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of surgery compared to non-surgical options.8 9 Despite standard care (continuing on the surgery waitlist
well-documented evidence regarding the signicant without conservative intervention) in the management
socioeconomic impact, CTS is typically considered a low of patients with CTS (gure 1).
surgical priority in publicly funded health systems.10 The
reality of long public hospital waiting times and trad- Participants
itional referral pathways (general medical practitioner to Patients with a diagnosis of CTS who are on the ortho-
surgeon to therapist) creates signicant delays in paedic department outpatient waitlist of participating
gaining access to treatment. Not only are these substan- Queensland Health hospitals will be contacted by tele-
tial waiting times likely to result in extended periods of phone. Those interested in participating in the study
reduced quality of life,11 they may also compromise long- will be sent an information sheet outlining the study as
term outcomes as delayed surgery has been shown to be well as a brief questionnaire to assess eligibility. Patients
associated with poorer prognosis.12 who meet the selection criteria (box 1) and agree to
Guidelines endorsed by professional associations participate will be invited for a baseline assessment by an
suggest a trial of non-surgical interventions for patients occupational therapist or physiotherapist employed
with mild or moderate CTS symptoms, with surgery within the Hand Therapy department of the participat-
being the treatment of choice where symptoms are ing hospitals. During this rst appointment, informed
severe or prolonged, or for those whose conservative written consent will be gained from each participant.
management has been unsuccessful.6 13 Commonly This study has received ethical clearance and approval
recommended non-surgical interventions include use of from the relevant hospital and university ethics review
splints, nerve and tendon gliding exercises and activity boards.
modication.5 6 1416 These recommendations are
largely based on clinical observations as there is limited Baseline assessment
research-based evidence to guide non-surgical treat- During the rst appointment, a clinical examination will
ments. Given the unconvincing evidence for conserva- be completed. This examination will include a detailed
tive approaches and the resulting reliance on clinical medical and social history (occupation, sports, hobbies),
trends to guide practice, further investigation into non- demographic data (age, gender, weight, height review of
surgical interventions is warranted. the nature and onset of symptoms, and observation for
The number of surgical interventions performed in thenar eminence wasting).
the UK for CTS has been predicted to increase from
66 833 per year in 2015 to 104 922 per year by 2030.17 Interventions
Given that a single carpal tunnel release in the UK is Once consented and included in the study, the patients
projected to cost between 83018 and 2600,19 the extra- will be allocated to randomly receive standard care or a
polated total cost of carpal tunnel release surgery to the programme of ESX.
UK health budget will exceed 55 million in 2015. This
level of expenditure creates incentives for publicly Education, splinting and exercise
funded health systems to manage CTS efciently. In an ESX will be provided by either an occupational therapist
effort to manage surgery waitlists and reduce costs, retro- or physiotherapist during a single appointment, and
spective studies in the UK and Australia have examined then continues as a patient self-applied home-based
the effect of alternative care pathways and therapist-led therapy programme while the patients are on the ortho-
clinics for patients with CTS on surgical waitlists.2022 paedic department outpatient waitlist.
Despite limited data regarding the cost or clinical effect- Patients allocated to receive ESX will attend a 20
iveness of conservative interventions,15 16 these retro- 30 min group education presentation by an occupational
spective case audits have shown a clear reduction in CTS therapist or physiotherapist on the same day as their
surgery waitlists. The potential benets of these models baseline assessment. This presentation will cover educa-
of care therefore warrant further investigation. tion regarding the pathophysiology of CTS, treatment
The aim of this project is to evaluate the efcacy of an options (conservative management and surgery),
alternative care pathway compared to standard care on posture and activity modication principles.23 This infor-
the need for surgery and patient-rated outcomes in the mation will also be provided in the form of an education
management of patients with CTS while on the surgical booklet which participants will be encouraged to review
waitlists. at home.
Participants will also be provided with a splint. The
Berger test5 will be used to determine if lumbrical
METHODS/DESIGN muscle excursion into the carpal tunnel may be contrib-
A randomised controlled multisite clinical trial will be uting to CTS symptoms.2426 This test involves the par-
conducted in four publicly funded hospitals within ticipant actively holding the ngers in full exion with
Queensland, Australia. This trial will compare thera- their wrist in neutral position. If symptoms worsen
peutic intervention (education, provision of splints and within 30 s, the test is deemed to be positive.5 Those
a home exercise programme (ESX)) to the current with a negative Berger test will receive neoprene wrist
supports with custom moulded thermoplastic stays that exercise ve times a day in a manner that does not
hold the wrist in a neutral position (gure 2A). Those cause pain or increase symptoms. Participants who
with a positive Berger test will receive splints as report an exercise-related increase of symptoms at any
described above but that extend distally to the level of point during the study will be advised to contact the
the proximal phalanx and therefore limit metacarpal occupational therapist or physiotherapist. On doing so,
phalangeal joint exion (gure 2B). Splinting has been the participant will be asked to trial a slightly modied
shown to be of benet in reducing symptoms9 14 and version (such as completing exercises through a reduced
patients will be requested to wear the splint during the range of motion) or to cease exercises completely if
night only.27 28 necessary.
In addition to education and splinting, participants
will be advised on a home exercise programme consist- Standard care
ing of four exercises including median nerve and The standard care group will continue as per current
tendon-gliding exercises (gure 3AC).2832 During the practice to remain on the orthopaedic department out-
education session, therapists will assure that an accurate patient waitlist for the length of the study (6 months)
performance of these exercises is achieved by the without receiving the education, splint or exercises
patients. Nerve and tendon-gliding exercises have been described above. At the completion of the trial, the par-
shown to have a positive impact on symptoms14 and ticipants who underwent standard care (and have not
reduce intraneural oedema in patients with CTS.28 had surgery) will be offered the option to receive the
Patients are asked to perform 510 repetitions of each ESX intervention outlined above.
to a very great deal better.36 This questionnaire has previ- distribution. This outcome measure is commonly used
ously been shown to have good reliability and validity in in patients with CTS48 and will be used to evaluate
patients with musculoskeletal disorders.37 As previously symptom spread and the presence of extra-median symp-
described, a score of 5 points (at least a good deal toms.49 50 Self-completed hand diagrams have been
better) on this scale will be classied as improved.38 39 shown to be reliable in patients with CTS.51
effects of these exercises in patients with CTS.28 29 The Twitter Follow Bill Vicenzino at @Bill_Vicenzino Follow Annina Schmid
relative ease of exercise completion and splint use may @AnninaBSchmid
encourage patient self-management, thus limiting the
Acknowledgements The authors would like to thank Dr Tyson Doneley and
number of therapy appointments required. Mr Michael Tay at QEII Jubilee Hospital for their support in developing this
It has been suggested that conservative management for clinic model. Acknowledgements are due to QEII Jubilee, Rockhampton, Gold
those with severe CTS is unlikely to reduce the need for Coast University Hospital and Logan Hospital Occupational Therapy,
surgery.6 However, there is limited evidence relating to Physiotherapy and Orthopaedic Departments for their site participation.
whether conservative management offers other benets to Contributors KJL is the primary investigator. KJL, ABS, LR, MWC and BV
those with severe symptoms, even if surgery is the end participated in the development of the study design and conduct. KJL, ABS
result. This information could be of signicance for both and LR contributed to applying for and gaining funding. All authors
contributed to the content and critical revision and approved the final draft of
patients and those managing their care. To assist in answer-
the manuscript.
ing this question, participants with severe CTS will not be
excluded from the study, but their group allocation will be Funding ABS is funded by a Neil Hamilton Fairley Fellowship from the
National Health and Medical Research Council Australia. This study is
stratied (mild/moderate and severe), allowing subgroup supported in part by a Health Practitioners Stimulus Grant from Queensland
analysis. It is acknowledged that those with severe CTS are Health.
recommended to obtain care within a timely manner in
Competing interests None declared.
order to prevent exacerbation of symptoms. In an effort to
reduce this risk, the study follow-up time of 6 months is sig- Ethics approval Ethics approval was gained via the Princess Alexandra
Hospital Centres for Health Research (HREC/13/QPAH/434SSA/13/QPAH/
nicantly less than current wait times (between 9 months 447) and the Medical Research Ethics Committee at the University of
and 6 years at the time of study commencement) to access Queensland.
specialist care at the sites included within this study.
Provenance and peer review Not commissioned; externally peer reviewed.
Additionally, participants will be monitored and managed
as discussed earlier in this manuscript. Open Access This is an Open Access article distributed in accordance with
the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license,
The surgeons opinion on whether surgery is or is not which permits others to distribute, remix, adapt, build upon this work non-
required was chosen as the basis for the conversion to commercially, and license their derivative works on different terms, provided
surgery outcome measures. Surgeons are the primary the original work is properly cited and the use is non-commercial. See: http://
decision-makers in determining the need for surgery in creativecommons.org/licenses/by-nc/4.0/
the majority of settings. We will seek participants per-
spective whether they wish to proceed to surgery prior
to their appointment with the surgeons. This will allow REFERENCES
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