<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/NCT03757702</url>
  </required_header>
  <id_info>
    <org_study_id>43</org_study_id>
    <nct_id>NCT03757702</nct_id>
  </id_info>
  <brief_title>Trunk Position Sense, Postural Stability and Spinal Posture in Fibromyalgia</brief_title>
  <official_title>Investigation of Trunk Position Sense, Postural Stability and Posture in Fibromyalgia Patients and Healthy Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Yildirim Beyazıt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara Yildirim Beyazıt 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>
      This study aims to investigate trunk position sense, postural stability and spine posture in&#xD;
      fibromyalgia patients and healthy women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2018</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Joint Position Sense</measure>
    <time_frame>20 days</time_frame>
    <description>Trunk position sense will be evaluated with a digital inclinometer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postural Stability</measure>
    <time_frame>20 days</time_frame>
    <description>The postural stability will be evaluated with a special balance device in eyes opened and closed position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spinal Posture</measure>
    <time_frame>20 days</time_frame>
    <description>.The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Fibromyalgia</condition>
  <condition>Postural Lordosis</condition>
  <condition>Postural Kyphosis</condition>
  <condition>Proprioception</condition>
  <condition>Postural Stability</condition>
  <condition>Balance</condition>
  <arm_group>
    <arm_group_label>Fibromiyalgia group</arm_group_label>
    <description>women with FMS between 18-65 years of age and being volunteered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy group</arm_group_label>
    <description>healthy women and being volunteereed</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation</intervention_name>
    <description>Trunk position sense will be evaluated with a digital inclinometer. Trunk reposition test will be used in evaluation.The postural stability will be evaluated with a special balance device in eyes opened and closed position. Ellipse area (mm2) and perimeter (mm) parameters will be recorded.The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer.</description>
    <arm_group_label>Fibromiyalgia group</arm_group_label>
    <arm_group_label>Healthy group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy women and Fibromyalgia patient&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being women&#xD;
&#xD;
          -  having FMS&#xD;
&#xD;
          -  being volunteer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have neurologic, infectious, endocrine, and other severe psychological disorders&#xD;
&#xD;
          -  malignancy,&#xD;
&#xD;
          -  being pregnant&#xD;
&#xD;
          -  any condition interfering with evaluation (advanced cardiac respiratory or orthopedic&#xD;
             problems)&#xD;
&#xD;
          -  spinal deformities such as scoliosis, spine surgery&#xD;
&#xD;
          -  inflammatory rheumatic diseases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Özge Çoban</last_name>
    <role>Study Chair</role>
    <affiliation>Research Assitant</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ankara Yıldırım Beyazıt University</name>
      <address>
        <city>Ankara</city>
        <zip>06010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>January 19, 2019</last_update_submitted>
  <last_update_submitted_qc>January 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
    <mesh_term>Kyphosis</mesh_term>
    <mesh_term>Lordosis</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/NCT03757702
org study id: 43
nct id: NCT03757702
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate trunk position sense, postural stability and spine posture in
      fibromyalgia patients and healthy women.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Joint Position Sense
time frame: 20 days
description: Trunk position sense will be evaluated with a digital inclinometer.
measure: Postural Stability
time frame: 20 days
description: The postural stability will be evaluated with a special balance device in eyes opened and closed position.
measure: Spinal Posture
time frame: 20 days
description: .The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer.
arm group label: Fibromiyalgia group
description: women with FMS between 18-65 years of age and being volunteered.
arm group label: Healthy group
description: healthy women and being volunteereed
intervention type: Other
intervention name: Evaluation
description: Trunk position sense will be evaluated with a digital inclinometer. Trunk reposition test will be used in evaluation.The postural stability will be evaluated with a special balance device in eyes opened and closed position. Ellipse area (mm2) and perimeter (mm) parameters will be recorded.The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer.
arm group label: Fibromiyalgia group
arm group label: Healthy group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Özge Çoban
role: Study Chair
affiliation: Research Assitant
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Kyphosis
mesh term: Lordosis
sharing ipd: No