Support, Health, and Fibromyalgia
|Fibromyalgia Quality of Life||Behavioral: Social support group Behavioral: Social support and education group||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
|Official Title:||Social Support and Health in Fibromyalgia|
|Study Start Date:||September 1996|
|Estimated Study Completion Date:||February 2001|
Next to osteoarthritis, FMS is the most common arthritis-related disease. Symptoms include musculoskeletal pain, fatigue, headaches, irritable bowel syndrome, morning stiffness, and sleep disturbances. Fluctuating severity, pain, and frustration with the difficulty of diagnosis and treatment lead patients to continually seek help from health care professionals. There is no known cause or cure for this disease.
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. To be eligible, people had to meet the American College of Rheumatology guidelines for FMS. After we confirmed the diagnosis, we assigned those who agreed to participate to one of three groups. The first group (social support) met with others who suffer from FMS for 2 hours every week for 10 weeks, and then monthly for an additional 10 months. The second group (social support and education) also had 10 2-hour weekly meetings followed by 10 monthly meetings with others who suffer from FMS, and its members learned about the disease and self-management techniques. The third group (control) participated only in the five assessment periods. We assessed people in all three groups before we assigned them to a group, after the intervention, and at yearly follow-ups. The study duration was 4 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000423
|United States, California|
|San Diego State University|
|San Diego, California, United States, 92120|
|Principal Investigator:||Thereasa A. Cronan||San Diego State University|