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Genetics of Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00071162
Recruitment Status : Unknown
Verified March 2009 by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Recruitment status was:  Active, not recruiting
First Posted : October 15, 2003
Last Update Posted : April 1, 2009
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Brief 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.

Condition or disease
Fibromyalgia Irritable Bowel Syndrome Chronic Fatigue Syndrome Depression

Detailed 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.

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Study Type : Observational
Actual Enrollment : 560 participants
Observational Model: Family-Based
Time Perspective: Retrospective
Official Title: Fibromyalgia Family Study Registry
Study Start Date : September 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Biospecimen Retention:   Samples With DNA
DNA, whole blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The population of this study is family based and aimed to recruit 160 multic-case FMS families. We plan to perform a genome scan and evaluate 200-300 linkage markers to FMS and FMS-related traits. Future plans include establishing a DNA and data repository for distribution for future studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00071162

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United States, Illinois
University of Illinois at Peoria
Peoria, Illinois, United States, 60612
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Case Western Reserve University
Cleveland, Ohio, United States, 44109
United States, Texas
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Study Chair: Sudha Iyengar, PhD Case Western Reserve University
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Responsible Party: Sudha Iyengar, PhD, Case Western Reserve University Identifier: NCT00071162    
Other Study ID Numbers: NIAMS-100
First Posted: October 15, 2003    Key Record Dates
Last Update Posted: April 1, 2009
Last Verified: March 2009
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Irritable Bowel Syndrome
Chronic Fatigue Syndrome
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Myofascial Pain Syndromes
Irritable Bowel Syndrome
Pathologic Processes
Behavioral Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Virus Diseases
Central Nervous System Diseases