The effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome: 24-month follow-up of a randomized trial.

OBJECTIVES: This follow-up study of the INSTinCTS (INjection vs SplinTing in Carpal Tunnel Syndrome) trial compared the effects of corticosteroid injection (CSI) and night splinting (NS) for the initial management of mild-to-moderate CTS on symptoms, resource use and carpal tunnel surgery, over 24 months. METHODS: Adults with mild-to-moderate CTS were randomized 1:1 to a local corticosteroid injection or a night splint worn for 6 weeks. Outcomes at 12 and 24 months included the Boston Carpal Tunnel Questionnaire (BCTQ), hand/wrist pain intensity numeric rating scale (NRS), the number of patients referred for and undergoing CTS surgery, and healthcare utilization. A cost-utility analysis was conducted. RESULTS: One hundred and sixteen participants received a CSI and 118 a NS. The response rate at 24 months was 73% in the CSI arm and 71% in the NS arm. By 24 months, a greater proportion of the CSI group had been referred for (28% vs 20%) and undergone (22% vs 16%) CTS surgery compared with the NS group. There were no statistically significant between-group differences in BCTQ score or pain NRS at 12 or 24 months. CSI was more costly [mean difference £68.59 (95% CI: -120.84, 291.24)] with fewer quality-adjusted life-years than NS over 24 months [mean difference -0.022 (95% CI: -0.093, 0.045)]. CONCLUSION: Over 24 months, surgical intervention rates were low in both groups, but less frequent in the NS group. While there were no differences in the clinical effectiveness of CSI and NS, initial treatment with CSI may not be cost-effective in the long-term compared with NS.

Predictors of the effects of treatment for shoulder pain: protocol of an individual participant data meta-analysis.

BACKGROUND: Shoulder pain is one of the most common presentations of musculoskeletal pain with a 1-month population prevalence of between 7 and 26%. The overall prognosis of shoulder pain is highly variable with 40% of patients reporting persistent pain 1 year after consulting their primary care clinician. Despite evidence for prognostic value of a range of patient and disease characteristics, it is not clear whether these factors also predict (moderate) the effect of specific treatments (such as corticosteroid injection, exercise, or surgery). OBJECTIVES: This study aims to identify predictors of treatment effect (i.e. treatment moderators or effect modifiers) by investigating the association between a number of pre-defined individual-level factors and the effects of commonly used treatments on shoulder pain and disability outcomes. METHODS: This will be a meta-analysis using individual participant data (IPD). Eligible trials investigating the effectiveness of advice and analgesics, corticosteroid injection, physiotherapy-led exercise, psychological interventions, and/or surgical treatment in patients with shoulder conditions will be identified from systematic reviews and an updated systematic search for trials, and risk of bias will be assessed. Authors of all eligible trials will be approached for data sharing. Outcomes measured will be shoulder pain and disability, and our previous work has identified candidate predictors. The main analysis will be conducted using hierarchical one-stage IPD meta-analysis models, examining the effect of treatment-predictor interaction on outcome for each of the candidate predictors and describing relevant subgroup effects where significant interaction effects are detected. Random effects will be used to account for clustering and heterogeneity. Sensitivity analyses will be based on (i) exclusion of trials at high risk of bias, (ii) use of restricted cubic splines to model potential non-linear associations for candidate predictors measured on a continuous scale, and (iii) the use of a two-stage IPD meta-analysis framework. DISCUSSION: Our study will collate, appraise, and synthesise IPD from multiple studies to examine potential predictors of treatment effect in order to assess the potential for better and more efficient targeting of specific treatments for individuals with shoulder pain. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018088298.

Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study).

BACKGROUND: Shoulder pain is a highly prevalent complaint and disorders of the rotator cuff, including tears, are thought to be the most common cause. The number of operations repair the torn rotator cuff has risen significantly in recent years. While surgical techniques have progressed, becoming less invasive and more secure, rehabilitation programmes have remained largely like those initially developed when surgical techniques were less advanced and more invasive. Uncertainty remains in relation to the length of post-surgical immobilisation and the amount of early load permitted at the repair site. In the context of this uncertainty, current practice is to follow a generally cautious approach, including long periods of immobilisation in a sling and avoidance of early active rehabilitation. Systematic review evidence suggests early mobilisation might be beneficial but further high-quality studies are required to evaluate this. METHODS/DESIGN: RaCeR is a two-arm, multi-centre pilot and feasibility randomised controlled trial with nested qualitative interviews. A total of 76 patients with non-traumatic rotator cuff tears who are scheduled to have a surgical repair will be recruited from up to five UK NHS hospitals and randomly allocated to either early patient-directed rehabilitation or standard rehabilitation that incorporates sling immobilisation. RaCeR will assess the feasibility of a future, substantive, multi-centre randomised controlled trial to test the hypothesis that, compared to standard rehabilitation incorporating sling immobilisation, early patient-directed rehabilitation is both more clinically effective and more cost-effective. In addition, a sample of patients and clinicians will be interviewed to understand the acceptability of the interventions and the barriers and enablers to adherence to the interventions. DISCUSSION: Research to date suggests that there is the possibility of reducing the patient burden associated with post-operative immobilisation following surgery to repair the torn rotator cuff and improve clinical outcomes. There is a clear need for a high-quality, adequately powered, randomised trial to better inform clinical practice. Prior to a large-scale trial, we first need to undertake a pilot and feasibility trial to address current uncertainties about recruitment, retention and barriers to adherence to the interventions, particularly in relation to whether patients will be willing to begin moving their arm early after their operation. TRIAL REGISTRATION: ISRCTN Registry, 18357968 . Registered on 10 August 2018.

Predicting surgical intervention in patients presenting with carpal tunnel syndrome in primary care.

PURPOSE: Carpal tunnel syndrome (CTS) is a symptomatic compression neuropathy of the median nerve. This study investigated the value of candidate prognostic factors (PFs) in predicting carpal tunnel release surgery. PATIENTS AND METHODS: This is a retrospective cohort study set in the Clinical Practice Research Datalink. Patients ≥18 years presenting with an incident episode of CTS were identified between 1989 and 2013. Candidate PF's defined in coded electronic patient records were identified following literature review and consultation with clinicians. Time to first carpal tunnel release surgery was the primary end point. A manual backward stepwise selection procedure was used to obtain an optimal prediction model, which included all the significant PFs. RESULTS: In total, 91,412 patients were included in the cohort. The following PFs were included in an optimal model (C-statistic: 0.588 [95% CI 0.584-0.592]) for predicting surgical intervention: geographical region; deprivation status; age hazard ratio (HR 1.02 per year, 95% CI 1.01-1.02); obesity (HR 1.23, 95% CI 1.19-1.27); alcohol drinker (HR 1.05, 95% CI 1.00-1.10); smoker (HR 1.06, 95% 1.03-1.10); inflammatory condition (HR 1.13, 95% CI 0.98-1.29); neck condition (HR 1.13, 95% CI 1.03-1.23); and multisite pain (HR 1.10, 95% CI 1.05-1.15). Although not included in the multivariable model, pregnancy (if gender female) within 1 year of the index consultation, reduced the risk of surgery (HR 0.24, 95% CI 0.21-0.28). CONCLUSION: This study shows that patients who are older and who have comorbidities including other pain conditions are more likely to have surgery, whereas patients presenting with CTS during or within a year of pregnancy are less likely to have surgery. This information can help to inform clinicians and patients about the likely outcome of treatment and to be aware of which patients may be less responsive to primary care interventions.

Trends in the prevalence, incidence and surgical management of carpal tunnel syndrome between 1993 and 2013: an observational analysis of UK primary care records.

OBJECTIVES: To describe the prevalence, incidence and surgical management of carpal tunnel syndrome (CTS), between 1993 and 2013, as recorded in the Clinical Practice Research Datalink (CPRD). DESIGN: We completed a series of cross-sectional epidemiological analyses to observe trends over time. SETTING: Primary care data collected between 1993 and 2013, stored in the CPRD. POPULATION: Individuals aged ≥18 years were selected. Prevalent and incident episodes of CTS and episodes of surgical intervention were identified using a list of preidentified Read codes. ANALYSIS: We defined incident episodes as those with no preceding diagnostic code for CTS in the past 2 years of data. Episodes of surgery were expressed as a percentage of the prevalent population during the same calendar year. Joinpoint regression was used to determine significant changes in the underlying trend. RESULTS: The prevalence of CTS increased over the study period, with a particular incline between 2000 and 2004 (annual percentage change 7.81). The female-to-male prevalence ratio reduced over time from 2.74 in 1993 to 1.93 in 2013. The median age of females and males with CTS were noted to increase from 49 and 53 years, respectively in 1993 to 54 and 59 years, respectively in 2013. Incidence was also noted to increase over time. After an initial increase between 1993 and 2007, the percentage of prevalent patients with a coded surgical episode began to decrease after 2007 to 27.41% in 2013 (annual percentage change -1.7). CONCLUSION: This study has demonstrated that the prevalence and incidence of CTS increased over the study period between 1993 and 2013. Rates of surgery for CTS also increased over the study period; however after 2007, the per cent of patients receiving surgery showed a statistically significant decline back to the rate seen in 2004.

The clinical and cost effectiveness of steroid injection compared with night splints for carpal tunnel syndrome: the INSTINCTS randomised clinical trial study protocol.

BACKGROUND: Patients diagnosed with idiopathic mild to moderate carpal tunnel syndrome (CTS) are usually managed in primary care and commonly treated with night splints and/or corticosteroid injection. The comparative effectiveness of these interventions has not been reliably established nor investigated in the medium and long term. The primary objective of this trial is to investigate whether corticosteroid injection is effective in reducing symptoms and improving hand function in mild to moderate CTS over 6 weeks when compared with night splints. Secondary objectives are to determine specified comparative clinical outcomes and cost effectiveness of corticosteroid injection over 6 and 24 months. METHOD/DESIGN: A multicentre, randomised, parallel group, clinical pragmatic trial will recruit 240 adults aged ≥18 years with mild to moderate CTS from GP Practices and Primary-Secondary Care Musculoskeletal Interface Clinics. Diagnosis will be by standardised clinical assessment. Participants will be randomised on an equal basis to receive either one injection of 20 mg Depo-Medrone or a night splint to be worn for 6 weeks. The primary outcome is the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. Secondary outcomes are the BCTQ symptom severity and function status subscales, symptom intensity, interrupted sleep, adherence to splinting, perceived benefit and satisfaction with treatment, work absence and reduction in work performance, EQ-5D-5L, referral to surgery and health utilisation costs. Participants will be assessed at baseline and followed up at 6 weeks, 6, 12 and 24 months. The primary analysis will use an intention to treat (ITT) approach and multiple imputation for missing data. The sample size was calculated to detect a 15 % greater improvement in the BTCQ overall score in the injection group compared to night-splinting at approximately 90 % power, 5 % two-tailed significance and allows for 15 % loss to follow-up. DISCUSSION: The trial makes an important contribution to the evidence base available to support effective conservative management of CTS in primary care. No previous trials have directly compared these treatments for CTS in primary care populations, reported on clinical effectiveness at more than 6 months nor compared cost effectiveness of the interventions. TRIAL REGISTRATION: Trial registration: EudraCT 2013-001435-48 (registered 05/06/2013), ClinicalTrials.gov NCT02038452 (registered 16/1/2014), and Current Controlled Trials ISRCTN09392969 (retrospectively registered 01/05/2014).