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.

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.

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.

The cost-effectiveness of different approaches to exercise and corticosteroid injection for subacromial pain (impingement) syndrome.

OBJECTIVES: To determine whether physiotherapist-led exercise intervention and US-guided subacromial CS injection is cost-effective when compared with standard advice and exercise leaflet and unguided injection in patients with subacromial pain (impingement) syndrome. METHODS: An incremental cost-utility analysis using patient responses to the five-level EuroQoL-5D (EQ-5D-5L) questionnaire was undertaken from a healthcare perspective alongside a 2 × 2 factorial randomized trial with 256 participants over a 12-month follow-up period. Uncertainty was explored through the use of cost-effectiveness acceptability curves. RESULTS: The cost-utility analysis indicated that physiotherapist-led exercise was associated with an incremental cost of £155.99 (95% CI 69.02, 241.93) and 0.031 (95% CI -0.01, 0.07) additional quality-adjusted life-years (QALYs), an incremental cost-effectiveness ratio (ICER) of £5031 per QALY gained and an 85% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with the advice and exercise leaflet. US-guided injection was associated with an incremental cost of £15.89 (95% CI -59.36, 109.86) and 0.024 (95% CI -0.02, 0.07) additional QALYs, an ICER of £662 per QALY gained and a 83% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with unguided injection. CONCLUSION: Physiotherapist-led exercise was cost-effective compared with the advice and exercise leaflet, and US-guided injection was cost-effective when compared with unguided injection. CLINICAL TRIAL REGISTRATION: ISRCTN, http://www.isrctn.com, ISRCTN42399123.

Optimising outcomes of exercise and corticosteroid injection in patients with subacromial pain (impingement) syndrome: a factorial randomised trial.

OBJECTIVES: To compare the clinical effectiveness of (1) physiotherapist-led exercise versus an exercise leaflet, and (2) ultrasound-guided subacromial corticosteroid injection versus unguided injection for pain and function in subacromial pain (formerly impingement) syndrome (SAPS). METHODS: This was a single-blind 2×2 factorial randomised trial. Adults with SAPS were randomised equally to one of four treatment groups: (1) ultrasound-guided corticosteroid injection and physiotherapist-led exercise, (2) ultrasound-guided corticosteroid injection and an exercise leaflet, (3) unguided corticosteroid injection and physiotherapist-led exercise and (4) unguided corticosteroid injection and an exercise leaflet. The primary outcome was the Shoulder Pain and Disability Index (SPADI), collected at 6 weeks, 6 and 12 months and compared at 6 weeks for the injection interventions and 6 months for the exercise interventions by intention to treat. RESULTS: We recruited 256 participants (64 treatment per group). Response rates for the primary outcome were 94% at 6 weeks, 88% at 6 months and 80% at 12 months. Greater improvement in total SPADI score was seen with physiotherapist-led exercise than with the exercise leaflet at 6 months (adjusted mean difference -8.23; 95% CI -14.14 to -2.32). There were no significant differences between the injection groups at 6 weeks (-2.04; -7.29 to 3.22), 6 months (-2.36; -8.16 to 3.44) or 12 months (1.59; -5.54 to 8.72). CONCLUSIONS: In patients with SAPS, physiotherapist-led exercise leads to greater improvements in pain and function than an exercise leaflet. Ultrasound guidance confers no additional benefit over unguided corticosteroid injection. TRIAL REGISTRATION NUMBER: ISRCTN42399123.

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.

Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2).

INTRODUCTION: Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the 'SupportBack' internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients. METHODS AND ANALYSIS: A three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted. ETHICS AND DISSEMINATION: This trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy. TRIAL REGISTRATION NUMBER: ISRCTN14736486.

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.

Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care: Study Protocol for the STarT MSK Cluster Randomized Controlled Trial.

BACKGROUND: Musculoskeletal (MSK) pain is a major cause of pain and disability. We previously developed a prognostic tool (Start Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision making using matched treatments. A logical next step is to determine whether prognostic stratified care has benefits for a broader range of common MSK pain presentations. OBJECTIVE: This study seeks to determine, in patients with 1 of the 5 most common MSK presentations (back, neck, knee, shoulder, and multisite pain), whether stratified care involving the use of the Keele Start MSK Tool to allocate individuals into low-, medium-, and high-risk subgroups, and matching these subgroups to recommended matched clinical management options, is clinical and cost-effective compared with usual nonstratified primary care. METHODS: This is a pragmatic, two-arm parallel (stratified vs nonstratified care), cluster randomized controlled trial, with a health economic analysis and mixed methods process evaluation. The setting is UK primary care, involving 24 average-sized general practices randomized (stratified by practice size) in a 1:1 ratio (12 per arm) with blinding of trial statistician and outcome data collectors. Randomization units are general practices, and units of observation are adult MSK consulters without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records are tagged and individuals invited using a general practitioner (GP) point-of-consultation electronic medical record (EMR) template. The intervention is supported by an EMR template (computer-based) housing the Keele Start MSK Tool (to stratify into prognostic subgroups) and the recommended matched treatment options. The primary outcome using intention-to-treat analysis is pain intensity, measured monthly over 6 months. Secondary outcomes include physical function and quality of life, and an anonymized EMR audit to capture clinician decision making. The economic evaluation is focused on the estimation of incremental quality-adjusted life years and MSK pain-related health care costs. The process evaluation is exploring a range of potential factors influencing the intervention and understanding how it is perceived by patients and clinicians, with quantitative analyses focusing on a priori hypothesized intervention targets and qualitative approaches using focus groups and interviews. The target sample size is 1200 patients from 24 general practices, with >5000 MSK consultations available for anonymized medical record data comparisons. RESULTS: Trial recruitment commenced on May 18, 2018, and ended on July 15, 2019, after a 14-month recruitment period in 24 GP practices. Follow-up and interview data collection was completed in February 2020. CONCLUSIONS: This trial is the first attempt, as far as we know, at testing a prognostic stratified care approach for primary care patients with MSK pain. The results of this trial should be available by the summer of 2020. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15366334; http://www.isrctn.com/ISRCTN15366334. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17939.

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).

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.

Determining responsiveness and meaningful changes for the Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways.

OBJECTIVES: We have previously developed and validated the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways, showing encouraging psychometric test results. The objective of this study was to determine the responsiveness of MSK-HQ following MSK treatments and to determine the minimally important change (MIC). SETTING: We collected data in four cohorts from community physiotherapy and secondary-care orthopaedic hip, knee and shoulder clinics. PARTICIPANTS: 592 individuals were recruited; 210 patients treated with physiotherapy for a range of MSK conditions in primary care; 150 patients undergoing hip replacement, 150 patients undergoing knee replacement and 82 undergoing shoulder surgery in secondary care. OUTCOME MEASURES: Preoperative data were collected including the MSK-HQ, European Quality of Life-5D (EQ-5D) and the OHS, OKS or OSS in each joint-specific group. The same scores, together with anchor questions, were collected postintervention at 3 months for the physiotherapy group and 6 months for all others. Following COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) guidelines, responsiveness was assessed using correlation between scores and the MIC was calculated for the entire cohort using receiver operating characteristic curve analysis. RESULTS: The MSK-HQ demonstrated strong correlation (R=0.73) with EQ-5D across the entire cohort and with each of the joint-specific Oxford scores (hip R=0.87, knee R=0.92 and shoulder R=0.77). Moderate correlation was seen between MSK-HQ and EQ-5D across each individual group (R value range 0.60-0.68), apart from the hip group where correlation was strong (R=0.77). The effect size with MSK-HQ was 0.93, in the entire cohort, double that measured with EQ-5D (0.43). In all subgroups, MSK-HQ measured a greater treatment effect compared with EQ-5D. The MIC is 5.5 (95% CI 2.7 to 8.3). CONCLUSION: Our study demonstrates that the MSK-HQ questionnaire is responsive to change across a range of musculoskeletal conditions, supporting its use as a generic MSK measurement instrument.

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.