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Managing Unexplained Symptoms (chronic widespread pain) In primary Care: Involving traditional and Accessible New approaches
DOI 10.1186/ISRCTN67013851
ClinicalTrials.gov identifier
EudraCT number
Public title Managing Unexplained Symptoms (chronic widespread pain) In primary Care: Involving traditional and Accessible New approaches
Scientific title
Serial number at source Arthritis Research Campaign (ARC) ID number: 17292
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the Cheshire Research Ethics Committee on the 4th July 2007 (REC ref: 07/Q1506/61).
Study design A multicentre 2 x 2 factorial design randomised controlled study.
Countries of recruitment United Kingdom
Disease/condition/study domain Chronic Widespread Pain (CWP)
Participants - 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)
Participants - exclusion criteria Patients who have contraindications for prescribed exercise or cognitive behavioural therapies, as determined by their GPs or the research nurse.
Anticipated start date 01/10/2007
Anticipated end date 30/09/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 552 patients
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 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 measure(s) 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 measure(s) 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.
Sources of funding Arthritis Research Campaign (UK) (ref: MUSICIAN ID number: 17292)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22082706
Contact name Prof  Gary  Macfarlane
  Address Epidemiology Group
Department of Public Health
University of Aberdeen
School of Medicine
Polwarth Building, Foresterhill
  City/town Aberdeen
  Zip/Postcode AB25 2ZD
  Country United Kingdom
Sponsor University of Aberdeen (UK)
  Address School of Medicine
Research and Innovation Office
Polwarth Building, Foresterhill
  City/town Aberdeen
  Zip/Postcode AB25 2ZD
  Country United Kingdom
  Email res-innov@abdn.ac.uk
  Sponsor website: http://www.abdn.ac.uk/r&i/
Date applied 12/09/2007
Last edited 05/04/2012
Date ISRCTN assigned 10/10/2007
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