Study 12 of 186 for search of: "Fibromyalgia"
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Support, Health, and Fibromyalgia
This study has been completed.
Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00000423
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Quality of Life
Behavioral: Social support group
Behavioral: Social support and education group
Phase II

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title: Social Support and Health in Fibromyalgia

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Estimated Enrollment: 600
Study Start Date: September 1996
Estimated Study Completion Date: February 2001
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000423

Locations
United States, California
San Diego State University
San Diego, California, United States, 92120
Sponsors and Collaborators
Investigators
Principal Investigator: Thereasa A. Cronan San Diego State University
  More Information

Publications of Results:
Study ID Numbers: R01 AR44020, NIAMS-029
Study First Received: November 3, 1999
Last Updated: December 28, 2006
ClinicalTrials.gov Identifier: NCT00000423  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Fibromyalgia
Health education
Program evaluation
Social support
Managed care
Quality of well-being

Study placed in the following topic categories:
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Fibromyalgia
Quality of Life
Pain
Rheumatic Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009