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Estrogen Receptor 1 Gene Polymorphism Frequency in Fibromyalgia Syndrome

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ClinicalTrials.gov Identifier: NCT03786393
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Ercan KAYDOK, Nigde Omer Halisdemir University

Brief Summary:

Fibromyalgia Syndrome (FMS) is a chronic musculoskeletal disorder accompanied by diffuse body pain, increased fatigue and tenderness in specific anatomical regions, and sleep disturbance. The higher prevalence of FMS in women and the observation of it from young adulthood suggest the effect of sex hormones on the pathophysiology of this condition. Steroid hormones, especially estrogen, have effects on both the peripheral and central nervous system receptors (estrogen receptor-a [ERa] and estrogen receptor-b [ERb]), on the inflammatory process, and on central pain delivery. However, the mechanism of action of these hormonal effects is still unknown and is a matter of debate.

The fact that fibromyalgia syndrome and migraine are more common in women of reproductive age and their incidence is higher than other populations suggests that these two diseases may have a common genetic basis. Previous studies have shown that ESR-1 594G> A (rs2228480), ESR-1 325C> G (rs2295190) polymorphisms significantly increase the risk of migraine occurrence. However, there are no studies investigating these polymorphisms in FMS. In this study, it was aimed to investigate whether there is a relationship between ESR-1 594G> A (rs2228480) and ESR-1 325C> G (rs2295190) polymorphisms and fibromyalgia disease.


Condition or disease Intervention/treatment
Fibromyalgia Diagnostic Test: ACR 1990 fibromyalgia critters

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Investigation of Estrogen Receptor 1 Gene Polymorphism Frequency in Patients With Fibromyalgia Syndrome
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

Group/Cohort Intervention/treatment
Fibromyalgia
100 participants diagnosed with fibromyalgia according to ACR 1990 criteria.
Diagnostic Test: ACR 1990 fibromyalgia critters
ACR 1990 fibromyalgia critters

Control Diagnostic Test: ACR 1990 fibromyalgia critters
ACR 1990 fibromyalgia critters




Primary Outcome Measures :
  1. polymorphism frequency [ Time Frame: 9 month ]
    The frequency of estrogen receptor alpha polymorphism in fibromyalgia and control group


Biospecimen Retention:   Samples With DNA
Estrogen receptor alpha polymorphism


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Fibromyalgia: 100 person, Control: 100 person.
Criteria

---Inclusion Criteria: As the inclusion criteria for the Fibromyalgia group ;

  • Being between 18 and 60 years of age,
  • Taking the diagnosis of primary FMS according to ACR 1990 diagnostic criteria,
  • Accepting to participate in the study

As the inclusion criteria for the Control group;

  • Being between 18 and 60 years of age,
  • Accepting to participate in the study
  • No diagnosis of fibromyalgia.

    ---Exclusion Criteria:

  • Having any sex hormone disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786393


Locations
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Turkey
BOR Physical medicine and rehabilitaton hospital Recruiting
Niğde, Turkey, 51000
Contact: Ercan KAYDOK, Ass. Proffessor    +905056298408    ercankaydok@ohu.edu.tr   
Sponsors and Collaborators
Nigde Omer Halisdemir University

Publications:
Bradley LA, Alarcon GS. Fibromyalgia. In: Kopman WJ (ed). Arthritis and Allied Conditions. Philedelphia. Lippincott & Williams & Wilkins, 2001, 1811-44.

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Responsible Party: Ercan KAYDOK, Assistant of Proffessor M.D. Ercan Kaydok, Nigde Omer Halisdemir University
ClinicalTrials.gov Identifier: NCT03786393     History of Changes
Other Study ID Numbers: Nigde O.H.U.
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ercan KAYDOK, Nigde Omer Halisdemir University:
Fibromyalgia
Migraine
estrogen receptor alpha
polymorphism

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs