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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00071162
Other study ID # NIAMS-100
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 14, 2003
Last updated March 31, 2009
Start date September 1999

Study information

Verified date March 2009
Source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

The Fibromyalgia Family Study identifies and collects blood samples from families with two or more members affected with Fibromyalgia Syndrome (FMS). The primary goal of the study is to identify genes that predispose people to FMS and/or symptoms related to FMS; identifying these genes may lead to a better understanding of the disease and more effective treatments.


Description:

FMS predominantly affects women and is characterized by chronic widespread musculoskeletal pain, fatigue, sleep disturbance, and multiple tender points on physical examination. The pathophysiological mechanisms underlying FMS are not clearly understood, but neuroendocrine factors seem to be of major importance. Studies of familial association suggest that genetic factors play a role in FMS. This study will establish patterns of genetic linkage in families with FMS.

Participating family members will undergo a brief physical exam (including tender point exam), donate a blood sample, and complete a detailed questionnaire that includes experience with pain, fatigue, depression, bowel symptoms, headache, anxiety, and physical limitations. Measurements of serum serotonin and related compounds will also be obtained. To detect genetic factors, a genome-wide linkage scan using 405 microsatellite markers will be performed.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 560
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria

- Diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology

- Have at least one living family member who has also been diagnosed with fibromyalgia

- No other major rheumatological disease

Study Design

Observational Model: Family-Based, Time Perspective: Retrospective


Locations

Country Name City State
United States University of Cincinnati Cincinnati Ohio
United States Case Western Reserve University Cleveland Ohio
United States University of Illinois at Peoria Peoria Illinois
United States University of Texas Health Sciences Center San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Yunus MB, Khan MA, Rawlings KK, Green JR, Olson JM, Shah S. Genetic linkage analysis of multicase families with fibromyalgia syndrome. J Rheumatol. 1999 Feb;26(2):408-12. — View Citation

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