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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)

Tracking Information
First Submitted Date October 14, 2003
First Posted Date October 15, 2003
Last Update Posted Date April 1, 2009
Study Start Date September 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Genetics of Fibromyalgia
Official Title Fibromyalgia Family Study Registry
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.
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.

Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
DNA, whole blood
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.
  • Fibromyalgia
  • Irritable Bowel Syndrome
  • Chronic Fatigue Syndrome
  • Depression
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: June 23, 2005)
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

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
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT00071162
Other Study ID Numbers NIAMS-100
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sudha Iyengar, PhD, Case Western Reserve University
Study Sponsor National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborators Not Provided
Study Chair: Sudha Iyengar, PhD Case Western Reserve University
PRS Account National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Verification Date March 2009