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/NCT05983614</url>
    </required_header>
    <id_info>
      <org_study_id>2022/16-2</org_study_id>
      <nct_id>NCT05983614</nct_id>
    </id_info>
    <brief_title>Effects of Body Structures and Function on Actıvıty and Partıcıpatıon in Patıents wıth Carpal Tunnel Syndrome</brief_title>
    <official_title>Investigation of the Effects of Pain, Proprioception and Electrodiagnostic Findings on Activity and Participation in Patients With Idiopathic Carpal Tunnel Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kutahya Health Sciences University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kutahya Health Sciences University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of our study is to determine pain, sensation and electrodiagnostic findings in CTS;&#xD;
        to examine its effects on activity and participation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        50 patients aged 20-55 years diagnosed with mild and moderate carpal tunnel syndrome&#xD;
        according to AANEM will be included. VAS, LANSS, Boston Carpal Tunnel Questionnaire (Symptom&#xD;
        Severity Scale - Functional Status Scale), Q-DASH, hand grip sensitivity measurement, hand&#xD;
        pressure sensitivity measurement will be applied to the participants. In order to examine the&#xD;
        relationship between body structure and functions (Pain, Sensation, EMG findings) and&#xD;
        activity and participation with the AMOS program, the maximum likelihood method will be&#xD;
        selected and a structural equation model (SEM) will be established.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 5, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Leeds Assessment Neuropathic Symptoms and Signs (LANSS)</measure>
      <time_frame>7 minutes</time_frame>
      <description>Leeds Assessment Neuropathic Symptoms and Signs (LANSS) scale is a clinical-based tool for identifying pain and patients with predominant neuropathic mechanisms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Boston Carpal Tunnel Questionnaire</measure>
      <time_frame>12 minutes</time_frame>
      <description>It is a questionnaire used to evaluate symptom severity and functional status in individuals with carpal tunnel syndrome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Q-DASH</measure>
      <time_frame>10 minutes</time_frame>
      <description>Q-DASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proprioception Assessment</measure>
      <time_frame>7 minutes</time_frame>
      <description>Hand grip sensitivity will be measured with a dynamometer and hand pressure sensitivity will be measured with a Stabilizer Pressure Biofeedback (SBP) instrument.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analog Scale</measure>
      <time_frame>2 minutes</time_frame>
      <description>Evaluates the severity of pain, scoring between 0-10.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Carpal Tunnel Syndrome</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who applied to the Physical Therapy Department of Kutahya Health Sciences&#xD;
          University Hospital and were diagnosed with mild and moderate CTS according to the American&#xD;
          Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) will be invited to the&#xD;
          study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being diagnosed with mild-moderate CTS&#xD;
  &#xD;
            -  Being between the ages of 20-55&#xD;
  &#xD;
            -  Volunteering to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being diagnosed with severe CTS&#xD;
  &#xD;
            -  Have systemic inflammatory disease&#xD;
  &#xD;
            -  Having a disease that can cause polyneuropathy, such as diabetes mellitus&#xD;
  &#xD;
            -  Being receiving psychotherapy&#xD;
  &#xD;
            -  Illiteracy&#xD;
  &#xD;
            -  Have a hearing problem&#xD;
  &#xD;
            -  Have cognitive impairment&#xD;
  &#xD;
            -  Having a pacemaker&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Emrah Afsar, Phd</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kutahya Health Sciences University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ayse Kocak Sezgin, Phd</last_name>
      <phone>+90 5072243706</phone>
      <email>ayse.kocaksezgin@ksbu.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kutahya Health Science University</name>
        <address>
          <city>Kutahya</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emrah Afsar, Phd</last_name>
        <phone>5062527008</phone>
        <email>emrah.afsar@ksbu.edu.tr</email>
      </contact>
      <investigator>
        <last_name>Emrah Afsar, Phd</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Zeynep Sena Namaz</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Merve Akdeniz Leblebicier, Md</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kutahya Health Sciences University</investigator_affiliation>
      <investigator_full_name>Emrah Afsar</investigator_full_name>
      <investigator_title>Head of Occupational Therapy Deparment</investigator_title>
    </responsible_party>
    <keyword>Pain</keyword>
    <keyword>Proprioception</keyword>
    <keyword>Sensation</keyword>
    <keyword>EMG</keyword>
    <keyword>ICF</keyword>
    <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>
  
  
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/NCT05983614
  org study id: 2022/16-2
  nct id: NCT05983614
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of our study is to determine pain, sensation and electrodiagnostic findings in CTS;
        to examine its effects on activity and participation.
  50 patients aged 20-55 years diagnosed with mild and moderate carpal tunnel syndrome
        according to AANEM will be included. VAS, LANSS, Boston Carpal Tunnel Questionnaire (Symptom
        Severity Scale - Functional Status Scale), Q-DASH, hand grip sensitivity measurement, hand
        pressure sensitivity measurement will be applied to the participants. In order to examine the
        relationship between body structure and functions (Pain, Sensation, EMG findings) and
        activity and participation with the AMOS program, the maximum likelihood method will be
        selected and a structural equation model (SEM) will be established.
  observational model: Other
  time perspective: Prospective
  measure: Leeds Assessment Neuropathic Symptoms and Signs (LANSS)
  time frame: 7 minutes
  description: Leeds Assessment Neuropathic Symptoms and Signs (LANSS) scale is a clinical-based tool for identifying pain and patients with predominant neuropathic mechanisms.
  measure: Boston Carpal Tunnel Questionnaire
  time frame: 12 minutes
  description: It is a questionnaire used to evaluate symptom severity and functional status in individuals with carpal tunnel syndrome.
  measure: Q-DASH
  time frame: 10 minutes
  description: Q-DASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
  measure: Proprioception Assessment
  time frame: 7 minutes
  description: Hand grip sensitivity will be measured with a dynamometer and hand pressure sensitivity will be measured with a Stabilizer Pressure Biofeedback (SBP) instrument.
  measure: Visual Analog Scale
  time frame: 2 minutes
  description: Evaluates the severity of pain, scoring between 0-10.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 55 Years
  last name: Emrah Afsar, Phd
  role: Principal Investigator
  affiliation: Kutahya Health Sciences University
  last name: Ayse Kocak Sezgin, Phd
  phone: +90 5072243706
  email: ayse.kocaksezgin@ksbu.edu.tr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Kutahya Health Sciences University
  investigator full name: Emrah Afsar
  investigator title: Head of Occupational Therapy Deparment
  mesh term: Carpal Tunnel Syndrome
  mesh term: Syndrome