Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077117143
Study information
Scientific title
Acronym
Study hypothesis
Null hypothesis: there is no significant difference in health status between people with fibromyalgia attending a relaxation programme and self management programme incorporating psycho-educational approaches.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Musculoskeletal Diseases: Fibromyalgia
Intervention
91 patients with fibromyalgia will be recruited over a 1 year period and randomly allocated to attend either a self-management programme or a relaxation programme. The self-management programme uses educational and behavioural strategies to increase use of self management methods. Both consist of 10 meetings. Outcomes will be evaluated using a self-report questionnaire mailed out before and at 4 and 10 months after intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Measures of adherence with self-management strategies, functional, psychological and health status as well as demographic and health care utilisation information.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2002
Overall trial end date
31/05/2005
Reason abandoned
Eligibility
Participant inclusion criteria
People with fibromyalgia (diagnosed by Consultant Physician) attending the Rheumatology Department, aged over 18 years, able to read English.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
91
Participant exclusion criteria
People with severe disease/functional/psychological problems will be excluded.
Recruitment start date
01/09/2002
Recruitment end date
31/05/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southern Derbyshire Acute Hosptials NHS Trust
Derby
DE1 2QY
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Southern Derbyshire Acute Hospitals NHS Trust (UK)
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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17008336
Publication citations
-
Results
Hammond A, Freeman K, Community patient education and exercise for people with fibromyalgia: a parallel group randomized controlled trial., Clin Rehabil, 2006, 20, 10, 835-846, doi: 10.1177/0269215506072173.