<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/NCT03794219</url>
  </required_header>
  <id_info>
    <org_study_id>E10654</org_study_id>
    <nct_id>NCT03794219</nct_id>
  </id_info>
  <brief_title>Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis?</brief_title>
  <official_title>Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis? A Randomized-single Blind Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara Education and Research Hospital</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>
      Lateral epicondylitis (LE) is the most frequent painful musculoskeletal condition, which is&#xD;
      characterized by a pain in the lateral epicondyle of the humerus and the common extensor&#xD;
      tendon. The incidence of LE is approximately one to three percent of general population. LE&#xD;
      is mostly the result of the overuse and repetitive movements of wrists and hands because of&#xD;
      occupational or recreational activities. Diagnosis depends on clinical symptoms, history and&#xD;
      physical examination including manual provocation tests. Magnetic resonance imaging,&#xD;
      ultrasound (US), x-ray and electrophysiological assessment may be used in patient who do not&#xD;
      response to conservative treatments. It is known that the radial nerve cross sectional-areas&#xD;
      (CSAs) are increased in cases of refractory LE, although nerve conduction studies are normal.&#xD;
      There is insufficient evidence to prove the superiority of any of conservative treatments to&#xD;
      the others in patients with LE. The literature indicates that Kinesio taping decreases pain&#xD;
      intensity, recovers grip strength, and improves functional status in patients with LE. The&#xD;
      investigators design a randomized, single-blind, controlled trail to evaluate the effects of&#xD;
      Kinesio taping both clinical and using ultrasonography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining written informed consent, patients of clinically diagnosed with LE are&#xD;
      randomized into intervention and control group. To all patients, activity modification is&#xD;
      suggested and 750 mg/day oral naproxen is administered for 10 days. Additionally, in&#xD;
      intervention group, kinesio tape was applied 3 times a week for 2 weeks with a total of 6&#xD;
      sessions. The primary outcome is visual analog scale (VAS) and secondary outcomes include the&#xD;
      Patient-Rated Forearm Evaluation Questionnare (PRTEQ), CET thickness and radial nerve CSAs.&#xD;
      The evaluation was performed pretreatment as well as on the 2nd week, and 6th week after the&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 7, 2019</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of pain on 2nd and 6th weeks</measure>
    <time_frame>Pre-treatment, 2nd and 6th weeks after treatment</time_frame>
    <description>Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. The VAS is a straight horizontal line of fixed length, 10cm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst, 0) to the right (best, 10).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of functional status on 2nd and 6th weeks</measure>
    <time_frame>Pre-treatment, 2nd and 6th weeks after treatment</time_frame>
    <description>Using Patient-Rated Forearm Evaluation Questionnare (PRTEQ) to evaluate functional status. The PRTEQ is a 15-item questionnaire which has two subscale: pain subscale and function subscale.. It is shown to be a reliable and valid tool for measuring pain and function in patients with LE. Pain subscale is comprised of 5 questions, and function subscale is comprised of 10 questions. The total score is calculated by the sum of these two subscales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of common extensor tendon (CET) thickness on 2nd and 6th weeks</measure>
    <time_frame>Pre-treatment, 2nd and 6th weeks after treatment.</time_frame>
    <description>Using the musculoskeletal ultrasonography to measure CET thickness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of radial nerve cross-sectional area (CSA) on 2nd and 6th weeks</measure>
    <time_frame>Pre-treatment, 2nd and 6th weeks after treatment.</time_frame>
    <description>Using the musculoskeletal ultrasonography to measure radial nerve cross-sectional area. Measurements of radial nerve CSA is taken from three different levels: spiral grove, just before bifurcation and between the two heads of supinator muscle (CSA)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Lateral Epicondylitis</condition>
  <arm_group>
    <arm_group_label>Kinesio tape plus NSAID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions in addition to 750 mg/day oral naproxen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NSAID</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>750 mg/day oral naproxen is administered for 10 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesio Tape</intervention_name>
    <description>To all patients,750 mg/day oral naproxen is administered for 10 days. Additionally, in intervention group kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions.</description>
    <arm_group_label>Kinesio tape plus NSAID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral naproxen</intervention_name>
    <description>750 mg/day oral naproxen is administered for 10 days.</description>
    <arm_group_label>Kinesio tape plus NSAID</arm_group_label>
    <arm_group_label>NSAID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the presence of pain in the lateral elbow region at least for three months&#xD;
&#xD;
          -  tenderness around the lateral humeral epicondyle following at least one of these&#xD;
             provocation tests: resisted wrist extension, resisted middle finger extension or&#xD;
             passive stretch of wrist extensors.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bilateral LE&#xD;
&#xD;
          -  presence of trigger point in the extensor muscles of the forearm&#xD;
&#xD;
          -  history of proximal upper extremity or neck symptoms&#xD;
&#xD;
          -  cervical pathology&#xD;
&#xD;
          -  central or peripheral neurologic disease&#xD;
&#xD;
          -  nerve entrapment syndromes&#xD;
&#xD;
          -  surgical treatments for LE&#xD;
&#xD;
          -  presence of condition that may prevent the patient using NSAIDs (i.e. gastrointestinal&#xD;
             disorders, using anticoagulant)&#xD;
&#xD;
          -  trauma history of upper extremity&#xD;
&#xD;
          -  previous steroid injection around the lateral epicondyle&#xD;
&#xD;
          -  physical therapy targeted for LE in the past 6 months&#xD;
&#xD;
          -  presence of structures like fibrous bands, arc or recurrent radial artery around the&#xD;
             radial nerve that may cause the entrapment of nerve&#xD;
&#xD;
          -  pregnancy and having any systemic disease that may cause swelling at nerves such as&#xD;
             diabetes mellitus, renal insufficiency, thyroid disease or rheumatic disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Basak Mansiz-Kaplan</name>
      <address>
        <city>Ankara</city>
        <zip>06230</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>September 19, 2019</last_update_submitted>
  <last_update_submitted_qc>September 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Basak Mansiz-Kaplan</investigator_full_name>
    <investigator_title>Principal Investigator of Department of Physical Medicine and Rehabilitation</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naproxen</mesh_term>
  </intervention_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/NCT03794219
org study id: E10654
nct id: NCT03794219
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Lateral epicondylitis (LE) is the most frequent painful musculoskeletal condition, which is
      characterized by a pain in the lateral epicondyle of the humerus and the common extensor
      tendon. The incidence of LE is approximately one to three percent of general population. LE
      is mostly the result of the overuse and repetitive movements of wrists and hands because of
      occupational or recreational activities. Diagnosis depends on clinical symptoms, history and
      physical examination including manual provocation tests. Magnetic resonance imaging,
      ultrasound (US), x-ray and electrophysiological assessment may be used in patient who do not
      response to conservative treatments. It is known that the radial nerve cross sectional-areas
      (CSAs) are increased in cases of refractory LE, although nerve conduction studies are normal.
      There is insufficient evidence to prove the superiority of any of conservative treatments to
      the others in patients with LE. The literature indicates that Kinesio taping decreases pain
      intensity, recovers grip strength, and improves functional status in patients with LE. The
      investigators design a randomized, single-blind, controlled trail to evaluate the effects of
      Kinesio taping both clinical and using ultrasonography.
After obtaining written informed consent, patients of clinically diagnosed with LE are
      randomized into intervention and control group. To all patients, activity modification is
      suggested and 750 mg/day oral naproxen is administered for 10 days. Additionally, in
      intervention group, kinesio tape was applied 3 times a week for 2 weeks with a total of 6
      sessions. The primary outcome is visual analog scale (VAS) and secondary outcomes include the
      Patient-Rated Forearm Evaluation Questionnare (PRTEQ), CET thickness and radial nerve CSAs.
      The evaluation was performed pretreatment as well as on the 2nd week, and 6th week after the
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change from baseline of pain on 2nd and 6th weeks
time frame: Pre-treatment, 2nd and 6th weeks after treatment
description: Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. The VAS is a straight horizontal line of fixed length, 10cm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst, 0) to the right (best, 10).
measure: Change from baseline of functional status on 2nd and 6th weeks
time frame: Pre-treatment, 2nd and 6th weeks after treatment
description: Using Patient-Rated Forearm Evaluation Questionnare (PRTEQ) to evaluate functional status. The PRTEQ is a 15-item questionnaire which has two subscale: pain subscale and function subscale.. It is shown to be a reliable and valid tool for measuring pain and function in patients with LE. Pain subscale is comprised of 5 questions, and function subscale is comprised of 10 questions. The total score is calculated by the sum of these two subscales.
measure: Change from baseline of common extensor tendon (CET) thickness on 2nd and 6th weeks
time frame: Pre-treatment, 2nd and 6th weeks after treatment.
description: Using the musculoskeletal ultrasonography to measure CET thickness.
measure: Change from baseline of radial nerve cross-sectional area (CSA) on 2nd and 6th weeks
time frame: Pre-treatment, 2nd and 6th weeks after treatment.
description: Using the musculoskeletal ultrasonography to measure radial nerve cross-sectional area. Measurements of radial nerve CSA is taken from three different levels: spiral grove, just before bifurcation and between the two heads of supinator muscle (CSA)
arm group label: Kinesio tape plus NSAID
arm group type: Experimental
description: Kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions in addition to 750 mg/day oral naproxen.
arm group label: NSAID
arm group type: Active Comparator
description: 750 mg/day oral naproxen is administered for 10 days.
intervention type: Other
intervention name: Kinesio Tape
description: To all patients,750 mg/day oral naproxen is administered for 10 days. Additionally, in intervention group kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions.
arm group label: Kinesio tape plus NSAID
intervention type: Drug
intervention name: oral naproxen
description: 750 mg/day oral naproxen is administered for 10 days.
arm group label: Kinesio tape plus NSAID
arm group label: NSAID
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ankara Education and Research Hospital
investigator full name: Basak Mansiz-Kaplan
investigator title: Principal Investigator of Department of Physical Medicine and Rehabilitation
mesh term: Tennis Elbow
mesh term: Naproxen