<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/NCT04498533</url>
  </required_header>
  <id_info>
    <org_study_id>127/29.05.2014</org_study_id>
    <nct_id>NCT04498533</nct_id>
  </id_info>
  <brief_title>Bracing or Kinesio Taping in The Management of Lateral Epicondylitis</brief_title>
  <official_title>Bracing or Kinesio Taping in The Management of Lateral Epicondylitis: a Randomized Single-blinded Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haseki Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haseki Training and Research Hospital</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>
      Lateral epicondylitis is an overuse syndrome of the forearm, which is associated with pain&#xD;
      and sensitivity in the lateral elbow region.&#xD;
&#xD;
      The aim of the study was to find out about is there any difference between the effects of&#xD;
      traditional orthotic devices and adhesive taping, in the management of lateral epicondylitis.&#xD;
      Therefore, the forearm counterforce brace, which was widely used in daily clinical practice&#xD;
      for lateral epicondylitis, was compared with kinesio tape, a new technique of adhesive taping&#xD;
      which has become increasingly popular. The study investigated and compared the effects of the&#xD;
      two interventions (the forearm counterforce brace and kinesio tape) on pain severity,&#xD;
      functional status and disability of patients with lateral epicondylitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2014</start_date>
  <completion_date type="Actual">January 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</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>
    <intervention_model_description>A prospective, randomized and assessor-blinded study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcome-assessing investigator (O. Celik) was blinded to the randomization. All study participants were assessed by the blinded investigator (O.Celik). Follow-up measurements were performed immediately after and one month later after treatment. All treatment sessions were applied by the same investigator (S. Sencan), who was not blinded to the study groups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Pressure Threshold</measure>
    <time_frame>Baseline to 3 week (İmmediately after treatment)</time_frame>
    <description>The tenderness on the lateral aspect of elbow was evaluated with pain pressure threshold measurements. An algometer device was used to measure pain pressure threshold. Pain pressure threshold measurements were performed at the baseline of the study, immediately after and one month later after treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Grip Strength</measure>
    <time_frame>Baseline to 3 week (İmmediately after treatment)</time_frame>
    <description>Affected upper limb function was evaluated with maximal hand grip strength. Grip strength was measured with a hydraulic hand dynamometer. Grip strength was evaluated at the baseline of the study, immediately after and one month later after treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-Rated Tennis Elbow Evaluation Questionnaire</measure>
    <time_frame>0 week (Baseline), 3 week (After treatment), 7 week (One month later after treatment)</time_frame>
    <description>The Turkish version of Patient-Rated Tennis Elbow Evaluation Questionnaire was used in the study. Patient-Rated Tennis Elbow Evaluation Questionnaire is a 15-item self-reported questionnaire to measure perceived pain and disability in people with tennis elbow.&#xD;
The questionnaire is composed of three subscales: pain, usual activities and specific activities. Each of the items of the Patient-Rated Tennis Elbow Evaluation Questionnaire is scored on a 0-10 scale, where 0 is 'no pain' or 'no difficulty' and 10 is 'worst ever' or 'unable to do'. The total score ranges from 0 to 100, where high scores indicate greater pain and disability.&#xD;
Patient-Rated Tennis Elbow Evaluation Questionnaire was evaluated at the baseline of the study, immediately after and one month later after treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Lateral Epicondylitis (Tennis Elbow)</condition>
  <arm_group>
    <arm_group_label>B (brace) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients in the B group were informed about the application of the forearm strap (counterforce brace). Patients were advised to wear the counterforce brace for three weeks continuously.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KT (kinesio tape) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the KT group, a standard 2-inch (5 cm) Kinesio®Tex tape (Kinesio Holding Corporation, Albuquerque, New Mexico, USA) was used with techniques of muscle inhibition and fascia correction. Kinesio tape was applied once a week for four weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>forearm strap (counterforce brace)</intervention_name>
    <arm_group_label>B (brace) group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesio tape application</intervention_name>
    <arm_group_label>KT (kinesio tape) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged between 18 and 65 years&#xD;
&#xD;
          -  presence of elbow pain lasting for less than three months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of acute trauma or fracture on forearm&#xD;
&#xD;
          -  congenital or acquired elbow deformities&#xD;
&#xD;
          -  demyelinating diseases&#xD;
&#xD;
          -  patients who had diagnosed as fibromyalgia&#xD;
&#xD;
          -  presence of skin lesion on lateral aspect of the elbow&#xD;
&#xD;
          -  presence of rheumatic disease&#xD;
&#xD;
          -  presence of systemic infection&#xD;
&#xD;
          -  presence of pregnancy&#xD;
&#xD;
          -  presence of malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Öznur Çelik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Health Sciences, Istanbul Haseki Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Health Sciences, Istanbul Haseki Training and Research Hospital</name>
      <address>
        <city>İstanbul</city>
        <zip>34130</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Struijs PA, Smidt N, Arola H, Dijk vC, Buchbinder R, Assendelft WJ. Orthotic devices for the treatment of tennis elbow. Cochrane Database Syst Rev. 2002;(1):CD001821. doi: 10.1002/14651858.CD001821.</citation>
    <PMID>11869609</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 2, 2020</last_update_submitted>
  <last_update_submitted_qc>August 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Haseki Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Öznur Çelik</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Lateral epicondylitis</keyword>
  <keyword>forearm counterforce brace</keyword>
  <keyword>kinesio taping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04498533
org study id: 127/29.05.2014
nct id: NCT04498533
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lateral epicondylitis is an overuse syndrome of the forearm, which is associated with pain
      and sensitivity in the lateral elbow region.

      The aim of the study was to find out about is there any difference between the effects of
      traditional orthotic devices and adhesive taping, in the management of lateral epicondylitis.
      Therefore, the forearm counterforce brace, which was widely used in daily clinical practice
      for lateral epicondylitis, was compared with kinesio tape, a new technique of adhesive taping
      which has become increasingly popular. The study investigated and compared the effects of the
      two interventions (the forearm counterforce brace and kinesio tape) on pain severity,
      functional status and disability of patients with lateral epicondylitis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective, randomized and assessor-blinded study
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: The outcome-assessing investigator (O. Celik) was blinded to the randomization. All study participants were assessed by the blinded investigator (O.Celik). Follow-up measurements were performed immediately after and one month later after treatment. All treatment sessions were applied by the same investigator (S. Sencan), who was not blinded to the study groups.
measure: Pain Pressure Threshold
time frame: Baseline to 3 week (İmmediately after treatment)
description: The tenderness on the lateral aspect of elbow was evaluated with pain pressure threshold measurements. An algometer device was used to measure pain pressure threshold. Pain pressure threshold measurements were performed at the baseline of the study, immediately after and one month later after treatment.
measure: Grip Strength
time frame: Baseline to 3 week (İmmediately after treatment)
description: Affected upper limb function was evaluated with maximal hand grip strength. Grip strength was measured with a hydraulic hand dynamometer. Grip strength was evaluated at the baseline of the study, immediately after and one month later after treatment.
measure: Patient-Rated Tennis Elbow Evaluation Questionnaire
time frame: 0 week (Baseline), 3 week (After treatment), 7 week (One month later after treatment)
description: The Turkish version of Patient-Rated Tennis Elbow Evaluation Questionnaire was used in the study. Patient-Rated Tennis Elbow Evaluation Questionnaire is a 15-item self-reported questionnaire to measure perceived pain and disability in people with tennis elbow.
The questionnaire is composed of three subscales: pain, usual activities and specific activities. Each of the items of the Patient-Rated Tennis Elbow Evaluation Questionnaire is scored on a 0-10 scale, where 0 is 'no pain' or 'no difficulty' and 10 is 'worst ever' or 'unable to do'. The total score ranges from 0 to 100, where high scores indicate greater pain and disability.
Patient-Rated Tennis Elbow Evaluation Questionnaire was evaluated at the baseline of the study, immediately after and one month later after treatment.
arm group label: B (brace) group
arm group type: Active Comparator
description: The patients in the B group were informed about the application of the forearm strap (counterforce brace). Patients were advised to wear the counterforce brace for three weeks continuously.
arm group label: KT (kinesio tape) group
arm group type: Active Comparator
description: In the KT group, a standard 2-inch (5 cm) Kinesio®Tex tape (Kinesio Holding Corporation, Albuquerque, New Mexico, USA) was used with techniques of muscle inhibition and fascia correction. Kinesio tape was applied once a week for four weeks.
intervention type: Other
intervention name: forearm strap (counterforce brace)
arm group label: B (brace) group
intervention type: Other
intervention name: Kinesio tape application
arm group label: KT (kinesio tape) group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Öznur Çelik, MD
role: Principal Investigator
affiliation: University of Health Sciences, Istanbul Haseki Training and Research Hospital
facility: 
country: Turkey
citation: Struijs PA, Smidt N, Arola H, Dijk vC, Buchbinder R, Assendelft WJ. Orthotic devices for the treatment of tennis elbow. Cochrane Database Syst Rev. 2002;(1):CD001821. doi: 10.1002/14651858.CD001821.
PMID: 11869609
responsible party type: Principal Investigator
investigator affiliation: Haseki Training and Research Hospital
investigator full name: Öznur Çelik
investigator title: Principal Investigator
mesh term: Tennis Elbow
sharing ipd: No