Clinical trial NCT00071162: Genetics of Fibromyalgia
Official title: Fibromyalgia Family Study Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibromyalgia
Irritable Bowel Syndrome
Chronic Fatigue Syndrome
Depression
Keywords: Pain
Fatigue
Sleep
Depression
Irritable Bowel Syndrome
Chronic Fatigue Syndrome
Lead sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sponsor class: NIH
First posted: 2003-10-15
Enrollment: 560
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: University of Illinois at Peoria
state: Illinois
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center
state: Texas
Study officials:
affiliation: Case Western Reserve University
name: Sudha Iyengar, PhD
role: STUDY_CHAIR
References:
citation: 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.