The Effectiveness of footwear, orthoses and casted devices in redistributing plantar pressure: a systematic review of the literature

Sharon Andrews

A dissertation submitted in partial requirement for the Bachelor of Science Degree (with Honours) In podiatry 2004

Division of Podiatry Centre for Healthcare studies Faculty of Applied Sciences

University College, Northampton

Word count: 11 618

Structured Abstract
Background
The need for the study Podiatrists see patients with systemic and painful foot conditions and provide preventative care and palliative relief. A range of materials, shoe inserts, off-loading devices, therapeutic footwear and footwear adaptations are available. To make the most effective choice appropriate measures of effectiveness are required. Reducing plantar pressures is often the objective. This review will consider pressure studies in two areas relevant to podiatric practice: diabetes and painful foot conditions.

Diabetes It is estimated that 2% of the UK population have Type I diabetes (Hutchinson 2000). Studies from Australia, Finland, the UK and the USA report the incidence of ulceration among people with diabetes as 2.5 10.7% and amputation rates as 1.8 -2.23%(Hunt and Gerstein 2003). Footwear, orthoses and casts are important in the prevention and treatment of diabetic foot problems.

The painful foot 10% of people may experience plantar heel pain (Crawford and Thomson 2004). Postema et al (1998) states that 83% of 459 subjects over the age of 60 years of age had foot pain. A study of foot-shoe problems in the

Netherlands found that 60% of women and 30% of men suffered from forefoot problems. Rheumatoid arthritis (RA)has a prevalence of 0.51.5% in industrialized nations and in the UK of 36/100 000 in women and 14/100 000 in men (Suarez-Almazor and Foster 2001). Chalmers et al (1999) reported that 90% of RA patients have foot problems. Holmes and Timmerman (1990) refer to the 1989 AOFAS Presidents Symposium on The use and abuse of orthotics (sic)(no reference given) which concluded that the medical community lacked the objective data to support the rational use of most orthotics (sic) prescribed to patients(p.144)

Objective To assess research evidence that footwear, orthoses and casted devices redistribute plantar pressures in the foot in a predictable fashion to allow informed clinical prescription for foot pressure related problems

Search strategy Searches of 24 databases, hand-searching of journals, interest groups, manufacturers and following-up citations Selection criteria Types of study included: randomised controlled trials (RCTs) investigating the quantitative effects of footwear, orthoses and casts in redistributing plantar pressures at the foot-shoe interface during gait, in adults with specific health problems. Qualitative measures will be included in studies where the main focus is pressure measurement.
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Data collection and analysis Titles and abstracts were assessed for relevance against objectives, inclusion and exclusion criteria. Full articles were checked again. Data was extracted on the following: 1. how subjects were selected for inclusion/exclusion 2. the organisational setting(s) in which the trial took place 3. baseline sample population variables 4. description of the intervention(s) and numbers assigned to each group 5. period/intervals of follow-up 6. methods/techniques of measurement 7. outcomes 8. findings/conclusions (based on Spencer 2000)

Parallel trials were assessed against quality standards for reporting parallel randomised control trials (Moher 2001). Most of the included studies were cross-over trials and were assessed against standards for critical appraisal of quantitative studies (Griffiths, 2004)

Main Results Seven RCTs of mixed quality were identified. The included studies demonstrated clinical, methodological and effects heterogeneity (Deeks et al 2001). Pooling of results was, therefore, not possible and a qualitative synthesis was undertaken.
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Five studies considered the effectiveness of insoles/orthoses (one good, two moderate, two poor). All concluded that insoles/orthoses were effective at redistributing pressure, reducing pressure time integrals and increasing contact areas. This was found in a variety of populations. The case for custom-moulding over off-the-shelf shoe inserts was not conclusive. Simple insoles had significant impact on pressure variables. Moulded insoles were positively perceived by users compared with flat inserts.

The evidence for footwear is too limited to draw conclusions. The quality of the two studies was poor.

The DH pressure relief walker performed well in two studies compared with total contact casts (TCCs) but the areas examined differed ( forefoot ulceration or heel pressure). The methodological quality of both papers was poor.

A single study on the effect of a rocker bar on 42 individuals with primary metatarsalgia found a reduction in force impulse and peak plantar pressure over the metatarsals. The addition of insoles (ready-made and custom-made) produced further off-loading. The quality of the study was moderate but too limited to be conclusive.

Reviewers conclusions
Implications for practice There is evidence from a single centre RCT that simple cleron insoles are an effective intervention for pressure reduction in low risk diabetic patients and moulded inserts are appropriate for higher risk patients without foot deformity. The insoles deteriorated

significantly over 6 months and should be replaced regularly. There is limited evidence from a small unique trial that rocker soles reduce plantar pressure over the central metatarsals in women with primary metatarsalgia. There is very limited evidence that visco-elastic heel pads reduce heel pressure in a small unique trial of patients with treated heel pain.

Implications for research Further multi-centre large scale RCTs are required to evaluate the effectiveness and cost-effectiveness of therapeutic footwear, orthoses and casted devices for the prevention and treatment of the insensate and painful foot. the development of standard measures and research protocols is urgently required to improve comparison of outcomes. Further research is needed to identify significant pressure variables

Acknowledgements
I would like to thank the following people for their assistance: Mike Curran, Senior Lecturer ,Podiatry, UCN Dissertation supervisor, for on-going help, enthusiasm and direction Prof.Jackie Campbell, UCN , for her invaluable help with the statistics Sue Griffiths, UCN for insight into the review process and help with the quality assessment process Alan Roslin and the library staff at the Park Campus Library, UCN for excellent service and assistance in accessing the literature Sarah Sutton Clinical librarian, University Hospitals Leicester for guidance on the clinical application of EBM and getting started with on-line medical literature searching Sue Barnett, Foot pressure Interest Group (FIG) for the International Protocol guidelines for Plantar Pressure Measurement Ann Walsh, Ewan Kinnear and Rheema Draper for kindly proof-reading and commenting on the text

Most of all, thank you to my husband, John, for coping with the last three years with humour and equanimity. Thanks also to Esther and Tom for successfully being very nice people and my children at the same time

ABBREVIATIONS
AFO ANOVA BMI DM FO FTI kPa MTPJ N PCT PPP PTI PWB RA RCT RCW s RCB RRB TCC VAS VPT Ankle foot orthoses Analysis of variance Body Mass Index (weight in kilo/height in metres2) Diabetes mellitus Foot orthoses Force time integral kilopascal = 1000 pascals = 1 Newton per sq metre Metatarsal-phalangeal joint Newton Primary care trust Peak plantar pressure Pressure time integral Prefabricated walking boot Rheumatoid arthritis Randomized controlled trial Removable cast walker seconds Removable cast walker Rigid rocker bottom Total contact cast Visual Analogue Scale Vibration perception threshold

Table of Contents Page Abstract Acknowledgements Abbreviations Background Review of the literature Search strategy Inclusion and exclusion criteria Methodology Data extraction Characteristics of included studies Ranking of studies Results Discussion Reviewers conclusions References Bibliography Appendices 1 7 8 10 12 35 36 41 42 43 54 61 66 69 71 79 92

Background

Mechanical therapy and footwear advice are central to the podiatrists workload. For successful treatment, it is important to make the most effective choice from the options available and to know what measures are appropriate to assess effectiveness. Off-loading is the aim of mechanical therapy in diabetes and for painful foot conditions.

Diabetes It is estimated that 2% of the UK population have Type I diabetes (Hutchinson 2000). Studies from Australia, Finland, the UK and the USA report the incidence of ulceration among diabetics as 2.5 10.7% and amputation rates as 1.8 -2.23%(Hunt and Gerstein 2003). Lavery et al (2003), in a two year study of 1666 individuals with diabetes, found that 15.8% presented with or developed an ulcer.

Clinical guidelines (NICE 2004) on the prevention and management of foot problems in Type 2 diabetes made five research recommendations, three of which are relevant to this study:

4.1 therapeutic footwear should be evaluated for effectiveness and cost effectiveness in patients at higher risk of ulceration 4.3 further research is required to identify the appropriate level and combination of risk factors at which patients should be categorised as at high risk for ulceration

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4.5 the use of standardised measures in research studies would greatly enhance the ability of reviewers to undertake better analysis, including comparison of outcomes of interventions (NICE, 2004 p.12)

Foot ulceration is preceded by peripheral vascular disease, neuropathy and repetitive trauma (Kastenbauer et al 1998). Loss of protective pain perception and proprioception produces abnormal foot loading, followed by tissue damage and ulceration (Spencer 2003

Footwear adaptations and pressure-relieving devices are recommended throughout the National Guideline for diabetic foot care (Hutchinson 2000, NICE 2004) and the National Service Framework for diabetes (Department of Health 2002. Research has suggested a threshold pressure level predictive of ulceration. This review considers the evidence that interventions off-load vulnerable areas.

The painful foot Mechanical therapy is used to redistribute pressure away from painful joints, to stabilise, to provide shock absorption or to accommodate foot abnormalities (Pratt and Tollafield 1995). Corrective insoles are provided which appear to correct foot position and improve patient comfort. Mueller (1997) states that high pressures from orthoses, prosthetics or footwear cause pain. Indirect measures are frequently used to assess whether pressure redistribution is occurring (e.g. visual analogue (VAS) pain

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scores or patient compliance). This approach relies on assumptions about pathogenesis and treatment which may be incorrect. This review considers the quantitative research available to support the underlying principle that orthoses work by redistributing dynamic pressure

An overview of research is offered below.

Review of the literature

Systematic Reviews A systematic review of off-loading devices for diabetic foot problems found limited evidence that orthoses were more effective than callus removal in preventing ulcers. Limited evidence existed regarding the effectiveness of two types of orthotic devices. The evidence for therapeutic shoes was very limited. There was very limited evidence for TCCs as effective treatments for diabetic foot ulcers. Quantitative measures used for assessment were indirect i.e. actual plantar pressure is not measured. Outcome measures included re-ulceration rates, healing rates and healing times (Spencer 2000).

TTCs, pneumatic and removable cast walkers (RCWs) were recommended to off-load ulcers in a cost-effectiveness review (Sinacore 1996). Reviewers critiquing this study noted that the choice of comparators was not justified, the definitions of a healed ulcer varied between studies and the included studies were equally weighted despite differences in quality (NHS CRD 1998).

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A systematic review of interventions for treating plantar heel pain included heel pads and orthoses. Outcome measures tended to be VAS pain scales. Due to the small scale of the included studies and poor methodological quality, there was little evidence to support treatment over no treatment in any intervention. (Crawford and Thomson 2003)

No current systematic review of the literature considers the effect of footwear and orthoses on dynamic in-shoe plantar pressures.

Literature reviews Landorf and Keenan(1998) evaluated foot orthoses (FOs) by outcomes such as patient satisfaction, pain and deformity, and plantar pressure. They noted that most reasoning for their (FOs) use is anecdotal, with a lack of scientific evidence to support the claims many practitioners make (p105). Footwear is not included in their review. Inclusion criteria and quality assessment is not provided.

A critical review by Pratt (2000) quality assessed published articles about FOs. Accepted trials treated foot and shoe as a basic functional unit (p399). The search strategy was not described. Only 40 references of low quality were identified and these were not critiqued.

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Choice of in-shoe pressure measurement devices A number of systems are available to measure foot function (Landorf and Keenan 1998). Some measure static rather than dynamic pressures or measure barefoot forces. Cavanagh and Ulbrecht (1994) provide an overview of the rationale and methodology of clinical plantar pressure measurement. Those systems requiring individuals to strike a pressure sensitive plate present difficulties for people with mobility problems and/or poor eyesight. Gait may be altered as subjects target the force plate. (Rose et al, 1992). The value of a single barefoot footfall is questionable when considering the effect of shoes or FOs or the influence of shoe wear on pressure distribution (Alexander et al 1990). Dynamic pressure distribution demonstrates at risk areas for plantar ulceration in diabetic individuals better than static ones. (Alexander et al 1990)

Pressure readings from floor-mounted transducers cannot be directly compared with in-shoe transducers because of differences in sampling speed and sensor resolution.

Pressure is derived from force. Transducers estimate force by measuring the deformation caused by an unknown force on a material with known force/deformation properties (Cavanagh and Ulbrecht 1994 p.125). The dynamic forces occurring during walking have three components: vertical, anterio-posterior shear and medio-lateral shear. No commercially available in-shoe systems measures shear forces.

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Measurement systems should be assessed for suitability. (Roy 1988, Rosenbaum and Becker 1997; Barnett 1998) Sampling rate and sensor resolution are more important in dynamic than in static systems. Measurement technology should provide data that is accurate, reproducible and repeatable with a high degree of reliability and durability, minimum variability and at an affordable cost. Specific technical problems include hysteresis, creep and linearity. These can be adjusted for if a consistent pattern can be identified. Environmental factors, such as temperature and humidity, are a particular problem in the shoe (Finch 1999). The quality of calibration by the manufacturer and carried out in the research or clinical environment is essential to good quality recording. (Nicolopoulis et al 2000). Resch et al (1997) describe the problems found by frail elderly patients, standing on one leg to calibrate a sensor.

Measurement technology In-shoe systems dominating the literature are matrix systems: F-scan (Tekscan,Inc. South Boston, MA) and the EMED system (Novel GMBH, Munich, Germany). No study using F-Scan met inclusion criteria for this review. One included study used the Parotec system ( Paramed, Germany ).

Emed EMED (Novel GMBH, Munich, Germany) is a range of instruments for recording and evaluating static and dynamic pressure distribution on flat and curved surfaces. EMED Pedar is an in-shoe pressure analysis tool

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based on capacitance. Finch (1999) describes capacitance technology as two conducting wires, separated by an insulating layer, which vary in distance according to pressure. Emed Mikro (or Micro) is a portable version. Pedarmobile dispenses with the cable linking subject to data collection computer, removing the need for gait-altering turns.

According to Graf (1993) capacitance measurements allow shear forces to be compensated for without changing sensor characteristics. Emed Pedar enables bi-lateral in-shoe pressure analysis, recording static and dynamic real time measurement. Described by Graf as highly accurate, the flexible 2mm insoles have around 85 sensors with a resolution of one sensor/cm2. Adult versions come in standard shoe sizes which are not cut to fit. Sampling frequency is variable. Data is collected in an infinite loop and the last 1000 pictures stored. This equates to about 17 seconds (s) walking time. Kernozek, La Mott and Dancisak (1996), Rozema et al (1996) and Barnett (2002) demonstrated reasonable reliability in bench and dynamic tests.

Finch (1999) notes that insole systems may affect the coefficient of friction between the foot and the shoe, but Lavery et al (1997b) states that EMED insoles do not affect gait. Sampling frequencies can be increased to 100Hz but as frequencies increase the proportion of sensors sampled decreases to maintain a sampling rate of 990 sensors per second. Thus, high frequencies result in low resolution. The flexibility of the insoles

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allows good conformity but on curved surfaces vertical forces (which are converted to pressure readings) become vector forces(non-perpendicular).

EMED has a lower threshold of 20kPa to reduce noise during recording but loads of less than this magnitude occur during parts of the gait cycle. In a comparison of Emed Pedar with a Kistler Force plate, pressures were consistently 3% lower on Emed for this reason. (Barnett 2002)

Kernozek , La Mott and Dancizak (1996) state that the key to measurement with sensors is the ability to calibrate each sensor. This is possible with the Pedar and Parotec systems. Calibration is via a patented air bladder pressure device.

Parotec Parotec (Paromed, Munich) is an insole system based on 24 conductive transducers embedded in 2.5 mm PVC. Each transducer is embedded in a hydrocell with a resolution of 2.5kPa and a range of 600kPa. The transducer consists of a membrane on a mounting ring, which bends a silicone beam when deflected by applied pressure. The deflected beam alters resistance in the transducer producing a measurable deviation in the current. Each sensor is positioned at a point of peak pressure as identified from 350 subjects. The insoles are calibrated by the manufacturer and are reported to have a measurement error of less than +/- 2.5%. (House et al 2002)

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The sensors cover 46% of the insole surface. The software stores pressure data at a rate of 250Hz for five complete gait cycles, ignoring the first steps. (Hsi, Lai, Yang 1999). As with Pedarmobile, there are no cables connecting the insole to the data-collecting computer. A rapid sampling rate improves the systems suitability for measuring pressures during running. Bauer, Cauraugh and Tillman (1997) found that Parotec provided stable and consistent values across six postural variables. Chesnin, Besser and Selby-Silverstein (n.d.) found no discernable drift, negligible hysteresis, temperature drift, humidity drift or non-linearity over a range of bench tests. In a study supported by the manufacturer, they compared output from Parotec with a force system and found correlation coefficients in the good to excellent range. Different insole sizes are available with the sensors placed in the correct relative position for each size.

The system requires an acceptance of pre-determined points of peak pressure, which may not be appropriate for subjects with deformity or abnormality. When assessing the effect of FOs, the relative position of the sensors may also be changed.

Comparing results from different studies Inter- and intra- sensor variability, differences in calibration, sensor resolution and sampling speeds make quantitative comparisons between pressure studies inadvisable and results should be used qualitatively. Shear stress cannot be measured and this is significant in many

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pathologies. The system chosen should be appropriate to the study design and population (Dhalla, Johnson and Engsberg 2003, Hartsell, Fellner and Saltzmann 2001, Lavery, 1997a).

The Foot Pressure Interest Group (FIG) produced draft protocol guidelines for plantar pressure measurement (Barnett 1998) to encourage comparability between studies. Regarding in-shoe systems, recommendations were made in a variety of areas (See appendix 1). As the protocol follows recommendations in the wider literature it has been referred to when assessing methodological quality.

Measurement variables In-shoe devices measure magnitudinal, temporal and spatial variable in all or part of the foot (Harrison and Hillard n.d.). Force is mass x acceleration and is measured in Newtons (N). Pressure is the distribution of force over an area. The SI unit is kilo Pascals (kPa) but Nm-2 is frequently used in the literature. (Rosenbaum and Becker 1997) Applied force is composed of vertical force (the effect of gravity or ground reaction force) and shear forces (friction). Vertical forces are usually the larger component. Forces are individual but consistent if measured on consecutive days or after several months. Time parameters are more consistent than force parameters (Roy 1988).

More research is required to identify the most useful variable in research or clinical practice.(Hodge et al 1997, Lavery et al 2003, Pitei et al 2000,

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Barnett 1998). Definitions/formulae are not consistent (Harrison and Hillard n.d.). Mean peak plantar pressure (PPP) is the maximum pressure detected by each sensor during the stance phase of gait and is described in kPa or N/cm2 (Stess, Jensen and Mirmiran 1997).

Pressure-time integral (PTI) is peak pressure multiplied by duration of weight-bearing in seconds. (Stess, Jensen and Mirmiran 1997). This variable includes loading time and is a better indicator of the pressure sustained during each gait cycle.

Walking speed data is important in trials where subjects self-select a comfortable pace. Zhu, H. et al (1995) demonstrated that gait speed has significant effects on plantar pressures. A self-selected pace better reflects normal walking style (Barnett 1998) but walking speed data should be collected and measurements rejected when velocity deviates by more than 10% from the average.

Pressure variables and the diabetic foot PPP became significant when linked with ulceration in the diabetic foot (Boulton et al 1983, Boulton et al 1985, Veves et al 1992, Lavery et al 1998). The possibility of a threshold for ulceration was investigated (Stess, Jensen and Mirmiran 1997, Frykberg et al 1998, Mueller 1999, Lavery et al 2003) but it is now recognized that ulceration is the result of the interplay between pressure, time and contact area and the permissive effects of neuropathy (Masson et al 1989). A case control study of 225

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age-matched patients evaluated risk factors for ulceration (Lavery et al 1998). PPP>65N/cm2, history of amputation, foot deformities and neuropathy were significantly associated with ulceration. Stacpoole-Shea, Shea and Lavery (1999) in a study of 36 subjects found a combination of PPP and PTI were predictive of ulceration. Sensitivity was 83% and specificity was 69%. A prospective study over 3.5 years of 187 type 2 diabetic patients with a history of ulceration analysed risk factors ( Kastenbauer et al 2001). Elevated vibration perception threshold (VPT), increased PPP and daily alcohol intake were significant predictors. Raised VPT was the strongest predictor (relative risk = 25.4). A 2-year study of 1 666 diabetic patients evaluated dynamic PPP as a screen for ulceration (Lavery et al 2003). PPP alone was insufficient as a diagnostic tool for high-risk. Strong correlations were found between elevated pressure and foot deformity and with callus. Stess, Jensen and Mirmiran (1997) measured PPP, PTI and force-time integral (FTI) over three areas of the forefoot in 97 diabetic patients. All pressure variables were raised but individual variables were not discussed. Barnett (2002) found that PTI was most influenced by diabetes and could be the most important variable to alter with footwear and orthotic interventions.

Research has identified strong links between plantar callus, raised PPP and ulceration. Wrobel et al (2003) in a cross-sectional study of 152 men with diabetes found that callus increased PPP by up to 29%. In a small group study, callus removal was found to reduce PPP by 25-32% (Pitei,

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Foster and Edmonds 1999). Callus should be removed before assessing the affect of interventions on PPP (Barnett 1998)

Pressure variables and the painful foot Metatarsalgia in rheumatoid arthritis is presumed to be due to excessive pressure to the metatarsal heads (Hodge, Bach and Carter 1999). In a study of 12 people with RA and a history of forefoot pain, PPP were assessed and patients asked to complete a VAS pain score whilst wearing prefabricated or custom-made EVA insoles (with/without metatarsal dome). Standing and walking pain were highly correlated suggesting that repetitive pressures were less significant than in the insensate foot. Pressure was distributed more uniformly with orthoses and both types significantly reduced average pressure. Custom-moulding with dome significantly reduced walking and standing pain and was preferred by most subjects. Pain and peak pressure were not correlated but pain and average pressure were. This correlation accounted for only 32% of the variance. It should be noted that the authors pooled the results from 20 out of 24 feet and the sample size was small. Postema et al (1998) similarly found no correlation between pain scores and peak pressures in a study of 42 patients with primary metatarsalgia.

Types of intervention
Total Contact Cast (TCC) A TCC is a close-fitting, below knee cast which protects neuropathic lower limbs and promotes healing of ulcers whilst allowing the patient to remain

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mobile. (Sinacore1996). TCCs had a 91% healing rate and led to substantial improvements in healing times compared with in-hospital care and daily wound dressing. Casting requires highly skilled people to make, renew and replace on a regular basis. Complications include superficial abrasions (27%) and fungal infections (15%). With undiagnosed osteomyelitis, casting can lead to more serious complications (Sinacore 1996). A Cochrane review of pressure-relieving interventions for diabetic foot ulcers found a single poor quality RCT testing TCCs (Spencer 2000). This does not mean that they are not effective but that more and better research is required.

Beiser et al (1991) investigated pressure variations in different cast designs and subjects were asked about comfort and ease of walking. Short leg casts (with/ without cast shoe) had greatest overall performance. Short leg casts with walking heel were most efficient at reducing peak pressures but awkward to wear. Pressures decreased as immobilization moved up the leg. PPP at the first metatarsophalangeal joint (MTPJ) in 20 asymptotic subjects was compared in athletic shoes (baseline condition), two types of post-operative shoes (one with a 1st MTPJ cut-out) and a fibre-glass short-leg walking cast. The cast and shoe with cut-out significantly reduced pressure (Corbett et al 1993). Zhu et al (1995) postulated that TCCs decelerate gait. TCCs have little padding, reducing compression, preventing shear within the cast.

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Rubber bottom cast boots, conventional short leg casts and TCCs were assessed for PPP in 10 healthy volunteers (Conti et al 1996). A significant reduction in forefoot pressure was found in both types of cast. Average weight-bearing area was significantly increased in the TCC, reducing forefoot pressures. Normal gait patterns are bi-phasic with pressure peaks at heel strike and toe-off. With casts, the force curves were bellshaped due to a flat-footed gait and restricted ankle movement. Subjects were not tested in normal footwear. In normal subjects, casts reduce forefoot and rearfoot loading, redistributing them to the mid-foot.

Total contact casts with terminal devices Cast boots and heels were added to TCCs and compared with therapeutic shoes (Lavery et al 1997a). For hallux and 1st MTPJ ulcers the devices were equally effective. TCC plus cast heel was more effective for 2nd-5th MTPJ ulcers. Casts were superior to therapeutic shoes and baseline footwear. Dhalla, Johnson and Engsbert (2003) added cast shoes and heels to TCCs. 28 healthy volunteers were assessed with six interventions: athletic shoe (control), TCC and TCC with four different terminal devices. For the forefoot, TCC with conventional cast or rigid rockers were best and would be indicated for fore-foot ulcers. All devices reduced midfoot pressure by at least 40%. In the rear-foot, PPP was significantly reduced in all configurations excluding the rigid rocker heel. This suggests that TCCs can be augmented.

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Removable cast walkers compared with TCCs 1. Asymptotic subjects The advantages of prefabricated walking boots (PWB) are: time of application, lightweight construction, relative low cost, provision of consistent and continuous pressure to off-load and minimize shear forces, ease of wound monitoring and hygiene (Hartsell, Fellner and Saltzman 2001). It was hypothesized that TCC and PWB would significantly and similarly reduce PPP compared with running shoes. 9 healthy volunteers were assessed. A 3/8 open-cell urethane foam insole was added to the PWB. Compared with running shoes, TCCs and the modified PWB significantly reduced pressure across the forefoot with an insignificant increase at the mid-foot. The impact of shear stresses, patient compliance, differences between healthy and symptomatic patients and activity levels were not addressed.

Aircast pneumatic walkers were equally good or better at reducing PPP than TCCs in a small sample of 12 healthy volunteers(Baumhauer 1997). In 18 healthy subjects, the Bledsoe Diabetic Conformer Boot was found to reduce PPP as well as a fibre-glass TCC( Pollo et al 2003)

2. In diabetes In a study of 25 diabetic neuropathic subjects, the effectiveness of TCCs, therapeutic shoes and removable walking casts (DH pressure relief walker, Aircast pneumatic walkers, Three D dura-steppers and CAM walkers were compared. The DH pressure relief walker which did not

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vary significantly from the TCC in reducing PPP over forefoot ulcers. Lavery et al (1996)

Boulton and Armstrong (2004) suggest that the failure of RCWs in clinical practice is because patients remove them. Instant TCCs made from a RCW made unremovable with the application of plaster or cohesive bandage are proposed as a solution.

Footwear 1.In diabetes Perry et al (1995) compared plantar pressures in 39 subjects barefoot, wearing leather-soled oxford-style shoes and in inexpensive running shoes. (Diabetes and neuropathy n= 13, diabeties without neuropathy n= 13, healthy controls, n=13). The oxford style shoes did not reduce pressures from barefoot levels. Running shoes reduced pressure significantly at the heel and forefoot. It was concluded that individuals with insensate feet should not wear leather-soled shoes and the running shoes are a useful alternative for individuals with sensory loss and without foot deformity.

Pitei et al (1996) (abstract only available) measured in-shoe pressures for 22 diabetic patients in three types of footwear patients own shoes, surgical shoes with an EVA-moulded insole and standard trainers. When newly fitted, the insoles significantly reduced plantar pressures compared

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with patients own shoes. When worn in (duration not given) pressures were further reduced. Trainers were less effective at pressure reduction.

Plantar pressures were assessed in 49 diabetic neuropathic patients (no existing or previous ulceration, n=19; existing or previous ulcers, n=30) (Resch et al 1997). PPP and PTI were assessed in patients own comfortable walking shoes, own shoe with Frelens custom-moulded semirigid insoles, jogging shoe with and without insoles and an orthopaedic shoe with metatarsal bar and insole. The high degree of variability of the F-Scan device (25-30% accuracy) made it impossible to draw any conclusions. The orthopaedic shoes tended to increase pressures and were found uncomfortable and awkward by patients. This study did not claim significant improvements from the interventions, possibly because the baseline was a good quality walking shoe.

Kastenbauer et al (1998) compared specially designed running shoes with a custom-made insole in an in-depth shoe. Running shoes were as effective in reducing pressures at the central metatarsals in a sample of 13 diabetic patients

2. Diabetes and amputation 30 patients with diabetes and trans-metatarsal amputations had PPP measured at the distal residuum and the contra-lateral forefoot in six types of footwear; full-length shoe with toe-filler (baseline) and combinations of

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total contact insert, ankle foot orthoses (AFO), rigid rocker bottom sole (RRB) or short shoe. All conditions except the short shoe reduced PPP on the residuum. The full shoe with insert and RRB had few complaints from patients. The addition of an AFO reduced pressure but patients had functional problems. (Mueller, Strube and Allen1997)

Insoles/Orthoses 1.Asymptotic subjects Windle, Gregory and Dixon (1999) used Parotec to assess the shock attenuation characteristics of visco-elastic, polymetric foam, Saran (military issue) and Sorbothane insoles in military boots during running and marching compared to a no insole baseline. 11 military recruits were trialled. All insoles significantly reduced PPP at heel strike and forefoot loading. The Sorbothane insole was significantly more effective than the other insoles. House et al (2002) demonstrated that 100 130 km of running on visco-elastic or polyurethane insoles did not reduce shock absorption. Foam insoles were more effective than visco-elastic and did not degrade. The most effective version reduced heel PPP by 37% and forefoot PPP by 24%.

Novick et al (1993) studied the effect of three types of rigid orthoses on PPP in 10 subjects to identify whether FOs were effective for off-loading sites of ulceration in diabetic individuals. Interventions were 1/8 Spenco, two rigid Sorbotholen custom-made insoles, one with 3/8 relief under the 1st MTPJ, the other without. Least pressure at the 1st MTPJ was recorded

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with the relief orthoses, the greatest with the plain rigid version, followed by simple Spenco insoles. Mid-foot and heel pressures were minimised with the Spenco insole, but increased with both rigid orthoses.

Brown, Rudicel and Esquenazi (1996) tested PPP in 10 subjects wearing off-the-shelf and customized orthoses in standard extra depth shoes. Plastizote, cork and plastic insoles reduced pressures at the forefoot, heel and 2nd-5th MTPJ, but increased pressures at the mid-foot.

2.In diabetes A small-scale study investigated the impact of flat and moulded customized inserts on PPP under the MTPJs of 12 diabetic patients, some with neuropathy. (Lord and Hosein (994) Testing the hypothesis that moulded inserts would be more effective than flat, the authors suggested that this occurred by redistributing load to the midfoot and by cushioning. Results were treated with caution because of problems with the pressure measurement system (F-Scan). Ashry et al (1997) considered the effectiveness of three different insoles in reducing plantar pressure in a sample of 11 diabetics with amputation of the hallux. A base-line reading in standard extra-depth shoes was compared with the same shoes with customized 6 mm plastizote insoles with and without the addition of a metatarsal pad, arch pad or both on the amputated and non-amputated foot. Mean peak pressure was significantly reduced across the forefoot, lesser toes and heel in both groups but there was no significant difference between interventions.

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Lobmann et al (2001) compared the effects of a mixed materials moulded orthosis (14 mm thick) on plantar pressure in 81 type 2 diabetics with no history of ulceration. 18 subjects were considered at risk of ulceration because of high plantar pressures and these received insoles. 63 subjects acted as the control group and wore conventional footwear. Using pedobarograph, a reduction of 30% was found in maximum peak pressure of the whole foot in the at risk group. Pressures gradually increased during the following 12 months sush that a 13% improvement over baseline measures remained after one year. The control group increased pressures over the year and there was no significant difference between the two groups at the end of the study. This demonstrates the importance of considering insole degradation.

Frykeberg et al (2002) considered the effect of a rocker insole on forefoot pressures on 25 subjects (with and without diabetes) wearing their own footwear, standard post-surgical boots and the boot with a rocker insole. The insole produced a reduction in PPP of greater than 40% over the baseline or the surgical boot alone.

3. The painful foot McLauchlan et al (1994) used a discrete sensor system (GaitScan) to compare treatments for metatarsalgia: a felt U-shaped pad and metatarsal dome. 30 asymptotic patients were investigated. The dome produced a significant reduction in pressure over 1st 4th MTPJs compared with

30

baseline values. Poon and Love (1997) study of a metatarsal dome on plantar pressures and pain in 14 patients with metatarsalgia found that mean pressure was reduced by 13% at the forefoot. The VAS revealed a 71% reduction in pain scores and 11 subjects found some or marked improvement of symptoms.

Kelly and Winsons (1998) assessment of commercially available insoles compared Viscoped with Langer in 33 patients with primary lesser metatarsalgia. Langer performed better objectively and subjectively.

Hodge, Bach and Carter (1999) completed a repeated measures pressure assessment of a variety of orthoses in a group of 12 subjects with rheumatoid arthritis with foot involvement and pain at the 2nd MTPJ. A shoe only baseline, pre-fabricated and custom-made orthoses of similar materials, density and size were assessed. The custom-made orthoses were also tested with the addition of pre-formed metatarsal bars and domes. Qualitative assessment was made by asking subjects to complete a VAS Pain Scale, and express a preference for one of the interventions. All orthoses significantly reduced pressure under the 1st and 2nd MTPJ but the custom-moulded orthoses with metatarsal dome was the intervention of choice. A correlation was found between average pressure and pain but this only accounted for 32% of the variation leading the authors to conclude that other factors were implicated in pain than PPP. Li et al (2000) investigated the effect of orthoses on PPP in subjects with rheumatoid arthritis (n=12) and an age-matched group of healthy subjects

31

(n=8). Moulded polyethylene orthoses reduced PPP and peak force significantly for both groups, with greater pressure relief and redistribution in RA patients.

External devices Schaff and Cavanagh (1990) hypothesized that rocker-bottom shoes might redistribute PPP in insensate feet. Healthy volunteers were tested (all US men size 9, n=8)) wearing extra-depth shoes (control) with/without rocker sole attached. PPP was reduced over the medial and middle MTPJ (-30%) but increased at the heel, mid-foot and lateral forefoot (+20%). Force impulse was significantly reduced at the metatarsals (53% medial, 35% control). It is difficult to generalize results as there is such diversity in rocker bottom shoe modifications (Brown et al 2004) and diabetic patients may respond differently.

Fuller, Schroeder and Edwards (2001) added rigid rocker bottoms to postoperative shoes to assess the effect on pressures over the forefoot in 16 healthy females. PPP and FTI were significantly reduced compared with the post-operative shoe alone.

Three types of rocker soles (toe-only, negative heel and double) were studied for their effect on PPP in 40 healthy subjects (Brown et al 2004). PPP, PTI and sensor contact time were compared with a baseline shoe. A significant reduction was found at the forefoot in all versions. Pressure was shifted to the mid-foot with the negative heel and toe-only rockers.

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Summary of the literature Plantar pressure studies are typified by small sample sizes and short-term cross-over studies. Very few studies were randomised and the use of asymptotic volunteers to test interventions for diabetic conditions is common. Recruitment information is rarely given and ethical and informed consent only occasionally reported. The general opinion of the research is that footwear interventions and casts do reduce plantar pressure.

Study design and Statistical Considerations

Cross-over studies Pressure measurement studies frequently use cross-over studies. This refers to trials where each subject acts as their own physiological control by being tested in all interventions. Sample size can be reduced, but there are potential carry-over effects i.e. one intervention affects the results of the next intervention. Williams designs account for carry-over effects but these were not mentioned in trials reviewed above or in included trials. (Qu, 2003)

Repeated measures Repeated measures refer to the number of trial runs each subject has with each intervention and the number of steps nested to find mean values. Repeated measures reduce intra-patient variability and increase statistical power. The degree of improvement is marginal and decreasing, therefore the aim is to find the number of repeats which maximise power but minimise data over-load. Increasing the number of follow-ups and/or

33

baseline measures from one to three or four, can reduce sample size by 35-70%, but there is little value in more the six or seven measures (Kernozek, LaMott and Dancisak, 1996; Vickers 2003).

Sample size and data analysis choices Sample size calculations were rarely offered in the literature. To calculate sample size, the researcher needs to know (i) the effect size, (ii) population standard deviation for continuous data (iii) desired power of the experiment () (iv) significance level () . The last two are fixed by convention (usually = 0.05 and = 0.8) but the former are unique to the experiment. Effect size is determined by the investigator. The population standard deviation is estimated by a pilot study. There was little evidence of this kind of calculation. For parametric studies, a minimum sample size of 30 is usually accepted (Pett, 1997)

An underlying normal variation is often assumed and statistical tests chosen accordingly particularly analysis of variance. Many are underpowered and non-parametric tests would be more appropriate (Pett, 1997).

One subject, two feet A further consideration is raised by Menz (2004) and relates to the use of data from an individual subject or as two individual feet. Statistical sampling has an underlying assumption that each observation is independent (Pett 1997, Polgar and Thomas 2000). This does not apply

34

to a pair of feet. Including both feet doubles the sample size, which might appear to make the evidence more powerful. The outcome of statistical analysis is distorted, however, because the observations are not independent. Menz (2003) recommends that the unit of analysis should be people, not feet.

Search strategy
The following databases were searched: 1.Cochrane Library including databases of systematic reviews, abstracts of effects (DARE), central register of controlled trials (CENTRAL), methodology, health technology and NHS economic evaluation. 2. Clinical effectiveness databases: NICE (National Institute for Clinical Effectiveness) technology appraisals and clinical guidelines, Research findings register 3. General health sites: British Nursing Index, AMED, Medline, Embase, Recal, CINAHL,PRODIGY 4. General databases: British Humanities Index, PsychInfo 5. Full-text electronic journals: Bandolier, BIOMED central, Clinical Effectiveness, Infotrac, Emerald Fulltext, Highwire, ASSIAnet, Science Direct, Swetswise, Web of Knowledge 6. ZETOC for tables of contents and conference proceedings 7. Index to theses 8. COPAC 9. Relevant journals were hand-searched. 10.Citations were followed up from relevant articles.
35

Inclusion and Exclusion criteria

Inclusion criteria
Study design Randomized control trials

Justification: Systematic reviews of non-RCTs can compound the problems of individually misleading trials and produce a lower quality of evidence. Sackett et al (2000) advises avoiding systematic reviews which include both levels of evidence unless these are analysed separately.

Types of participants Studies of patients with specific conditions where clear inclusion criteria stated Adults

Justification: considering literature on effectiveness of interventions in a broad spectrum as appropriate to podiatric clinical practice. Eligibility criteria are necessary to establish where findings can be applied. Findings with healthy individuals may not be transferable to the target group. (Barnett 2002)

Outcome measures Quantitative plantar pressure measures

36

Dynamic in-shoe measures. An appropriate base-line for comparison as required by study design

Adequate sample size

Justification: to test the hypotheses that footwear and orthoses are effective because they redistribute pressure in real-life situations i.e. dynamic, in-shoe. Cross-over studies require a smaller sample size than parallel trials. Of the crossover trials only Hsi, Lai and Yang (1999) offered a calculation of 22 subjects. For this reason, a minimum sample size of 20 was accepted for inclusion. The only parallel trial (Barnett, 2002) used a power calculation and found a minimum sample of 47 was required for the control and intervention groups. Type 1errors are more likely with small samples. (Pett 1997)

Interventions Footwear o Orthopaedic shoes o Footwear adaptations for purposes of pressure redistribution o Specific types of shoe e.g. running shoes

Orthoses o Rigid o Flexible

37

o Customized o Off-the-shelf

total contact casts surgical shoes/post-operative shoes walkers ankle-foot orthoses

Justification: these represent the range of interventions for redistributing pressure regularly available in clinical practice. Combinations of interventions were also accepted

Measuring devices systems which measure in-shoe dynamic plantar pressures systems which had been independently tested and demonstrated to be reliable, accurate, repeatable. Thin, flexible, individually calibrated pressure sensors where used systems based on array/matrices rather than a few discrete sensors

Justification: Most individuals are ambulatory and wear footwear. Systems should measure actual pressures between the foot and the shoe/cast. Discrete systems have been shown to alter gait and identified points of pressure may alter when orthoses/footwear are changed for

38

testing. The thickness of the transducers can cause alterations in gait. Some insole measurement systems are thick and change the position and movement of the foot. They can fill the shoe, leaving too little space for the foot. Thick insoles do not mould to the foot or the orthoses being assessed. Thin, flexible pressure sensitive insoles overcome many of these problems. (Nicolopoulis 2002).

Exclusion criteria
Types of participants Healthy, asymptotic subjects Children Non-ambulatory Those using walking aids such as walking sticks or frames

Justification: walking aids alter pressures on the foot, change gait and make dynamic testing difficult (Resch et al 1997). Subjects with systemic conditions such as diabetes or with biomechanical abnormalities do not have the same plantar pressure distributions and responses as asymptotic subjects (Barnett 2002). Children have different plantar pressure distributions from adults (Rosenbaum and Becker 1997)

Interventions Dressings Hosiery

39

Strapping

Justification: These are included if one of a range of interventions. As temporary interventions, it was decided to exclude them from the study. Outcome measures Qualitative studies unless findings linked within studies with a primarily quantitative focus e.g. pain questionnaire, expressing a preference between interventions Pressures other than plantar pressures. Studies of other gait parameters e.g. timing, sequences, stance pressure distributions, postural sway Studies which focus on barefoot or stance pressure distributions centre of pressure, centre of force studies

Justification: this study is investigating the case that footwear and orthoses redistribute pressure. Qualitative studies look at indirect measures. Variables implicated in ulceration, pain and healing relate to amount and length of pressure and contact area over which it is distributed. Other variables are not directly related. Barefoot and stance measures are excluded for reasons explained above. Centre of pressure and force do not have consistent formulae for calculation and there is some question of their value in clinical practice. (McPoil and Cornwall 1998; Barnett1998)

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Measuring devices systems which measure barefoot pressures only static pressure measurement systems discrete sensor systems systems for which independent test data could not be found early prototypes which were demonstrably unreliable

Language/Date English language only Post-1990

Justification: The researcher did not have access to translation services and is aware that this may introduce bias into the selection of data (Khan and Kleijnen 2001.The technology required was developed from the early 1990s onwards.

Methodology

Searching was undertaken between August 2003 April 2004. The search strategycwas constructed around the inclusion critieria. By referring to indexed terms a large number of possible search terms were collated and used to test the available literature (See Appendix 2). A highly specific search strategy could not be devised. Searches were sensitive, producing many references. For this reason a list of excluded
41

articles has not been provided although recommended by the Centre for Disseminations and Reviews. (Glanville, 2001)

Titles and abstracts were assessed for relevance against the objectives of the review, inclusion and exclusion criteria. Full articles were checked again. Ideally, this process would be carried out by more than one reviewer and conducted blind i.e. unaware of authors identities. (Khan and Kleijnen 2001) Because of the nature of this research, this has not been possible and selection bias may be introduced as a result.

Data extraction
Data extraction is potentially subjective and open to bias. It would ideally be completed with the reviewer blinded, that is, unaware of authorship. A panel of reviewers to independently assess studies is an alternative solution. Both options are unavailable in a single-authored dissertation. A number of extraction protocols are available (Khan and Kleijnen 2001) but relate to double blind parallel RCTs. In this study data was extracted on: how subjects were selected for inclusion/exclusion the organisational setting(s) in which the trial took place baseline population variables such as age and gender description of the intervention(s) and numbers assigned to each group period and intervals of follow-up methods and techniques of measurement Outcomes

42

findings and conclusions (based on Spencer 2000)

Characteristics of included studies

Study

Armstrong (1999)

Methods

Repeat measures, crossover design single centre RCT Method of randomisation of treatments not described

Participants 25 consecutive diabetic patients with grade 1A (University of Texas)((Oyibo et al n.d.) plantar forefoot ulcerations: existing or recently healed single ulcers, peripheral neuropathy and a diagnosis of DM. Neuropathy established as loss of protection to 10g monofiliament and biothesiometer

Interventions Baseline: Reebok canvas sneaker Total contact cast: method of Kominsky without plywood sole Aircast pneumatic walker DH pressure relief walker Prescription-depth inlay shoes with PW Minor stock inlays

Outcomes

PPP (N/cm2) PTI (N.s/cm2)

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Measured over heel

Measurement system Emed pedar Five trials, mid-gait steps, 40 steps per subject per modality Allocation concealment No

Notes

High percentage of male participants (92%) Type I/ type II not described. Treatment of participants not described. No a priori sample size calculation. No discussion of informed consent or ethical approval. Suitability of modalities for patients with active ulceration not discussed. No review after trial or follow-up to ensure no adverse effect. Did not appear to be supported by industry. Masking not described.

Full citation Armstrong, DG and Stacpoole-Shea, S (1999) Total contact casts and removable cast walkers: mitigation of plantar heel pressure Journal of the American Podiatric Medical Association 89 (1) pp 50-53

Study

Barnett (2002)

Method

Prospective randomised clinical control trial Single centre

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Method of randomisation described Baseline, three month and six month follow-up Mixed methods

Participants 103 Type I and Type II diabetic individuals without major vascular disease, foot deformity, mobility problems, existing or previous ulceration Control and intervention group matched demographically and health characteristics except for age

Interventions Control: 3 mm unadapted Cleron shoe inserts (n=52) Intervention: polyurethane gel and EVA orthoses (off-theshelf) (n=51) Pressures measured in standard extra-depth orthopaedic shoes. Inserts transferred to patients own footwear between follow-ups

Outcomes

PPP (kPa/cm2) PTI (kPa.s/cm2) Contact area Pressure variables measured over 9 described masks and the whole foot Bristol Foot Health Questionnaire

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Diary of wear

Measurement system Emed pedarmobile

Allocation concealment No

Notes

Participants with DM recruited from City PCT podiatry database. Intention to treat analysis included. Does not appear to be supported by industry.

Full citation Barnett, S, (2002) The clinical effectiveness of orthoses prescribed to control and reduce diabetic foot pathology Ph.D Thesis, University of the West of England

Study

Fleischli (1997)

Method

Repeated measures crossover study Single centre RCT Method of randomisation of treatments not described

Participants 26 patients with existing or recently healed diabetic neuropathic plantar forefoot ulcers. Analysed in two groups;

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Forefoot (metatarsals) ulcers

(n=19), Hallux ulcers

(n=7). Groups not matched. VPT assessed with biothesiometer. Some participants do not meet generally accepted criteria for neuropathy (VPT > 25) Baseline demographic and health data given

Interventions Baseline: rubber soled canvas sneaker Total contact cast: method of Coleman, without plywood sole DH pressure relief walker Darco ortho-wedge shoe (also described as Darco halfshoe) Darco rigid-soled post-operative shoe Accomodative felt and foam dressings

Outcomes

PPP (Ncm-2) Percentage change from baseline Measured over sites of ulceration

Measurement system Emed pedar

Allocation concealment

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No

Notes

Recruited from clinics at University health systems of an American city. No sample size calculation. Ethical issues not addressed. Masking not explained. No support from industry reported.

Full citation Fleischli, JG et al (1997Comparison of strategies for reducing pressure at the site of neuropathic ulcers Journal of the American Podiatric Medical Association 87 (10) pp.466472

Study

Hsi (1999)

Method

Single centre RCT. Method of randomisation of treatment order not described Two-factor analysis of variance with interactions between orthosis and subject. Repeated measures, cross-over design

Participants 22 consecutive patients with treated unilateral heel pain

Interventions Baseline: patients own shoes and hosiery

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Visco-elastic heel orthoses

Outcomes

PPP (kPa/cm2) PTI Foot to sensor contact time Measured over whole foot

Measuring system Parotec

Allocation concealment No

Notes

Did not appear to be supported by industry

Full citation Hsi, WL; Lai, JS and Yang, PY (1999) In-shoe pressure measurements with a visco-elastic heel orthosis Archives of physical medicine and rehabilitation 80 (7) pp 805-810

Study

Lavery (1997b)

Method

Repeated measures crossover study Single centre RCT Method of randomisation of treatment order not described

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Participants 32 consecutive patients with DN and existing or recently healted plantar forefoot ulcers. Method of establishing DM or neuropathy not described Stratified into three sub-groups: 1st MTPJ ulcers (n=10), 2nd 5th MTPJ ulcers (n=12), ulcers of hallux (n=12)

Interventions Baseline: thin rubber-soled canvas oxford sneaker Extra-depth shoes in men and womens styles New Balance cross-trainers in men and womens styles SAS Timeout (men) and Free-time (women) comfort shoes Each assessed with and without plastazote/urethane insoles

Outcomes

PPP (N/cm2) and percentage change from baseline over the three sites of ulceration

Measurement system Emed pedar

Allocation concealment Yes

Notes

Recruited from clinics at an American city university hospital. No a priori sample size calculation. Patient characteristics of

50

sub-groups not given. Ethical issues not addressed. Masking over ulcers not described. Does not appear to be supported by industry.

Full citation Lavery, LA et al (1997b) Reducing plantar pressure in the neuropathic foot: a comparison of footwear Diabetes Care 20 (11) pp 1706-1710

Study

Postema (1998)

Method

Repeated measures, cross-over design Multi-centre double-blind RCT Method of randomisation of treatment order described but not justified Mixed methods

Participants 42 patients with a history of primary metatarsalgia 41 female Clear inclusion and exclusion criteria

Interventions Baseline: same brand of extra depth shoe

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Standard insole and custom-made insole of the same materials. Standard insole not a commercial product but made to standard pattern rather than customized. Rocker bar Pain questionnaire and patient preference

Outcomes

PPP (N/cm2) Force impulse (N s) Pain scores from patients with pain Preference ratings

Measurement system Emed pedar

Allocation concealment Yes

Notes

Recruited from three areas of the Netherlands. No a priori sample size calculation. Does not appear to be supported by industry

Full citation Postema, K et al (1998) Primary metatarsalgia: the influence of a custom moulded insole and a rockerbar on plantar

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pressure Prosthetics and orthotics international 22 (1) pp.3544

Study

Redmond (2000)

Method

Repeated measures crossover study RCT probably single centre Treatment order randomised but method not described

Participants 22 subjects with excessive pronation (criteria given)

Interventions Baseline: Dunlop Volley athletic shoe Non-cast insole made of card with a 60 high density EVA varus rear-foot post Modified Root orthosis: 4mm high density polypropylene shell, PVC cover, 60 extrinsic EVA varus rear-foot post

Outcomes

Maximum force (N) FTI (N.s) PPP (kPa) Maximum PPP(kPa/cm2) PTI (kPa.s/cm2) Contact area (cm2)

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Measurement system Emed pedar

Allocation concealment No

Notes

No subject demographic information. No recruitment information. Ethical approval form University of Sydney. No a priori sample size calculation. Non-casted orthosis is not an appropriate treatment for abnormal pronation. Does not appear supported by industry.

Full citation Redmond, A; Lumb, PS and Landorf, K. (2000) Effect of cast and non-cast foot orthoses on plantar pressure and force during gait Journal of the American Podiatric Medical Association 90 (9) pp.441-449

Ranking of studies
Seven RCTs met inclusion criteria. Heterogeneity in every aspect of study design prevents any pooling of data. Six cross-over studies were quality assessed against standards produced by Griffiths(2004) (Appendix 3). One parallel trial was assessed against the Consort standards (Moher, Schulz and Altman 2001) for reporting of RCTs (Appendix 4). Trials were ranked on the following:
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1. How participants were allocated to interventions 2. provision of scientific background and rationale for the study 3. method should include how participants were chosen, settings where data collected, precise details of the interventions, specific aims and objectives, primary and secondary outcome measures, how sample size was determined 4. randomisation: technique for allocation and blinding 5. statistical methods used for primary outcome comparisons 6. results: participant flow, protocol deviations, recruitment and followup, baseline demographic data, numbers analysed, outcomes and estimation, adverse events. 7. Discussion: should include interpretation of results considering hypotheses, sources of bias or lack of precision, statistical problems. Should also consider generalizability. (Moher, Schulz and Altmann 2001; Griffiths 2004)

Study design of included trials

Methodological quality was generally poor particularly regarding sample calculations and sizes, ethical considerations, data analysis and study design. (See appendices 3,5 and 6). All except Barnett (2002) were crossover studies. Barnetts study took baseline measures with follow-ups at three and six months. Postema et al (1998) allowed subjects to wear each intervention for a month before in-shoe pressure measures were taken and a new intervention fitted

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Participants of included studies

Four studies involved diabetic patients involving 200 participants (Armstrong 1999; Barnett 2002; Fleischli 1997; Lavery 1997b). Barnett(2002) included patients with types I and II diabetes with no history or existing ulceration or significant pathology. Armstrong (1999), Fleischli (1997) and Lavery (1997) studied patients with existing or recently healed single plantar diabetic ulcers but did not specify if patients were Type I or Type II diabetes (DM).

Hsi (1999) selected patients with treated unilateral heel pain (n=22). Postema (1998) chose patients with primary metatarsalgia. (n=42) Redmond (2000) included asymptotic individuals with abnormal pronation (n=22).

Interventions studied in included trials (Appendix 7)

Eighteen different interventions were tested, excluding baseline footwear. TCCs, the DH pressure relief walker and the PW Minor extra depth shoe were covered by more than one paper. The quality of the papers examining these interventions (Fleischli 1999, Armstrong 1997 and Lavery 1997) were poor. The methods of cast construction differed.

The Four subgroups of intervention were identified: TCCs and RCWs, footwear, insoles/orthoses and external shoe adaptations.

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Outcome measures (Appendices 8 and 9)

All included trials collected mean PPP. Trials used different sampling speeds (50 100hz) and different masks i.e. areas of the foot. Studies examining pressure over healed ulcers sites did not explain how this was done. PTIs were collected by four studies

Mean contact area was collected in two studies (Barnett 2002 and Redmond 2000). This data is relevant as pressure is dependent on the available surface area for dispersion. Only Barnett (2002) and Hsi(1999) collected walking speed data whilst all studies asked subjects to walk at their own pace.

Two studies used a mixed methods approach. Barnett asked subjects to complete a Foot Health questionnaire and to keep a diary of orthoses/insole use. Postema et al asked subjects to complete a pain questionnaire and asked for their preference between interventions

Methodological quality
Objectives of study Study design, in some trials, did not match objectives. Armstrong (1999) selected patients with fore-foot ulcers to consider the impact of off-loading devices on heel pressures. Armstrong (1999) and Fleischli (1997) considered ulcer treatment. The inclusion of patients with healed ulcers
57

was not jusitified. Walking speeds were not collected although speed has a bearing on repetitive stresses which delay healing and on the validity of the study (Zhu et al 1995). Lavery (1997b) considers ulcer prevention but includes patients with existing ulcers in the sample population. Barnett (2002) also studies interventions to prevent ulcers and, therefore, excludes subjects with existing or previous u ulceration. Two studies examine the relationship between pain and plantar pressure distribution. (Postema 1998; Hsi 1999). Hsi (1999) does not justify recruiting subjects who do not have heel pain and have had treatments which might affect results. One study investigated the use of functional orthoses to change forces acting on abnormally pronated feet. (Redmond 2000)

Quality of studies
All the cross-over trials randomised their treatment order but did not describe how this was done. Ethical considerations were poor. Some papers did not mention informed consent, right to withdraw or consider the advisability of testing ulcerated individuals in sneakers. Callus reduction was only carried out by one researcher although callus increased plantar pressures by up to 30%. Appendix 5 assesses trials against the foot pressure measurement protocol. (Barnett 1998)

58

Statistical considerations (Appendix 6)

Sample sizes tended to be small (Armstrong, n=25; Fleischli, n=26; Hsi, n=22; Redmond, n=22). Sample sizes were calculated in two studies (Hsi 1999 and Barnett 2002), but no justification given for assumptions required for the calculations. Most studies presumed an underlying parametric distribution apart from Barnett (2002)and Redmond (2000), who tested their data. Redmond (2000) found that some data could not be transformed to a normal distribution and used non-parametric tests instead. High order crossovers studies require particular procedures to calculate sample size and power determination to take into account potential carry-over effects from different treatments (Qu, 2003). There was no evidence of this in the affected studies.

Six studies used repeated measures. The number of steps per subject per modality varied from 5 40. (Appendix 9). These are within guidelines (Kernozec, La Mott and Dancisak 1996)

Four studies had less than thirty subjects in their sample. An adequate sample is required to guard against type I errors i.e. optimistically concluding a significant difference between intervention and control. Only Barnett (2002) stated a clear hypothesis. All studies found significant improvements on their chosen baseline, reflecting the findings of the literature review. This may be evidence of a publication bias in English. Only three studies offered a power calculation (Barnett, Hsi and

59

Redmond) to assess the risk of a type II error i.e. falsely accepting the null hypothesis.

Non-parametric tests should be used for non-normal distributions. Most included studies did not discuss data distribution. All studies used mean and standard deviations as descriptive statistics without justification. Medians and ranges should be used with non-parametric data (Pett, 1997). Two studies (Fleischli 1999 and Lavery 1997) sub-divide their sample into small, uneven groups. Pett (1997) considers that unequal cell sizes cause serious problems for the repeated measures designs and multivariate ANOVAs that these studies use.

Treatment of data from right and left feet (Menz 2003) varies betweem included studies (Appendix 10). Fleischli and Lavery investigated pressure over single ulcer sites. Postema selected the most painful foot. If neither foot was more painful, the choice was randomised, but the method was not given. Barnett collected readings from ten left and ten right steps, but later figures appear pooled as do those of Hsi. Redmond pools data after statistical testing and justifies this, doubling of the sample size. Armstrong does not give any figures.

Results
Total contact casts and removable cast walkers 1.Fleischli (1997) studied the effect of pressure off-loading devices over ulcer sites of 26 neuropathic diabetics, sub-divided into

60

subjects with ulcers under the metatarsals (n=19) and those under the hallux (n=7). The DH pressure relief walker was equivalent to the TCC at off-loading the hallucal ulcers (79%, 85% respectively) and more effective for metatarsal ulcers (85%, 76%). Both devices were significantly better than the Darco OrthoWedge shoe (66% forefoot group, 64% hallux group) , accomodative felt and foam dressings (48% forefoot group, 34% hallux group) and the Darco rigid post-operative shoe (36%, 7% respectively). The authors concluded that if pressure reduction is strongly correlated with healing, the DH pressure relief walker is an acceptable alternative to the TCC.

2.Armstrong (1999) investigated the impact of TCCs, Aircast pneumatic walker, the DH pressure relief walker and extra-depth therapeutic shoes on heel pressure in 25 diabetic neuropathic subjects with plantar forefoot ulcers. The TCC was found to be significantly better at reducing PPP. There was no significant difference between removable casts. Extra-depth shoes offered the least protection. Considering PTIs, the DH walker was significantly better than other modalities. All interventions, including the baseline sneakers, reduced PTI significantly more than therapeutic shoes.

The DH pressure relief walker performed well compared with TCCs but the areas examined differed (area of forefoot ulceration or heel pressure).

61

The methodological quality of both papers is poor. Currently debate about patient compliance (Boulton and Armstrong 2004) suggests that patients remove walkers, impairing clinical outcomes. TCCs may, therefore, remain the intervention of choice.

Shoes
1. Lavery (1997b) considered three kinds of therapeutic footwear. For individuals with metatarsal ulcers (n=22), comfort shoes were more effective than cross-trainers and therapeutic shoes. For those with hallucal ulcers (n=10), extra depth shoes were equivalent to comfort shoes and significantly better than cross-trainers. 2. Armstrong (1999) examined heel pressures (PPP, PTI and foot contact areas) in 25 diabetic patients with forefoot ulcers whilst wearing TTCs, RCWs and extra-depth shoes. The latter were the least effective intervention as PTI exceeded the baseline sneaker.

The evidence for footwear from these studies is insufficient to draw conclusions regarding effectiveness. The quality of both studies was poor.

Insoles/orthoses Terminology was not consistent some authors described a moulded device as an insole, others as an orthoses.

1. Hsi (1999) studied the effect of visco-elastic heel orthoses in 22 patients with treated heel pain whilst wearing their own shoes.

62

This intervention reduced mechanical load in the posterior heel and midfoot and increased load over the first metatarsal and hallux during gait. 2. Postema (1998) considered the effect of two types of insole and a rocker bar on forefoot pressures in 42 patients from several centres across The Netherlands with a history of primary metatarsalgia. The custom-moulded insole reduced force impulse by 10.1% and peak pressure by 18.25% over the central forefoot. Lower pain scores were found in patients experiencing pain whilst wearing the customized insole and more users expressed a preference for this intervention. 3. Redmond (2000) tested the effect of a modified Root orthosis and a flat, non-cast insole (both with 60 varus posting) on a sample of 22 individuals with abnormal pronation. The Root orthosis reduced pressures and forces at the heel and increased heel surface area. Midfoot forces remained unchanged as an increased load was offset by increased contact area. Forefoot pressures were also reduced leading the authors to conclude that foot function was altered profoundly with the Root orthosis in healthy young adults with abnormal pronation. The choice of non-Root comparator was questionable: a card base with EVA varus rear-foot post. This is not a typical alternative treatment for pronation and therefore a poor indication of the relative benefits of the modified Root intervention. Study quality was poor.

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4. Barnett (2002) recruited 103 neuropathic diabetic patients who were randomised to receive 3mm unadapted Cleron insoles or off-the-shelf polyurethane and EVA moulded orthoses for six months in their own footwear. Plantar pressures were assessed at baseline, three and six months. Orthoses reduced PPP by 22%, PTI by 16% and increased mean contact areas by 11%. The Cleron insoles (designed as a blind and for control purposes) also reduced PPP (16%),and PTI (10%). Mean contact area was increased by 2%. The author concluded that Cleron insoles were successful at reducing pressure in individuals with diabetes and neuropathy but without substantial foot deformity. Pre-formed orthoses were suitable for patients with higher planter pressure and increased risk of ulceration. Foot health questionnaires suggested that orthoses improved subjects perception of foot health. Compliance appeared to be good. Gait speed increased significantly in both sub-groups. 5. Lavery (1997) investigated the effect of footwear with and without an unmodified 4 mm plastazote/urethane insole on mean peak pressure in a sample of 32 subjects with existing or recently healed diabetic, neuropathic plantar ulcers. The insoles reduced mean peak pressures at ulcer sites by an additional 5.4 20.1% from baseline and a similar trend was observed at non-ulcerated areas of the foot. Study quality was poor.

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Included studies concluded that one or more insoles/orthoses were effective at redistributing PPP, reducing PTI (where collected) and increasing contact areas in a variety of populations. The case for custommoulding over off-the-shelf shoe inserts was very limited. Simple insoles had significant impact on pressure variables. Moulded insoles were wellreceived.

Visco-elastic heel orthoses appear to distribute pressure away from the heel to the 1st MTPJ and hallux in a small group of subjects with treated heel pain.

External shoe adaptations

1. Postema et al (1998) tested rocker soles with 42 patients with primary metatarsalgia. Force impulse was reduced over the lateral and central metatarsal heads by 10.5% and 15.1%. PPP was reduced by 7.6% and 15.7% over the same areas. The addition of insoles produced further off-loading which was independent of the rocker sole. The sample composed of 41 women out of 42 subjects. The authors do not describe metatarsalgia as confined exclusively to women. This sample is, therefore, biased.

There is limited evidence from a moderate quality multi-centre RCT that rocker soles reduce forefoot pressure in a sample of women with primary metarsalgia.

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Discussion
Heterogeneity of studies made pooling results impossible. Methodological quality was generally poor. Qualitative synthesis provides reasonable evidence from one RCT that insoles/orthoses are effective in redistributing plantar pressure. Evidence for TTCs, RCW and footwear is very limited because of small sample sizes, unique studies and poor quality. There is limited evidence that a version of the rocker sole reduces loading over the metatarsals. Visco-elastic heel pads redistribute pressure away from the heel in one small study.

Comparing the results for the diabetic studies with those of Spencer (2000) on preventing and healing diabetic ulcers, some similarities emerge. In preventative studies, orthotic devices appeared effective in preventing ulcers and treating callus. There was limited evidence that TCCs are effective in treating ulcers. No trials of RCWs were identified. Preventative studies were underpowered.

Crawford and Thomsons (2003) review of interventions for treating plantar heel pain found little evidence for treatment (including heel pads and orthoses) over no treatment.

Both reviews mention small sample sizes and the need for multi-centred RCTs to reduce the risk of Type I errors. Similarly, in this review, study groups were generally small and only one (Postema 1998) was multicentred. Poor methodological quality was typical of included studies.

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The objective of the review was to consider whether footwear, orthoses and casts redistributed plantar pressure. Reviewed literature generally supports this. This suggests either an overwhelming case has been made, many Type I errors or a publication bias in English language literature towards releasing only positive results. Better quality research is required to clarify this.

Work started by the Foot Pressure Interest Group in providing protocol guidelines based on research and best practice goes some way towards providing consistency between studies and should be more widely adopted. Three trials (Armstrong 1997; Fleischli 1999 and Lavery 1997) were by the same team of researchers and showed many similarities. Fleischli (1999), in particular, cites heavily from the teams output (14 from 28 cited papers). There are potential benefits in developing consistent, good quality protocols but there are dangers if the template devised is poor (all three studies scored low) and if poor research is then repeatedly repackaged.

Most studies did not evaluate the long term effects on subjects and interventions. Barnett (2002) noted quite rapid degradation of interventions over 6 months. A synergy was noted between insole and shoe as the insert moulded to the individual foot and shoe shape and walking speed increased in subjects with moulded orthoses. These

67

outcomes are worth investigating further. A general weakness of ethical considerations in some studies was a concern.

A mixed methods approach demonstrated benefits in the two studies using it, suggesting the weakness of the link between pressure and pain (Postema 1998) and to identify factors affecting patient compliance. (Barnett 2002) Qualitative research can be a valuable adjunct to quantitative studies.

Shear stress may be important in understanding the limited correlations found between pressure and pain or pressure and ulceration. It is a weakness of current in-shoe technology that shear stress cannot be measured.

The evidence suggests that footwear and orthoses redistribute plantar pressure but the value of this to clinical practice is unclear as there is no conclusive evidence that the pressure variables measured are the most significant in treating the insensate or painful foot.

Weaknesses in the study The review is weakened by being single-authored. This may have introduced bias into the search, selection and review of the literature. A lack of specificity during searching may have resulted in relevant studies being missed. Limiting the review to research in English may have

68

introduced a publications bias. The use of unpublished literature is also weak.

Reviewers conclusions
Implications for practice
There is evidence from a single centre RCT that simple cleron insoles are an effective intervention for pressure reduction in low risk diabetic patients and moulded inserts are appropriate for higher risk patients without foot deformity. The insoles deteriorated significantly over 6 months and

should be replaced regularly. Research is required to assess the most effective and efficient time scale.

Visco-elastic heel orthoses appear to distribute pressure away from the heel to the 1st MTPJ and hallux in a small group of subjects with treated heel pain

There is limited evidence from a small unique trial that rocker soles reduce plantar pressure over the central metatarsals in women with primary metatarsalgia.

Implications for research

. Multi-centre large scale RCTs are required to evaluate the effectiveness of footwear, orthoses and casted devices for the treatment of the insensate and painful foot.

69

development of standard measures and research protocols is urgently required to improve comparison of outcomes.

Further research is needed to identify significant pressure variables.

70

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Gravante, G. et al (2003) Comparison of ground reaction forces between obese and control young adults during quiet standing on a baropodometric platform Clinical biomechanics 18 (8) pp 780-782 Greenhalgh, T. (1997) How to read a paper: assessing the methodological quality of published papers BMJ 315 pp.305-308 Available at http://bmj.bmjjournals.com accessed on 27 February 2004 Greenhalgh, T. (1997) How to read a paper: papers that summarise other papers (systematic reviews and meta-analyses) BMJ 315 pp.672-675 Available at http://bmj.bmjjournals.com accessed on 27 February 2004 Griffin, CJ (1995) Clinical measurement In: Merriman, LM and Tollafield, DR. (eds) Assessment of the lower limb Edinburgh: Churchill Livingstone pp.35-50 Griffiths, S. (2004) Critical appraisal table for a quantitative study University College, Northampton. unpublished Han, TR, Paik, NJ and Im, MS (1999) Quantification of the path of centre of pressure (COP) using an F-scan in-shoe transducer Gait and posture10 (3) pp.248-254 Hart, C. (1998) Doing a literature review: releasing the social science imagination London: Sage Hartsell, HD, Fellner, C. and Saltzman, CL (2001) Pneumatic bracing and total contact casting have equivocal effects on plantar pressure relief Foot and ankle international 22 (6) pp 502-506 Harrison, AJ and Hillard, PJ (n.d.) Foot pressure data analysis: an assessment of the merits of frequently cited parameters [on-line] Available from: http://www.figroup.com/ Accessed on 10th March 2004 Hayda, R. et al (1994) Effect of metatarsal pads and their positioning: a quantitative assessment Foot and ankle international 15 (10) pp.561-566 Hodge, MC. Bach, TM and Carter, GM (1999) Orthotic management of plantar pressure and pain in rheumatoid arthritis Clinical biomechanics 14 (8) pp.567-575 Holmes, GB and Timmerman, L (1990) A quantitative assessment of the effect of metatarsal pads on plantar pressures Foot and ankle 11 (3) pp.141-145 House, CM. et al (2002) The influence of simulated wear upon the ability of insoles to reduce peak pressures during running when wearing military boots Gait and posture 16 (3) pp.297-303

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Hsi, WL. Lai, JS and Yang, PY (1999) In-shoe pressure measurements with a visco-elastic heel orthosis Archives of physical medicine and rehabilitation 80 (7) pp 805-810 Hunt, D. and Gerstein, H. (2003) Foot ulcers and amputations in diabetes Clinical evidence 9 pp651-659 Hunter, S and Dolan, G (1995) Foot orthotics in therapy and sport Champaign, Ill.: Human Kinetics Hutchinson, A. et al (2000) Clinical guidelines and evidence review for Type 2 diabetes: prevention and management of foot problems London: Royal College of General Practitioners Janisse, D.J.(1993) A scientific approach to insole design for the diabetic foot The foot 3 pp105-108 Kanamori, A et al (1997) The efficacy of orthopaedic shoes for reduction of high plantar pressure and prevention of diabetic gangrene in patients with diabetic neuropathy and foot deformities usefulness of in-shoe plantar pressures measurement system (F-scan) Journal of Japan Diabetic Society 40 (9) pp.589-598 Kastenbauer, T et al (1998) Running shoes for relief of plantar pressure in diabetic patients Diabetic medicine 15 (6) pp 518-522 Kastenbauer, T et al (2001) A prospective study of predictors for ulcerations in type 2 diabetes Journal of the American Podiatric Medical Association 91 (7) pp.343-350 Kelly, A. and Winson, I. (1998) Use of ready made insoles in the treatment of lesser metatarsalgia: a prospective randomised controlled trial Foot and ankle international 19 (4) pp.217-220 Kernozek, TW, LaMott, EE and Dancisak, MJ (1996) Releiability of an inshoe pressure measurement system during treadmill walking Foot and ankle international 17 (4) pp204-209 Khan, KS and Kleijnen, J.(2001) Data extraction and monitoring progress, In Khan, KS et al (eds) Undertaking systematic reviews of research on effectiveness: CRDs guidance for those carrying out or commissioning reviews 2nd edition York: NHS Centre for Reviews and Dissemination, University of York (CRD report Number 4) Stage III Phase 6 pp 1-7 Kuncir, EJ, Wirta, RW and Golbranson, FL (1990) Load-bearing characteristics of polyethylene foam: an examination of structural and compression properties Journal of rehabilitation research and development 27 (3) pp.229-238

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Landorf, KB and Keenan, A-M (1998) Efficacy of foot orthoses: what does the literature tell us? American journal of podiatric medicine 32 (3) pp. 105-113 Landsman, AS and Sage, R. (1997) Off-loading neuropathic wounds associated with diabetes using an ankle-foot orthosis Journal of the American Podiatric Medical Association 87 (8) pp.349-357 Lavery, LA et al (1996) Reducing dynamic foot pressures in high-risk diabetic subjects with foot ulcerations Diabetes care 19 (8) pp. 816-821 Lavery, LA et al (1997a) Reducing plantar pressure in the neuropathic foot: a comparison of footwear Diabetes care 20 pp,1706-1710 Lavery, LA et al (1997b) Total contact casts: pressure reduction at ulcer sites and the effect on the contralateral foot Archives of physical medicine and rehabilitation 78 (11) pp.1268-1271 Lavery, LA et al (1998) Practical criteria for screening patients at high risk for diabetic foot ulceration Archives of internal medicine 158 (2) pp.157162 Lavery, LA et al (2003) Predictive value of foot pressure assessment as part of a population-based diabetes disease management programme Diabetes Care 26 (4) pp.1069-1073 Lawless, MW. Reveal, GT and Laughlin, RT (2001) Foot pressures during gait: a comparison of techniques for reducing pressure points Foot and ankle international 22 (7) pp.594-597 Levin, ME; ONeal, LW and John, H. (eds.)(1993) The diabetic foot 5th edition London: Mosby Year Book Li, CY et al (2000) Biomechanical evaluation of foot pressure and loading force during gait in rheumatoid arthritic patients with and without foot orthosis Kurume medical journal 47 (3) pp.211-217 Lobmann, R. et al (2001) Effects of preventative footwear on foot pressure as determined by pedobarography in diabetic patients: a prospective study Diabetic medicine 18 (4) pp. 314-319 Lord, M. and Hosein, R. (1994) Pressure redistribution by moulded inserts in diabetic footwear: a pilot study Journal of rehabilitation research and development 31 (3) pp 214-221 Luo, Z. Berglund, LJ and An, K (1998) Validation of F-Scan pressure sensor system: a technical note Journal of rehabilitation research and development 35 (2) pp.186-191

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Manly, BFJ (1994) Multivariate statistical methods: a primer 2nd edition London: Chapman and Hall/CRC Masson, EA et al (1989) Abnormal foot pressure alone may not cause ulceration Diabetic medicine 6 pp.426-428 Maluf, KS. Et al (2001) Monitoring in-shoe plantar pressures, temperature, and humidity: reliability and validity of measures from a portable device Archives of physical medicine and rehabilitation 82 pp.1119-1127 McCabe, CJ, Stevenson, RC and Dolan, AM (1998) Evaluation of a diabetic foot screening and protection programme Diabetic medicine 15 (1) pp.80-84 McLauchlan, PT et al (1994) Use of an in-shoe pressure system to investigate the effect of two clinical treatment methods for metatarsalgia Foot 4 (4) pp. 204-208 McPoil, TG, Adrian, M. and Pidcoe, P (1989) Effects of foot orthoses on centre-of-pressure patterns in women Physical therapy 69 (2) pp.149-154 McPoil, TG and Cornwall, MW (1991) Rigid versus soft foot orthoses: a single subject design Journal of the American Podiatric Medical Association 81 (12) pp.638-642 McPoil, TG and Cornwall, MW (1998) Variability of the centre of pressure pattern integral during walking Journal of the American Podiatric Medical Association 88 (6) pp.259-267 McPoil, TG et al (1999) Variability of plantar pressure data: a comparison of the two-step and midgait methods Journal of the American Podiatric Medical Association 89 (10) pp. 495-501 Menz, HB (2003) Two feet , or one person? Problems associated with statistical analysis of paired data in foot and ankle medicine The foot 14 (1) pp 2-5 Moher, D. Schulz, KF and Altman, DG (2001) The CONSORT statement: revised recommendations for improving the quality of reports of parallelgroup randomised trials Annals of internal medicine 134 (8) pp.657-662 Mueller, MJ, Strube, MJ and Allen, BT (1997) Therapeutic footwear can reduce plantar pressures in patients with diabetes and transmetatarsal amputation Diabetes care 20 (4) pp. 637-641 Mueller, MJ (1999) Application of plantar pressure assessment in footwear and insert design Journal of orthopaedic and sports physical therapy 29 (12) pp. 747-755

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Munro, BH (1997) Statistical methods for health care research 3rd edition Philadelphia: Lippincott Munzenberg, KJ (1985) The orthopaedic shoe: indications and prescription Weinheim, Federal Republic of Germany: VCH Murray, HJ et al (1996) Association between callus formation, high pressures and neuropathy in diabetic foot ulceration Diabetic medicine pp.979-982 NHS Centre for Reviews and Dissemination (CRD) (1998) Total contact casting for diabetic neuropathic ulcers (structured abstract) York: University of York NICE (National Institute for Clinical Excellence) (2004) Type 2 diabetes: prevention and management of foot problems London: National Institute for Clinical Excellence: available from www.nice.org.uk/CG010NICEguidelines Nicolopoulis, CS et al (2000) Evaluation of the gait analysis FSCAN pressure system: clinical tool or toy? Foot 10 (3) pp. 124 130 Nicolopoulis, CS (2002) Diagnosis of the normal and pathological foot using the plantar pressure measurements Masters thesis, University College, Northampton Nigg, BM et al (2003) Effect of shoe inserts on kinematics, centre of pressure and leg joint moments during running Medicine and science in sports and exercise 35 (2) pp. 314-319 Nowak, MD, Abu-Hasaballah, KS and Cooper, PS (2000) Design enhancement of a solid ankle-foot orthosis: real-time contact pressures evaluation Journal of rehabilitation research and development 37 (3) pp. 273-281 Novick, A. et al (1993) Reduction of plantar pressure with the rigid relief orthosis Journal of the American Podiatric Medical Association 83 (3) pp.115-122 Oyibo, S. et al (n.d.) The Wagner and University of Texas ulcer classification systems: which is a better predictor of outcome? Available form Http://www.medforum.nl/reviews Accessed on 1st May 2004 Perry, JE et al The use of running shoes to reduce plantar pressures in patients who have diabetes Journal of bone and joint surgery 77 (12) pp. 1819-1828

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Pett, MA (1997) Nonparametric statistics for health care research: statistics for small samples and unusual distributions London: SAGE Pitei, DL et al (1996) Do new EVA moulded insles or trainers efficiently reduce the high foot pressures in the diabetic foot? Abstract book: 56th annual meeting and scientific sessions; Saturday, 8th June Tuesday 11th June 1996 Moscone Center, San Francisco, California published in Diabetes 45 (2S) Supplement p25A Abstract 87 Pitei, DL, Foster, A and Edmonds, ME (1999) The effect of regular callus removal on foot pressure Journal of foot and ankle surgery 38 (4) pp251255: discussion 306 Pitei, DL and Edmonds, ME (2000) Foot pressure measurements Wounds: a compendium of clinical research and practice 12 (6): supplement B: pp 19B-29B Philps, PW (1990) The functional foot orthosis Edinburgh: Churchill Livingstone Polgar, S.and Thomas, SA (2000) Introduction to research in the health sciences 4th edition Edinburgh: Churchill Livingstone Pollo, FE et al (2003) Plantar pressures in fibreglass total contact casts vs. a new diabetic walking boot Foot and ankle international 24 (1) pp. 45-49 Poon, C. and Love, B (1997) Efficacy of foot orthotics for metatarsalgia Foot 7 pp.202-204 Potter, J. and Potter, MJ. (2000) Effect of callus removal on peak plantar pressures Foot 10 pp. 23-26 Postema, K. et al (1998) Primary metatarsalgia: the influence of a custom moulded insole and a rockerbar on plantar pressure Prosthetics and orthotics international 22 (1) pp.35-44 Pratt, PJ and Tollafield, DR (1997) An introduction to mechanical therapeutics In: Tollafield, DR and Merriman, LM (eds) Clinical skills in treating the foot Edinburgh: Churchill Livingstone pp.171-186 Pratt, PJ (2000) A critical review of the literature on foot orthoses Journal of the American Podiatric Medical Association 90 (7) pp. 339-341 Qu, RP (2003) Sample size and power calculation for high order crossover designs (s.n.) Available from http://www.biopharm.uk/htm/quarterly/March_2003/sample%20size.pdf accessed on 4th March 2004 Quesada, PM and Rash, GS (1997) Simultaneous pedar and Fscan plantar pressure measurements during walking Gait and Posture 5 (2) pp.164-165
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Ramsey, SD et al (1999) Incidence, outcomes and cost of foot ulcers in patients with diabetes Diabetes care 22 (3) pp. 382-387 Randolph, AL et al (1999) Use of computerized insole sensor system to evaluate the efficacy of a modified ankle-foot orthosis for redistributing heel pressures Archives of physical medicine and rehabilitation 80 pp.801804 Rash, GS. Quesada, PM and Jarboe, N. (1997) Static assessment of Pedar and F-scan in-shoe pressure sensors: revisited Presented at the Twenty-first annual meeting of the American Society of Biomechanics, Clemson University, South Carolina; 4-27 September 1997 Available from; http://asb-biomech.org/onlineabs/abstracts97/111/ [accessed 22 January 2004 Redmond, A. Lumb, PS and Landorf, K (2000) Effect of cast and non-cast foot orthoses on plantar pressure and force during normal gait Journal of the American Podiatric Medical Association 90 (9) pp. 441-449 Reed, L and Bennett, PJ (2001) Changes in foot function with the use of Root and Blake orthoses Journal of the American Podiatric Medical Association 91 (4) pp. 184-193 Reiber, GE et al (2002) Effect of therapeutic footwear on foot re-ulceration in patients with diabetes: a randomised controlled trial JAMA 287 (19) pp. 2552-2558 Renders, CM et al (2004) Interventions to improve the management of diabetes mellitus in primary care, outpatient and community settings (Cochrane Review) The Cochrane Library Issue 2 Chichester UK: John Wiley and Sons Accessed on 5th May 2004 Resch, S et al (1997) Dynamic plantar pressure measurement in 49 patients with diabetic neuropathy with or without foot ulcers Foot and ankle surgery 3 pp. 165-174 Rose, NE et al (1992) A method for measuring foot pressures using a high resolution computerized insole sensor: the effect of heel wedges on plantar pressure distribution and centre of force Foot and ankle 13 (5) pp 263-270 Rosenbaum, D and Becker, H-P (1997) Plantar pressure distribution measurements: technical background and clinical applications Foot and ankle surgery 3 (1) pp.1 - 14 Roy, KJ (1988) Force, pressure and motion measurements in the foot: current concepts Clinics in podiatric medicine and surgery 5 (3) pp.491508

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Rozema, A. et al (1996) In-shoe plantar pressures during activities of daily living: implications for therapeutic footwear design Foot and ankle international 17 (6) pp.352-359 Sackett, DL et al (2000) Evidence-based medicine: how to practice and teach EBM 2nd edition Edinburgh: Churchill Livingstone Sarnow, MR et al (1994) In-shoe foot pressure measurements in diabetic patients with at-risk feet and in healthy subjects Diabetes care17 (9) pp 1002-1006 Schaff, PS and Cavanagh, PR (1990) Shoes for the insensitive foot: the effect of a rocker bottom shoe modification on plantar pressure distribution Foot and ankle 11 (3) pp129-140 Scherer, PR and Sobiesk, GA (1994) The centre of pressure index in the evaluation of foot orthoses in shoes Clinics in podiatric medicine and surgery 11 (2) pp 355-363 Sinacore, DR (1996) Total contact casting for diabetic neuropathic ulcers Physical therapy 76 (3) pp296-301 Spencer, S. (2003) Pressure relieving interventions for preventing and treating diabetic foot ulcers (Cochrane Review) The Cochrane Library Issue 2 Oxford: Update Software Accessed on 25 May 2003 Stacpoole-Shea, S. Shea, G and Lavery, L (1999) An examination of plantar pressure measurements to identify the location of diabetic forefoot ulceration Journal of foot and ankle surgery 38 (2) pp 109-115 Stacpoole-Shea, SJ et al (n.d.) Do rocker soles reduce plantar pressure in persons at risk for diabetic neuropathic ulceration? (unpublished abstract) electronic source Foot Pressure Interest Group:available at:: http://www.figroup.com/abstracts/papers/ accessed on 10 March 2003 Stess, RM; Jensen, SR and Mirmiran, R. (1997) The role of dynamic plantar pressures in diabetic foot ulcers Diabetes Care 20 (5) pp.855-858 Suarez-Almazor, M and Foster, W. (2001) Rheumatoid arthritis Clinical evidence Issue 5 pp.832-849 Sumiya, T et al (1998) Sensing stability and dynamic response of the FScan in-shoe sensing system: a technical note Journal of rehabilitation research and development 35 (2) pp.192-200 Uhlenbruck, C (1997) Plantar load shifting in response to foreign body is impaired in patients with severe diabetic neuropathy Practical diabetes international 14 (5) pp.126-127

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University of Leicester Clinical Sciences Library (n.d.) Introduction to critical appraisal Leicester: University of Leicester Van Gheluwe, B and Dananberg, HJ (2004) Changes in plantar foot pressure with in-shoe varus or valgus wedging Journal of the American Podiatric Medical Association 94 (1) pp.1-11 Veves, A. et al (1992) The risk of foot ulceration in diabetic patients with high foot pressure: a prospective study Diabetologia 35 pp 660-663 Vickers, AJ (2003) How many repeated measures in repeated measures designs?: statistical issues for comparative trials BMC Medical research methodology 3:22 Available at: http://www.biomedcentral.com/14712288/3/22 accessed on 4th March 2004 Windle, CM, Gregory, SM and Dixon, SJ (1999) The shock attenuation characteristics of four different insoles when worn in a military boot during running and marching Gait and posture 9 (1) pp. 31-37 Woodburn, J and Helliwell, PS (1996) Observations on the F-Scan in-shoe pressure measuring system Clinical biomechanics 11 (5) pp.301-304 Woodburn, J. Barker, S. and Helliwell, PS (2002) Randomized control trial of foot orthoses in rheumatoid arthritis Journal of rheumatology 29 (7) pp1377-1383 Wrobel, JS et al (2003) Do clinical examination variables predict high plantar pressures in the diabetic foot? Journal of the American Podiatric Medical Association 93 (5) pp.367-372 Wu, KK (1990) Foot orthoses: principles and clinical applications London: Williams and Wilkins Xu, H. et al (1999) Effect of shoe modifications on centre of pressure and in-shoe plantar pressure American journal of physical medicine and rehabilitation 78 (6) pp.516-524 Young, CR (1993) The F-scan system of foot pressure analysis Clinics in podiatric medicine and surgery 10 (3) pp.455-461 Zhu, H. et al (1995) Walking cadence effect on plantar pressures Archives of Physical medicine and rehabilitation 76 pp1000-1005

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Appendix 1:Draft protocol guidelines: in-shoe measurement

(Barnett 1998)
Standardisation of Report system specifications (thresholds) should be standardised floor surface data collection run socks velocity

Manufacturers protocols should be acknowledged and understood usually require acclimatization, bedding in and in-shoe calibration should be stated in reporting

Floor and walkway should be non-slip, flat, level and stable a figure of eight if possible protocols should excluded acceleration and deceleration data data should be recorded mid-cycle PC and wires should not distract

Footwear For longitudinal studies, standardised, manufacturer supplied footwear should be used, depending on research question

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For intervention studies, patients own comfortable shoes should be used. Should be classified and the degree of wear noted.

Should reflect real-life footwear

Socks Pop socks (thin nylons) Dressings removed and film dressings used to cover wounds

Callus State whether callus has been removed and why. Should apply to all subjects

Walking speed Self-selected at comfortable pace decided by subject Velocity noted and reported

Inserting and removing insoles Controlled by researcher Allow for bedding in

Calibration Reflect real-life, not rely on bench testing Follow manufacturers guidelines and publish these.

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Appendix 2: Indexed terms from papers checked against inclusion and exclusion criteria Participants: adults; human; military personnel; diabetic foot [prevention and control]; diabetic foot[therapy]; foot[physiology]; gait[physiology], aged; metatarsalgia; cumulative trauma disorders[prevention]; foot disease[complications]; obesity[complications]; pain[physiopathology]; pain[therapy]; diabetes mellitus; foot deformities [acquired]]; foot disease [complications]; plantar fasciitis

Interventions: Orthoses; foot: sport shoes; casts: casting: device; shoe; foot orthoses; orthotic devices; shoes; shoes [adverse effects]; cast, surgical; metatarsophalangeal joint; foot sole; forefoot [human]; metatarsal bone; polyurethanes; silicones; metatarsus; heel

Outcomes: Pressure measurement; pressure; transducers; pressure sense; weight-bearing; piezoelectricity; sensor; force; stress, mechanical; running; risk factors; patient satisfaction; risk assessment; walking; body weight; gait; activities of daily living; ankle pressure; physical stress.

Study Design: controlled study; quantitative diagram; analysis of variance; crossover studies; double-blind method; multivariate analysis; clinical trials; conference paper; major clinical study; cohort studies

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Appendix 3: Crossover trials assessed against quality criteria (Griffiths 2004)

Armstrong Fleischli Hsi Lavery Postema Redmond

Is the research question clearly focussed? Is the study grounded on an adequate knowledge base? Was the research methodology appropriate for the research issue? Was the study design appropriate to the issue? Were ethical issues recognised and addressed? Was the sampling strategy appropriate and clearly explained? Were all of the participants accounted for at its conclusion? Were there clear inclusion/ exclusion criteria? Were measures taken to reduce bias? Sampling procedures Intervention Protocol

0 1

0 1

2 1

0 0

1 2

1 2

Was the data collection method sound?

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Was the data analysis: Appropriate Clearly described Justified Is there sufficient detail to assess the credibility of the findings? Can the findings be applied to your situation? Were all clinically important outcomes considered? Are the benefits worth the harms and costs? 9 9 26 10 22 14 0 0 1 0 2 0 0 0 1 2 1 1 0 0 1 0 2 0 0 0 0 0 0 0 0 0 1 1 1 1 0 0 0 0 1 1 1 1 0 2 2 0

Coding:

0= not met 1= partly met 2= well met

Quality

< 20 = poor 20-30= moderate > 30= good

Possible total =36

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Appendix 4 Parallel trial (Barnett 2002) assessed against Consort Statement (Moher, Schulz, and Altman (2001)

1. title and abstract: prospective randomised clinical control trial. Participants randomly assigned to EVA orthoses or 3 mm Cleron insoles. Qualitative research on patient perception of foot health and diary of wear. Longitudinal study (6 months) 2. Introduction/background: thorough 3. Participants: clear inclusion and exclusion criteria. Location of data collection unclear 4. Interventions: control: 3mm cleron insole, intervention: noncustomized, pre-formed, TEC urethane orthoses with EVA cover. Used in patients own shoes between readings. Measures taken at baseline, 3 months and 6 months in standardized shoes 5. Objectives: specific hypothesis, clear objectives 6. Outcomes: peak plantar pressure and pressure time integral (whole foot and 9 masks). Foot contact area, walking speed. Bristol Foot health questionnaire, diary of use. Measures taken from 10 right steps and 10 left steps. Calibration and acclimatization reported. Callus debrided, standard nylon socks, lesions covered with Opsite. Thickness of insoles/orthoses recorded at baseline and follow-ups to assess degradation. All assessments by lead researcher. 7. Sample size: a priori power calculation of 47 subjects per group. 103 participants recruited.

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8. Randomization: letters in envelope in box. Subjects assigned as recruited. 9. Allocation concealment 10. Implementation: see 8. 11. Blinding: control group also an intervention. Both groups told contributing to research. Not double-blinded 12. Statistical methods: normal distribution assessed, used ANOVA for multivariate analysis 13. Participant flow: described, including drop-out from each group with reasons. No diagrammatic representation of flow 14. Recruitment: dates not given. Intervals of follow-up given 15. Baseline data: provided in detail for both groups. Cleron group significantly older than intervention group. 16. Numbers analysed: 117 recruited, 14 left study before completion reasons explored. Data analysed on intention to treat basis 17. Outcomes and estimation: results summary provided for each group, by mask areas and whole, by foot type, for participants with above average pressures for group. P= 0.01 18. ancillary analyses: developed, trialled and used Bristol Foot Health Quesionnaire. Results reported. Diary of use information assessed for patient compliance and patient comments on ease of use, comfort, etc. 19. Adverse events: causes of drop-out. Discomfort with Cleron explored. Increased walking speeds in both groups, particularly

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with orthoses. Possible causes discussed: confidence with testing, improved foot functionality 20. Interpretation: would like more time to consider increased walking speeds. Changes to interventions over time not adequately predicted by thickness. Problems with sensor resolution over digits with Emed Pedar. Differences between actual and expected outcomes discussed. Similarities/difference with earlier literature explored. Statistics used appropriately. 21. generalizability: good. Inclusion criteria sufficiently broad to allow clinical application to the majority of DM patients without major complications or deformity 22. overall evidence. Good. Only longitudinal study. Appendix 5:Trials assessed against Protocol for foot pressure measurement
Armstrong Barnett Manufacturer'sProtocols no Floor/walkway Footwear Socks Dressings Callus Mid-gait steps self-set speed Walking speed insert/remove insoles Calibration no no no no no yes yes no no no yes yes yes yes yes yes yes yes yes yes yes Fleischli no no no no no no yes yes no no no Hsi yes no yes no n/a no yes yes yes yes yes Lavery no no no no no no yes yes no no no Postema Redmond no yes yes no n/a no no yes no no no no yes no no n/a no yes yes no no no

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Appendix 6: Statistics

sample size calc Power calc

Stats test ANOVA and tukeys post hoc

Armstrong

No

Yes

studentized range test t-tests for matched pairs,regression

Barnett

Yes

Yes

analysis Univariate and multivariate ANOVA and

Fleischli

No

No

tukeys two-factor ANOVA, F-test for significance, coeffs of reliability and

Hsi

Yes

Yes

variability Univariate and multivariate ANOVA.

Lavery

No

No

Tukey and Paired T-Tests Paired T-Test for repeated measures. Multivariate ANOVA. One sided

Postema

No

No

Fisher exact tes Checied distribution for normalality. ANOVA Friedman and Wilcoxon for

Redmond

No

Yes

non-ratio data

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Appendix 7: Interventions studied in included trials

Armstrong Viscoelastic Heel orthoses Standard insoles (6.5 mm polymeric foam flat inserts Custom-made Insoles (6.5 polymeric foam) Rocker Bar TCC Darco orthowedge/half shoe Darco rigid post-op. shoe DH pressure relief walker Accomodative foam and felt dressing Card insole with 60 EVA varus rearfoot post Modi Root orthosis polypropylene shell with PVC cover and 60 EVA varus rearfoot post Cleron insole: 3mm flat insert EVA (off the shelf moulded orthoses Aircast pneumatic walker Extra depth shoes with PW Minor inlays men/ women SAS comfort shoes for men and women New Balance crosstrainers for men and women Plastazote/urethane insole, preformed Baseline Footwear Reebok sneaker Standard orthopaedic shoe Rubber soled canvas oxford Own shoesx Dunlop athletic shoes Socks Barnett Fleischli Hsi Lavery Postema Redmond

X X X X X X X X X X X X X

X X X X X X X X X X X X
unknown Thin nylons No socks Own socks Unknown unknown unknown

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Appendix 8: Variables collected in included studies

Armstrong Barnett Peak Pressure Pressure time integral Mean contact area Average step length Average step time Walking speed Foot to sensor contact time Force impulse Force time integral Maximum force Bristol foot health questionnaire Diary of wear Pain questionnaire Patient preference N cm2 N.s/cm2 kPa cm2 Kpa.s/cm Cm2

Fleischli N cm2

Hsi kPa cm2 kPa.s/cm2

Lavery Ncm2

Postema Redmond Ncm2 kPa cm2 kPa.s/cm2 Cm2

x x x x x x x x x x x x

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Appendix 9: Masking and sampling speed data

Heel pressures collected. Masking not specified. Sampling Armstrong Barnett speed not specified 9 regions of foot masked and whole foot. Sampling speed 99 Hz Pressure over existing or former ulcers: masking not described. Fleischli Hsi Sampling speed 50 Hz Parotec. Over whole foot. Sampling speed 100 Hz Pressure at ulcer sites and hallux, 1st met and 2nd-5th met Masking not described Lavery Sampling speed 50 Hz Pressure over four regions of forefoot, established using Emed Postema platform. Sampling speed 70 Hz with Emed Mikro Six masks over whole foot lateral digits discarded. Sampling Redmond speed 50 Hz

Appendix 10: Use of data from Right/Left feet (Menz 2003)

Armstrong (1999) Does not specify if pressures are taken for both feet and pooled or only the ulcerated foot. Barnett (2002) Tests 10 right steps and 10 left steps for each participant at baseline and each follow-up but appear to pool data. Fleischli (1997)

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Mean peak pressures over the site of ulceration. Sample size implies one ulcer per subject and therefore assume only ulcerated foot is included in study but not specified. Hsi(1999) Studies 22 consecutive patients with unilateral heel pain. Assume that only data from painful heel is used but not specified. Lavery(1997) 32 consecutive patients with diabetes and recent or existing neuropathic ulcer. Pressure measured over ulcer. Presume one ulcer per patient but not specified. Postema (1998) 42 primary metatarsalgia patients. Specified use of the most painful foot or if no pain a random choice is made (method not specified). Explicit states that this is to avoid dependency of measurement. Redmond(2000) Tested 22 patients with abnormal pronation. Tested results from right and left, found no statistical difference and therefore pooled.

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