Genetics of Fibromyalgia

March 31, 2009 updated by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Fibromyalgia Family Study Registry

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Actual)

560

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Peoria, Illinois, United States, 60612
        • University of Illinois at Peoria
    • Ohio
      • Cincinnati, Ohio, United States, 45221
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44109
        • Case Western Reserve University
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Family-Based
  • Time Perspectives: Retrospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Study Chair: Sudha Iyengar, PhD, Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Study Registration Dates

First Submitted

October 14, 2003

First Submitted That Met QC Criteria

October 14, 2003

First Posted (Estimate)

October 15, 2003

Study Record Updates

Last Update Posted (Estimate)

April 1, 2009

Last Update Submitted That Met QC Criteria

March 31, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAMS-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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