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Support, Health, and Fibromyalgia

This study has been completed.
Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Support, Health, and Fibromyalgia
Official Title  Social Support and Health in Fibromyalgia
Brief Summary

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.

Detailed Description

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.

Study Phase Phase II
Study Type  Interventional
Study Design  Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Fibromyalgia
Quality of Life
Intervention  Behavioral: Social support group
Behavioral: Social support and education group
MEDLINE PMIDs 11764222
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  600
Start Date  September 1996
Completion Date February 2001
Eligibility Criteria 

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.
Gender Both
Ages 21 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000423
Organization ID R01 AR44020
Secondary IDs †† NIAMS-029
Study Sponsor  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborators ††
Investigators 
Principal Investigator:     Thereasa A. Cronan     San Diego State University    
Information Provided By National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Verification Date March 2001
First Received Date  November 3, 1999
Last Updated Date December 28, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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