Fibromyalgia Clinical Trial
Official title:
Investigation of Estrogen Receptor 1 Gene Polymorphism Frequency in Patients With Fibromyalgia Syndrome
NCT number | NCT03786393 |
Other study ID # | Nigde O.H.U. |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 11, 2019 |
Est. completion date | May 15, 2021 |
Verified date | January 2021 |
Source | Nigde Omer Halisdemir University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | May 15, 2021 |
Est. primary completion date | April 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | ---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 |
Country | Name | City | State |
---|---|---|---|
Turkey | BOR Physical medicine and rehabilitaton hospital | Nigde |
Lead Sponsor | Collaborator |
---|---|
Nigde Omer Halisdemir University |
Turkey,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | polymorphism frequency | The frequency of estrogen receptor alpha polymorphism in fibromyalgia and control group | 9 month |
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