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Objectives: To describe the design, development and pilot of a multicomponent intervention aimed at supporting withdrawal of opioids for people with chronic non-malignant pain for future evaluation in the Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial., Design: The I-WOTCH intervention draws on previous literature and collaboration with stakeholders (patient and public involvement). Intervention mapping and development activities of Behaviour Change Taxonomy are described., Setting: The intervention development was conducted by a multidisciplinary team with clinical, academic and service user perspectives. The team had expertise in the development and testing of complex health behaviour interventions, opioid tapering and pain management in primary and secondary care, I.T programming, and software development-to develop an opioid tapering App., Participants: The I-WOTCH trial participants are adults (18 years and over) with chronic non-malignant pain using strong opioids for at least 3 months and on most days in the preceding month., Outcomes: A multicomponent self-management support package to help people using opioids for chronic non-malignant pain reduce opioid use., Interventions and Results: Receiving information on the impact of long-term opioid use, and potential adverse effects were highlighted as important facilitators in making the decision to reduce opioids. Case studies of those who have successfully stopped taking opioids were also favoured as a facilitator to reduce opioid use. Barriers included the need for a 'trade-off to fill the deficit of the effect of the drug'. The final I-WOTCH intervention consists of an 8-10 week programme incorporating: education; problem-solving; motivation; group and one to one tailored planning; reflection and monitoring. A detailed facilitator manual was developed to promote consistent delivery of the intervention across the UK., Conclusions: We describe the development of an opioid reduction intervention package suitable for testing in the I-WOTCH randomised controlled trial., Trial Registration Number: ISRCTN49470934., Competing Interests: Competing interests: SE is the Chair of the specialised pain CRG at NHS England, he is Chief investigator and principal investigator of a number of NIHR and Industry funded trials, he has received personal fees from Medtronic Ltd, Mainstay Medical, Boston Scientific Corp for consultancy work. His department has received research funding from the National Institute of Health Research, Medtronic Ltd and Boston Scientific Corp. HS is director of Health Psychology Services Ltd, providing psychological services for a range of health related conditions. NKYT is chief investigator or coinvestigator of other chronic pain related projects funded by the NIHR, MRC, Warwick-Wellcome Translational Partnership. MU is chief investigator or coinvestigator on multiple previous and current research grants from the UK National Institute for Health Research, Arthritis Research UK and is a coinvestigator on grants funded by the Australian NHMRC. He was an NIHR Senior Investigator until March 2021. He has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is a director and shareholder of Clinvivo Ltd that provides electronic data collection for health services research. He is part of an academic partnership with Serco Ltd, funded by the European Social Fund, related to return to work initiatives. He receives some salary support from University Hospitals Coventry and Warwickshire. He is a coinvestigator on three NIHR funded studies receiving additional support from Stryker Ltd. He has accepted honoraria for teaching/lecturing from consortium for advanced research training in Africa. Until March 2020, he was an editor of the NIHR journal series, and a member of the NIHR Journal Editors Group, for which he received a fee. ADF is author of the My Opioid Manager book and App distributed in iTunes and Google Play. Both book and app are free of charge. She is author of the Opioid Manager App, a paid app distributed only in iTunes for healthcare professionals. The app is owned by UHN, the hospital where ADF works. ADF does not get any financial benefit from the sales of the app. ADF has a monetized YouTube channel since January 2021 that contains some videos about opioids and opioid tapering. Since April 2021, ADF has an unrestricted educational grant to maintain an online self-assessment opioid course for healthcare professionals in Canada. The funding is provided by the Canadian Generics Pharmaceutical Association (CGPA). The funding organisation has no role in the preparation, approval, recruitment of participants, or data analysis of the course content. Responsibility for the course content is solely that of the authors. ST is chief investigator or coinvestigator on multiple previous and current research grants from the UK National Institute for Health Research., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Objectives: Contextual components of treatment previously associated with patient outcomes include the environment, therapeutic relationship and expectancies. Questions remain about which components are most important, how they influence outcomes and comparative effects across treatment approaches. We aimed to identify significant and strong contextual predictors of patient outcomes, test for psychological mediators and compare effects across three treatment approaches., Design: Prospective cohort study with patient-reported and practitioner-reported questionnaire data (online or paper) collected at first consultation, 2 weeks and 3 months., Setting: Physiotherapy, osteopathy and acupuncture clinics throughout the UK., Participants: 166 practitioners (65 physiotherapists, 46 osteopaths, 55 acupuncturists) were recruited via their professional organisations. Practitioners recruited 960 adult patients seeking treatment for low back pain (LBP)., Primary and Secondary Outcomes: The primary outcome was back-related disability. Secondary outcomes were pain and well-being. Contextual components measured were: therapeutic alliance; patient satisfaction with appointment systems, access, facilities; patients' treatment beliefs including outcome expectancies; practitioners' attitudes to LBP and practitioners' patient-specific outcome expectancies. The hypothesised mediators measured were: patient self-efficacy for pain management; patient perceptions of LBP and psychosocial distress., Results: After controlling for baseline and potential confounders, statistically significant predictors of reduced back-related disability were: all three dimensions of stronger therapeutic alliance (goal, task and bond); higher patient satisfaction with appointment systems; reduced patient-perceived treatment credibility and increased practitioner-rated outcome expectancies. Therapeutic alliance over task (η p 2 =0.10, 95% CI 0.07 to 0.14) and practitioner-rated outcome expectancies (η p 2 =0.08, 95% CI 0.05 to 0.11) demonstrated the largest effect sizes. Patients' self-efficacy, LBP perceptions and psychosocial distress partially mediated these relationships. There were no interactions with treatment approach., Conclusions: Enhancing contextual components in musculoskeletal healthcare could improve patient outcomes. Interventions should focus on helping practitioners and patients forge effective therapeutic alliances with strong affective bonds and agreement on treatment goals and how to achieve them., Competing Interests: Competing interests: FB received an honorarium and travel expenses for presenting the preliminary results of this research at the Acupuncture Research Resource Centre research symposium and has also received speaker’s fees and travel expenses from the Acupuncture Association of Chartered Physiotherapists. The authors declare that they have no other competing interests., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Chronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches., Methods and Analysis: Chronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained., Ethics and Dissemination: This trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West - Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019., Trial Registration Number: ISRCTN79708100., Competing Interests: Competing interests: MU is a director and shareholder of Clinvivo Ltd. Use of this company was specified in original application for funding to NIHR. MU has recused himself from all discussion regarding the use of the app in this study. All contracting processes have been in accord with University of Warwick financial regulations. MU was chair of the National Institute for Health and Care Excellence accreditation advisory committee until March 2017 for which he received a fee. He is chief investigator or coinvestigator on multiple previous and current research grants from the UK NIHR, Arthritis Research UK and is a coinvestigator on grants funded by Arthritis Australia and Australian NHMRC. He has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is part of an academic partnership with Serco Ltd related to return to work initiatives. He is an editor of the NIHR journal series and a member of the NIHR Journal Editors group for which he receives a fee. He has published multiple papers on chronic pain some of which are referenced in this paper. MM serves on the advisory board for Allergan, Medtronic, Novartis and TEVA and has received payment for the development of educational presentations from Allergan, electroCore, Medtronic, Novartis and TEVA. ShP and HKS are directors of Health Psychology Services Ltd, which in part provides psychological treatments for those with chronic pain., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Objective: To conduct a systematic review of systematic reviews and national guidelines to assess the effectiveness of four treatment approaches (manual therapy, probiotics, proton pump inhibitors and simethicone) on colic symptoms including infant crying time, sleep distress and adverse events., Methods: We searched PubMed, Embase, Cochrane and Mantis for studies published between 2009 and 2019. Inclusion criteria were systematic reviews and guidelines that used evidence and expert panel opinion. Three reviewers independently selected articles by title, abstract and full paper review. Data were extracted by one reviewer and checked by a second. Selected studies were assessed for quality using modified standardised checklists by two authors. Meta-analysed data for our outcomes of interest were extracted and narrative conclusions were assessed., Results: Thirty-two studies were selected. High-level evidence showed that probiotics were most effective for reducing crying time in breastfed infants (range -25 min to -65 min over 24 hours). Manual therapies had moderate to low-quality evidence showing reduced crying time (range -33 min to -76 min per 24 hours). Simethicone had moderate to low evidence showing no benefit or negative effect. One meta-analysis did not support the use of proton pump inhibitors for reducing crying time and fussing. Three national guidelines unanimously recommended the use of education, parental reassurance, advice and guidance and clinical evaluation of mother and baby. Consensus on other advice and treatments did not exist., Conclusions: The strongest evidence for the treatment of colic was probiotics for breastfed infants, followed by weaker but favourable evidence for manual therapy indicated by crying time. Both forms of treatment carried a low risk of serious adverse events. The guidance reviewed did not reflect these findings., Prospero Registration Number: CRD42019139074., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Chronic non-malignant pain has a major impact on the well-being, mood and productivity of those affected. Opioids are increasingly prescribed to manage this type of pain, but with a risk of other disabling symptoms, when their effectiveness has been questioned. This trial is designed to implement and evaluate a patient-centred intervention targeting withdrawal of strong opioids in people with chronic pain., Methods and Analysis: A pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of a group-based multicomponent intervention combined with individualised clinical facilitator led support for the management of chronic non-malignant pain against the control intervention (self-help booklet and relaxation compact disc). An embedded process evaluation will examine fidelity of delivery and investigate experiences of the intervention. The two primary outcomes are activities of daily living (measured by Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A)) and opioid use. The secondary outcomes are pain severity, quality of life, sleep quality, self-efficacy, adverse events and National Health Service (NHS) healthcare resource use. Participants are followed up at 4, 8 and 12 months, with a primary endpoint of 12 months. Between-group differences will indicate effectiveness; we are looking for a difference of 3.5 points on our pain interference outcome (scale 40 to 77). We will undertake an NHS perspective cost-effectiveness analysis using quality adjusted life years., Ethics and Dissemination: Full approval was given by Yorkshire & The Humber - South Yorkshire Research Ethics Committee on 13 September, 2016 (16/YH/0325). Appropriate local approvals were sought for each area in which recruitment was undertaken. The current protocol version is 1.6 date 19 December 2018. Publication of results in peer- reviewed journals will inform the scientific and clinical community. We will disseminate results to patient participants and study facilitators in a study newsletter as well as a lay summary of results on the study website., Trial Registration Number: ISRCTN49470934; Pre-results., Competing Interests: Competing interests: MU was Chair of the NICE accreditation advisory committee until March 2017 for which he received a fee. He is the chief investigator or co-investigator on multiple previous and current research grants from the UK National Institute for Health Research, Arthritis Research UK and is co-investigator on grants funded by the Australian NHMRC. He is an NIHR Senior Investigator. He has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is a director and shareholder of Clinvivo Ltd that provides electronic data collection for health services research. He is part of an academic partnership with Serco Ltd related to return to work initiatives. He is a co-investigator on a study receiving support in kind from Orthospace Ltd. He is an editor of the NIHR journal series, and a member of the NIHR Journal Editors Group, for which he receives a fee. SE is investigator on a number of NIHR and industry sponsored studies. He received travel expenses for speaking at conferences from the professional organisations. SE consults for Medtronic, Abbott, Boston Scientific and Mainstay Medical, none in relation to opioids. SE is chair of the BPS Science and Research Committee. SE is deputy Chair of the NIHR CRN Anaesthesia Pain and Perioperative Medicine National Specialty Group. SE’s department has received fellowship funding from Medtronic as well as nurse funding from Abbott. HS is director of Health Psychology Services Ltd, providing psychological services for a range of health related conditions. AF developed an app that is sold in iTunes for US$9.99 (Opioid Manager). The app is owned by the hospital (UHN) where Dr Furlan works, and Dr Furlan does not retain any profits of the sales of this app for herself. KS received grant funding as PI and CoI from NIHR for other projects. She was on the NIHR HS&DR Funding Board until January 2018. NT received grant funding as PI and CoI from NIHR for other projects and current funding as PI from the Medical Research Council., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The aim of this study was to describe osteopathic activity and scope of practice to understand the current and future role of osteopathy in the Swiss healthcare system., Design: A questionnaire survey that included a patient record-based retrospective clinical audit., Setting/population: Osteopaths with a national diploma (n=1086) were invited by mail to participate in an online survey. Osteopathic assistants (n=84) were identified through their national association., Questionnaire: The survey was constructed from previous surveys and tested for face validity with experts, osteopaths and patient representatives. The questionnaires were completed online in English, German and French between April and August 2017. Osteopaths anonymously reported information about themselves, their practice, and the treatment and care for four randomly selected patients they managed in 2016., Results: The response rate from the survey was 44.5% (521/1171). Data on osteopathic care were collected for 1144 patients and 3449 consultations. In 2016, osteopaths saw approximately 6.8% of the Swiss population for 1700 000 consultations and an overall estimated cost of 200 million Swiss francs. 76% of patients sought care directly without a referral from another care provider. Few osteopaths (<1%) work in a hospital setting and 46% work in isolation in private practice. Infants (under 2 years old) made up 10% of all patients and 9% of patients were ≥65 years. Patients most commonly sought treatment for musculoskeletal conditions (81%) with the spine being the most frequent location (66%). Treatments also included exercise advice (34.2%) and lifestyle management (35.4%). Fewer than 1 patient out of 10 were referred to another health profession or provider., Conclusions: In Switzerland, osteopathic care represents an important first line management for musculoskeletal conditions that alleviates some of the burden of care in the Swiss primary healthcare system., Competing Interests: Competing interests: The researchers work for the Unit of Research in Mobility at the School of Health Sciences Fribourg which includes the division of osteopathy., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To establish the level of opioid prescribing for patients with chronic musculoskeletal pain in a sample of patients from primary care and to estimate prescription costs., Design: Secondary data analyses from a two-arm pragmatic randomised controlled trial (COPERS) testing the effectiveness of group self-management course and usual care against relaxation and usual care for patients with chronic musculoskeletal pain (ISRCTN 24426731)., Setting: 25 general practices and two community musculoskeletal services in the UK (London and Midlands)., Participants: 703 chronic pain participants; 81% white, 67% female, enrolled in the COPERS trial., Main Outcome Measures: Anonymised prescribing data over 12 months extracted from GP electronic records., Results: Of the 703 trial participants with chronic musculoskeletal pain, 413 (59%) patients were prescribed opioids. Among those prescribed an opioid, the number of opioid prescriptions varied from 1 to 52 per year. A total of 3319 opioid prescriptions were issued over the study period, of which 53% (1768/3319) were for strong opioids (tramadol, buprenorphine, morphine, oxycodone, fentanyl and tapentadol). The mean number of opioid prescriptions per patient prescribed any opioid was 8.0 (SD=7.9). A third of patients on opioids were prescribed more than one type of opioid; the most frequent combinations were: codeine plus tramadol and codeine plus morphine. The cost of opioid prescriptions per patient per year varied from £3 to £4844. The average annual prescription cost was £24 (SD=29) for patients prescribed weak opioids and £174 (SD=421) for patients prescribed strong opioids. Approximately 40% of patients received >3 prescriptions of strong opioids per year, with an annual cost of £236 per person., Conclusions: Long-term prescribing of opioids for chronic musculoskeletal pain is common in primary care. For over a quarter of patients receiving strong opioids, these drugs may have been overprescribed according to national guidelines., Trial Registration Number: ISRCTN24426731; Post-results., Competing Interests: Competing interests: TA, NH, DC, SJCT, KH, SE, AS, AR and JF have no competing interests with relation to this paper. MRU is an applicant and coapplicant on multiple studies on pain funded by NIHR and ARUK. These include the I-WOTCH trial of opioid reduction 14/224/04 ISRCTN 49470934. He is an editor for the NIHR journal series for which he receives a fee. He is a director and shareholder of Clinvivo., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective: To conduct a systematic review and meta-analyses to assess the effect of manual therapy interventions for healthy but unsettled, distressed and excessively crying infants and to provide information to help clinicians and parents inform decisions about care., Methods: We reviewed published peer-reviewed primary research articles in the last 26 years from nine databases (Medline Ovid, Embase, Web of Science, Physiotherapy Evidence Database, Osteopathic Medicine Digital Repository , Cochrane (all databases), Index of Chiropractic Literature, Open Access Theses and Dissertations and Cumulative Index to Nursing and Allied Health Literature). Our inclusion criteria were: manual therapy (by regulated or registered professionals) of unsettled, distressed and excessively crying infants who were otherwise healthy and treated in a primary care setting. Outcomes of interest were: crying, feeding, sleep, parent-child relations, parent experience/satisfaction and parent-reported global change., Results: Nineteen studies were selected for full review: seven randomised controlled trials, seven case series, three cohort studies, one service evaluation study and one qualitative study.We found moderate strength evidence for the effectiveness of manual therapy on: reduction in crying time (favourable: -1.27 hours per day (95% CI -2.19 to -0.36)), sleep (inconclusive), parent-child relations (inconclusive) and global improvement (no effect). The risk of reported adverse events was low: seven non-serious events per 1000 infants exposed to manual therapy (n=1308) and 110 per 1000 in those not exposed., Conclusions: Some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe., Prospero Registration Number: CRD42016037353., Competing Interests: Competing interests: CM had financial support from the National Council for Osteopathic Research from crowd-funded donations., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Components other than the active ingredients of treatment can have substantial effects on pain and disability. Such 'non-specific' components include: the therapeutic relationship, the healthcare environment, incidental treatment characteristics, patients' beliefs and practitioners' beliefs. This study aims to: identify the most powerful non-specific treatment components for low back pain (LBP), compare their effects on patient outcomes across orthodox (physiotherapy) and complementary (osteopathy, acupuncture) therapies, test which theoretically derived mechanistic pathways explain the effects of non-specific components and identify similarities and differences between the therapies on patient-practitioner interactions., Methods and Analysis: This research comprises a prospective questionnaire-based cohort study with a nested mixed-methods study. A minimum of 144 practitioners will be recruited from public and private sector settings (48 physiotherapists, 48 osteopaths and 48 acupuncturists). Practitioners are asked to recruit 10-30 patients each, by handing out invitation packs to adult patients presenting with a new episode of LBP. The planned multilevel analysis requires a final sample size of 690 patients to detect correlations between predictors, hypothesised mediators and the primary outcome (self-reported back-related disability on the Roland-Morris Disability Questionnaire). Practitioners and patients complete questionnaires measuring non-specific treatment components, mediators and outcomes at: baseline (time 1: after the first consultation for a new episode of LBP), during treatment (time 2: 2 weeks post-baseline) and short-term outcome (time 3: 3 months post-baseline). A randomly selected subsample of participants in the questionnaire study will be invited to take part in a nested mixed-methods study of patient-practitioner interactions. In the nested study, 63 consultations (21/therapy) will be audio-recorded and analysed quantitatively and qualitatively, to identify communication practices associated with patient outcomes., Ethics and Dissemination: The protocol is approved by the host institution's ethics committee and the NHS Health Research Authority Research Ethics Committee. Results will be disseminated via peer-reviewed journal articles, conferences and a stakeholder workshop., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Objectives: The aim of this study was to (1) demonstrate the development and testing of tools and procedures designed to monitor and assess the integrity of a complex intervention for chronic pain (COping with persistent Pain, Effectiveness Research into Self-management (COPERS) course); and (2) make recommendations based on our experiences., Design: Fidelity assessment of a two-arm randomised controlled trial intervention, assessing the adherence and competence of the facilitators delivering the intervention., Setting: The intervention was delivered in the community in two centres in the UK: one inner city and one a mix of rural and urban locations., Participants: 403 people with chronic musculoskeletal pain were enrolled in the intervention arm and 300 attended the self-management course. Thirty lay and healthcare professionals were trained and 24 delivered the courses (2 per course). We ran 31 courses for up to 16 people per course and all were audio recorded., Interventions: The course was run over three and a half days; facilitators delivered a semistructured manualised course., Outcomes: We designed three measures to evaluate fidelity assessing adherence to the manual, competence and overall impression., Results: We evaluated a random sample of four components from each course (n=122). The evaluation forms were reliable and had good face validity. There were high levels of adherence in the delivery: overall adherence was two (maximum 2, IQR 1.67-2.00), facilitator competence exhibited more variability, and overall competence was 1.5 (maximum 2, IQR 1.25-2.00). Overall impression was three (maximum 4, IQR 2.00-3.00)., Conclusions: Monitoring and assessing adherence and competence at the point of intervention delivery can be realised most efficiently by embedding the principles of fidelity measurement within the design stage of complex interventions and the training and assessment of those delivering the intervention. More work is necessary to ensure that more robust systems of fidelity evaluation accompany the growth of complex interventions., Trial Registration Isrctn No: ISRCTN24426731.

Objective: To devise and test a self-management course for chronic pain patients based on evidence and underpinned by theory using the Medical Research Council (MRC) framework for developing complex interventions., Design: We used a mixed method approach. We conducted a systematic review of the effectiveness of components and characteristics of pain management courses. We then interviewed chronic pain patients who had attended pain and self-management courses. Behavioural change theories were mapped onto our findings and used to design the intervention. We then conducted a feasibility study to test the intervention., Setting: Primary care in the inner city of London, UK., Participants: Adults (18 years or older) with chronic musculoskeletal pain., Outcomes: Related disability, quality of life, coping, depression, anxiety, social integration and healthcare resource use., Results: The systematic reviews indicated that group-based courses with joint lay and healthcare professional leadership and that included a psychological component of short duration (<8 weeks) showed considerable promise. The qualitative research indicated that participants liked relaxation, valued social interaction and course location, and that timing and good tutoring were important determinants of attendance. We used behavioural change theories (social learning theory and cognitive behaviour approaches (CBA)) to inform course content. The course addressed: understanding and accepting pain, mood and pain, unhelpful thoughts and behaviour, problem solving, goal setting, action planning, movement, relaxation and social integration/reactivation. Attendance was 85%; we modified the recruitment of patients, the course and the training of facilitators as a result of testing., Conclusions: The MRC guidelines were helpful in developing this intervention. It was possible to train both lay and non-psychologists to facilitate the courses and deliver CBA. The course was feasible and well received.

Introduction: Chronic musculoskeletal pain is a common condition that often responds poorly to treatment. Self-management courses have been advocated as a non-drug pain management technique, although evidence for their effectiveness is equivocal. We designed and piloted a self-management course based on evidence for effectiveness for specific course components and characteristics., Methods/analysis: COPERS (coping with persistent pain, effectiveness research into self-management) is a pragmatic randomised controlled trial testing the effectiveness and cost-effectiveness of an intensive, group, cognitive behavioural-based, theoretically informed and manualised self-management course for chronic pain patients against a control of best usual care: a pain education booklet and a relaxation CD. The course lasts for 15 h, spread over 3 days, with a -2 h follow-up session 2 weeks later. We aim to recruit 685 participants with chronic musculoskeletal pain from primary, intermediate and secondary care services in two UK regions. The study is powered to show a standardised mean difference of 0.3 in the primary outcome, pain-related disability. Secondary outcomes include generic health-related quality of life, healthcare utilisation, pain self-efficacy, coping, depression, anxiety and social engagement. Outcomes are measured at 6 and 12 months postrandomisation. Pain self-efficacy is measured at 3 months to assess whether change mediates clinical effect., Ethics/dissemination: Ethics approval was given by Cambridgeshire Ethics 11/EE/046. This trial will provide robust data on the effectiveness and cost-effectiveness of an evidence-based, group self-management programme for chronic musculoskeletal pain. The published outcomes will help to inform future policy and practice around such self-management courses, both nationally and internationally., Trial Registration: ISRCTN24426731.