Managing Unexplained Symptoms (chronic widespread pain) In primary Care: Involving traditional and Accessible New approaches

Not Applicable

Completed

Conditions: Chronic Widespread Pain (CWP)
Musculoskeletal Diseases
Soft tissue disorders

Registration Number: ISRCTN67013851

Lead Sponsor: niversity of Aberdeen (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 552

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

Patients who have contraindications for prescribed exercise or cognitive behavioural therapies, as determined by their GPs or the research nurse.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Pain<br>2. Fatigue<br>3. Coping<br>4. Psychological distress<br>5. Sleep problems<br>6. Fear of movement<br>7. Quality of life<br>8. Treatment side-effects<br><br>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.