Genetics of Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00071162
First received: October 14, 2003
Last updated: March 31, 2009
Last verified: March 2009
  Purpose

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
Fibromyalgia
Irritable Bowel Syndrome
Chronic Fatigue Syndrome
Depression

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Retrospective
Official Title: Fibromyalgia Family Study Registry

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Biospecimen Retention:   Samples With DNA

DNA, whole blood


Enrollment: 560
Study Start Date: September 1999
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071162

Locations
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
Investigators
Study Chair: Sudha Iyengar, PhD Case Western Reserve University
  More Information

Publications:
Responsible Party: Sudha Iyengar, PhD, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00071162     History of Changes
Other Study ID Numbers: NIAMS-100
Study First Received: October 14, 2003
Last Updated: March 31, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Pain
Fatigue
Sleep
Depression
Irritable Bowel Syndrome
Chronic Fatigue Syndrome

Additional relevant MeSH terms:
Depression
Depressive Disorder
Irritable Bowel Syndrome
Fatigue
Fibromyalgia
Myofascial Pain Syndromes
Fatigue Syndrome, Chronic
Syndrome
Behavioral Symptoms
Mood Disorders
Mental Disorders
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Virus Diseases
Encephalomyelitis
Central Nervous System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014