Long-Term Results from a Randomised Controlled Trial (RCT) Of Telephone Delivered Cognitive Behaviour Therapy (TCBT) And Exercise In The Management Of Chronic Widespread Pain (CWP), And Predictors Of Treatment-Effectiveness

Abstract

BackgroundChronic Widespread Pain (CWP), the primary symptom associated with fibromyalgia, has been shown to persist over time. It is challenging to manage and can have impacts on functioning and quality of life. Recent reviews have, however, suggested that non-pharmacological treatments such as behaviour therapy and exercise may be effective, at least for short-term management. The MUSICIAN study was a trial of 6-month courses of treatment by telephone-delivered cognitive behavioural therapy (tCBT), exercise, or a combination of both for the management of CWP that have previously shown short-term improvements in patient-reported health compared to treatment as usual (TAU). The aim of the current study is to determine whether these improvements are maintained long-term (2 years after the end of treatment), to determine if any of the active treatments were cost-effective in relation to TAU, and to determine if pre-treatment characteristics identify patients who are more likely to benefit from these treatments.MethodsPopulation survey was used to identify patients who: met the American College of Rheumatology (ACR) definition of CWP, consulted a GP for pain in the last year, and had no contraindications for exercise. Random assignation was to: a) 8 weekly sessions of tCBT, with refreshers at 3 and 6 months; b) an individually tailored exercise programme with monthly review over 6 months; c) both active treatments, or d) TAU. Follow-ups were at end of treatment, and 3 and 24 months later. Primary outcome was self-reported change in health since before the trial. Positive outcomes were Much better or Very much better, on a 7-point scale from Very much worse to Very much better. Analysis was by longitudinal logistic regression. Results are presented as odds ratios (OR) with 95% Confidence Intervals (CI). Additional models were run to assess cost-effectiveness, and the influence of baseline characteristics on the effectiveness of each treatment.Results442 persons (median age 57 years, 57% female) were randomised of which 361 (82%) provided information 24 months post-treatment. The percentage of patients reporting positive outcome at the final follow-up was: TAU 12.8%, tCBT 35.4%, exercise 29.4%, and combined treatment 31.2%. At 24 months, positive outcome after adjustment for baseline characteristics was more likely for tCBT (OR 3.6; 95% CI 1.7, 7.6), exercise (2.5; 1.2, 5.4), and combined treatment (2.9; 1.4, 6.0) compared to TAU. Of all four groups, tCBT had highest probability of being cost-effective at a ceiling willingness to pay ratio of £20,000 per Quality Adjusted Life Year gained. Baseline characteristics associated with greater response to tCBT at any time-point were high psychological distress (treatment-predictor interaction OR 5.6; 1.5, 21.2), and high kinesiophobia (4.7; 1.1, 20.5). High Chronic Pain Grade at baseline was significantly associated with a greater response to Combined Treatment (8.3; 1.6, 43.4).ConclusionA six-month programme of exercise or tCBT is associated with improvements in health in CWP patients which are maintained two years after treatment has finished. The size of effect is similar for both treatments, and there is no advantage in receiving both treatments together. Characteristics were identified associated with response to the treatments which could allow future targeting of such interventions to those likely to benefit.BackgroundChronic Widespread Pain (CWP), the primary symptom associated with fibromyalgia, has been shown to persist over time. It is challenging to manage and can have impacts on functioning and quality of life. Recent reviews have, however, suggested that non-pharmacological treatments such as behaviour therapy and exercise may be effective, at least for short-term management. The MUSICIAN study was a trial of 6-month courses of treatment by telephone-delivered cognitive behavioural therapy (tCBT), exercise, or a combination of both for the management of CWP that have previously shown short-term improvements in patient-reported health compared to treatment as usual (TAU). The aim of the current study is to determine whether these improvements are maintained long-term (2 years after the end of treatment), to determine if any of the active treatments were cost-effective in relation to TAU, and to determine if pre-treatment characteristics identify patients who are more likely to benefit from these treatments.MethodsPopulation survey was used to identify patients who: met the American College of Rheumatology (ACR) definition of CWP, consulted a GP for pain in the last year, and had no contraindications for exercise. Random assignation was to: a) 8 weekly sessions of tCBT, with refreshers at 3 and 6 months; b) an individually tailored exercise programme with monthly review over 6 months; c) both active treatments, or d) TAU. Follow-ups were at end of treatment, and 3 and 24 months later. Primary outcome was self-reported change in health since before the trial. Positive outcomes were Much better or Very much better, on a 7-point scale from Very much worse to Very much better. Analysis was by longitudinal logistic regression. Results are presented as odds ratios (OR) with 95% Confidence Intervals (CI). Additional models were run to assess cost-effectiveness, and the influence of baseline characteristics on the effectiveness of each treatment.Results442 persons (median age 57 years, 57% female) were randomised of which 361 (82%) provided information 24 months post-treatment. The percentage of patients reporting positive outcome at the final follow-up was: TAU 12.8%, tCBT 35.4%, exercise 29.4%, and combined treatment 31.2%. At 24 months, positive outcome after adjustment for baseline characteristics was more likely for tCBT (OR 3.6; 95% CI 1.7, 7.6), exercise (2.5; 1.2, 5.4), and combined treatment (2.9; 1.4, 6.0) compared to TAU. Of all four groups, tCBT had highest probability of being cost-effective at a ceiling willingness to pay ratio of £20,000 per Quality Adjusted Life Year gained. Baseline characteristics associated with greater response to tCBT at any time-point were high psychological distress (treatment-predictor interaction OR 5.6; 1.5, 21.2), and high kinesiophobia (4.7; 1.1, 20.5). High Chronic Pain Grade at baseline was significantly associated with a greater response to Combined Treatment (8.3; 1.6, 43.4).ConclusionA six-month programme of exercise or tCBT is associated with improvements in health in CWP patients which are maintained two years after treatment has finished. The size of effect is similar for both treatments, and there is no advantage in receiving both treatments together. Characteristics were identified associated with response to the treatments which could allow future targeting of such interventions to those likely to benefit.