Genetics of Fibromyalgia

Depression Clinical Trial

Official title:

Fibromyalgia Family Study Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00071162
• Other study ID #: NIAMS-100
• 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
• 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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Depression
• Fatigue Syndrome, Chronic
• Fibromyalgia
• Irritable Bowel Syndrome
• Myofascial Pain Syndromes
• Syndrome

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