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/NCT05997823</url>
    </required_header>
    <id_info>
      <org_study_id>2023/11-08</org_study_id>
      <nct_id>NCT05997823</nct_id>
    </id_info>
    <brief_title>Dorsovolar Kinesiotape in Carpal Tunnel Syndrome</brief_title>
    <official_title>Is Dorso-Volar Kinesiotape Added to the Home Exercise Program Effective in the Treatment of Carpal Tunnel Syndrome?-Prospective Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Selcuk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Selcuk 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 aimed to compare the short- and medium-term efficacy of dorso-volar kinesiotape&#xD;
        (KT) added to home exercises (HE) with sham-KT and HE alone in the treatment of mild or&#xD;
        moderate carpal tunnel syndrome (CTS) in terms of pain, symptom severity, function, grip&#xD;
        strength, and electrophysiological parameters.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Actual">July 29, 2023</completion_date>
    <primary_completion_date type="Actual">July 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Electrodiagnostic Evaluation</measure>
      <time_frame>30 minutes</time_frame>
      <description>Superficial recording electrodes were placed in the abductor pollicis brevis (APB) muscles (recording stimulus distance 5 cm) for median nerve motor conduction and in the abductor digiti minimi (ADM) muscles (recording stimulus distance 5 cm) for ulnar nerve motor conduction.Superficial recording electrodes were placed on the 3rd finger for median nerve sensory conduction (recording stimulus distance 13 cm) and on the 5th finger for ulnar nerve sensory conduction (recording stimulus distance 11 cm).The ground electrode was placed between the recording and stimulus electrodes for all electrophysiological tests.Sensory latency, amplitude, and conduction velocity of the median nerve and motor latency, amplitude, and conduction velocity were recorded</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hand Strength</measure>
      <time_frame>10 minutes</time_frame>
      <description>A Jamar hand dynamometer (Baseline ® hydraulic hand dynamometer, Irvington, NY, USA) was used to measure handgrip strength.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain Evaluation</measure>
      <time_frame>5 minutes</time_frame>
      <description>A 10-point visual analog scale (VAS) was used to rate pain. Patients were asked to rate the pain they felt at rest, at night, and with movement with a number ranging from 0 (no pain) to 10 (very severe), VAS movement, VAS night, and VAS rest</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Finger Strength</measure>
      <time_frame>10 minutes</time_frame>
      <description>A pinch meter (Baseline ® hydraulic pinch gauge, Irvington, NY, USA) was used to evaluate lateral grip strength (LGS) and pinch grip strength</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">120</enrollment>
    <condition>Carpal Tunnel Syndrome Treatment</condition>
    <arm_group>
      <arm_group_label>home exercises</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>sham-KT and home exercises</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>dorso-volar KT and home exercises</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>kinesiotape</intervention_name>
      <description>The button hole technique was used for area correction during the KT application (Figure 1). Two I-tapes were applied, one from the medial epicondyle to the proximal phalanx on the palmar side and the other from the lateral epicondyle to the proximal phalanx on the dorsal side. The area where the phalanges are located was marked, and two hole was drilled in the center.After cleaning the skin with alcohol, the tape to be applied to the palmar side was passed over the 3rd and 4th fingers, and the patient was asked to perform radial deviation and wrist extension</description>
      <arm_group_label>dorso-volar KT and home exercises</arm_group_label>
      <arm_group_label>sham-KT and home exercises</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>home exercises</intervention_name>
      <description>home exercises</description>
      <arm_group_label>dorso-volar KT and home exercises</arm_group_label>
      <arm_group_label>home exercises</arm_group_label>
      <arm_group_label>sham-KT and home exercises</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  pain or numbness radiating to the palm for at least 6 weeks,&#xD;
  &#xD;
            -  at least one positive Tinel's, Phalen's, or carpal compression test on physical&#xD;
               examination, and&#xD;
  &#xD;
            -  mild/moderate CTS on EMG examination.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Metabolic disease (diabetes, rheumatoid arthritis, thyroid disease),&#xD;
  &#xD;
            -  systemic or malignant disease, history of trauma, fracture or surgery to the wrist,&#xD;
  &#xD;
            -  physical therapy programs, surgical procedures, injections or KT applications to the&#xD;
               wrist for CTS treatment in the past year,&#xD;
  &#xD;
            -  severe thenar atrophy,&#xD;
  &#xD;
            -  C6-C7 radiculopathy among CTS differential diagnoses,&#xD;
  &#xD;
            -  cervical spondylosis, thoracic outlet syndrome, entrapment of the median nerve above&#xD;
               the wrist,&#xD;
  &#xD;
            -  polyneuropathy or traumatic injury to the median nerve,&#xD;
  &#xD;
            -  rashes or open wounds on the skin of the wrist and forearm that could prevent&#xD;
               treatment with kinesiology taping&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Health Sciences University, Kocaeli Derince Training and Research Hospital</name>
        <address>
          <city>Kocaeli</city>
          <state>Deince</state>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Selcuk University</investigator_affiliation>
      <investigator_full_name>Emine Cihan</investigator_full_name>
      <investigator_title>Asst. Prof</investigator_title>
    </responsible_party>
    <keyword>carpal tunnel syndromes</keyword>
    <keyword>kinesiotape</keyword>
    <keyword>electromyography</keyword>
    <keyword>median neuropathy</keyword>
    <keyword>muscle strength</keyword>
    <keyword>pain</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>
    <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/NCT05997823
  org study id: 2023/11-08
  nct id: NCT05997823
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to compare the short- and medium-term efficacy of dorso-volar kinesiotape
        (KT) added to home exercises (HE) with sham-KT and HE alone in the treatment of mild or
        moderate carpal tunnel syndrome (CTS) in terms of pain, symptom severity, function, grip
        strength, and electrophysiological parameters.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Electrodiagnostic Evaluation
  time frame: 30 minutes
  description: Superficial recording electrodes were placed in the abductor pollicis brevis (APB) muscles (recording stimulus distance 5 cm) for median nerve motor conduction and in the abductor digiti minimi (ADM) muscles (recording stimulus distance 5 cm) for ulnar nerve motor conduction.Superficial recording electrodes were placed on the 3rd finger for median nerve sensory conduction (recording stimulus distance 13 cm) and on the 5th finger for ulnar nerve sensory conduction (recording stimulus distance 11 cm).The ground electrode was placed between the recording and stimulus electrodes for all electrophysiological tests.Sensory latency, amplitude, and conduction velocity of the median nerve and motor latency, amplitude, and conduction velocity were recorded
  measure: Hand Strength
  time frame: 10 minutes
  description: A Jamar hand dynamometer (Baseline ® hydraulic hand dynamometer, Irvington, NY, USA) was used to measure handgrip strength.
  measure: Pain Evaluation
  time frame: 5 minutes
  description: A 10-point visual analog scale (VAS) was used to rate pain. Patients were asked to rate the pain they felt at rest, at night, and with movement with a number ranging from 0 (no pain) to 10 (very severe), VAS movement, VAS night, and VAS rest
  measure: Finger Strength
  time frame: 10 minutes
  description: A pinch meter (Baseline ® hydraulic pinch gauge, Irvington, NY, USA) was used to evaluate lateral grip strength (LGS) and pinch grip strength
  arm group label: home exercises
  arm group type: Active Comparator
  arm group label: sham-KT and home exercises
  arm group type: Experimental
  arm group label: dorso-volar KT and home exercises
  arm group type: Experimental
  intervention type: Other
  intervention name: kinesiotape
  description: The button hole technique was used for area correction during the KT application (Figure 1). Two I-tapes were applied, one from the medial epicondyle to the proximal phalanx on the palmar side and the other from the lateral epicondyle to the proximal phalanx on the dorsal side. The area where the phalanges are located was marked, and two hole was drilled in the center.After cleaning the skin with alcohol, the tape to be applied to the palmar side was passed over the 3rd and 4th fingers, and the patient was asked to perform radial deviation and wrist extension
  arm group label: dorso-volar KT and home exercises
  arm group label: sham-KT and home exercises
  intervention type: Other
  intervention name: home exercises
  description: home exercises
  arm group label: dorso-volar KT and home exercises
  arm group label: home exercises
  arm group label: sham-KT and home exercises
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Selcuk University
  investigator full name: Emine Cihan
  investigator title: Asst. Prof
  mesh term: Carpal Tunnel Syndrome
  mesh term: Syndrome
  sharing ipd: No