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1.  Clinical course, costs and predictive factors for response to treatment in carpal tunnel syndrome: the PALMS study protocol 
Background
Carpal tunnel syndrome (CTS) is the most common neuropathy of the upper limb and a significant contributor to hand functional impairment and disability. Effective treatment options include conservative and surgical interventions, however it is not possible at present to predict the outcome of treatment. The primary aim of this study is to identify which baseline clinical factors predict a good outcome from conservative treatment (by injection) or surgery in patients diagnosed with carpal tunnel syndrome. Secondary aims are to describe the clinical course and progression of CTS, and to describe and predict the UK cost of CTS to the individual, National Health Service (NHS) and society over a two year period.
Methods/Design
In this prospective observational cohort study patients presenting with clinical signs and symptoms typical of CTS and in whom the diagnosis is confirmed by nerve conduction studies are invited to participate. Data on putative predictive factors are collected at baseline and follow-up through patient questionnaires and include standardised measures of symptom severity, hand function, psychological and physical health, comorbidity and quality of life. Resource use and cost over the 2 year period such as prescribed medications, NHS and private healthcare contacts are also collected through patient self-report at 6, 12, 18 and 24 months. The primary outcome used to classify treatment success or failures will be a 5-point global assessment of change. Secondary outcomes include changes in clinical symptoms, functioning, psychological health, quality of life and resource use. A multivariable model of factors which predict outcome and cost will be developed.
Discussion
This prospective cohort study will provide important data on the clinical course and UK costs of CTS over a two-year period and begin to identify predictive factors for treatment success from conservative and surgical interventions.
doi:10.1186/1471-2474-15-35
PMCID: PMC3921988  PMID: 24507749
2.  Predicting response to physiotherapy treatment for musculoskeletal shoulder pain: a systematic review 
Background
People suffering from musculoskeletal shoulder pain are frequently referred to physiotherapy. Physiotherapy generally involves a multimodal approach to management that may include; exercise, manual therapy and techniques to reduce pain. At present it is not possible to predict which patients will respond positively to physiotherapy treatment. The purpose of this systematic review was to identify which prognostic factors are associated with the outcome of physiotherapy in the management of musculoskeletal shoulder pain.
Methods
A comprehensive search was undertaken of Ovid Medline, EMBASE, CINAHL and AMED (from inception to January 2013). Prospective studies of participants with shoulder pain receiving physiotherapy which investigated the association between baseline prognostic factors and change in pain and function over time were included. Study selection, data extraction and appraisal of study quality were undertaken by two independent assessors. Quality criteria were selected from previously published guidelines to form a checklist of 24 items. The study protocol was prospectively registered onto the International Prospective Register of Systematic Reviews.
Results
A total of 5023 titles were retrieved and screened for eligibility, 154 articles were assessed as full text and 16 met the inclusion criteria: 11 cohort studies, 3 randomised controlled trials and 2 controlled trials. Results were presented for the 9 studies meeting 13 or more of the 24 quality criteria. Clinical and statistical heterogeneity resulted in qualitative synthesis rather than meta-analysis. Three studies demonstrated that high functional disability at baseline was associated with poor functional outcome (p ≤ 0.05). Four studies demonstrated a significant association (p ≤ 0.05) between longer duration of shoulder pain and poorer outcome. Three studies, demonstrated a significant association (p ≤ 0.05) between increasing age and poorer function; three studies demonstrated no association (p > 0.05).
Conclusion
Associations between prognostic factors and outcome were often inconsistent between studies. This may be due to clinical heterogeneity or type II errors. Only two baseline prognostic factors demonstrated a consistent association with outcome in two or more studies; duration of shoulder pain and baseline function. Prior to developing a predictive model for the outcome of physiotherapy treatment for shoulder pain, a large adequately powered prospective cohort study is required in which a broad range of prognostic factors are incorporated.
doi:10.1186/1471-2474-14-203
PMCID: PMC3717132  PMID: 23834747
Physical therapy; Shoulder; Shoulder pain; Musculoskeletal; Predict; Prognosis
3.  Predicting response to physiotherapy treatment for musculoskeletal shoulder pain: protocol for a longitudinal cohort study 
Background
Shoulder pain affects all ages, with a lifetime prevalence of one in three. The most effective treatment is not known. Physiotherapy is often recommended as the first choice of treatment. At present, it is not possible to identify, from the initial physiotherapy assessment, which factors predict the outcome of physiotherapy for patients with shoulder pain. The primary objective of this study is to identify which patient characteristics and baseline measures, typically assessed at the first physiotherapy appointment, are related to the functional outcome of shoulder pain 6 weeks and 6 months after starting physiotherapy treatment.
Methods/Design
Participants with musculoskeletal shoulder pain of any duration will be recruited from participating physiotherapy departments. For this longitudinal cohort study, the participants care pathway, including physiotherapy treatment will be therapist determined.
Potential prognostic variables will be collected from participants during their first physiotherapy appointment and will include demographic details, lifestyle, psychosocial factors, shoulder symptoms, general health, clinical examination, activity limitations and participation restrictions.
Outcome measures (Shoulder Pain and Disability Index, Quick Disability of the Arm, Shoulder and Hand, and Global Impression of Change) will be collected by postal self-report questionnaires 6 weeks and 6 months after commencing physiotherapy.
Details of attendance and treatment will be collected by the treating physiotherapist. Participants will be asked to complete an exercise dairy.
An initial exploratory analysis will assess the relationship between potential prognostic factors at baseline and outcome using univariate statistical tests. Those factors significant at the 5% level will be further considered as prognostic factors using a general linear model.
It is estimated that 780 subjects will provide more than 90% power to detect an effect size of less than 0.25 adjusted for other variables which have a co-efficient of determination (R-squared) with the outcome of up to 0.5. Assuming a 22% loss to follow up at 6 months, 1000 participants will initially be recruited.
Discussion
This study may offer service users and providers with guidance to help identify whether or not physiotherapy is likely to be of benefit. Clinicians may have some direction as to what key factors indicate a patient’s likely response to physiotherapy.
doi:10.1186/1471-2474-14-192
PMCID: PMC3720561  PMID: 23800352
Physical therapy; Shoulder; Shoulder pain; Musculoskeletal; Predict; Prognosis
4.  The responsiveness of sensibility and strength tests in patients undergoing carpal tunnel decompression 
Background
Several clinical measures of sensory and motor function are used alongside patient-rated questionnaires to assess outcomes of carpal tunnel decompression. However there is a lack of evidence regarding which clinical tests are most responsive to clinically important change over time.
Methods
In a prospective cohort study 63 patients undergoing carpal tunnel decompression were assessed using standardised clinician-derived and patient reported outcomes before surgery, at 4 and 8 months follow up. Clinical sensory assessments included: touch threshold with monofilaments (WEST), shape-texture identification (STI™ test), static two-point discrimination (Mackinnon-Dellon Disk-Criminator) and the locognosia test. Motor assessments included: grip and tripod pinch strength using a digital grip analyser (MIE), manual muscle testing of abductor pollicis brevis and opponens pollicis using the Rotterdam Intrinsic Handheld Myometer (RIHM). The Boston Carpal Tunnel Questionnaire (BCTQ) was used as a patient rated outcome measure.
Results
Relative responsiveness at 4 months was highest for the BCTQ symptom severity scale with moderate to large effects sizes (ES = -1.43) followed by the BCTQ function scale (ES = -0.71). The WEST and STI™ were the most responsive sensory tests at 4 months showing moderate effect sizes (WEST ES = 0.55, STI ES = 0.52). Grip and pinch strength had a relatively higher responsiveness compared to thenar muscle strength but effect sizes for all motor tests were very small (ES ≤0.10) or negative indicating a decline compared to baseline in some patients.
Conclusions
For clinical assessment of sensibility touch threshold assessed by monofilaments (WEST) and tactile gnosis measured with the STI™ test are the most responsive tests and are recommended for future studies. The use of handheld myometry (RIHM) for manual muscle testing, despite more specifically targeting thenar muscles, was less responsive than grip or tripod pinch testing using the digital grip analyser (MIE). When assessing power and pinch strength the effect of other concomitant conditions such as degenerative joint disease on strength needs to be considered.
doi:10.1186/1471-2474-12-244
PMCID: PMC3214851  PMID: 22032626
5.  Night-time splinting after fasciectomy or dermo-fasciectomy for Dupuytren's contracture: a pragmatic, multi-centre, randomised controlled trial 
Background
Dupuytren's disease is a progressive fibroproliferative disorder which can result in fixed flexion contractures of digits and impaired hand function. Standard treatment involves surgical release or excision followed by post-operative hand therapy and splinting, however the evidence supporting night splinting is of low quality and equivocal.
Methods
A multi-centre, pragmatic, open, randomised controlled trial was conducted to evaluate the effect of night splinting on self-reported function, finger extension and satisfaction in patients undergoing fasciectomy or dermofasciectomy. 154 patients from 5 regional hospitals were randomised after surgery to receive hand therapy only (n = 77) or hand therapy with night-splinting (n = 77). Primary outcome was self-reported function using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcomes were finger range of motion and patient satisfaction. Primary analysis was by intention to treat.
Results
148 (96%) patients completed follow-up at 12 months. No statistically significant differences were observed on the DASH questionnaire (0-100 scale: adjusted mean diff. 0.66, 95%CI - 2.79 to 4.11, p = 0.703), total extension deficit of operated digits (degrees: adjusted mean diff 5.11, 95%CI -2.33 to 12.55, p = 0.172) or patient satisfaction (0-10 numerical rating scale: adjusted mean diff -0.35, 95%CI -1.04 to 0.34, p = 0.315) at 1 year post surgery. Similarly, in a secondary per protocol analysis no statistically significant differences were observed between the groups in any of the outcomes.
Conclusions
No differences were observed in self-reported upper limb disability or active range of motion between a group of patients who were all routinely splinted after surgery and a group of patients receiving hand therapy and only splinted if and when contractures occurred. Given the added expense of therapists' time, thermoplastic materials and the potential inconvenience to patients having to wear a device, the routine addition of night-time splinting for all patients after fasciectomy or dermofasciectomy is not recommended except where extension deficits reoccur.
Trial registration
The trial was registered as an International Standard Randomised Controlled Trial ISRCTN57079614
doi:10.1186/1471-2474-12-136
PMCID: PMC3146906  PMID: 21693044
6.  Clinical effectiveness of post-operative splinting after surgical release of Dupuytren's contracture: a systematic review 
Background
Splinting after contracture release for Dupuytren's disease of the hand is widely advocated. The purpose of this systematic review was to evaluate the quantity and quality of evidence regarding the effectiveness of splinting in the post-surgical management of Dupuytren's contractures.
Methods
Studies were identified by searching the electronic databases Medline, AMED, CINAHL and EMBASE. Studies were included if they met the following inclusion criteria: prospective or retrospective, experimental, quasi-experimental or observational studies investigating the effectiveness of static or dynamic splints worn day and/or night-time for at least 6 weeks after surgery and reporting either individual joint or composite finger range of motion and/or hand function. The methodological quality of the selected articles was independently assessed by the two authors using the guidelines for evaluating the quality of intervention studies developed by McDermid.
Results
Four studies, with sample sizes ranging from 23 to 268, met the inclusion criteria for the systematic review. Designs included retrospective case review, prospective observational and one controlled trial without randomisation. Interventions included dynamic and static splinting with a mean follow-up ranging from 9 weeks to 2 years. Pooling of results was not possible due to the heterogeneity of interventions (splint type, duration and wearing regimen) and the way outcomes were reported.
Conclusion
There is empirical evidence to support the use of low load prolonged stretch through splinting after hand surgery and trauma, however only a few studies have investigated this specifically in Dupuytren's contracture. The low level evidence regarding the effect of post-operative static and dynamic splints on final extension deficit in severe PIP joint contracture (>40°) is equivocal, as is the effect of patient adherence on outcome. Whilst total active extension deficit improved in some patients wearing a splint there were also deficits in composite finger flexion and hand function. The lack of data on the magnitude of this effect makes it difficult to interpret whether this is of clinical significance. There is a need for well designed controlled trials with proper randomisation to evaluate the short-term and long-term effectiveness of splinting following Dupuytren's surgery.
doi:10.1186/1471-2474-9-104
PMCID: PMC2518149  PMID: 18644117
7.  Splinting after contracture release for Dupuytren's contracture (SCoRD): protocol of a pragmatic, multi-centre, randomized controlled trial 
Background
Splinting as part of the overall post-surgical management of patients after release of Dupuytren's contracture has been widely reported, though there is variation in practice and criteria for using it. The evidence on its effectiveness is sparse, of poor quality and contradictory with studies reporting negative and positive effects.
Methods/Design
A multi-centre, pragmatic, randomized, controlled trial is being conducted to evaluate the effect of static night splinting for six months on hand function, range of movement, patient satisfaction and recurrence at 1 year after fasciectomy or dermofasciectomy. Using a centrally administered computer randomization system consented patients will be allocated to one of two groups: i) splint group who will be given a static splint at approximately 10 to 14 days after surgery to be worn for 6 months at night time only as well as hand therapy; ii) non-splint group, who will receive hand therapy only. The primary outcome measure is the patient-reported Disabilities of the Arm, Hand and Shoulder Questionnaire (DASH). Secondary outcomes are total active flexion and extension of fingers, patient satisfaction and recurrence of contracture. Outcome measures will be collected prior to surgery, 3 months, 6 months and 1 year after surgery. Using the DASH as the primary outcome measure, where a difference of 15 points is considered to be a clinically important difference a total of 51 patients will be needed in each group for a power of 90%. An intention-to-treat analysis will be used.
Discussion
This pragmatic randomized controlled trial will provide much needed evidence on the clinical effectiveness of post-operative night splinting in patients who have undergone fasciectomy or dermofasciectomy for Dupuytren's contracture of the hand.
Trial Registration
Current Controlled Trials ISRCTN 57079614
doi:10.1186/1471-2474-9-62
PMCID: PMC2386788  PMID: 18447898
8.  Power grip, pinch grip, manual muscle testing or thenar atrophy – which should be assessed as a motor outcome after carpal tunnel decompression? A systematic review 
Background
Objective assessment of motor function is frequently used to evaluate outcome after surgical treatment of carpal tunnel syndrome (CTS). However a range of outcome measures are used and there appears to be no consensus on which measure of motor function effectively captures change. The purpose of this systematic review was to identify the methods used to assess motor function in randomized controlled trials of surgical interventions for CTS. A secondary aim was to evaluate which instruments reflect clinical change and are psychometrically robust.
Methods
The bibliographic databases Medline, AMED and CINAHL were searched for randomized controlled trials of surgical interventions for CTS. Data on instruments used, methods of assessment and results of tests of motor function was extracted by two independent reviewers.
Results
Twenty-two studies were retrieved which included performance based assessments of motor function. Nineteen studies assessed power grip dynamometry, fourteen studies used both power and pinch grip dynamometry, eight used manual muscle testing and five assessed the presence or absence of thenar atrophy. Several studies used multiple tests of motor function. Two studies included both power and pinch strength and reported descriptive statistics enabling calculation of effect sizes to compare the relative responsiveness of grip and pinch strength within study samples. The study findings suggest that tip pinch is more responsive than lateral pinch or power grip up to 12 weeks following surgery for CTS.
Conclusion
Although used most frequently and known to be reliable, power and key pinch dynamometry are not the most valid or responsive tools for assessing motor outcome up to 12 weeks following surgery for CTS. Tip pinch dynamometry more specifically targets the thenar musculature and appears to be more responsive. Manual muscle testing, which in theory is most specific to the thenar musculature, may be more sensitive if assessed using a hand held dynamometer – the Rotterdam Intrinsic Handheld Myometer. However further research is needed to evaluate its reliability and responsiveness and establish the most efficient and psychometrically robust method of evaluating motor function following surgery for CTS.
doi:10.1186/1471-2474-8-114
PMCID: PMC2213649  PMID: 18028538
9.  A systematic review of outcomes assessed in randomized controlled trials of surgical interventions for carpal tunnel syndrome using the International Classification of Functioning, Disability and Health (ICF) as a reference tool 
Background
A wide range of outcomes have been assessed in trials of interventions for carpal tunnel syndrome (CTS), however there appears to be little consensus on what constitutes the most relevant outcomes. The purpose of this systematic review was to identify the outcomes assessed in randomized clinical trials of surgical interventions for CTS and to compare these to the concepts contained in the International Classification of Functioning, Disability and Health (ICF).
Methods
The bibliographic databases Medline, AMED and CINAHL were searched for randomized controlled trials of surgical treatment for CTS. The outcomes assessed in these trials were identified, classified and linked to the different domains of the ICF.
Results
Twenty-eight studies were retrieved which met the inclusion criteria. The most frequently assessed outcomes were self-reported symptom resolution, grip or pinch strength and return to work. The majority of outcome measures employed assessed impairment of body function and body structure and a small number of studies used measures of activity and participation.
Conclusion
The ICF provides a useful framework for identifying the concepts contained in outcome measures employed to date in trials of surgical intervention for CTS and may help in the selection of the most appropriate domains to be assessed, especially where studies are designed to capture the impact of the intervention at individual and societal level. Comparison of results from different studies and meta-analysis would be facilitated through the use of a core set of standardised outcome measures which cross all domains of the ICF. Further work on developing consensus on such a core set is needed.
doi:10.1186/1471-2474-7-96
PMCID: PMC1713237  PMID: 17147807
10.  A systematic review of the psychometric properties of the Boston Carpal Tunnel Questionnaire 
Background
The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome. We conducted a systematic review of published studies on the psychometric properties of the BCTQ to determine the level of evidence on the instrument's validity, reliability and responsiveness to date.
Methods
A search of the databases Medline, CINAHL, AMED and PsychInfo was conducted to retrieve studies which investigated one or more of the psychometric properties of the BCTQ. Data abstraction was undertaken by the first two authors.
Results
Ten studies were retrieved which met the inclusion criteria. One study evaluated face and content validity (43 patients) eight studies assessed construct validity (932 patients), four studies tested reliability (126 patients) and nine studies assessed responsiveness (986 patients). Interpretability was evaluated in one study and acceptability in eight studies (978 patients).
Conclusion
The BCTQ is a standardised, patient-based outcome measure of symptom severity and functional status in patients with carpal tunnel syndrome. The evidence base of the psychometric properties indicates that the BCTQ is a valid, reliable, responsive and acceptable instrument and should be included as a primary outcome measures in future CTS trials.
doi:10.1186/1471-2474-7-78
PMCID: PMC1624826  PMID: 17054773

Results 1-10 (10)