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Support, Health, and Fibromyalgia
This study has been completed.
Study NCT00000423   Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First Received: November 3, 1999   Last Updated: December 28, 2006   History of Changes

November 3, 1999
December 28, 2006
September 1996
 
 
 
Complete list of historical versions of study NCT00000423 on ClinicalTrials.gov Archive Site
 
 
 
Support, Health, and Fibromyalgia
Social Support and Health in Fibromyalgia

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.

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.

Phase II
Interventional
Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
  • Fibromyalgia
  • Quality of Life
  • Behavioral: Social support group
  • Behavioral: Social support and education group
 
Oliver K, Cronan TA, Walen HR, Tomita M. Effects of social support and education on health care costs for patients with fibromyalgia. J Rheumatol. 2001 Dec;28(12):2711-9.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
600
February 2001
 

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000423
 
R01 AR44020, NIAMS-029
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 
Principal Investigator: Thereasa A. Cronan San Diego State University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
March 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP