Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gary Macfarlane

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Arthritis Research Campaign (ARC) ID number: 17292

Study information

Scientific title

Acronym

MUSICIAN

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.

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.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

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.

Overall trial start date

01/10/2007

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

552 patients

Participant exclusion criteria

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

Recruitment start date

01/10/2007

Recruitment end date

30/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Epidemiology Group
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

School of Medicine
Research and Innovation Office
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
res-innov@abdn.ac.uk

Sponsor type

University/education

Website

http://www.abdn.ac.uk/r&i/

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (UK) (ref: MUSICIAN ID number: 17292)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22082706

Publication citations

  1. Results

    McBeth J, Prescott G, Scotland G, Lovell K, Keeley P, Hannaford P, McNamee P, Symmons DP, Woby S, Gkazinou C, Beasley M, Macfarlane GJ, Cognitive behavior therapy, exercise, or both for treating chronic widespread pain., Arch. Intern. Med., 2012, 172, 1, 48-57, doi: 10.1001/archinternmed.2011.555.

Editorial Notes