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

ISRCTN	ISRCTN67013851
DOI	https://doi.org/10.1186/ISRCTN67013851
Protocol serial number	Arthritis Research Campaign (ARC) ID number: 17292
Sponsor	University of Aberdeen (UK)
Funder	Arthritis Research Campaign (UK) (ref: MUSICIAN ID number: 17292)

Submission date: 12/09/2007
Registration date: 10/10/2007
Last edited: 29/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gary Macfarlane
Scientific

Epidemiology Group
Department of Public Health
University of Aberdeen
School of Medicine
Polwarth Building, Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre 2 x 2 factorial design randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Managing Unexplained Symptoms (chronic widespread pain) In primary Care: Involving traditional and Accessible New approaches
Study acronym	MUSICIAN
Study objectives	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.
Ethics approval(s)	Cheshire Research Ethics Committee, 04/07/2007, REC ref: 07/Q1506/61
Health condition(s) or problem(s) studied	Chronic Widespread Pain (CWP)
Intervention	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.
Intervention type	Other
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).
Key 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.
Completion date	30/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	552
Key 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)
Key exclusion criteria	Patients who have contraindications for prescribed exercise or cognitive behavioural therapies, as determined by their GPs or the research nurse.
Date of first enrolment	01/10/2007
Date of final enrolment	30/09/2010

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

University of Aberdeen

Aberdeen
AB25 2ZD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/01/2012		Yes	No
Results article	results	18/02/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes