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| Managing Unexplained Symptoms (chronic widespread pain) In primary Care: Involving traditional and Accessible New approaches |
| Source of record | UK Trials |
| ISRCTN | ISRCTN67013851 |
| Date ISRCTN assigned | 10/10/2007 |
| Local reference number(s) | Arthritis Research Campaign (ARC) ID number: 17292 |
| Public title | Managing Unexplained Symptoms (chronic widespread pain) In primary Care: Involving traditional and Accessible New approaches |
| Scientific title | |
| Acronym | MUSICIAN |
| Disease/condition/study domain | Chronic Widespread Pain (CWP) |
| 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. Hypothesis: 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. |
| Design/methodology | A multicentre 2 x 2 factorial design randomised controlled study. |
| Research ethics review | Ethics approval received from the Cheshire Research Ethics Committee on the 4th July 2007 (REC ref: 07/Q1506/61). |
| Countries of trial | United Kingdom |
| 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. |
| Patient information material | |
| Anticipated start date | 01/10/2007 |
| Anticipated end date | 30/09/2010 |
| Status of trial | Ongoing |
| 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) |
| Sponsor name | University of Aberdeen (UK) |
| Sponsor details | School of Medicine Research and Innovation Office Polwarth Building, Foresterhill Aberdeen United Kingdom AB25 2ZD |
| Sponsor email | res-innov@abdn.ac.uk |
| Sponsor website | http://www.abdn.ac.uk/r&i/ |
| Contact name | Prof Gary Macfarlane |
| Contact details | Epidemiology Group Department of Public Health University of Aberdeen School of Medicine Polwarth Building, Foresterhill Aberdeen United Kingdom AB25 2ZD |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN67013851 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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