Arthritis Research Campaign (ARC) ID number: 17292
Managing Unexplained Symptoms (chronic widespread pain) In primary Care: Involving traditional and Accessible New approaches
Chronic Widespread Pain (CWP) is the cardinal feature of the fibromyalgia syndrome. It has a population prevalence of approximately 13% in the UK and is amongst the most common reasons for referral to a rheumatologist. Managing patients with chronic widespread pain is difficult. No individual management modality (pharmacological, physical, psychological therapies) has been demonstrated to be effective in relieving symptoms. Treatment is often prolonged and improvement likely to occur slowly. There is a need therefore to develop interventions at a primary care level that are potentially available to a large number of patients, which result in an improvement of symptoms, are acceptable and convenient to patients, and ideally which are inexpensive to provide.
Amongst patients with "unexplained" chronic widespread musculoskeletal pain that in addition to usual care:
1. A telephone-based Cognitive Behavioural Therapy (CBT) programme
2. Prescribed exercise
3. A combination of both treatments
will improve pain and disability in the short (6 months) and medium (9 months) term, in comparison to patients receiving "usual care" only.
Cheshire Research Ethics Committee, 04/07/2007, REC ref: 07/Q1506/61
Multicentre 2 x 2 factorial design randomised controlled study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Chronic Widespread Pain (CWP)
When eligibility is established and consent is obtained, subjects will be randomly allocated into one of four treatment groups, stratified by two important predictors of outcome: initial chronic pain grade score (I/II/III/IV) and by psychological distress (high/low). The four groups, which will be of equal size are:
Group 1: telephone-based CBT intervention (10 sessions in total)
Group 2: prescribed exercise intervention in a local leisure facility under the supervision of a fitness instructor (2 - 3 times a week)
Group 3: telephone-based CBT and prescribed exercise intervention
Group 4: treatment as usual
Each patient will receive the intervention for a period of 6 months.
Primary outcome measures
The primary outcome of the trial will be a self-rated clinical global impression change score at 6 (end of intervention) and 9 months post-randomisation. This is a seven-point scale measuring how participants feel that their health has changed since the period prior to entering the trial. It ranges from "I feel much worse" (score 1) to "I feel better" (score 6) and "I feel much better" (score 7).
Secondary outcome measures
4. Psychological distress
5. Sleep problems
6. Fear of movement
7. Quality of life
8. Treatment side-effects
This corresponds to the recommendations of core outcome domains for chronic pain clinical trials, and outcomes considered by the Outcome Measures in Rheumatology Clinical Trials initiative. All secondary outcomes will be measured at 6 and 9 months post-randomisation.
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Satisfy the American College of Rheumatology (ACR) definition of Chronic Widespread Pain (CWP) as used in the criteria for fibromyalgia
2. Symptoms have an impact on physical function as assessed by the Chronic Pain Grade Questionnaire
3. Consulted their general practitioner because of these symptoms within the past year
4. Have access to a landline telephone
5. Age above 25 years (both genders will be included)
Target number of participants
Participant exclusion criteria
Patients who have contraindications for prescribed exercise or cognitive behavioural therapies, as determined by their GPs or the research nurse.
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University of Aberdeen
Arthritis Research Campaign (UK) (ref: MUSICIAN ID number: 17292)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
McBeth J, Prescott G, Scotland G, Lovell K, Keeley P, Hannaford P, McNamee P, Symmons DP, Woby S, Gkazinou C, Beasley M, Macfarlane GJ, Cognitive behavior therapy, exercise, or both for treating chronic widespread pain., Arch. Intern. Med., 2012, 172, 1, 48-57, doi: 10.1001/archinternmed.2011.555.
Beasley M, Prescott GJ, Scotland G, McBeth J, Lovell K, Keeley P, Hannaford PC, Symmons DP, MacDonald RI, Woby S, Macfarlane GJ, 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, RMD Open, 2015, 1, 1, e000026, doi: 10.1136/rmdopen-2014-000026.