CClinicalTrials.gg
Status unknownNCT00071162Updated Apr 1, 2009

Genetics of Fibromyalgia

An observational study in Fibromyalgia, Irritable Bowel Syndrome and Chronic Fatigue Syndrome, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Status unknown at 4 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2009-04-01.

Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Observational

The sponsor has not verified this record recently (last verified Mar 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Family-based
Time perspective
Retrospective
Enrollment
560
Ages
12 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Fibromyalgia
  • Irritable Bowel Syndrome
  • Chronic Fatigue Syndrome
  • Depression

Keywords

  • Pain
  • Fatigue
  • Sleep
  • Depression
  • Irritable Bowel Syndrome
  • Chronic Fatigue Syndrome
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In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 560 is above the median of 100 across 270 observational studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is the lead sponsor of 100 studies on the registry; 12 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years and older
Sexes eligible
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.

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
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Study design

Observational model
Family-based
Time perspective
Retrospective
Enrollment
560 participants (actual)
Biospecimen retention
Samples with dna
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Study locations

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

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. PubMed 9972977 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00071162
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted
Oct 15, 2003
Start date
Sep 1999
Last update
Apr 1, 2009

Study contacts

Sudha Iyengar, PhD
study chair · Case Western Reserve University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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