Estrogen Receptor 1 Gene Polymorphism Frequency in Fibromyalgia Syndrome

NCT03786393 | Completed

• 1 other identifier: Nigde O.H.U.
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Migraine; estrogen receptor alpha; polymorphism

Outcome Measures

Primary Outcomes (1)

• polymorphism frequency

  The frequency of estrogen receptor alpha polymorphism in fibromyalgia and control group

  9 month

Study Arms (2)

Fibromyalgia

100 participants diagnosed with fibromyalgia according to ACR 1990 criteria.

Diagnostic Test: ACR 1990 fibromyalgia critters

Control

Diagnostic Test: ACR 1990 fibromyalgia critters

Interventions

ACR 1990 fibromyalgia critters DIAGNOSTIC_TEST

ACR 1990 fibromyalgia critters

Control; Fibromyalgia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Fibromyalgia: 100 person, Control: 100 person.

You may qualify if:

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

You may not qualify if:

• Having any sex hormone disease

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

BOR Physical medicine and rehabilitaton hospital

Niğde, 51000, Turkey (Türkiye)

Location

Related Publications (8)

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

  BACKGROUND

• Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.

  PMID: 2306288 BACKGROUND

• Ertas M, Baykan B, Orhan EK, Zarifoglu M, Karli N, Saip S, Onal AE, Siva A. One-year prevalence and the impact of migraine and tension-type headache in Turkey: a nationwide home-based study in adults. J Headache Pain. 2012 Mar;13(2):147-57. doi: 10.1007/s10194-011-0414-5. Epub 2012 Jan 14.

  PMID: 22246025 BACKGROUND

• Lipton RB, Stewart WF, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache. 2001 Jul-Aug;41(7):646-57. doi: 10.1046/j.1526-4610.2001.041007646.x.

  PMID: 11554952 BACKGROUND

• Schurks M, Rist PM, Kurth T. Sex hormone receptor gene polymorphisms and migraine: a systematic review and meta-analysis. Cephalalgia. 2010 Nov;30(11):1306-28. doi: 10.1177/0333102410364155. Epub 2010 May 4.

  PMID: 20959426 BACKGROUND

• Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.

  PMID: 14979299 BACKGROUND

• Hudson JI, Goldenberg DL, Pope HG Jr, Keck PE Jr, Schlesinger L. Comorbidity of fibromyalgia with medical and psychiatric disorders. Am J Med. 1992 Apr;92(4):363-7. doi: 10.1016/0002-9343(92)90265-d.

  PMID: 1558082 BACKGROUND

• Clark S, Campbell SM, Forehand ME, Tindall EA, Bennett RM. Clinical characteristics of fibrositis. II. A "blinded," controlled study using standard psychological tests. Arthritis Rheum. 1985 Feb;28(2):132-7. doi: 10.1002/art.1780280204.

  PMID: 3882093 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Estrogen receptor alpha polymorphism

MeSH Terms

Conditions

Fibromyalgia; Migraine Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant of Proffessor M.D. Ercan Kaydok

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 26, 2018
• Study Start: March 11, 2019
• Primary Completion: April 15, 2021
• Study Completion: May 15, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)