xml: <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/NCT06012630</url>
    </required_header>
    <id_info>
      <org_study_id>22/04/2022; 2011-KAEK-50;126</org_study_id>
      <nct_id>NCT06012630</nct_id>
    </id_info>
    <brief_title>Carpal Tunnel Syndrome Evaluation With Ultrasound in Rheumatoid Arthritis Patients</brief_title>
    <official_title>Ultrasound Evaluation of the Median Nerve in Patients With Rheumatoid Arthritis and Its Relationship With Disease Activity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Burak Tayyip Dede</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Training and Research Hospital</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>
        In rheumatoid arthritis (RA) patients, the diagnosis of Carpal tunnel syndrome (CTS) was made&#xD;
        based on clinical findings and physical examinations. Then, the cross-sectional areas of the&#xD;
        participants' median nerves from different levels were measured. Meidolateral and&#xD;
        anteroposterior diameter were measured at the level of the carpal tunnel inlet. Flattening&#xD;
        ratio was calculated. wrist to forearm ratio and wrist to forearm difference were calculated.&#xD;
        The obtained data were compared between RA with CTS, RA without CTS and healthy control.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 15, 2023</start_date>
    <completion_date type="Actual">August 15, 2023</completion_date>
    <primary_completion_date type="Actual">July 1, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>8 Months</target_duration>
    <primary_outcome>
      <measure>Comparison of US findings among participants</measure>
      <time_frame>6 months</time_frame>
      <description>Comparison of US findings among participants</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Relationship between US findings and disease activity in the patient group</measure>
      <time_frame>6 months</time_frame>
      <description>The correlation between the US findings of the participants in the patient group and the CDA, which evaluates disease activity, was examined.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">90</enrollment>
    <condition>Median Nerve Entrapment</condition>
    <arm_group>
      <arm_group_label>group 1: RA without CTS</arm_group_label>
      <description>Rheumatoid arthritis patients without a diagnosis of CTS based on clinical findings and physical examination</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group 2: RA with CTS</arm_group_label>
      <description>Rheumatoid arthritis patients with a diagnosis of CTS based on clinical findings and physical examination</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group:3 Healthy Control</arm_group_label>
      <description>Healthy Control without rheumatologic disease and Carpal tunnel syndrome</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Ultarsound</intervention_name>
      <description>Median nerve evaluation of participants with ultrasound</description>
      <arm_group_label>group 1: RA without CTS</arm_group_label>
      <arm_group_label>group 2: RA with CTS</arm_group_label>
      <arm_group_label>group:3 Healthy Control</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          RA patients identified according to the 2010 American College of Rheumatology/Europan Leage&#xD;
          Against Rheumatism classification criteria healthy controls (HC) with no history of&#xD;
          rheumatic diseases and CTS.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  RA patients identified according to the 2010 American College of Rheumatology/Europan&#xD;
               Leage Against Rheumatism classification criteria&#xD;
  &#xD;
            -  healthy controls (HC) with no history of rheumatic diseases and CTS.&#xD;
  &#xD;
            -  Individuals aged 18-65 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  thoese with hypothyroidism,&#xD;
  &#xD;
            -  gout,&#xD;
  &#xD;
            -  diabetes mellitus,&#xD;
  &#xD;
            -  history of CTS surgery,&#xD;
  &#xD;
            -  upper extremity plexopathy,&#xD;
  &#xD;
            -  polinöropathy,&#xD;
  &#xD;
            -  uncontrollable fibromyalgia,&#xD;
  &#xD;
            -  steroid injection for CTS&#xD;
  &#xD;
            -  For the HC group, those with phalen or tinnel detected in at least one wrist and those&#xD;
               with bifid median nerve detected during US evaluation were not included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Istanbul Training and Resarch Hospital</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Burak Tayyip Dede</investigator_full_name>
      <investigator_title>Physical Medicine and Rehabilitation</investigator_title>
    </responsible_party>
    <keyword>Rheumatoid arthritis</keyword>
    <keyword>Ultrasound</keyword>
    <keyword>Carpal Tunnel Syndrome</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
      <mesh_term>Arthritis, Rheumatoid</mesh_term>
      <mesh_term>Carpal Tunnel Syndrome</mesh_term>
      <mesh_term>Nerve Compression Syndromes</mesh_term>
      <mesh_term>Median Neuropathy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012630
  org study id: 22/04/2022; 2011-KAEK-50;126
  nct id: NCT06012630
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In rheumatoid arthritis (RA) patients, the diagnosis of Carpal tunnel syndrome (CTS) was made
        based on clinical findings and physical examinations. Then, the cross-sectional areas of the
        participants' median nerves from different levels were measured. Meidolateral and
        anteroposterior diameter were measured at the level of the carpal tunnel inlet. Flattening
        ratio was calculated. wrist to forearm ratio and wrist to forearm difference were calculated.
        The obtained data were compared between RA with CTS, RA without CTS and healthy control.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Comparison of US findings among participants
  time frame: 6 months
  description: Comparison of US findings among participants
  measure: Relationship between US findings and disease activity in the patient group
  time frame: 6 months
  description: The correlation between the US findings of the participants in the patient group and the CDA, which evaluates disease activity, was examined.
  arm group label: group 1: RA without CTS
  description: Rheumatoid arthritis patients without a diagnosis of CTS based on clinical findings and physical examination
  arm group label: group 2: RA with CTS
  description: Rheumatoid arthritis patients with a diagnosis of CTS based on clinical findings and physical examination
  arm group label: group:3 Healthy Control
  description: Healthy Control without rheumatologic disease and Carpal tunnel syndrome
  intervention type: Diagnostic Test
  intervention name: Ultarsound
  description: Median nerve evaluation of participants with ultrasound
  arm group label: group 1: RA without CTS
  arm group label: group 2: RA with CTS
  arm group label: group:3 Healthy Control
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Istanbul Training and Research Hospital
  investigator full name: Burak Tayyip Dede
  investigator title: Physical Medicine and Rehabilitation
  mesh term: Arthritis
  mesh term: Arthritis, Rheumatoid
  mesh term: Carpal Tunnel Syndrome
  mesh term: Nerve Compression Syndromes
  mesh term: Median Neuropathy
  sharing ipd: Yes