The acceptability and feasibility of conducting a randomised controlled trial to test the effectiveness of a walking intervention for older people with persistent musculoskeletal pain in primary care: A mixed methods evaluation of the iPOPP pilot trial.

INTRODUCTION: Persistent musculoskeletal (MSK) pain is associated with physical inactivity in older people. While walking is an acceptable form of physical activity, the effectiveness of walking interventions in this population has yet to be established. OBJECTIVES: To assess the acceptability and feasibility of conducting a randomised controlled trial (RCT) to test the effectiveness of a healthcare assistant-led walking intervention for older people with persistent MSK pain (iPOPP) in primary care. METHODS: A mixed method, three arm pilot RCT was conducted in four general practices and recruited patients aged ≥65 years with persistent MSK pain. Participants were randomised in a 1:1:1 ratio to: (i) usual care, (ii) usual care plus a pedometer intervention, or (iii) usual care plus the iPOPP walking intervention. Descriptive statistics were used in an exploratory analysis of the quantitative data. Qualitative data were analysed using thematic analysis. A triangulation protocol was used to integrate the analyses from the mixed methods. RESULTS: All pre-specified success criteria were achieved in terms of feasibility (recruitment, follow-up and iPOPP intervention adherence) and acceptability. Triangulation of the data identified the need, in the future, to make the iPOPP training (for intervention deliverers) more patient-centred to better support already active patients and the use of individualised goal setting and improve accelerometry data collection processes to increase the amount of valid data. CONCLUSIONS: This pilot trial suggests that the iPOPP intervention and a future full-scale RCT are both acceptable and feasible. The use of a triangulation protocol enabled more robust conclusions about acceptability and feasibility to be drawn.

Improving the Effectiveness of Exercise Therapy for Adults With Knee Osteoarthritis: A Pragmatic Randomized Controlled Trial (BEEP Trial).

Objective: To investigate whether knee osteoarthritis (OA) related pain and function can be improved by offering enhanced physical therapist-led exercise interventions. Design: Three-arm prospectively designed pragmatic randomized controlled trial. Setting: General practices and National Health Service physical therapy services in England. Participants: 514 adults (252 men, 262 women) aged ≥45 years with a clinical diagnosis of knee osteoarthritis (N=514). Mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at baseline were 8.4 for pain and 28.1 for function. Interventions: Participants were individually randomized (1:1:1 allocation) to usual physical therapy care (UC control: up to 4 sessions of advice and exercise over 12 weeks), individually tailored exercise (ITE: individualized, supervised, and progressed lower limb exercises, 6-8 sessions over 12 weeks), or targeted exercise adherence (TEA: transitioning from lower limb exercise to general physical activity, 8-10 contacts over 6 months). Main Outcome Measures: Primary outcomes were pain and physical function measured by the WOMAC at 6 months. Secondary outcomes were measured at 3, 6, 9, 18, and 36 months. Results: Participants receiving UC, ITE, and TEA all experienced moderate improvement in pain and function. There were no significant differences between groups at 6 months (adjusted mean differences (95% confidence intervals): pain UC vs ITE, -0.3 (-1.0 to 0.4), UC vs TEA, -0.3 (-1.0 to 0.4); function UC vs ITE, 0.5 (-1.9 to 2.9), UC vs TEA, -0.9 (-3.3 to 1.5)), or any other time-point. Conclusions: Patients receiving UC experienced moderate improvement in pain and function; however, ITE and TEA did not lead to superior outcomes. Other strategies for patients with knee osteoarthritis to enhance the benefits of exercise-based physical therapy are needed.

Risk-based stratified primary care for common musculoskeletal pain presentations (STarT MSK): a cluster-randomised, controlled trial.

Background: Risk-based stratified care shows clinical effectiveness and cost-effectiveness versus usual primary care for non-specific low back pain but is untested for other common musculoskeletal disorders. We aimed to test the clinical effectiveness and cost-effectiveness of point-of-care risk stratification (using Keele's STarT MSK Tool and risk-matched treatments) versus usual care for the five most common musculoskeletal presentations (back, neck, knee, shoulder, and multi-site pain). Methods: In this cluster-randomised, controlled trial in UK primary care with embedded qualitative and health economic studies we recruited patients from 24 general practices in the West Midlands region of England. Eligible patients were those aged 18 years or older whose general practitioner (GP) confirmed a consultation for a musculoskeletal presentation. General practices that consented to participate via a representative of the cluster were randomly assigned (1:1) to intervention or usual care, using stratified block randomisation. Researchers involved in data collection, outcome data entry, and statistical analysis were masked at both the cluster and individual participant level. Participating patients were told the study was examining GP treatment of common aches and pains and were not aware they were in a randomised trial. GPs in practices allocated to the intervention group were supported to deliver risk-based stratified care using a bespoke computer-based template, including the risk-stratification tool, and risk-matched treatment options for patients at low, medium, or high risk of poor disability or pain outcomes. There were 15 risk-matched treatment options. In the usual care group, patients with musculoskeletal pain consulting their GP received treatment as usual, typically including advice and education, medication, referral for investigations or tests, or referral to other services. The primary outcome was time-averaged pain intensity over 6 months. All analyses were done by intention to treat. The trial is registered with ISRCTN, ISRCTN15366334. Results: Between May 1, 2018, and April 30, 2019, 104 GPs from 24 practices (12 per study group) identified 2494 patients with musculoskeletal pain. 1211 (49%) participants consented to questionnaires (534 in the intervention group and 677 in the usual care group), with 1070 (88%) completing the follow-up questionnaire at 6 months. We found no significant difference in time-averaged pain intensity (mean(SD) mean 4·4 [SD 2·3] in the intervention group vs 4·6 [2·5] in the control group; adjusted mean difference -0·16, 95% CI -0·65 to 0·34) or in standardised function score (mean -0·06 [SD 0·94] in the intervention group vs 0·05 [1·04]; adjusted mean difference -0·07, 95% CI -0·22 to 0·08). No serious adverse events or adverse events were reported. Risk stratification received positive patient and clinician feedback. Interpretation: Risk stratification for patients in primary care with common musculoskeletal presentations did not lead to significant improvements in pain or function, although some aspects of GP decision making were affected, and GP and patients had positive experiences. The costs of risk-based stratified care were similar to usual care, and such a strategy only offers marginal changes in cost-effectiveness outcomes. The clinical implications from this trial are largely inconclusive. Funding: National Institute for Health Research.

Refinement and validation of a tool for stratifying patients with musculoskeletal pain.

BACKGROUND: Patients with musculoskeletal pain in different body sites share common prognostic factors. Using prognosis to stratify and treatment match can be clinically and cost-effective. We aimed to refine and validate the Keele STarT MSK Tool for prognostic stratification of musculoskeletal pain patients. METHODS: Tool refinement and validity was tested in a prospective cohort study, and external validity examined in a pilot cluster randomized controlled trial (RCT). Study population comprised 2,414 adults visiting U.K. primary care with back, neck, knee, shoulder or multisite pain returning postal questionnaires (cohort: 1,890 [40% response]; trial: 524). Cohort baseline questionnaires included a draft tool plus refinement items. Trial baseline questionnaires included the Keele STarT MSK Tool. Physical health (SF-36 Physical Component Score [PCS]) and pain intensity were assessed at 2- and 6-month cohort follow-up; pain intensity was measured at 6-month trial follow-up. RESULTS: The tool was refined by replacing (3), adding (3) and removing (2) items, resulting in a 10-item tool. Model fit (R2 ) was 0.422 and 0.430 and discrimination (c statistic) 0.839 and 0.822 for predicting 6-month cohort PCS and pain (respectively). The tool classified 24.9% of cohort participants at low, 41.7% medium and 33.4% high risk, clearly discriminating between subgroups. The tool demonstrated model fit of 0.224 and discrimination 0.73 in trial participants. Multiple imputation confirmed robustness of findings. CONCLUSIONS: The Keele STarT MSK Tool demonstrates good validity and acceptable predictive performance and clearly identifies groups of musculoskeletal pain patients with different characteristics and prognosis. Using prognostic information for stratification and treatment matching may be clinically/cost-effective. SIGNIFICANCE: The paper presents the first musculoskeletal pain prognostic stratification tool specifically for use among all primary care patients with the five most common musculoskeletal pain presentations (back, neck, knee, shoulder or multisite pain). The Keele STarT MSK Tool identifies groups of musculoskeletal pain patients with clearly different characteristics and prognosis. Using this tool for stratification and treatment matching may be clinically and cost-effective.

Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT.

BACKGROUND: Sciatica has a substantial impact on patients and society. Current care is 'stepped', comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensive interventions if symptoms fail to resolve. No study has yet tested a model of stratified care in which patients are subgrouped and matched to different care pathways based on their prognosis and clinical characteristics. OBJECTIVES: The objectives were to investigate the clinical effectiveness and cost-effectiveness of a stratified care model compared with usual, non-stratified care. DESIGN: This was a two-parallel group, multicentre, pragmatic, 1 : 1 randomised controlled trial. SETTING: Participants were recruited from primary care (42 general practices) in North Staffordshire, North Shropshire/Wales and Cheshire in the UK. PARTICIPANTS: Eligible patients were aged ≥ 18 years, had suspected sciatica, had access to a mobile phone/landline, were not pregnant, were not receiving treatment for the same problem and had not had previous spinal surgery. INTERVENTIONS: In stratified care, a combination of prognostic and clinical criteria associated with referral to spinal specialist services was used to allocate patients to one of three groups for matched care pathways. Group 1 received advice and up to two sessions of physiotherapy, group 2 received up to six sessions of physiotherapy, and group 3 was fast-tracked to magnetic resonance imaging and spinal specialist opinion. Usual care was based on the stepped-care approach without the use of any stratification tools/algorithms. Patients were randomised using a remote web-based randomisation service. MAIN OUTCOME MEASURES: The primary outcome was time to first resolution of sciatica symptoms (six point ordinal scale, collected via text messages). Secondary outcomes (at 4 and 12 months) included pain, function, psychological health, days lost from work, work productivity, satisfaction with care and health-care use. A cost-utility analysis was undertaken over 12 months. A qualitative study explored patients' and clinicians' views of the fast-track care pathway to a spinal specialist. RESULTS: A total of 476 patients were randomised (238 in each arm). For the primary outcome, the overall response rate was 89.3% (88.3% and 90.3% in the stratified and usual care arms, respectively). Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46; p = 0.288). On average, participants in both arms reported good improvement from baseline, on most outcomes, over time. Following the assessment at the research clinic, most participants in the usual care arm were referred to physiotherapy. CONCLUSIONS: The stratified care model tested in this trial was not more clinically effective than usual care, and was not likely to be a cost-effective option. The fast-track pathway was felt to be acceptable to both patients and clinicians; however, clinicians expressed reluctance to consider invasive procedures if symptoms were of short duration. LIMITATIONS: Participants in the usual care arm, on average, reported good outcomes, making it challenging to demonstrate superiority of stratified care. The performance of the algorithm used to allocate patients to treatment pathways may have influenced results. FUTURE WORK: Other approaches to stratified care may provide superior outcomes for sciatica. TRIAL REGISTRATION: Current Controlled Trials ISRCTN75449581. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 49. See the NIHR Journals Library website for further project information.

Sciatica is pain that spreads into the leg because of a trapped nerve in the lower back. It can be a very painful condition that affects everyday life and ability to work. People with sciatica usually see their general practitioner first; if they do not get better over time, they may be referred to a physiotherapist or, eventually, to a spinal specialist. It is difficult to know which sciatica patient will do well without much treatment and who might need to see a physiotherapist or spinal specialist sooner. Stratified care is an approach aiming to help decide, early on, which patients need to see which health professionals. It has previously been shown to be helpful for patients with lower-back pain. In a trial of 476 patients with sciatica a stratified care model was tested to see if it led to faster improvements in sciatica-related leg pain, when compared with usual care. Adults seeing their general practitioner with sciatica were invited to attend a research clinic. Those willing to take part were randomly assigned to stratified care or usual care. Patients in the stratified care arm were referred either to physiotherapy for a short or a longer course of treatment, or to undergo magnetic resonance imaging and see a spinal specialist with the magnetic resonance imaging results within 4 weeks. Pain, function and quality-of-life data were collected over 12 months using text messages and questionnaires. Although patients in the stratified care arm improved slightly more quickly (2 weeks, on average), we did not find convincing evidence that stratified care led to better results than usual care. On average, most patients in both trial arms improved in a similar way over 12 months. The stratified care model tested in this trial did not lead to faster recovery for patients with sciatica than usual care.

Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial.

BACKGROUND: Sciatica has a substantial impact on individuals and society. Stratified care has been shown to lead to better outcomes among patients with non-specific low back pain, but it has not been tested for sciatica. We aimed to investigate the clinical and cost-effectiveness of stratified care versus non-stratified usual care for patients presenting with sciatica in primary care. METHODS: We did a two-parallel arm, pragmatic, randomised controlled trial across three centres in the UK (North Staffordshire, North Shropshire/Wales, and Cheshire). Eligible patients were aged 18 years or older, had a clinical diagnosis of sciatica, access to a mobile phone or landline number, were not pregnant, were not currently receiving treatment for the same problem, and had no previous spinal surgery. Patients were recruited from general practices and randomly assigned (1:1) by a remote web-based service to stratified care or usual care, stratified by centre and stratification group allocation. In the stratified care arm, a combination of prognostic and clinical criteria associated with referral to spinal specialist services were used to allocate patients to one of three groups for matched care pathways. Group 1 was offered brief advice and support in up to two physiotherapy sessions; group 2 was offered up to six physiotherapy sessions; and group 3 was fast-tracked to MRI and spinal specialist assessment within 4 weeks of randomisation. The primary outcome was self-reported time to first resolution of sciatica symptoms, defined as "completely recovered" or "much better" on a 6-point ordinal scale, collected via text messages or telephone calls. Analyses were by intention to treat. Health-care costs and cost-effectiveness were also assessed. This trial is registered on the ISRCTN registry, ISRCTN75449581. FINDINGS: Between May 28, 2015, and July 18, 2017, 476 patients from 42 general practices around three UK centres were randomly assigned to stratified care or usual care (238 in each arm). For the primary outcome, the overall response rate was 89% (9467 of 10 601 text messages sent; 4688 [88%] of 5310 in the stratified care arm and 4779 [90%] of 5291 in the usual care arm). Median time to symptom resolution was 10 weeks (95% CI 6·4-13·6) in the stratified care arm and 12 weeks (9·4-14·6) in the usual care arm, with the survival analysis showing no significant difference between the arms (hazard ratio 1·14 [95% CI 0·89-1·46]). Stratified care was not cost-effective compared to usual care. INTERPRETATION: The stratified care model for patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes. These results do not support a transition to this stratified care model for patients with sciatica. FUNDING: National Institute for Health Research.

Exploring Patients' Experiences of Internet-Based Self-Management Support for Low Back Pain in Primary Care.

OBJECTIVE: We explored patients' experiences of using Internet-based self-management support for low back pain (LBP) in primary care, with and without physiotherapist telephone guidance. DESIGN: Exploratory descriptive qualitative study using thematic analysis, nested within a randomized feasibility trial. METHODS: Patients with LBP who participated in a feasibility trial of the SupportBack Internet intervention (ISRCTN: 31034004) were invited to take part in semistructured telephone interviews after the three-month intervention period (a convenience sample from within the trial population). Fifteen participants took part (age range = 36-87 years, 66.7% female, characteristics representative of the trial population). Data were analyzed thematically. RESULTS: Analysis resulted in the development of six themes (subthemes in parentheses): Perceptions of SupportBack's design (Clarity and ease of use, Variety and range of information provided, Need for specificity and flexibility), Engaging with the SupportBack intervention, Promoting positive thought processes (Reassurance, Awareness of self-management), Managing behavior with SupportBack (Motivation and goal setting, Using activity as a pain management strategy, Preferences for walking or gentle back exercises), Feeling supported by telephone physiotherapists (Provision of reassurances and clarity, Physiotherapists are motivating), Severity and comorbidity as barriers (Preexisting condition or severity acting as a barrier, Less useful for mild low back pain). CONCLUSIONS: The Internet intervention SupportBack appeared to feasibly support self-management of LBP. Reassurance and ongoing support to implement behavioral changes were central to reported benefits. The addition of physiotherapist telephone support further enhanced the patient experience and the potential utility of the intervention.

Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care.

OBJECTIVES: To compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care. METHODS: This was a multicentre open-label randomised trial. Adults with a gout flare recruited from 100 general practices were randomised equally to naproxen 750 mg immediately then 250 mg every 8 hours for 7 days or low-dose colchicine 500 mcg three times per day for 4 days. The primary outcome was change in worst pain intensity in the last 24 hours (0-10 Numeric Rating Scale) from baseline measured daily over the first 7 days: mean change from baseline was compared between groups over days 1-7 by intention to treat. RESULTS: Between 29 January 2014 and 31 December 2015, we recruited 399 participants (naproxen n=200, colchicine n=199), of whom 349 (87.5%) completed primary outcome data at day 7. There was no significant between-group difference in average pain-change scores over days 1-7 (colchicine vs naproxen: mean difference -0.18; 95% CI -0.53 to 0.17; p=0.32). During days 1-7, diarrhoea (45.9% vs 20.0%; OR 3.31; 2.01 to 5.44) and headache (20.5% vs 10.7%; 1.92; 1.03 to 3.55) were more common in the colchicine group than the naproxen group but constipation was less common (4.8% vs 19.3%; 0.24; 0.11 to 0.54). CONCLUSION: We found no difference in pain intensity over 7 days between people with a gout flare randomised to either naproxen or low-dose colchicine. Naproxen caused fewer side effects supporting naproxen as first-line treatment for gout flares in primary care in the absence of contraindications. TRIAL REGISTRATION NUMBER: ISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).

Matching treatment options for risk sub-groups in musculoskeletal pain: a consensus groups study.

BACKGROUND: Musculoskeletal (MSK) pain represents a considerable worldwide healthcare burden. This study aimed to gain consensus from practitioners who work with MSK pain patients, on the most appropriate primary care treatment options for subgroups of patients based on prognostic risk of persistent disabling pain. Agreement was sought on treatment options for the five most common MSK pain presentations: back, neck, knee, shoulder and multisite pain, across three risk subgroups: low, medium and high. METHODS: Three consensus group meetings were conducted with multi-disciplinary groups of practitioners (n = 20) using Nominal Group Technique, a systematic approach to building consensus using structured in-person meetings of stakeholders which follows a distinct set of stages. RESULTS: For all five pain presentations, "education and advice" and "simple oral and topical pain medications" were agreed to be appropriate for all subgroups. For patients at low risk, across all five pain presentations "review by primary care practitioner if not improving after 6 weeks" also reached consensus. Treatment options for those at medium risk differed slightly across pain-presentations, but all included: "consider referral to physiotherapy" and "consider referral to MSK-interface-clinic". Treatment options for patients at high risk also varied by pain presentation. Some of the same options were included as for patients at medium risk, and additional options included: "opioids"; "consider referral to expert patient programme" (across all pain presentations); and "consider referral for surgical opinion" (back, knee, neck, shoulder). "Consider referral to rheumatology" was agreed for patients at medium and high risk who have multisite pain. CONCLUSION: In addressing the current lack of robust evidence on the effectiveness of different treatment options for MSK pain, this study generated consensus from practitioners on the most appropriate primary care treatment options for MSK patients stratified according to prognostic risk. These findings can help inform future clinical decision-making and also influenced the matched treatment options in a trial of stratified primary care for MSK pain patients.

Inflammatory biomarkers do not distinguish between patients with sciatica and referred leg pain within a primary care population: results from a nested study within the ATLAS cohort.

BACKGROUND: There is increasing interest in the role of pro-inflammatory cytokines in the pathogenesis of sciatica and whether these could be potential targets for treatment. We sought to investigate serum biomarker levels in patients with low back-related leg pain, including sciatica. METHODS: Primary care consulters aged > 18 with low back-related leg pain were recruited to a cohort study (ATLAS). Participants underwent a standardised clinical assessment, lumbar spine MRI and a subsample (n = 119) had samples taken for biomarker analysis. Participants were classified having: a) clinically confirmed sciatica or referred leg pain, and then subdivided into those with (or without) MRI confirmed nerve root compression due to disc prolapse. Seventeen key cytokines, chemokines and matrix metalloproteinases (MMPs) implicated in sciatica pathogenesis including TNFα and IL-6, were assayed in duplicate using commercial multiplex detection kits and measured using a Luminex suspension array system. Median biomarker levels were compared between the groups using a Mann Whitney U test. Multivariate logistic regression analysis was used to investigate the association between clinical measures and biomarker levels adjusted for possible confounders such as age, sex, and symptom duration. RESULTS: No difference was found in the serum level of any of the 17 biomarkers tested in patients with (n = 93) or without (n = 26) clinically confirmed sciatica, nor between those with (n = 44) or without (n = 49) sciatica and MRI confirmed nerve root compression. CONCLUSION: In this cohort, no significant differences in serum levels of TNFα, IL-6 or any other biomarkers were seen between patients with sciatica and those with back pain with referred leg pain. These results suggest that in patients with low back-related leg pain, serum markers associated with inflammation do not discriminate between patients with or without clinically confirmed sciatica or between those with or without evidence of nerve root compression on MRI.

Cost-utility analysis of interventions to improve effectiveness of exercise therapy for adults with knee osteoarthritis: the BEEP trial.

OBJECTIVES: Evidence regarding the cost-effectiveness of enhancing physical therapy exercise programmes in order to improve outcomes for patients with knee OA remains unclear. This study investigates the cost-effectiveness of two enhanced physical therapy interventions compared with usual physical therapy care (UC) for adults with knee OA. METHODS: A trial-based cost-utility analysis of individually tailored exercise (ITE) or targeted exercise adherence (TEA) compared with UC was undertaken over a period of 18 months. Patient-level costs were obtained, and effectiveness was measured in terms of quality-adjusted life years (QALYs), allowing the calculation of cost per QALY gained from a base-case UK health-care perspective. RESULTS: The UC group was associated with lower National Health Service (NHS) costs [ITE-UC: £273.30, 95% CI: £-62.10 to £562.60; TEA-UC: £141.80, 95% CI: £-135.60 to £408.10)] and slightly higher QALY gains (ITE-UC: -0.015, 95% CI: -0.057 to 0.026; TEA-UC: -0.003, 95% CI: -0.045 to 0.038). In the base case, UC was the most likely cost-effective option (probability <40% of ITE or TEA cost-effective at £20 000/QALY). Differences in total costs were attributable to intervention costs, number of visits to NHS consultants and knee surgery, which were higher in both ITE and TEA groups. CONCLUSION: This is the first economic evaluation comparing usual physical therapy care vs enhanced exercise interventions for knee OA that involves greater exercise individualization, supervision and progression or that focuses on exercise and physical activity adherence over the longer term. Our findings show that UC is likely to be the most cost-effective option. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 93634563. TRIAL PROTOCOL: Full details of the trial protocol can be found in the Supplementary Appendix, available with the full text of this article at http://www.biomedcentral.com/1471-2474/15/254 doi: 10.1186/1471-2474-15-254.

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.

Uptake of the NICE osteoarthritis guidelines in primary care: a survey of older adults with joint pain.

BACKGROUND: Osteoarthritis (OA) is a leading cause of pain and disability. NICE OA guidelines (2008) recommend that patients with OA should be offered core treatments in primary care. Assessments of OA management have identified a need to improve primary care of people with OA, as recorded use of interventions concordant with the NICE guidelines is suboptimal in primary care. The aim of this study was to i) describe the patient-reported uptake of non-pharmacological and pharmacological treatments recommended in the NICE OA guidelines in older adults with a self-reported consultation for joint pain and ii) determine whether patient characteristics or OA diagnosis impact uptake. METHODS: A cross-sectional survey mailed to adults aged ≥45 years (n = 28,443) from eight general practices in the UK as part of the MOSAICS study. Respondents who reported the presence of joint pain, a consultation in the previous 12 months for joint pain, and gave consent to medical record review formed the sample for this study. RESULTS: Four thousand fifty-nine respondents were included in the analysis (mean age 65.6 years (SD 11.2), 2300 (56.7%) females). 502 (12.4%) received an OA diagnosis in the previous 12 months. More participants reported using pharmacological treatments (e.g. paracetamol (31.3%), opioids (40.4%)) than non-pharmacological treatments (e.g. exercise (3.8%)). Those with an OA diagnosis were more likely to use written information (OR 1.57; 95% CI 1.26,1.96), paracetamol (OR 1.30; 95% CI 1.05,1.62) and topical NSAIDs (OR 1.30; 95% CI 1.04,1.62) than those with a joint pain code. People aged ≥75 years were less likely to use written information (OR 0.56; 95% CI 0.40,0.79) and exercise (OR 0.37; 95% CI 0.25,0.55) and more likely to use paracetamol (OR 1.91; 95% CI 1.38,2.65) than those aged < 75 years. CONCLUSION: The cross-sectional population survey was conducted to examine the uptake of the treatments that are recommended in the NICE OA guidelines in older adults with a self-reported consultation for joint pain and to determine whether patient characteristics or OA diagnosis impact uptake. Non-pharmacological treatment was suboptimal compared to pharmacological treatment. Implementation of NICE guidelines needs to examine why non-pharmacological treatments, such as exercise, remain under-used especially among older people.

Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC).

BACKGROUND: Adalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early. METHODS: A pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months' duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase. RESULTS: The internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants. CONCLUSIONS: Improved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN14569274 . Registered on 15 December 2014.

A multi-modal recruitment strategy using social media and internet-mediated methods to recruit a multidisciplinary, international sample of clinicians to an online research study.

BACKGROUND: Challenges exist in recruiting an international sample of clinicians and researchers to an online survey. Traditional recruitment methods remain relevant but issues such as narrow geographical reach, high cost and time intensity limit what can be achieved when aiming to recruit an international, multi-disciplinary sample. Internet-mediated and social media approaches to recruitment and engagement offer new, untested ways of capitalizing upon existing professional networks. OBJECTIVE: To develop, use and appraise a multi-modal recruitment strategy for an online, international survey regarding the management of shoulder pain. METHODS: Traditional recruitment methods were combined with internet-mediated recruitment methods to form a multi-modal recruitment strategy. An overview of the development of this three-month recruitment strategy is provided and the value and role of each strand of the recruitment strategy discussed. RESULTS: In response to the multi-modal recruitment strategy, data was received from 565 clinicians and researchers from 31 countries (64% UK). Complete data was received from 387 respondents with no demographic differences between respondents who completed, and those who started but did not complete the survey. Over 30% of responses were received within 1 week, 50% within 4 weeks and 81% within 8 weeks. CONCLUSIONS: This study shows the acceptability and international, multidisciplinary reach of a low cost multi-modal recruitment strategy for an online survey of international clinicians and researchers. Incorporating the use of social media proved to be an effective, time and resource-efficient recruitment strategy for this online survey and appeared to enhance clinician engagement. A multimodal recruitment strategy is worthy of consideration for future online surveys of clinicians and researchers.

Clinical diagnostic model for sciatica developed in primary care patients with low back-related leg pain.

BACKGROUND: Identification of sciatica may assist timely management but can be challenging in clinical practice. Diagnostic models to identify sciatica have mainly been developed in secondary care settings with conflicting reference standard selection. This study explores the challenges of reference standard selection and aims to ascertain which combination of clinical assessment items best identify sciatica in people seeking primary healthcare. METHODS: Data on 394 low back-related leg pain consulters were analysed. Potential sciatica indicators were seven clinical assessment items. Two reference standards were used: (i) high confidence sciatica clinical diagnosis; (ii) high confidence sciatica clinical diagnosis with confirmatory magnetic resonance imaging findings. Multivariable logistic regression models were produced for both reference standards. A tool predicting sciatica diagnosis in low back-related leg pain was derived. Latent class modelling explored the validity of the reference standard. RESULTS: Model (i) retained five items; model (ii) retained six items. Four items remained in both models: below knee pain, leg pain worse than back pain, positive neural tension tests and neurological deficit. Model (i) was well calibrated (p = 0.18), discrimination was area under the receiver operating characteristic curve (AUC) 0.95 (95% CI 0.93, 0.98). Model (ii) showed good discrimination (AUC 0.82; 0.78, 0.86) but poor calibration (p = 0.004). Bootstrapping revealed minimal overfitting in both models. Agreement between the two latent classes and clinical diagnosis groups defined by model (i) was substantial, and fair for model (ii). CONCLUSION: Four clinical assessment items were common in both reference standard definitions of sciatica. A simple scoring tool for identifying sciatica was developed. These criteria could be used clinically and in research to improve accuracy of identification of this subgroup of back pain patients.

Cost-Utility Analysis of Routine Anxiety and Depression Screening in Patients Consulting for Osteoarthritis: Results From a Clinical, Randomized Controlled Trial.

OBJECTIVE: To investigate the cost-effectiveness (cost-utility) of introducing general practitioner screening for anxiety and depression in patients consulting for osteoarthritis (OA). METHODS: A cluster-randomized trial-based economic evaluation to assess general practitioners screening for anxiety and depression symptoms in patients consulting for OA compared to usual care (screening for pain intensity) was undertaken over a 12-month period from a UK National Health Service and societal perspective. Patient-level mean costs and mean quality-adjusted life years (QALYs) were estimated, and cost-effectiveness acceptability curves controlling for cluster-level data were constructed. The base-case analysis used the net benefit regressions approach. The 2-stage nonparametric sampling technique was explored in a sensitivity analysis. RESULTS: The base-case analysis demonstrated that the intervention was as costly as, and less effective than, the control (QALY differential -0.029 [95% confidence interval -0.062, 0.003]). In the base-case analyses, general practitioner screening for anxiety and depression was unlikely to be a cost-effective option (probability <5% at £20,000/QALY). Similar results were observed in all sensitivity analyses. CONCLUSION: Prompting general practitioners to routinely screen and manage comorbid anxiety and depression in patients presenting with OA is unlikely to be cost-effective. Further research is needed to explore clinically effective and cost-effective models of managing anxiety and depression in patients presenting with clinical OA.

Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack).

OBJECTIVE: To determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support. DESIGN AND SETTING: A three-armed randomised controlled feasibility trial conducted in 12 general practices in England. PARTICIPANTS: Primary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness. INTERVENTIONS: The 'SupportBack' internet intervention delivers a 6-week, tailored programme, focused on graded goal setting, self-monitoring and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consisted of three brief telephone calls over a 4-week period, to address any concerns and provide reassurance. OUTCOMES: The primary outcomes were the feasibility of the trial design including recruitment, adherence and retention at follow-up. Secondary descriptive and exploratory analyses were conducted on clinical outcomes including LBP-related disability at 3 months follow-up. RESULTS: Primary outcomes: 87 patients with LBP were recruited (target 60-90) over 6 months, and there were 3 withdrawals. Adherence to the intervention was higher in the physiotherapist-supported arm, compared with the stand-alone internet intervention. Trial physiotherapists adhered to the support protocol. Overall follow-up rate on key clinical outcomes at 3 months follow-up was 84%. CONCLUSIONS: This study demonstrated the feasibility of a future definitive randomised controlled trial to determine the clinical and cost-effectiveness of the SupportBack intervention in primary care patients with LBP. TRIAL REGISTRATION NUMBER: ISRCTN31034004; Results.

Novel approach to characterising individuals with low back-related leg pain: cluster identification with latent class analysis and 12-month follow-up.

Traditionally, low back-related leg pain (LBLP) is diagnosed clinically as referred leg pain or sciatica (nerve root involvement). However, within the spectrum of LBLP, we hypothesised that there may be other unrecognised patient subgroups. This study aimed to identify clusters of patients with LBLP using latent class analysis and describe their clinical course. The study population was 609 LBLP primary care consulters. Variables from clinical assessment were included in the latent class analysis. Characteristics of the statistically identified clusters were compared, and their clinical course over 1 year was described. A 5 cluster solution was optimal. Cluster 1 (n = 104) had mild leg pain severity and was considered to represent a referred leg pain group with no clinical signs, suggesting nerve root involvement (sciatica). Cluster 2 (n = 122), cluster 3 (n = 188), and cluster 4 (n = 69) had mild, moderate, and severe pain and disability, respectively, and response to clinical assessment items suggested categories of mild, moderate, and severe sciatica. Cluster 5 (n = 126) had high pain and disability, longer pain duration, and more comorbidities and was difficult to map to a clinical diagnosis. Most improvement for pain and disability was seen in the first 4 months for all clusters. At 12 months, the proportion of patients reporting recovery ranged from 27% for cluster 5 to 45% for cluster 2 (mild sciatica). This is the first study that empirically shows the variability in profile and clinical course of patients with LBLP including sciatica. More homogenous groups were identified, which could be considered in future clinical and research settings.

Effectiveness and costs of a vocational advice service to improve work outcomes in patients with musculoskeletal pain in primary care: a cluster randomised trial (SWAP trial ISRCTN 52269669).

Musculoskeletal pain is a common cause of work absence, and early intervention is advocated to prevent the adverse health and economic consequences of longer-term absence. This cluster randomised controlled trial investigated the effect of introducing a vocational advice service into primary care to provide occupational support. Six general practices were randomised; patients were eligible if they were consulting their general practitioner with musculoskeletal pain and were employed and struggling at work or absent from work <6 months. Practices in the intervention arm could refer patients to a vocational advisor embedded within the practice providing a case-managed stepwise intervention addressing obstacles to working. The primary outcome was number of days off work, over 4 months. Participants in the intervention arm (n = 158) had fewer days work absence compared with the control arm (n = 180) (mean 9.3 [SD 21·7] vs 14·4 [SD 27·7]) days, incidence rate ratio 0·51 (95% confidence interval 0·26, 0·99), P = 0·048). The net societal benefit of the intervention compared with best care was £733: £748 gain (work absence) vs £15 loss (health care costs). The addition of a vocational advice service to best current primary care for patients consulting with musculoskeletal pain led to reduced absence and cost savings for society. If a similar early intervention to the one tested in this trial was implemented widely, it could potentially reduce days absent over 12 months by 16%, equating to an overall societal cost saving of approximately £500 million (US $6 billion) and requiring an investment of only £10 million.