at the spectators. This may have reduced the spectators inuence on the subject, although it may have replicated the clinical setting, as in a typical physiotherapy scenario, subjects are encouraged to focus attention on the exercise being performed rather than on other people present. The spectators were unknown to the subject. In the clinical setting, there may be a mixture of people present, some known and some unknown to the patient. Therefore, the effect of spectators known to the patient on performance also needs to be determined. Strauss [1] outlined the contrasting views in the literature relating to audience size and its effect. It is conceivable that a larger number of spectators would have increased subject stimulation and perhaps affected performance. For the purposes of the current study, it was felt that three spectators replicated many clinical scenarios, where a small number of people may be present (e.g. an assistant, a student and a relative). It is also worth noting that while the spectators had no effect on performance in this study of healthy volunteers, the effect of spectators on a patient population may differ. Due to the anxieties inherent with being a patient, there may be a different interaction between a patient and spectators compared with that of healthy volunteers, so a study should be performed in a patient population. However, patients at end-stage rehabilitation may be similar to healthy subjects, and physiotherapists may be involved in the screening, assessment and rehabilitation of healthy individuals (e.g. occupational health, sports physiotherapy, preventative medicine). As such, the ndings of this study may be applicable to females of such populations. Finally, while the spectators had no effect on the performance of single leg stance, as this is a fairly straightforward exercise, it would be useful to investigate the effect of spectators on more complex physiotherapy activities. In summary, while this study showed that the presence of three spectators had no effect on the performance of single leg stance by females, further research is required to determine the effects of different numbers of spectators and spectators of different characteristics on the performance of a variety of physiotherapy activities by both males and females of differing personality types.
Conclusion There is conicting evidence in the literature in relation to the effects of spectators on performance; positive effects, negative effects and no effects have been reported. In the clinical setting, people other than the patient and physiotherapist are often present during the performance of physiotherapy activities. In this study, the presence of three spectators had no effect on the performance of single leg stance in healthy females. Therefore, decisions regarding the most appropriate environment or location for optimal performance of such exercises, by females, should be based on individual patient and physiotherapist needs rather than the presence or absence of a few other people. However, research into the effect of various spectator types and numbers on different personality types and on the performance of more complex physiotherapy activities needs to be conducted on both males and females before denitive conclusions are drawn.
Acknowledgements The authors would like to thank Dr. Kathleen Bennett, Trinity College Dublin, for statistical advice. Ethical approval: Faculty of Health Sciences Ethics Committee, Trinity College Dublin. Conict of interest: None.
References
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[18] Berg K, Wood-Dauphine SL, Williams JL, Gayton D. Measuring balance in the elderly: validation of an instrument. Can J Public Health 1992;83(Suppl. 2):S711. [19] Petty NJ. Neuromusculoskeletal examination and assessment. 3rd ed. Edinburgh: Elsevier Churchill Livingstone; 2006. [20] Sahrmann SA. Diagnosis and treatment of movement impairment syndromes. St. Louis: Mosby; 2002. [21] Brukner P, Khan K. Clinical sports medicine. 3rd ed. Sydney: McGrawHill; 2007.
The vastus medialis oblique:vastus lateralis electromyographic intensity ratio does not differ by gender in young participants without knee pathology
Damien Bowyer a,b , Mikaela Armstrong a , John Dixon a, , Toby O. Smith b
b a School of Health and Social Care, University of Teesside, Middlesbrough, UK Orthopaedic Physiotherapy Research Unit, Physiotherapy Department, Norfolk and Norwich University Hospital, Colney Lane, Norwich, UK
Abstract Objectives To investigate whether there was a gender difference in the intensity of electromyographic (EMG) activity in vastus medialis oblique (VMO) relative to vastus lateralis (VL). Design A cross-sectional observational study measuring EMG activity during stepping down from a step and during straight leg raise exercises. Setting University campus laboratory. Participants Two groups of healthy participants were tested, one female (mean age 23.5 years, n = 15) and one male (mean age 23.5 years, n = 15). Main outcome measures Surface EMG activity (sampling rate 1000 Hz) was recorded from VMO and VL of the dominant limb during ve repetitions of a step down activity and ve repetitions of a straight leg raise exercise. The average intensity of the rectied and smoothed EMG activity from each activity was normalised to that elicited in a maximal quadriceps setting exercise. The ratio of normalised VMO:VL EMG intensity levels was calculated. Results The median difference in the VMO:VL ratio between the groups was 0.11 [approximate 95% condence interval (CI) 0.62 to 1.00] during step down and 0.07 (approximate 95% CI 0.26 to 0.20) during straight leg raise. Using Mann Whitney U-tests, these differences were not statistically signicant (P = 0.648 and 0.619, respectively). Conclusions This study found no gender difference in the VMO:VL EMG intensity ratio in asymptomatic participants. This suggests that the difference in incidence of patellofemoral pain syndrome between genders is not inuenced by quadriceps intensity ratios, when participants are asymptomatic. 2007 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Keywords: Electromyography; Quadriceps muscle; Knee; Pathology; Male; Female
Introduction Patellofemoral pain syndrome is a common musculoskeletal condition that has a higher prevalence rate in females than males [13], and which is typically managed conservatively through exercise and other physiotherapeutic modalities [48]. It has been speculated that neuromuscular imbalances of the vastus medialis obliqus (VMO) relative to the vastus lateralis (VL) muscle may contribute to patellofemoral pain
Corresponding author. Tel.: +44 1642 384125; fax: +44 1642 342770. E-mail address: John.Dixon@tees.ac.uk (J. Dixon).
syndrome [912]. Consequently, numerous studies have been undertaken to assess the electromyographic (EMG) activity of these muscles [11,1318]. These studies have been clinically important since either a delay in EMG onset timing or a reduced EMG intensity in VMO relative to VL may lead to a biomechanical imbalance at the patellofemoral joint [19]. Furthermore, patellofemoral malalignment has been suggested to be one of the major causes of patellofemoral pain syndrome [68]. It is hypothesised that the higher prevalence of patellofemoral pain syndrome in females could be due, in part, to gender differences in muscle activity. The cause of such a gender difference is unclear. However, the issue
D. Bowyer et al. / Physiotherapy 94 (2008) 168173
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of whether the ratio of VMO:VL EMG intensity (VMO:VL ratio) differs between genders has not been resolved within the literature. A literature review identied three studies that have assessed this difference. Cerny [14] reported no gender difference in the VMO:VL ratios of male and female participants. Unfortunately, actual gender data were not presented, as this comparison was not one of the main study aims. In a recent study, Herrington et al. [20] observed no gender difference in VMO:VL ratios during open and closed kinetic chain exercises with participants assessed using an isokinetic dynamometer. In contrast, Myer et al. [21] reported that in their cohort, there was a gender difference in the VMO:VL ratio where subjects exed and leaned on the examined knee. This study also reported that male participants had a greater VMO:VL ratio than females. Other studies have investigated gender differences in muscle activity around the knee joint, but have not compared VMO and VL simultaneously [22,23]. This area therefore needs to be addressed further as a gender difference in the VMO:VL ratio could be important for two reasons. Firstly, any imbalance in the VMO:VL ratio may account for the difference in incidence of patellofemoral pain syndrome in males and females. Secondly, if such a difference in VMO:VL ratios existed, this may question the appropriateness of comparing male and female subjects in studies assessing the VMO:VL ratio that are not matched for gender [4,11,15,18,2427]. The aim of this study was to investigate whether there is a gender difference in the VMO:VL ratio in asymptomatic participants. It was hypothesised that there would be a statistically signicant difference in the VMO:VL ratios between male and female participants.
Table 1 Descriptive characteristics of participants: mean (standard deviation) Group Female Male Number of participants 15 15 Age (years) 23.5 (0.6) 23.5 (0.7) Height (m) 1.68 (0.06) 1.79 (0.07) Weight (kg) 66.8 (12.5) 81.2 (13.0)
Ethics Committee. Before taking part, each participant provided written informed consent. The age, height and weight of each participant were recorded prior to testing, and are presented in Table 1. Electromyography EMG recordings were collected and stored digitally using a physiological data acquisition system (Biopac Inc., Goleta, CA, USA) comprising of a MP100 workstation with a high level transducer (HLT100) and dedicated software (AcqKnowledge 3.7) on a personal computer. The EMG sampling rate was 1000 Hz. EMG activity was recorded using bipolar surface electrodes (TSD150B, Biopac Inc., Goleta, CA, USA) with diameter 11.4 mm, interelectrode distance 20 mm, built-in pre-amplication (350) and 3 dB band pass 12500 Hz. Each participant was positioned in half lying on a plinth for EMG electrode placement. Recordings were taken from the dominant limb of each participant, determined by asking which leg they would use to kick a ball. Placement and orientation of the electrode positions was performed using a retractable tape measure and a goniometer. The recording electrode was positioned on the VMO 4 cm superior to and 3 cm medial to the superomedial border of the patella [18], and orientated 55 to the femur along the presumed line of muscle bre orientation [39]. The position of the electrode on the VL was 10 cm superior to and 7 cm lateral to the superior border of the patella [18], and orientated 15 to the femur along the line of muscle bre orientation [39]. A reference electrode was positioned on the tibial tuberosity on the contralateral limb [18]. Prior to electrode application, the skin area was shaved and cleaned with an alcohol wipe to improve conductivity. Hypoallergenic conductance gel (Lectron II, ECG-TENS) was applied to each electrode to improve electrical conductance between the skin and the electrode. All electrodes were held rmly in position using hypoallergenic tape. Straight leg raise
Methods This was a cross-sectional observational study to investigate whether the VMO:VL ratio differed between male and female participants. This was measured during step down activity, which is cited as aggravating patellofemoral pain syndrome symptoms [5,2832] and has been studied previously in mixed gender cohorts [9,18,24,25,3336]; and during a straight leg raise (SLR) exercise, a commonly prescribed quadriceps exercise [5,37,38]. The independent variable was gender and the dependent variable was the VMO:VL ratio. Participants A convenience sample of 30 participants (15 males and 15 females) was recruited from physiotherapy degree courses at the University of Teesside; two groups were formed according to gender. To be included, participants had to be aged between 18 and 25 years. Exclusion criteria included: subjects with any lower limb pathology; neuropathology; or any history of ongoing knee pain. Ethical approval was granted by the University of Teesside, School of Health and Social Care
The participants were positioned in half lying on the plinth and asked to maintain both lower limbs in the position of: hip neutral (no rotation), knee in extension and ankle plantar grade throughout the execution of the SLR. Verbal commands were given to commence the SLR. The height of the SLR was 17.5 cm, mimicking a typical outpatient protocol, measured from the plinth to the participants heel. The height was con-
170
trolled by a piece of card 17.5 cm long, and the participant was instructed to use the necessary muscular effort to hold the SLR when they judged their heel to be in line with the top edge of the card. At this height, the contraction was held for 3 seconds and then released. A 3-second contraction was chosen as an arbitrary gure for this exercise. The activity was repeated ve times with 30-second rest periods between repetitions. Step down The step down activity took place from a step measuring 19 cm in height, performing an eccentric quadriceps muscle contraction. Participants were asked to stand on top of the step, with their feet shoulder width apart, their toes just behind the step edge and their arms relaxed by their sides. The participants were then instructed to step down from the step, leading with their non-dominant limb. This was repeated ve times. Maximal voluntary isometric contraction To enable normalisation of the EMG amplitudes during the activities, a maximal voluntary isometric contraction of the quadriceps was carried out [40,41]. Normalisation is the conversion of an EMG amplitude during a particular activity to a percentage of its maximal amplitude, and is necessary when comparing EMG levels between subjects [41] as nonnormalised amplitudes may differ because of factors such as body fat or muscle bulk. As in previous studies, the normalising maximal voluntary isometric contraction was performed with the knee joint in full extension [17,40], commonly described as a quadriceps setting exercise [42], with the participant positioned in half lying on the plinth. Whilst the EMG data were being recorded, the participant was instructed to perform a quadriceps maximal voluntary isometric contraction for 5 seconds and then to relax. For all activities, participants carried out practice attempts for familiarisation with the procedures. The order of activities was always SLR, step down and maximal voluntary isometric contraction. All EMG recordings were stored digitally for later analysis. Data analysis Using dedicated analysis software (AcqKnowledge 3.7), raw EMG data were rectied and smoothed using an innite impulse response 6 Hz low pass lter. For each of the ve repetitions of each activity from each participant, the area under the curve (V.second) and time (seconds) were extracted, and the average EMG (V) was calculated by dividing area under the curve (V.second) by time (seconds). The onset and cessation of EMG activity were determined as the point at which the EMG exceeded three standard deviations (SD) above the baseline mean resting level, dened as a 300-millisecond window prior to activity [18,25,34]. All EMG traces were inspected visually to ensure that movement
artefacts did not affect the results. The mean of the ve average EMG values was calculated for VMO and VL for each activity. For the maximal voluntary isometric contraction recordings, using the contraction plateau of approximately 4 seconds in duration [41], the average EMG was calculated similarly. Normalisation was then achieved for each participant by converting the average value (V) during step down and SLR to a percentage of that during the maximal voluntary isometric contraction [40]. To calculate the VMO:VL ratio during step down and SLR for each participant, the normalised VMO amplitude was divided by the normalised VL amplitude. Statistical analysis was performed using Statistical Package for the Social Sciences Version 10 for Windows. As the EMG data breached the assumptions of normality, differences between the groups were tested for statistical signicance using the Mann Whitney U-test. Alpha was set at 0.05. The VMO:VL ratio data were compared as the main variable of interest. Differences between the groups in the normalised EMG amplitudes (percentage of maximal voluntary isometric contraction) of VMO and VL were also analysed separately, providing median and approximate 95% condence interval values. The relative repeatability of within-subject EMG activation levels was assessed by analysing the repeated measurements of the participants during the test session using the intra-class correlation method (ICC 3,5) [43]. Results The average intra-class correlation method (ICC 3,5) values for repeatability of the within-session EMG levels during step down were 0.96 (95% CI 0.92 to 0.99) for male VMO, 0.96 (95% CI 0.91 to 0.98) for male VL, 0.96 (95% CI 0.91 to 0.98) for female VMO and 0.95 (95% CI 0.89 to 0.98) for female VL. For SLR, these values were 0.98 (95% CI 0.94 to 0.99) for male VMO, 0.96 (95% CI 0.90 to 0.98) for male VL,
Fig. 1. Normalised vastus medialis oblique (VMO):vastus lateralis (VL) intensity ratios during step down activity.
171
during step down for VMO (P = 0.756) or VL (P = 0.852), or during SLR for VMO (P = 0.494) or VL (P = 0.520).
Discussion The aim of this study was to determine whether a gender difference existed between VMO:VL ratios in asymptomatic participants. The results of this study showed that the differences between males and females in the VMO:VL EMG ratio during step down and SLR were not statistically signicant. This concurs with studies by Cerny [14] and Herrington et al. [20]. In contrast, the present results differ from those of Myer et al. [21] who reported that the VMO:VL ratio was signicantly greater in males than females during a weightbearing activity. Interestingly, however, in the study by Myer et al. [21], EMG data for all participants were normalised to levels elicited during a seated knee extension with a 20-kg weight, rather than to a maximal contraction which is more commonly recommended and adopted [9,10,32,44]; the latter method was adopted in the present study. It should be noted that in the study by Cerny [14], during the step down activity, average VMO:VL ratios in the asymptomatic group were greater than those in the symptomatic patellofemoral pain syndrome group (asymptomatic mean 1.2, SD 0.6; patellofemoral pain syndrome mean 0.9, SD 0.3). This may indicate that the patellofemoral pain syndrome group had either decreased VMO activity, increased VL activity or both. Hence, although there were no differences in activity ratios between genders in asymptomatic participants in the present study, there may still be differences in patients with patellofemoral pain syndrome. In addition, it is interesting to note that the present study found no signicant difference between males and females in the levels of EMG activity elicited during SLR and step down, as shown in Table 2. This is similar to the results of Myer et al. [21], but differs from the results of Cerny [14], who reported that the female group exhibited a trend for greater EMG activity than the male group in both VMO and VL during step down when normalised to maximal voluntary isometric contraction levels. Cerny [14] found that asymptomatic females required approximately twice the activity in VMO and VL to perform the step down activity compared with males, but no between-group statistical tests were performed. Several methodological differences existed between the studies, such as recording electrode type, electrode placement, sampling rate and normalisation procedures, that could have produced differences. Due to the dearth of published research on this topic, further research is recommended. This study exhibited a number of limitations. Firstly, the participants were asymptomatic. Accordingly, it would be inappropriate to use these ndings to make generalisations on patellofemoral pain syndrome populations. Further study should be undertaken to assess gender differences in VMO:VL activity in patients with patellofemoral pain syn-
Fig. 2. Normalised vastus medialis oblique (VMO):vastus lateralis (VL) intensity ratios during straight leg raise.
0.99 (95% CI 0.97 to 0.99) for female VMO and 0.94 (95% CI 0.86 to 0.98) for female VL. These all indicated excellent repeatability [43]. The results for the normalised VMO:VL ratios during step down and SLR are presented in Figs. 1 and 2, respectively. During step down, the median VMO:VL ratio was 1.55 [interquartile range (IQR) 1.44] for females and 1.40 (IQR 1.13) for males. During SLR, the median VMO:VL ratio was 0.79 (IQR 0.27) for females and 0.92 (IQR 0.36) for males. The median difference between the groups in the VMO:VL ratio was 0.11 (approximate 95% CI 0.62 to 1.00) during step down and 0.07 (approximate 95% CI 0.26 to 0.20) during SLR. Using Mann Whitney U-tests, these differences were not statistically signicant (P = 0.648 and 0.619, respectively). Table 2 presents a comparison of the average normalised EMG activity for VMO and VL separately (i.e. as a percentage of maximal voluntary isometric contraction, in non-ratio form) during the step down and SLR. During step down, the median difference between the groups in the level of activation was 5.5% (approximate 95% CI 21.3 to 28.8) for VMO, and 0.8% (approximate 95% CI 8.6 to 9.4) for VL. During SLR, the median difference between the groups in the level of activation was 3.8% (approximate 95% CI 15.3 to 8.8) for VMO and 5.6% (approximate 95% CI 14.6 to 9.1) for VL. Again, analysis with Mann Whitney U-tests revealed that the differences between the groups were not signicant
Table 2 Median (interquartile range) normalised vastus medialis oblique (VMO) and vastus lateralis (VL) average electromyographic activity (percentages of maximal) during step down and straight leg raise Group Step down VMO Female Male 38.4 (57.4) 41.7 (40.1) VL 24.7 (16.3) 27.3 (14.9) Straight leg raise VMO 20.3 (12.9) 24.7 (21.7) VL 23.3 (18.7) 32.8 (22.9)
172
drome, as this may be a signicant factor in symptomatic populations. In addition, any potential neuromuscular imbalances may only be important in particular subgroups, e.g. females with larger than average Q angle [45]. It is suggested that onset timing of VMO and VL is an area for further investigation, as studies that have reported a difference between patients with patellofemoral pain syndrome and healthy participants have shown that timing is a signicant diagnostic factor [18,46]. Alternatively, other muscle imbalances at the knee joint could be important, such as quadriceps:hamstring activity. Finally, this study also used a small sample size; as such, the results should be treated with some caution and followed-up in a larger study. Sample size calculations were not performed due to the limited data available in the literature. The results of this study will hopefully inform sample size calculations for future research. Therefore, despite these limitations, this study provides important information that will improve the knowledge base in this topic area and will hopefully inform further research. If, as these results indicate, there is no gender difference in the VMO:VL EMG ratio, presumably other factors, such as Q angle or strength per body weight, may be more clinically relevant to the higher prevalence of patellofemoral pain syndrome in women compared with men [47,48].
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Conclusion This study found that the difference between males and females in the VMO:VL ratio was not statistically signicant during step down and SLR activities. Accordingly, this study suggests that the difference in incidence of patellofemoral pain syndrome between genders is not inuenced by quadriceps ratios, when participants are asymptomatic. It appears that it is appropriate to compare asymptomatic male and female VMO:VL ratios when cohorts are not matched for gender. Further study is suggested to investigate how the ndings of this study compare with those of symptomatic cohorts.
Acknowledgements The authors would like to thank Vicki Whittaker, Medical Statistician, for statistical advice, and all the participants who took part. The two elements of the study were carried out as part of MSc degrees in Allied Health Professional Studies (Physiotherapy), the University of Teesside, School of Health and Social Care. Ethical approval: School of Health and Social Care Research Ethics Committee, University of Teesside, Middlesbrough, UK. Conict of interest: None declared.
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Client-centred rehabilitation: what is it and how do we measure it?

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985 936 939

792 752 754

69.4 8.5 27.6 5.0 502 141 111

193 184 185

71.1 8.5 27.0 4.3 122 33 30

0.014 0.135 0.865

LLD, leg length discrepancy; SD, standard deviation.

D.J. Beard et al. / Physiotherapy 94 (2008) 9196

D.J. Beard et al. / Physiotherapy 94 (2008) 9196

D.J. Beard et al. / Physiotherapy 94 (2008) 9196

Available online at www.sciencedirect.com

Physiotherapy 94 (2008) 97104

D.M. Hettinga et al. / Physiotherapy 94 (2008) 97104

Table 1 Characteristics of randomised controlled trials (RCTs)

Evans 1978 [22] Gibson 1985 [23] Haas 2004 [30]

5 (B, E, G, H, I) 4 (D, G, H, I) 4 (A, H, I, J)

32 (32) cross-over design 41 (109) 6 (72)

Function: modied Oswestry Questionnaire Pain: four-point scale Pain: VAS

D.M. Hettinga et al. / Physiotherapy 94 (2008) 97104

Pain: modied Von Korff pain scale

Hernandez-Reif 2001 [24] Postachini 1988 [25]

Triano 1995 [26]

UK BEAM 2004 [27]

Waagen 1986 [28]

Manual therapy (chiropractic manipulation) vs sham manipulation

D.M. Hettinga et al. / Physiotherapy 94 (2008) 97104

D.M. Hettinga et al. / Physiotherapy 94 (2008) 97104

D.M. Hettinga et al. / Physiotherapy 94 (2008) 97104

D.M. Hettinga et al. / Physiotherapy 94 (2008) 97104

Available online at www.sciencedirect.com

Physiotherapy 94 (2008) 105114

Constraint-induced movement therapy: a narrative review

106 Table 1 Criteria for inclusion of trials in this study

A. Tuke / Physiotherapy 94 (2008) 105114

CIMT, constraint-induced movement therapy.

A. Tuke / Physiotherapy 94 (2008) 105114

Table 4 Inclusion criteria

, not listed as a criterion; +, listed as a criterion.

A. Tuke / Physiotherapy 94 (2008) 105114

A. Tuke / Physiotherapy 94 (2008) 105114

Outpatient/chronic (>12 months)

14 Week days for 10 weeks

Travelling, sleeping, dressing, toileting None None reported

Nil Log book

Nil None reported A. Tuke / Physiotherapy 94 (2008) 105114

10 continuous inpatient days Week days for 10 weeks

None reported None reported

None reported Log book

None reported None reported

Glove Mesh, polystyrene-lled mitts and sling Mitt

10 Week days for 10 weeks

None reported None reported

47.3 (18.2)* 10 (8.3)* 3.5 (1.4)* 3.2 (1.4)

2 0.54* 0.44* 0.49* 0.39* 0.28* 0.38* (two-tailed).

0.50* 0.31* 0.21* 0.32* 0.29* 0.29* 0.32* (two-tailed),

0.50* 0.59* 0.54* 0.43* 0.49***

0.46* 0.49* 0.37* 0.36*

0.41* 0.37* 0.40***