<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/NCT03033173</url>
  </required_header>
  <id_info>
    <org_study_id>TCRD-TPE-102-05</org_study_id>
    <nct_id>NCT03033173</nct_id>
  </id_info>
  <brief_title>Ratio of the Cross Sectional Area of Median Nerve to Ulnar Nerve in Diagnosing Carpal Tunnel Syndrome</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</source>
  <brief_summary>
    <textblock>
      An innovative diagnostic ultrasound method for carpal tunnel syndrome was proposed and&#xD;
      compared between carpal tunnel syndrome patients and healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Sonographical findings between hands with CTS and healthy hands</measure>
    <time_frame>Within one week after ultrasound examination</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">74</enrollment>
  <condition>An Innovative Diagnostic Method for Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>CTS group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        CTS patients were recruited from the Physical Medicine and Rehabilitation Department of&#xD;
        Taipei Tzu Chi hospital.&#xD;
&#xD;
        Healthy subjects were recruited from hospital staff, health volunteers and their friends.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CTS patients were required to have subjective symptoms of numbness, tingling pain, or&#xD;
             dysesthesia over the median nerve innervated area of the involved hand.&#xD;
&#xD;
          -  Patients should have positive response in either Tinel's test or Phalen's test during&#xD;
             physical examination&#xD;
&#xD;
          -  Evidence of median neuropathy at wrist level in NCS.&#xD;
&#xD;
          -  Control subjects should have neither symptoms nor signs of CTS along with no abnormal&#xD;
             findings in electrodiagnostic study of the median nerve and the ulnar nerve across the&#xD;
             wrist joint.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age younger than 20 years old&#xD;
&#xD;
          -  Electrodiagnostic evidence of ulnar neuropathy at the wrist level&#xD;
&#xD;
          -  Previous trauma or surgery history of hand&#xD;
&#xD;
          -  Medical history of hypothyroidism, diabetes mellitus, uremia, rheumatoid arthritis,&#xD;
             amyloidosis, and acromegaly&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</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>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT03033173
org study id: TCRD-TPE-102-05
nct id: NCT03033173
lead sponsor: 
An innovative diagnostic ultrasound method for carpal tunnel syndrome was proposed and
      compared between carpal tunnel syndrome patients and healthy volunteers.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Sonographical findings between hands with CTS and healthy hands
time frame: Within one week after ultrasound examination
arm group label: CTS group
arm group label: Healthy subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome