Novel three-day community-based, non-pharmacological, group intervention for chronic musculoskeletal pain (COPERS): a randomized clinical trial

Abstract

Background Chronic musculoskeletal pain is the leading cause of disability worldwide. The effectiveness of pharmacological treatments for chronic pain is often limited and there is growing concern about adverse effects, including opioid dependence. Non-pharmacological approaches to chronic pain may be an attractive alternative or adjunctive treatment. We describe the effectiveness of a novel, theoretically-based, group pain management support intervention for chronic musculoskeletal pain. Methods and findings We conducted a multi-centre, pragmatic, randomized controlled effectiveness and cost-effectiveness (cost utility) trial across 27 general practices and community musculoskeletal services in the UK. We recruited 703 adults with musculoskeletal pain of at least 3 months duration between August 2011 and July 2012 and randomized, 1.33:1, to intervention (403) or control (300). Intervention participants were offered a participative, group intervention (COPERS) delivered over 3 alternate days with a follow up session at 2 weeks. The intervention introduced cognitive behavioural approaches and was designed to promote self efficacy to manage chronic pain. Controls received usual care and a relaxation CD. The primary outcome was pain related disability at 12 months (Chronic Pain Grade, CPG, disability subscale); secondary outcomes, measured at 6 and 12 months, included: Hospital Anxiety and Depression Scale (HADS) scores, Chronic Pain Acceptance Questionnaire; Health education impact Questionnaire Social integration subscale; Pain Self Efficacy Questionnaire; pain intensity (CPG subscale), the Census global health question, health utility (EQ-5D-3L) and healthcare resource use. Analyses followed intention to treat principles, accounted for clustering by course in the intervention arm, and used multiple imputation for missing, or incomplete, primary outcome data. The mean age of participants was 59.9 years with: 81% white, 67% female, 23% in employment, 85% with pain for at least three years, 23% on strong opioids. Symptoms of depression and anxiety were common 3 (baseline mean HADS scores 7.4 (SD 4.1) and 9.2 (4.6), respectively). Overall 282 (70%) intervention participants met the pre-defined intervention adherence criterion. Primary outcome data were obtained from 88% of participants. There was no significant difference between groups in: pain related disability at six or 12 months (12 months: difference -1.0, intervention vs. control, 95% CI -4.9 to 3.0); pain intensity; or the global health question. Anxiety, depression, pain self-efficacy, pain acceptance and social integration were better in the intervention group at six months; at 12 months these differences only remained statistically significant for depression (-0.7, 95% CI -1.2 to -0.2) and social integration (0.8, 95% CI 10.4 to 1.2). Intervention participants received more analgesics than the controls across 12 months. The total cost of the course per person was £145 ($214). The cost utility analysis showed there to be a small benefit in terms of QALYs (0.0325, 95% CI: -0.0074 to 0.0724), and on the cost side the intervention was a little more expensive (i.e. £188 ($277), 95% CI -£125 (-$184) to £501 ($738)), resulting in an ICER of £5,786 ($8,521) per QALY. Limitations include the fact that the intervention was relatively brief and did not include any physical activity components. Conclusions The COPERS intervention was not effective for reducing pain related disability over 12 months (primary outcome). For secondary outcomes, we found sustained benefits on depression and social integration at 6 and 12 months, but there was no effect on anxiety, pain-related self-efficacy, pain acceptance, pain intensity or the census global health question at 12 months. There was some evidence that the intervention may be cost-effective based on a modest benefit on QALYs between groups. The intervention is brief, safe and inexpensive with a low attrition rate and has potential as a useful addition to pain management strategies.