<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03786393</url>
  </required_header>
  <id_info>
    <org_study_id>Nigde O.H.U.</org_study_id>
    <nct_id>NCT03786393</nct_id>
  </id_info>
  <brief_title>Estrogen Receptor 1 Gene Polymorphism Frequency in Fibromyalgia Syndrome</brief_title>
  <official_title>Investigation of Estrogen Receptor 1 Gene Polymorphism Frequency in Patients With Fibromyalgia Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nigde Omer Halisdemir University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nigde Omer Halisdemir University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fibromyalgia Syndrome (FMS) is a chronic musculoskeletal disorder accompanied by diffuse body&#xD;
      pain, increased fatigue and tenderness in specific anatomical regions, and sleep disturbance.&#xD;
      The higher prevalence of FMS in women and the observation of it from young adulthood suggest&#xD;
      the effect of sex hormones on the pathophysiology of this condition. Steroid hormones,&#xD;
      especially estrogen, have effects on both the peripheral and central nervous system receptors&#xD;
      (estrogen receptor-a [ERa] and estrogen receptor-b [ERb]), on the inflammatory process, and&#xD;
      on central pain delivery. However, the mechanism of action of these hormonal effects is still&#xD;
      unknown and is a matter of debate.&#xD;
&#xD;
      The fact that fibromyalgia syndrome and migraine are more common in women of reproductive age&#xD;
      and their incidence is higher than other populations suggests that these two diseases may&#xD;
      have a common genetic basis. Previous studies have shown that ESR-1 594G&gt; A (rs2228480),&#xD;
      ESR-1 325C&gt; G (rs2295190) polymorphisms significantly increase the risk of migraine&#xD;
      occurrence. However, there are no studies investigating these polymorphisms in FMS. In this&#xD;
      study, it was aimed to investigate whether there is a relationship between ESR-1 594G&gt; A&#xD;
      (rs2228480) and ESR-1 325C&gt; G (rs2295190) polymorphisms and fibromyalgia disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: The fact that fibromyalgia and migraine are more common in women of reproductive&#xD;
      age and their incidence are higher than other populations suggests that these three diseases&#xD;
      may have a common genetic basis. Therefore, we aimed to investigate whether there is a&#xD;
      relationship between ESR-1 594G&gt; A (rs2228480), ESR-1 325C&gt; G (rs2295190) polymorphisms and&#xD;
      fibromyalgia disease.&#xD;
&#xD;
      Introduction: Fibromyalgia syndrome (FMS), diffuse body pain, chronic musculoskeletal disease&#xD;
      with increased fatigue and tenderness and sleep disorder in specific anatomical regions . The&#xD;
      FMS diagnosis is based on American College of Rheumatology(ACR) 1990 classification criteria.&#xD;
      FM frequently affects women between 30 and 50 years of age and its prevalence is between 1%&#xD;
      and 4% of the whole population, 0-4% in men and 2.5-10.5% in women. Researchers have found&#xD;
      that the strong familial tendency in FM has a risk of developing FM in first-degree relatives&#xD;
      of patients with FM, 8 times more than in the general population. Family members of FM&#xD;
      patients are more susceptible to pain and are more likely to develop conditions such as&#xD;
      irritable bowel syndrome (IBS), temporomandibular disorder (TMD), headache-migraine, restless&#xD;
      leg syndrome, and other regional pain syndromes . Several studies have been conducted to&#xD;
      demonstrate specific genetic polymorphism in FM. To date, polymorphisms in the serotonin&#xD;
      receptor, serotonin transporter, dopamine D4 receptor and catechol-O-methyltransferase genes&#xD;
      have been found to be high . All these identified polymorphisms are responsible for the&#xD;
      metabolism and transport of monoamines; These are compounds that play a critical role in the&#xD;
      human stress response.&#xD;
&#xD;
      The more frequent occurrence of FMS in women is observed in young adults, indicating the&#xD;
      effect of sex hormones on the pathophysiology of this condition. However, the mechanism of&#xD;
      action of these hormonal effects is still unknown and is a matter of debate. Steroid&#xD;
      hormones, in particular estrogen, affect both peripheral and central nervous system (CNS)&#xD;
      receptors (Estrogen Receptor-1; estrogen receptor-a [Era] and Estrogen Receptor-2;estrogen&#xD;
      receptor-b [ERb]), the inflammatory process and the transmission of central pain. For&#xD;
      example, estrogen may directly affect monocytes and macrophages to regulate the production of&#xD;
      cytokines (eg, Interleukin-1 [IL-1], IL-6 and tumor necrosis factor-a [TNF-a]).&#xD;
&#xD;
      Migraine is a neurological disorder characterized by episodes of hemicranial pain&#xD;
      characterized by attacks. one-year prevalence of migraine in the general population in Turkey&#xD;
      16.4%, while the proportion of patients with FM were significantly lower (9). The incidence&#xD;
      of headache increased in patients with fibromyalgia syndrome. Migraine and non-migraine&#xD;
      headaches have been reported in patients with FM between 28% and 58% . Similarly, in a study&#xD;
      conducted on 33 FM patients, the current migraine was present at 45% and the lifetime&#xD;
      migraine history was 55% . The prevalence of migraine has been reported to be approximately&#xD;
      2-fold (reproductive period) and the severity of migraine attacks in women compared to men .&#xD;
      Studies investigating the relationship between sex hormone levels and polymorphisms due to&#xD;
      more frequent reproductive states have shown that they are associated with estrogen&#xD;
      receptor-alpha (ERa 594G&gt; A (rs2228480), ERa 325C&gt; G (rs2295190) polymorphisms.&#xD;
&#xD;
      Methods: Establishment of study groups: 100 patients diagnosed as Fibromyalgia syndrome&#xD;
      according to the criteria of ACR 1990, 18-65 years old, and having similar sociodemographic&#xD;
      characteristics. 100 control patients will be taken. As the inclusion criteria for the&#xD;
      patients; Being between 18 and 60 years of age, taking the diagnosis of primary FMS according&#xD;
      to ACR 1990 diagnostic criteria, accepting to participate in the study, lack of any sex&#xD;
      hormone disease. The control group will be composed of volunteers with similar age and gender&#xD;
      characteristics. The volunteers taken into the control group will have no sex hormone. The&#xD;
      participants will be informed about the subject before being taken into the study and the&#xD;
      necessary permits will be taken.&#xD;
&#xD;
      Semi-structured sociodemographic information form prepared by us will be used in accordance&#xD;
      with the clinical experience and the information obtained from the scanned sources and the&#xD;
      aims of the study (ANNEX-1) Age, gender, education level, marital status, BMI, family history&#xD;
      of fibromyalgia diseases and accompanying symptoms. Accompanied by the symptoms; TMD symptoms&#xD;
      such as migraine type headache, jaw pain and locking, sleep disorder, dry mouth, dry eyes,&#xD;
      irritable bowel symptoms, restless leg symptoms, soft tissue swelling, fatigue, depressive&#xD;
      symptoms or depression history will be questioned. Patients with headache will be evaluated&#xD;
      by a neurologist in terms of the diagnosis of migraine. Pain evaluation of the cases will be&#xD;
      done by Visual Analog Scale (VAS). A 10 cm ruler will be used for this. Patients will be&#xD;
      evaluated once and the appropriate amount of blood samples will be collected from the&#xD;
      patients after the evaluation.&#xD;
&#xD;
      Collection of Blood Samples: 5 mL blood samples from the control and patient groups will be&#xD;
      taken into sterile, citrate tubes. The blood in the tubes will be stored at -80 ° C until&#xD;
      isolation of the DNA.&#xD;
&#xD;
      Isolation of Genomic DNA: Genomic DNA will be isolated from the blood using a DNA isolation&#xD;
      kit. DNA purity will be determined by spectrophotometric method.&#xD;
&#xD;
      Genotyping: Genotyping of ESR-1 325 C&gt; G and 594 G&gt; A polymorphisms in the study group will&#xD;
      be performed by using single nucleotide polymorphism analysis kit and sequence-specific&#xD;
      double-dye hydrolysis probes and allelic segregation analysis in real-time polimerase chain&#xD;
      reaction (RT-PCR) using primers. Genotyping of each patient and control will be repeated 3&#xD;
      times to ensure the reliability of the analysis results.&#xD;
&#xD;
      Statistical methods: The number of individuals to be included in the study was determined by&#xD;
      Statistical Power Analysis. In this study, when α = 0.05, β = 0.10, 1- β = 0.90, it was&#xD;
      decided to take 100 individuals to each patient and control groups, and the strength of the&#xD;
      test was found to be p = 0.9072. All data obtained from the study will be evaluated with SPSS&#xD;
      18 program. The χ2 test and Student-t and Mann-Whitney tests will be used to evaluate the&#xD;
      suitability of nominal and continuous variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Actual">May 15, 2021</completion_date>
  <primary_completion_date type="Actual">April 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>polymorphism frequency</measure>
    <time_frame>9 month</time_frame>
    <description>The frequency of estrogen receptor alpha polymorphism in fibromyalgia and control group</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Fibromyalgia</arm_group_label>
    <description>100 participants diagnosed with fibromyalgia according to ACR 1990 criteria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ACR 1990 fibromyalgia critters</intervention_name>
    <description>ACR 1990 fibromyalgia critters</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Fibromyalgia</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Estrogen receptor alpha polymorphism&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Fibromyalgia: 100 person, Control: 100 person.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        ---Inclusion Criteria: As the inclusion criteria for the Fibromyalgia group ;&#xD;
&#xD;
          -  Being between 18 and 60 years of age,&#xD;
&#xD;
          -  Taking the diagnosis of primary FMS according to ACR 1990 diagnostic criteria,&#xD;
&#xD;
          -  Accepting to participate in the study&#xD;
&#xD;
        As the inclusion criteria for the Control group;&#xD;
&#xD;
          -  Being between 18 and 60 years of age,&#xD;
&#xD;
          -  Accepting to participate in the study&#xD;
&#xD;
          -  No diagnosis of fibromyalgia.&#xD;
&#xD;
             ---Exclusion Criteria:&#xD;
&#xD;
          -  Having any sex hormone disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>BOR Physical medicine and rehabilitaton hospital</name>
      <address>
        <city>Niğde</city>
        <zip>51000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Bradley LA, Alarcon GS. Fibromyalgia. In: Kopman WJ (ed). Arthritis and Allied Conditions. Philedelphia. Lippincott &amp; Williams &amp; Wilkins, 2001, 1811-44.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>2306288</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22246025</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11554952</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20959426</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>14979299</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>1558082</PMID>
  </reference>
  <reference>
    <citation>Clark S, Campbell SM, Forehand ME, Tindall EA, Bennett RM. Clinical characteristics of fibrositis. II. A &quot;blinded,&quot; controlled study using standard psychological tests. Arthritis Rheum. 1985 Feb;28(2):132-7. doi: 10.1002/art.1780280204.</citation>
    <PMID>3882093</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nigde Omer Halisdemir University</investigator_affiliation>
    <investigator_full_name>Ercan KAYDOK</investigator_full_name>
    <investigator_title>Assistant of Proffessor M.D. Ercan Kaydok</investigator_title>
  </responsible_party>
  <keyword>Fibromyalgia</keyword>
  <keyword>Migraine</keyword>
  <keyword>estrogen receptor alpha</keyword>
  <keyword>polymorphism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786393
org study id: Nigde O.H.U.
nct id: NCT03786393
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Objective: The fact that fibromyalgia and migraine are more common in women of reproductive
      age and their incidence are higher than other populations suggests that these three diseases
      may have a common genetic basis. Therefore, we aimed to investigate whether there is a
      relationship between ESR-1 594G> A (rs2228480), ESR-1 325C> G (rs2295190) polymorphisms and
      fibromyalgia disease.

      Introduction: Fibromyalgia syndrome (FMS), diffuse body pain, chronic musculoskeletal disease
      with increased fatigue and tenderness and sleep disorder in specific anatomical regions . The
      FMS diagnosis is based on American College of Rheumatology(ACR) 1990 classification criteria.
      FM frequently affects women between 30 and 50 years of age and its prevalence is between 1%
      and 4% of the whole population, 0-4% in men and 2.5-10.5% in women. Researchers have found
      that the strong familial tendency in FM has a risk of developing FM in first-degree relatives
      of patients with FM, 8 times more than in the general population. Family members of FM
      patients are more susceptible to pain and are more likely to develop conditions such as
      irritable bowel syndrome (IBS), temporomandibular disorder (TMD), headache-migraine, restless
      leg syndrome, and other regional pain syndromes . Several studies have been conducted to
      demonstrate specific genetic polymorphism in FM. To date, polymorphisms in the serotonin
      receptor, serotonin transporter, dopamine D4 receptor and catechol-O-methyltransferase genes
      have been found to be high . All these identified polymorphisms are responsible for the
      metabolism and transport of monoamines; These are compounds that play a critical role in the
      human stress response.

      The more frequent occurrence of FMS in women is observed in young adults, indicating the
      effect of sex hormones on the pathophysiology of this condition. However, the mechanism of
      action of these hormonal effects is still unknown and is a matter of debate. Steroid
      hormones, in particular estrogen, affect both peripheral and central nervous system (CNS)
      receptors (Estrogen Receptor-1; estrogen receptor-a [Era] and Estrogen Receptor-2;estrogen
      receptor-b [ERb]), the inflammatory process and the transmission of central pain. For
      example, estrogen may directly affect monocytes and macrophages to regulate the production of
      cytokines (eg, Interleukin-1 [IL-1], IL-6 and tumor necrosis factor-a [TNF-a]).

      Migraine is a neurological disorder characterized by episodes of hemicranial pain
      characterized by attacks. one-year prevalence of migraine in the general population in Turkey
      16.4%, while the proportion of patients with FM were significantly lower (9). The incidence
      of headache increased in patients with fibromyalgia syndrome. Migraine and non-migraine
      headaches have been reported in patients with FM between 28% and 58% . Similarly, in a study
      conducted on 33 FM patients, the current migraine was present at 45% and the lifetime
      migraine history was 55% . The prevalence of migraine has been reported to be approximately
      2-fold (reproductive period) and the severity of migraine attacks in women compared to men .
      Studies investigating the relationship between sex hormone levels and polymorphisms due to
      more frequent reproductive states have shown that they are associated with estrogen
      receptor-alpha (ERa 594G> A (rs2228480), ERa 325C> G (rs2295190) polymorphisms.

      Methods: Establishment of study groups: 100 patients diagnosed as Fibromyalgia syndrome
      according to the criteria of ACR 1990, 18-65 years old, and having similar sociodemographic
      characteristics. 100 control patients will be taken. As the inclusion criteria for the
      patients; 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, lack of any sex
      hormone disease. The control group will be composed of volunteers with similar age and gender
      characteristics. The volunteers taken into the control group will have no sex hormone. The
      participants will be informed about the subject before being taken into the study and the
      necessary permits will be taken.

      Semi-structured sociodemographic information form prepared by us will be used in accordance
      with the clinical experience and the information obtained from the scanned sources and the
      aims of the study (ANNEX-1) Age, gender, education level, marital status, BMI, family history
      of fibromyalgia diseases and accompanying symptoms. Accompanied by the symptoms; TMD symptoms
      such as migraine type headache, jaw pain and locking, sleep disorder, dry mouth, dry eyes,
      irritable bowel symptoms, restless leg symptoms, soft tissue swelling, fatigue, depressive
      symptoms or depression history will be questioned. Patients with headache will be evaluated
      by a neurologist in terms of the diagnosis of migraine. Pain evaluation of the cases will be
      done by Visual Analog Scale (VAS). A 10 cm ruler will be used for this. Patients will be
      evaluated once and the appropriate amount of blood samples will be collected from the
      patients after the evaluation.

      Collection of Blood Samples: 5 mL blood samples from the control and patient groups will be
      taken into sterile, citrate tubes. The blood in the tubes will be stored at -80 ° C until
      isolation of the DNA.

      Isolation of Genomic DNA: Genomic DNA will be isolated from the blood using a DNA isolation
      kit. DNA purity will be determined by spectrophotometric method.

      Genotyping: Genotyping of ESR-1 325 C> G and 594 G> A polymorphisms in the study group will
      be performed by using single nucleotide polymorphism analysis kit and sequence-specific
      double-dye hydrolysis probes and allelic segregation analysis in real-time polimerase chain
      reaction (RT-PCR) using primers. Genotyping of each patient and control will be repeated 3
      times to ensure the reliability of the analysis results.

      Statistical methods: The number of individuals to be included in the study was determined by
      Statistical Power Analysis. In this study, when α = 0.05, β = 0.10, 1- β = 0.90, it was
      decided to take 100 individuals to each patient and control groups, and the strength of the
      test was found to be p = 0.9072. All data obtained from the study will be evaluated with SPSS
      18 program. The χ2 test and Student-t and Mann-Whitney tests will be used to evaluate the
      suitability of nominal and continuous variables.
observational model: Cohort
time perspective: Cross-Sectional
measure: polymorphism frequency
time frame: 9 month
description: The frequency of estrogen receptor alpha polymorphism in fibromyalgia and control group
arm group label: Fibromyalgia
description: 100 participants diagnosed with fibromyalgia according to ACR 1990 criteria.
arm group label: Control
intervention type: Diagnostic Test
intervention name: ACR 1990 fibromyalgia critters
description: ACR 1990 fibromyalgia critters
arm group label: Control
arm group label: Fibromyalgia
Estrogen receptor alpha polymorphism
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
citation: Bradley LA, Alarcon GS. Fibromyalgia. In: Kopman WJ (ed). Arthritis and Allied Conditions. Philedelphia. Lippincott & Williams & Wilkins, 2001, 1811-44.
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Nigde Omer Halisdemir University
investigator full name: Ercan KAYDOK
investigator title: Assistant of Proffessor M.D. Ercan Kaydok
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No