Quality of Life Clinical Trial
Official title:
Social Support and Health in Fibromyalgia
Verified date | March 2001 |
Source | San Diego State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
This study tests the effects of social support and education on the health and well-being of people with fibromyalgia (FMS). We recruited 600 adults with a confirmed diagnosis of FMS from a large health maintenance organization. We randomly assigned the study participants to one of three groups. People in the social support group met with others who suffer from FMS for 2 hours every week for 10 weeks, and then monthly for an additional 10 months. The social support and education group also had 10 2-hour weekly meetings followed by 10 monthly meetings with others who suffer from FMS. Members of this group learned about the disease and ways they can manage it themselves. The third group participated only in the five assessment periods. The study lasted 4 years.
Status | Completed |
Enrollment | 600 |
Est. completion date | February 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - A diagnosis of fibromyalgia documented in medical records and confirmed using The American College of Rheumatology criteria for classification of FMS: (1) A history of widespread pain (pain on both sides of the body, above and below the waist, and present for at least 3 months). (2) Pain in 11 or more of 18 tender-point sites. - Patient willing to attend 10 weekly meetings and 10 monthly meetings. Exclusion Criteria: - Patients who do not meet ACR criteria for FMS described above. - Patients who cannot attend meetings once a week for 10 weeks and once a month for 10 months were excluded. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | San Diego State University | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
San Diego State University | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Oliver K, Cronan TA, Walen HR, Tomita M. Effects of social support and education on health care costs for patients with fibromyalgia. J Rheumatol. 2001 Dec;28(12):2711-9. — View Citation
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