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Support, Health, and Fibromyalgia - Article


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Social Support




Clinical Trial: 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)

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 Treatment or Intervention Phase
Fibromyalgia
Quality of Life
 Behavior: Social support group
 Behavior: Social support and education group
Phase II

MedlinePlus related topics:  Fibromyalgia

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: 

Expected Total Enrollment:  600

Study start: September 1996;  Study completion: February 2001

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 above,  Genders Eligible for Study:  Both

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.

Location Information


California
      San Diego State University, San Diego,  California,  92120,  United States

Study chairs or principal investigators

Thereasa A. Cronan,  Principal Investigator,  San Diego State University   

More Information

Publications that report results of this study

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.

Study ID Numbers:  NIAMS-029; R01 AR44020
Record last reviewed:  March 2001
Last Updated:  November 3, 2004
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00000423
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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January 9, 2009



Page Updated: November 5, 2004
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