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/NCT05969093</url>
    </required_header>
    <id_info>
      <org_study_id>012/TINEL2023</org_study_id>
      <nct_id>NCT05969093</nct_id>
    </id_info>
    <brief_title>Refining the Interpretation of the Tinel's Sign for Carpal Tunnel Syndrome</brief_title>
    <official_title>Refining the Interpretation of the Tinel's Sign for Carpal Tunnel Syndrome: An Electromyographic and Nerve Conduction Velocity Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ahram Canadian University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ahram Canadian 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>
        This is an observational study to investigate the electromyographic (EMG) activity and nerve&#xD;
        conduction velocity (NCV) of healthy individuals during the Tinel's Sign performed at&#xD;
        different wrist positions. The study aims to identify the wrist position that best isolates&#xD;
        median nerve activity during the Tinel's Sign.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be conducted in a controlled laboratory setting, equipped with an&#xD;
        electromyography (EMG) machine and a nerve conduction velocity (NCV) measurement device. We&#xD;
        will recruit 30 healthy adults, aged 18-45 years, with no history of hand or wrist pain,&#xD;
        neurological or muscular disorders. Participants will be excluded if they have any&#xD;
        contraindications to EMG or NCV measurement. The independent variable will be the wrist&#xD;
        position during the Tinel's Sign, and the dependent variables will be the EMG activity of the&#xD;
        thenar and hypothenar muscles and the NCV of the median and ulnar nerves. EMG activity will&#xD;
        be measured using surface electrodes placed on the thenar and hypothenar muscles. NCV will be&#xD;
        measured using a standard NCV measurement device. To minimize bias, the same trained examiner&#xD;
        will perform all tests and measurements, and the examiner will be blinded to the EMG and NCV&#xD;
        data during the tests. Differences in EMG activity and NCV across different wrist positions&#xD;
        will be analyzed using repeated measures ANOVA. Post-hoc pairwise comparisons will be&#xD;
        performed using Bonferroni correction. The study protocol will be submitted to the local&#xD;
        ethics committee for approval, and all participants will provide informed consent.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 29, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 23, 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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>EMG activity of the thenar muscles during the Tinel's Sign performed at different wrist positions.</measure>
      <time_frame>Baseline</time_frame>
      <description>The amplitude of EMG activity of the thenar muscles will be measured during the Tinel's Sign performed at different wrist positions. The amplitude will be quantified in microvolts (µV).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EMG activity of the hypothenar muscles during the Tinel's Sign performed at different wrist positions.</measure>
      <time_frame>Baseline</time_frame>
      <description>The amplitude of EMG activity of the hypothenar muscles will be measured during the Tinel's Sign performed at different wrist positions. The amplitude will be quantified in microvolts (µV).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Nerve conduction velocity of the median nerve during the Tinel's Sign performed at different wrist positions.</measure>
      <time_frame>Baseline</time_frame>
      <description>The NCV of the median nerve will be measured during the Tinel's Sign performed at different wrist positions. The NCV will be quantified in meters per second (m/s).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Nerve conduction velocity of the ulnar nerve during the Tinel's Sign performed at different wrist positions.</measure>
      <time_frame>Baseline</time_frame>
      <description>The NCV of the ulnar nerve will be measured during the Tinel's Sign performed at different wrist positions. The NCV will be quantified in meters per second (m/s).</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Carpal Tunnel Syndrome</condition>
    <arm_group>
      <arm_group_label>Healthy individuals</arm_group_label>
      <description>Participants will undergo the Tinel's Sign at different wrist positions while EMG activity and NCV are recorded.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Tinel's Sign performed at different wrist positions</intervention_name>
      <description>Participants will undergo the Tinel's Sign at different wrist positions while EMG activity and NCV are recorded to investigate the effect of wrist position on median nerve activity.</description>
      <arm_group_label>Healthy individuals</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy individuals aged 18-60 years&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy individuals aged 18-45 years&#xD;
  &#xD;
            -  No history of hand or wrist pain, neurological or muscular disorders&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any contraindications to EMG or NCV measurement&#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>
    <overall_official>
      <last_name>Amal Fawzy, Ph.d</last_name>
      <role>Study Chair</role>
      <affiliation>Faculty of Physical Therapy, Ahram Canadian University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mohamed M ElMeligie, Ph.d</last_name>
      <phone>+201064442032</phone>
      <email>mohamed.elmeligie@acu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Outpatient clinic of faculty of physical therapy, Ahram Canadian University</name>
        <address>
          <city>Al Ḩayy Ath Thāmin</city>
          <state>Giza</state>
          <zip>3221405</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mohamed M ElMeligie, Ph.d</last_name>
        <phone>01064442032</phone>
        <email>mohamed.elmeligie@acu.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 22, 2023</last_update_submitted>
    <last_update_submitted_qc>July 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ahram Canadian University</investigator_affiliation>
      <investigator_full_name>Mohamed Magdy ElMeligie</investigator_full_name>
      <investigator_title>Lecturer of Physical Therapy and Director of Electromyography Lab</investigator_title>
    </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>
    <patient_data>
      <sharing_ipd>No</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/NCT05969093
  org study id: 012/TINEL2023
  nct id: NCT05969093
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is an observational study to investigate the electromyographic (EMG) activity and nerve
        conduction velocity (NCV) of healthy individuals during the Tinel's Sign performed at
        different wrist positions. The study aims to identify the wrist position that best isolates
        median nerve activity during the Tinel's Sign.
  The study will be conducted in a controlled laboratory setting, equipped with an
        electromyography (EMG) machine and a nerve conduction velocity (NCV) measurement device. We
        will recruit 30 healthy adults, aged 18-45 years, with no history of hand or wrist pain,
        neurological or muscular disorders. Participants will be excluded if they have any
        contraindications to EMG or NCV measurement. The independent variable will be the wrist
        position during the Tinel's Sign, and the dependent variables will be the EMG activity of the
        thenar and hypothenar muscles and the NCV of the median and ulnar nerves. EMG activity will
        be measured using surface electrodes placed on the thenar and hypothenar muscles. NCV will be
        measured using a standard NCV measurement device. To minimize bias, the same trained examiner
        will perform all tests and measurements, and the examiner will be blinded to the EMG and NCV
        data during the tests. Differences in EMG activity and NCV across different wrist positions
        will be analyzed using repeated measures ANOVA. Post-hoc pairwise comparisons will be
        performed using Bonferroni correction. The study protocol will be submitted to the local
        ethics committee for approval, and all participants will provide informed consent.
  observational model: Other
  time perspective: Cross-Sectional
  measure: EMG activity of the thenar muscles during the Tinel's Sign performed at different wrist positions.
  time frame: Baseline
  description: The amplitude of EMG activity of the thenar muscles will be measured during the Tinel's Sign performed at different wrist positions. The amplitude will be quantified in microvolts (µV).
  measure: EMG activity of the hypothenar muscles during the Tinel's Sign performed at different wrist positions.
  time frame: Baseline
  description: The amplitude of EMG activity of the hypothenar muscles will be measured during the Tinel's Sign performed at different wrist positions. The amplitude will be quantified in microvolts (µV).
  measure: Nerve conduction velocity of the median nerve during the Tinel's Sign performed at different wrist positions.
  time frame: Baseline
  description: The NCV of the median nerve will be measured during the Tinel's Sign performed at different wrist positions. The NCV will be quantified in meters per second (m/s).
  measure: Nerve conduction velocity of the ulnar nerve during the Tinel's Sign performed at different wrist positions.
  time frame: Baseline
  description: The NCV of the ulnar nerve will be measured during the Tinel's Sign performed at different wrist positions. The NCV will be quantified in meters per second (m/s).
  arm group label: Healthy individuals
  description: Participants will undergo the Tinel's Sign at different wrist positions while EMG activity and NCV are recorded.
  intervention type: Diagnostic Test
  intervention name: Tinel's Sign performed at different wrist positions
  description: Participants will undergo the Tinel's Sign at different wrist positions while EMG activity and NCV are recorded to investigate the effect of wrist position on median nerve activity.
  arm group label: Healthy individuals
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Amal Fawzy, Ph.d
  role: Study Chair
  affiliation: Faculty of Physical Therapy, Ahram Canadian University
  last name: Mohamed M ElMeligie, Ph.d
  phone: +201064442032
  email: mohamed.elmeligie@acu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ahram Canadian University
  investigator full name: Mohamed Magdy ElMeligie
  investigator title: Lecturer of Physical Therapy and Director of Electromyography Lab
  mesh term: Carpal Tunnel Syndrome
  mesh term: Syndrome
  sharing ipd: No