Maintaining musculoskeletal health using a behavioural therapy approach: a population-based randomised controlled trial (the MAmMOTH Study).

OBJECTIVE: Cognitive-behavioural therapy (CBT) has been shown to be effective in the management of chronic widespread pain (CWP); we now test whether it can prevent onset among adults at high risk. METHODS: A population-based randomised controlled prevention trial, with recruitment through UK general practices. A mailed screening questionnaire identified adults at high risk of CWP. Participants received either usual care (UC) or a short course of telephone CBT (tCBT). The primary outcome was CWP onset at 12 months assessed by mailed questionnaire. There were seven secondary outcomes including quality of life (EuroQol Questionnaire-five dimensions-five levels/EQ-5D-5L) used as part of a health economic assessment. RESULTS: 996 participants were randomised and included in the intention-to-treat analysis of which 825 provided primary outcome data. The median age of participants was 59 years; 59% were women. At 12 months there was no difference in the onset of CWP (tCBT: 18.0% vs UC: 17.5%; OR 1.05; 95% CI 0.75 to 1.48). Participants who received tCBT were more likely to report better quality of life (EQ-5D-5L utility score mean difference 0.024 (95% CI 0.009 to 0.040)); and had 0.023 (95% CI 0.007 to 0.039) more quality-adjusted life-years at an additional cost of £42.30 (95% CI -£451.19 to £597.90), yielding an incremental cost-effectiveness ratio of £1828. Most secondary outcomes showed significant benefit for the intervention. CONCLUSIONS: A short course of tCBT did not prevent onset of CWP in adults at high risk, but improved quality of life and was cost-effective. A low-cost, short-duration intervention benefits persons at risk of CWP. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT02668003).

Patient-reported improvements in health are maintained 2†years after completing a short course of cognitive behaviour therapy, exercise or both treatments for chronic widespread pain: long-term results from the MUSICIAN randomised controlled trial.

OBJECTIVES: The MUSICIAN study has previously shown short-term benefit but only marginal cost-effectiveness for two non-pharmacological interventions for chronic widespread pain (CWP). We wished to determine their long-term effectiveness and cost-effectiveness. METHODS: A 2×2 factorial randomised controlled trial based in primary care in the UK. People were eligible if they were aged ≥25 years with CWP for which they had consulted their general practitioner. The interventions were a 6-month telephone cognitive behaviour therapy (tCBT) and/or a tailored exercise programme, in comparison to usual care. The primary outcome was patient-reported change in health. RESULTS: 884 persons were eligible, 442 were randomised and 81.7% were followed up 24 months post-treatment. In comparison to usual care (positive outcome 12.8%), tCBT (35.4%; OR 3.7 95% CI (1.8 to 8.0)), exercise (29.3%; OR 2.8 95% CI (1.3 to 6.0)) and both interventions (31.2%; OR 3.1 95% CI (1.3 to 6.0)) were significantly more effective. There was only a small decrease in effectiveness over time for individual and combined treatments. Those with more intense/disabling pain, higher distress and those who exhibited passive coping at baseline were more likely to have a positive outcome with tCBT than persons without these characteristics. tCBT was associated with the greatest increase in quality of life and lowest costs. Cost per quality adjusted life year was £3957-£5917 depending on method of analysis. CONCLUSIONS: A short course of tCBT for people with CWP was effective long-term and was highly cost-effective. Exercise was also effective but delivered positive outcome for fewer patients at greater cost, and there was no advantage for patients receiving both interventions. TRIAL REGISTRATION NUMBER: ISRCTN67013851.