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.

Comparative effectiveness of treatment options for subacromial shoulder conditions: a systematic review and network meta-analysis.

BACKGROUND: There are currently many treatment options for patients with subacromial shoulder conditions (SSCs). Clinical decision-making regarding the best treatment option is often difficult. This study aims to evaluate the comparative effectiveness of treatment options for relieving pain and improving function in patients with SSCs. METHODS: Eight databases [including MEDLINE, Embase, CINAHL, AMED, PEDro, Cochrane Database of Systematic Reviews and World Health Organization (WHO) International Clinical Trials Registry] were searched from inception until April 2020. Randomised clinical/controlled trials of adult patients investigating the effects of nonsurgical (e.g. corticosteroid injections, therapeutic exercise, shockwave therapy) and surgical treatment for SSCs, compared with each other, placebo, usual care or no treatment, were retrieved. Pairs of reviewers screened studies independently, quality appraised eligible studies using the Cochrane risk of bias tool, extracted and checked data for accuracy. Primary outcomes were pain and disability in the short term (⩽3 months) and long term (⩾6 months). Direct and indirect evidence of treatment effectiveness was synthesised using random-effects network meta-analysis. RESULTS: The review identified 177 eligible trials. Summary estimates (based on 99 trials providing suitable data, 6764 patients, 20 treatment options) showed small to moderate effects for several treatments, but no significant differences on pain or function between many active treatment comparisons. The primary analysis indicated that exercise and laser therapy may provide comparative benefit in terms of both pain and function at different follow-up time-points, with larger effects found for laser in the short term at 2-6 weeks, although direct evidence was provided by one trial only, and for exercise in the longer term [standardised mean difference (SMD) 0.39, 95% confidence interval (CI) 0.18, 0.59 at 3-6 months] compared with control. Sensitivity analyses excluding studies at increased risk of bias confirmed only the comparative effects of exercise as being robust for both pain and function up until 3-month follow-up. CONCLUSION: Current evidence shows small to moderate effect sizes for most treatment options for SSCs. Six treatments had a high probability of being most effective, in the short term, for pain and function [acupuncture, manual therapy, exercise, exercise plus manual therapy, laser therapy and Microcurrent (MENS) (TENS)], but with low certainty for most treatment options. After accounting for risk of bias, there is evidence of moderate certainty for the comparative effects of exercise on function in patients with SSCs. Future large, high-quality pragmatic randomised trials or meta-analyses are needed to better understand whether specific subgroups of patients respond better to some treatments than others.

Self-management advice, exercise and foot orthoses for plantar heel pain: the TREADON pilot and feasibility randomised trial.

BACKGROUND: Plantar heel pain (PHP) is common and impacts negatively on physical function and quality of life. Initial treatment usually comprises analgesia and self-management advice (SMA), with referral to a physiotherapist or podiatrist recommended only when symptoms persist. Systematic reviews highlight limitations of existing evidence for the effectiveness of exercises and orthoses. The objective of the TREADON pilot and feasibility trial was to inform the design of a future main trial to compare the clinical and cost-effectiveness of self-management advice (SMA), individualised exercises and foot orthoses for PHP. METHODS: This was a four-arm randomised feasibility and pilot trial with 12-week follow-up. Adults aged ≥ 18 years with PHP were identified from primary care by general practice consultation, retrospective general practice medical record review or a population survey. Participants were randomised to either (i) SMA, (ii) SMA plus individualised exercises (SMA-exercises), (iii) SMA plus prefabricated foot orthoses (SMA-orthoses) or (iv) SMA plus combined individualised exercises and prefabricated foot orthoses (SMA-combined). Feasibility outcomes were recruitment; retention; intervention adherence, credibility and satisfaction; performance of three potential primary outcome measures (pain numeric rating scale (NRS), Foot Function Index-pain subscale (FFI-pain), Manchester Foot Pain and Disability Index-pain subscale (MFPDI-pain)); and parameters for informing the main trial sample size calculation. RESULTS: Eighty-two participants were recruited. All three identification methods met the target number of participants. Retention at 12 weeks was 67%. All interventions were successfully delivered as per protocol. Adherence (range over 12 weeks 64-100%) and credibility (93%) were highest in the SMA-combined arm. Satisfaction with treatment was higher for the three clinician-supported interventions (SMA 29%, SMA-exercises 72%, SMA-orthoses 71%, SMA-combined 73%). Responsiveness (baseline to 12 weeks) was higher for FFI-pain (standardised response mean 0.96) and pain NRS (1.04) than MFPDI-pain (0.57). Conservative sample size parameter estimates for standard deviation were pain NRS 2.5, FFI-pain 25 and MFPDI-pain 4, and baseline-outcome correlations were 0.5-0.6, 0.4 and < 0.3, respectively. CONCLUSIONS: We demonstrated the feasibility of conducting a future main randomised clinical trial comparing the clinical and cost-effectiveness of SMA, exercises and/or foot orthoses for PHP. TRIAL REGISTRATION NUMBER: ISRCTN 12160508 . Prospectively registered 5th July 2016.

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.

Physiotherapists' use of suprascapular nerve blocks: an online survey.

BACKGROUND: There is some evidence to support the use of suprascapular nerve blocks (SSNBs) to manage shoulder pain. Although many patients with shoulder pain are referred to physiotherapy, there are no data describing whether physiotherapists currently use SSNBs for these patients. OBJECTIVE: To explore if physiotherapists who manage musculoskeletal shoulder pain are using SSNBs and identify, of those who responded to an online questionnaire, how commonplace this practice is in the United Kingdom (UK) DESIGN: An online, cross-sectional, questionnaire survey was developed for physiotherapists involved in the management of patients with shoulder pain. METHODS: A snowball sampling method was used to invite physiotherapists to complete the online survey, using email, research advertisements in a professional magazine and via social media. The questionnaire captured respondents' demographic and professional practice characteristics, their knowledge and use of SSNBs and their views and experiences regarding SSNBs as a treatment for shoulder pain. RESULTS: In total, there were 529 responders to the survey. Of these, 492 were eligible and formed the sample for analyses. The majority of responders (290/474; 61%) were from the UK. Of these, the majority (259/282; 92%) were familiar with SSNBs as a method of treatment for shoulder pain, although few (9/149; 6%) reported regularly using SSNBs in their clinical practice. Only 8 of 287 responders from the UK (3%) reported delivering SSNBs to patients. CONCLUSIONS: This survey provides preliminary evidence that the use and delivery of SSNBs by UK physiotherapists is uncommon. Future research is required to investigate the potential value of physiotherapists using this treatment option for their patients with shoulder pain.

How do UK physiotherapists address weight loss among individuals with hip osteoarthritis? A mixed-methods study.

BACKGROUND: Weight loss is recommended as a core treatment for individuals with hip osteoarthritis who are overweight or obese. Physiotherapists play an important role in managing patients with hip osteoarthritis, but little is known about how they address weight. We aimed to explore how UK-based physiotherapists currently address weight loss among individuals with hip OA. METHODS: We carried out a mixed-methods study. A cross-sectional questionnaire was mailed to 3,126 UK-based musculoskeletal physiotherapists. Self-reported approaches to addressing weight loss among individuals with hip osteoarthritis were explored using a case vignette and associated clinical management questions. Semi-structured telephone interviews (n = 21) were completed with a purposeful sample of physiotherapists who returned the questionnaire and provided consent for further contact. Interview data were analysed thematically. RESULTS: There was a 53% response rate to the questionnaires (n = 1,646), and 1,148 responders were eligible for analyses (based on having treated an individual with hip OA in the last 6 months). Eight-five per cent of physiotherapists reported that they would address the vignette patient's weight, usually via advice (70%). Interviews identified that advice often focused on the importance of weight loss, with some physiotherapists offering basic advice on how to achieve weight loss. Multiple factors influenced their approach, including confidence, perceived remit and patient receptiveness. CONCLUSIONS: UK physiotherapists commonly address weight loss among patients with hip osteoarthritis, by offering advice relating to the importance of weight loss. However, provision of more specific guidance on how to achieve weight loss is variable. With additional training, physiotherapists could play an important role in supporting weight loss among patients with hip OA, thus potentially optimizing treatment outcomes.

Coexistence of plantar calcaneal spurs and plantar fascial thickening in individuals with plantar heel pain.

Objectives: To examine associations between plantar calcaneal spurs, plantar fascia thickening and plantar heel pain (PHP), and to determine whether tenderness on palpation of the heel differentiates between these presentations. Methods: Adults aged ⩾50 years registered with four general practices were mailed a Health Survey. Responders reporting foot pain within the last 12 months underwent a detailed clinical assessment. PHP in the past month was documented using a foot manikin. Plantar calcaneal spurs were identified from weight-bearing lateral radiographs and plantar fascia thickening (defined as >4 mm) from ultrasound. Tenderness on palpation of the plantar fascia insertion was documented. Associations between these factors and PHP were explored using generalized estimating equations. Results: Clinical and radiographic data were available from 530 participants (296 women, mean [s.d.] age 64.9 [8.4] years), 117 (22.1%) of whom reported PHP. Plantar calcaneal spurs and plantar fascia thickening were identified in 281 (26.5%) and 501 (47.3%) feet, respectively, but frequently coexisted (n = 217, 20.4%). Isolated plantar calcaneal spurs were rare (n = 64, 6.0%). Participants with PHP were more likely to have a combination of these features compared with those without PHP (odds ratio 2.16, 95% CI 1.24, 3.77, P = 0.007). Tenderness on palpation of the heel was not associated with plantar calcaneal spurs or plantar fascia thickening, either in isolation or in combination, in those with PHP. Conclusion: Plantar calcaneal spurs and plantar fascial thickening are associated with PHP, but frequently coexist. Tenderness on palpation of the heel does not appear to differentiate between clinical presentations of PHP.

Comparative effectiveness of treatment options for plantar heel pain: a systematic review with network meta-analysis.

OBJECTIVE: To evaluate the comparative effectiveness of current treatment options for plantar heel pain (PHP). DESIGN: Systematic review and network meta-analysis (NMA). DATA SOURCES: Medline, EMBASE, CINAHL, AMED, PEDro, Cochrane Database, Web of Science and WHO Clinical Trials Platform were searched from their inception until January 2018. STUDY SELECTION: Randomised controlled trials (RCTs) of adults with PHP investigating common treatments (ie, corticosteroid injection, non-steroidal anti-inflammatory drugs, therapeutic exercise, orthoses and/or extracorporeal shockwave therapy (ESWT)) compared with each other or a no treatment, placebo/sham control. DATA EXTRACTION AND ANALYSIS: Data were extracted and checked for accuracy and completeness by pairs of reviewers. Primary outcomes were pain and function. Comparative treatment effects were analysed by random effects NMA in the short term, medium term and long term. Relative ranking of treatments was assessed by surface under the cumulative ranking probabilities (0-100 scale). RESULTS: Thirty-one RCTs (total n=2450 patients) were included. There was no evidence of inconsistency detected between direct and indirect treatment comparisons in the networks, but sparse data led to frequently wide CIs. Available evidence does not suggest that any of the commonly used treatments for the management of PHP are better than any other, although corticosteroid injections, alone or in combination with exercise, and ESWT were ranked most likely to be effective for the management of short-term, medium-term and long-term pain or function; placebo/sham/control appeared least likely to be effective; and exercise appeared to only be beneficial for long-term pain or function. CONCLUSIONS: Current evidence is equivocal regarding which treatment is the most effective for the management of PHP. Given limited understanding of long-term effects, there is need for large, methodologically robust multicentre RCTs investigating and directly comparing commonly used treatments for the management of PHP. PROSPERO REGISTRATION NUMBER: CRD42016046963.

The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial.

BACKGROUND: To our knowledge, the comparative effectiveness of commonly used conservative treatments for carpal tunnel syndrome has not been evaluated previously in primary care. We aimed to compare the clinical and cost-effectiveness of night splints with a corticosteroid injection with regards to reducing symptoms and improving hand function in patients with mild or moderate carpal tunnel syndrome. METHODS: We did this randomised, open-label, pragmatic trial in adults (≥18 years) with mild or moderate carpal tunnel syndrome recruited from 25 primary and community musculoskeletal clinics and services. Patients with a new episode of idiopathic mild or moderate carpal tunnel syndrome of at least 6 weeks' duration were eligible. We randomly assigned (1:1) patients (permutated blocks of two and four by site) with an online web or third party telephone service to receive either a single injection of 20 mg methylprednisolone acetate (from 40 mg/mL) or a night-resting splint to be worn for 6 weeks. Patients and clinicians could not be masked to the intervention. The primary outcome was the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. We used intention-to-treat analysis, with multiple imputation for missing data, which was concealed to treatment group allocation. The trial is registered with the European Clinical Trials Database, number 2013-001435-48, and ClinicalTrial.gov, number NCT02038452. FINDINGS: Between April 17, 2014, and Dec 31, 2016, 234 participants were randomly assigned (118 to the night splint group and 116 to the corticosteroid injection group), of whom 212 (91%) completed the BCTQ at 6 weeks. The BCTQ score was significantly better at 6 weeks in the corticosteroid injection group (mean 2·02 [SD 0·81]) than the night splint group (2·29 [0·75]; adjusted mean difference -0·32; 95% CI -0·48 to -0·16; p=0·0001). No adverse events were reported. INTERPRETATION: A single corticosteroid injection shows superior clinical effectiveness at 6 weeks compared with night-resting splints, making it the treatment of choice for rapid symptom response in mild or moderate carpal tunnel syndrome presenting in primary care. FUNDING: Arthritis Research UK.

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.

How Do Physical Therapists in the United Kingdom Manage Patients With Hip Osteoarthritis? Results of a Cross-Sectional Survey.

Background: Hip osteoarthritis (OA) is common, painful, and disabling. Physical therapists have an important role in managing patients with hip OA; however, little is known about their current management approach and whether it aligns with clinical guideline recommendations. Objective: The objective of this study is to describe United Kingdom (UK) physical therapists' current management of patients with hip OA and to determine whether it aligns with clinical guidelines. Design: The design is a cross-section questionnaire. Methods: A questionnaire was mailed to 3126 physical therapists in the UK that explored physical therapists' self-reported management of a patient with hip OA using a case vignette and clinical management questions. Results: The response rate was 52.7% (n = 1646). In total, 1148 (69.7%) physical therapists had treated a patient with hip OA in the last 6 months and were included in the analyses. A treatment package was commonly provided incorporating advice, exercise (strength training 95.9%; general physical activity 85.4%), and other nonpharmacological modalities, predominantly manual therapy (69.6%), and gait retraining (66.4%). There were some differences in reported management between physical therapists based in the National Health Service (NHS) and non-NHS-based physical therapists, including fewer treatment sessions being provided by NHS-based therapists. Limitations: Limitations include the potential for nonresponder bias and, in clinical practice, physical therapists may manage patients with hip OA differently. Conclusion: UK-based physical therapists commonly provide a package of care for patients with hip OA that is broadly in line with current clinical guidelines, including advice, exercise, and other nonpharmacological treatments. There were some differences in clinical practice between NHS and non-NHS-based physical therapists, but whether these differences impact on clinical outcomes remains unknown.

Symptomatic Course of Foot Osteoarthritis Phenotypes: An 18-Month Prospective Analysis of Community-Dwelling Older Adults.

OBJECTIVE: Osteoarthritis (OA) is a heterogeneous disease, and symptom progression at the foot is unclear. This study investigated the symptomatic course of 3 predefined foot OA phenotypes over an 18-month period. METHODS: The Clinical Assessment Study of the Foot is a community-based cohort of adults ages ≥50 years in North Staffordshire, UK. Participants who reported foot pain in a postal health survey and underwent radiographic assessment were mailed an 18-month followup survey. Changes in descriptive and symptomatic outcomes over 18 months were compared across the 3 phenotypes to determine within-phenotype changes and between-phenotype differences. RESULTS: Of 533 participants at baseline, 478 (89.7%) responded at 18 months. All 3 phenotypes showed small within-phenotype improvements in mean foot pain severity (scale range 0-10, where 0 = no pain and 10 = worst pain): no or minimal foot OA (18 months 4.0, mean change -1.15 [95% confidence interval (95% CI) -1.46, -0.83]), isolated first metatarsophalangeal (MTP) joint OA (18 months 4.1, mean change -0.60 [95% CI -1.11, -0.10]), and polyarticular foot OA (18 months 5.1, mean change -0.77 [95% CI -1.42, -0.12]). The isolated first MTP joint OA phenotype had an increased likelihood of hallux valgus in the left foot (adjusted odds ratio 2.96 [95% CI 1.23, 7.12]) compared to the no or minimal foot OA phenotype. CONCLUSION: Three foot OA phenotypes showed few descriptive or symptomatic changes over 18 months. Future clinical trials should consider that people recruited with mild-to-moderate symptomatic foot OA appear likely to remain relatively stable with usual care. Longer-term followup using additional time points is required to describe further the natural history of foot OA.

Management of shoulder pain by UK general practitioners (GPs): a national survey.

OBJECTIVES: Studies in Canada, the USA and Australia suggested low confidence among general practitioners (GPs) in diagnosing and managing shoulder pain, with frequent use of investigations. There are no comparable studies in the UK; our objective was to describe the diagnosis and management of shoulder pain by GPs in the UK. METHODS: A national survey of a random sample of 5000 UK GPs collected data on shoulder pain diagnosis and management using two clinical vignettes that described primary care presentations with rotator cuff tendinopathy (RCT) and adhesive capsulitis (AdhC). RESULTS: Seven hundred and fourteen (14.7%) responses were received. 56% and 83% of GPs were confident in their diagnosis of RCT and AdhC, respectively, and a wide range of investigations and management options were reported. For the RCT presentation, plain radiographs of the shoulder were most common (60%), followed by blood tests (42%) and ultrasound scans (USS) (38%). 19% of those who recommended a radiograph and 76% of those who recommended a USS did so 'to confirm the diagnosis'. For the AdhC presentation, the most common investigations were blood tests (60%), plain shoulder radiographs (58%) and USS (31%). More than two-thirds of those recommending a USS did so 'to confirm the diagnosis'. The most commonly recommended treatment for both presentations was physiotherapy (RCT 77%, AdhC 71%) followed by non-steroidal anti-inflammatory drugs (RCT 58%, AdhC 74%). 17% opted to refer the RCT to secondary care (most often musculoskeletal interface service), compared with 31% for the AdhC. CONCLUSIONS: This survey of GPs in the UK highlights reliance on radiographs and blood tests in the management of common shoulder pain presentations. GPs report referring more than 7 out of 10 patients with RCT and AdhC to physiotherapists. These findings need to be viewed in the context of low response to the survey and, therefore, potential non-response bias.

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).

Clinical Course and Prognostic Factors in Conservatively Managed Carpal Tunnel Syndrome: A Systematic Review.

OBJECTIVE: To summarize the available evidence regarding the course of symptoms and prognostic factors in patients with diagnosed carpal tunnel syndrome (CTS) who are treated conservatively. DATA SOURCES: Computerized databases, reference checking, and experts in the field were used to identify studies for inclusion in the review. STUDY SELECTION: Multiple reviewers were used to identify studies which included adults (aged ≥18y) diagnosed with CTS in either a clinical setting or population setting. The study must have observed the course of CTS over at least a 6-week period in patients receiving no treatment or usual care that included conservative (nonsurgical) treatments. The design was of a longitudinal cohort study with either prospective or retrospective data collection. There were no language restrictions, and none of the research identified was only reported in abstract form. DATA EXTRACTION: Methodological bias was assessed using the Quality in Prognosis Studies tool. A high risk of bias (predominantly relating to study attrition, confounding, and/or statistical analysis and reporting) was judged to be present in 8 studies. Designs showed wide variability with respect to characteristics of the included population, definition of CTS, assessment of prognostic factors, types of interventions provided, and types of outcome measures applied. This prevented pooled estimates from being produced. DATA SYNTHESIS: A negative outcome at 3 years' follow-up of conservatively treated participants ranged from 23% to 89%. Four included studies observed the rate of surgical intervention after initial conservative management and found this to be 57% to 66%. Evidence regarding factors predicting the negative outcome of no treatment or conservative treatment was graded, taking into account the number of studies evaluating the factor, the methodological quality of these studies, and the consistency of the available evidence. There was 100% agreement in at least 3 cohorts with a medium or high risk of bias that symptom duration, a positive Phalen's test, and thenar wasting were associated with a negative outcome of conservative management; however, not all results were statistically significant, and hence the overall judgment remained inconclusive. CONCLUSIONS: Results of this review should be treated with caution because of the heterogeneity of studies and the risks of bias identified. However, the course of CTS appears variable, and poor prognosis may be predicted by a longer symptom duration, a positive Phalen's test, and thenar wasting.

An Economic Evaluation of TENS in Addition to Usual Primary Care Management for the Treatment of Tennis Elbow: Results from the TATE Randomized Controlled Trial.

BACKGROUND: The TATE trial was a multicentre pragmatic randomized controlled trial of supplementing primary care management (PCM)-consisting of a GP consultation followed by information and advice on exercises-with transcutaneous electrical nerve stimulation (TENS), to reduce pain intensity in patients with tennis elbow. This paper reports the health economic evaluation. METHODS AND FINDINGS: Adults with new diagnosis of tennis elbow were recruited from 38 general practices in the UK, and randomly allocated to PCM (n = 120) or PCM plus TENS (n = 121). Outcomes included reduction in pain intensity and quality-adjusted-life-years (QALYs) based on the EQ5D and SF6D. Two economic perspectives were evaluated: (i) healthcare-inclusive of NHS and private health costs for the tennis elbow; (ii) societal-healthcare costs plus productivity losses through work absenteeism. Mean outcome and cost differences between the groups were evaluated using a multiple imputed dataset as the base case evaluation, with uncertainty represented in cost-effectiveness planes and through probabilistic cost-effectiveness acceptability curves). Incremental healthcare cost was £33 (95%CI -40, 106) and societal cost £65 (95%CI -307, 176) for PCM plus TENS. Mean differences in outcome were: 0.11 (95%CI -0.13, 0.35) for change in pain (0-10 pain scale); -0.015 (95%CI -0.058, 0.029) for QALYEQ5D; 0.007 (95%CI -0.022, 0.035) for QALYSF6D (higher score differences denote greater benefit for PCM plus TENS). The ICER (incremental cost effectiveness ratio) for the main evaluation of mean difference in societal cost (£) relative to mean difference in pain outcome was -582 (95%CI -8666, 8113). However, incremental ICERs show differences in cost-effectiveness of additional TENS, according to the outcome being evaluated. CONCLUSION: Our findings do not provide evidence for or against the cost-effectiveness of TENS as an adjunct to primary care management of tennis elbow.

Transcutaneous electrical nerve stimulation as adjunct to primary care management for tennis elbow: pragmatic randomised controlled trial (TATE trial).

STUDY QUESTION: Can transcutaneous electrical nerve stimulation (TENS), as a patient controlled adjunct to primary care management for tennis elbow, provide superior pain relief to primary care management alone. SUMMARY ANSWER: TENS conferred no additional clinical benefit over primary care management consisting of information and advice on analgesia and exercise for patients with tennis elbow, probably partly owing to poor adherence to treatment recommendations. WHAT IS KNOWN AND WHAT THIS PAPER ADDS: A need exists for safe, self administered interventions to provide pain relief for patients with tennis elbow. TENS as an adjunct to primary care management failed to show any additional pain relief compared with primary care management alone.