Support, Health, and Fibromyalgia

Completed · Phase 2

Conditions studied: Fibromyalgia, Quality of Life

In brief

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.

Key facts

Study ID: NCT00000423
Run by: San Diego State University
People needed: 600
Starts: 1996-09-01
Expected to finish: 2001-02-01
Last updated by the study team: 2013-12-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

San Diego State University — San Diego, California, United States

Full record on ClinicalTrials.gov

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