Centre for Primary Care and Public Health, Blizard Institute Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
BMJ Open. 2013 Jan 28;3(1):e002492. doi: 10.1136/bmjopen-2012-002492.
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.
ISRCTN24426731.
慢性肌肉骨骼疼痛是一种常见病症，通常对治疗反应不佳。自我管理课程已被提倡作为一种非药物疼痛管理技术，尽管其有效性的证据存在争议。我们根据特定课程组成部分和特征的有效性证据，设计并试行一种自我管理课程。
方法/分析：COPERS（应对持续性疼痛，自我管理的有效性研究）是一项实用随机对照试验，旨在测试针对慢性疼痛患者的强化、小组、基于认知行为的、理论指导和手册化的自我管理课程与最佳常规护理（疼痛教育手册和放松 CD）相比的有效性和成本效益。该课程持续 15 小时，分 3 天进行，2 周后进行 2 小时的随访。我们计划从英国两个地区的初级、中级和二级保健服务中招募 685 名患有慢性肌肉骨骼疼痛的患者。该研究的目的是显示主要结局（疼痛相关残疾）的标准化均数差为 0.3。次要结局包括一般性健康相关生活质量、医疗保健利用、疼痛自我效能感、应对、抑郁、焦虑和社会参与度。结局在随机分组后 6 个月和 12 个月进行测量。疼痛自我效能感在 3 个月时进行测量，以评估变化是否介导临床效果。
伦理/传播：剑桥伦理委员会 11/EE/046 批准了该研究。这项试验将提供关于基于证据的小组慢性肌肉骨骼疼痛自我管理计划的有效性和成本效益的有力数据。已发表的结果将有助于在国家和国际层面上为这种自我管理课程的未来政策和实践提供信息。
ISRCTN24426731。
