Chronic Widespread Pain (CWP) Musculoskeletal Diseases Soft tissue disorders
Conditions
Interventions
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
Sponsors
University of Aberdeen (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
Exclusion criteria: Patients who have contraindications for prescribed exercise or cognitive behavioural therapies, as determined by their GPs or the research nurse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Pain 2. Fatigue 3. Coping 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. | — |
Countries
United Kingdom
Outcome results
None listed