Completed

Social Support and Health in Fibromyalgia

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What is being tested

Data Collection

Who is being recruted

Treatment Adherence and Compliance+11

+ Adherence Interventions

+ Behavior

Over 21 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Phase 2
Interventional
Study Start: September 1996
See protocol details

Summary

Principal SponsorSan Diego State University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1996

Actual date on which the first participant was enrolled.

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.

Official TitleSocial Support and Health in Fibromyalgia
NCT00000423
Principal SponsorSan Diego State University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Treatment Adherence and ComplianceAdherence InterventionsBehaviorFibromyalgiaHealth EducationMuscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeuromuscular DiseasesPatient Acceptance of Health CarePatient ComplianceRheumatic DiseasesHealth BehaviorMedication Adherence

Criteria

2 inclusion criteria required to participate
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.

2 exclusion criteria prevent from participating
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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

San Diego State University

San Diego, United StatesOpen San Diego State University in Google Maps
CompletedOne Study Center