<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/NCT02235818</url>
  </required_header>
  <id_info>
    <org_study_id>HSREB103099</org_study_id>
    <nct_id>NCT02235818</nct_id>
  </id_info>
  <brief_title>Determining the Immediate Effects of Counterforce Bracing Versus Kinesiotaping in Patients With Tennis Elbow</brief_title>
  <acronym>LE</acronym>
  <official_title>Immediate Effectiveness of Counterforce Bracing Versus Kinesiotaping During Activity: A Randomized Crossover Trial in Patients With Lateral Epicondylosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to compare the immediate efficacy of Counterforce brace versus&#xD;
      kinesiotaping on patients with lateral epicondylosis/tennis elbow with respect to a&#xD;
      repetitive physical task. The investigators hypothesized that there would be difference in&#xD;
      the outcomes with respect to interventions and activity. Patient came for one hour long&#xD;
      Single occasion testing session and were not followed up after the testing was complete.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a cross over randomized control trial. Thirty patients with clinical diagnosis of&#xD;
      lateral epicondylosis/tennis elbow were recruited from a local community and were tested on&#xD;
      single occasion (one time testing session) before and after a five minute upper extremity&#xD;
      repetitive task first with control and then brace and kinesiotape assigned in cross-over&#xD;
      design. The testing session was one hour long and there was no follow up of patients&#xD;
      following the testing. The patients were recruited between Jan-June 2013.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain free grip strength</measure>
    <time_frame>initial visit</time_frame>
    <description>Pain free grip strength was recorded with J-tech medical dynamometer before and after five minutes of repetitive physical exposure with first control (no intervention) and then brace and kinesiotape assigned randomly in cross-over fashion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pressure Pain Threshold</measure>
    <time_frame>initial visit</time_frame>
    <description>Pressure Pain Threshold was recorded with J-tech medical Algometer before and after five minutes of repetitive physical exposure with first control (no intervention) and then brace and kinesiotape assigned randomly in cross-over fashion.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain levels</measure>
    <time_frame>initial visit</time_frame>
    <description>Pain levels were recorded with Numeric Pain Rating scale before and after five minutes of repetitive physical exposure with first control (no intervention) and then brace and kinesiotape assigned randomly in cross-over fashion.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Tennis Elbow</condition>
  <arm_group>
    <arm_group_label>Kinesiotape (KT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Kinesiotape was used only on the affected side as per the manufacturer instructions. With the elbow extended, wrist fully flexed and fingers pointed down 24, KT was applied with slight stretch (10-15%) and paper off tension to the lateral arm beginning just above the bony portion of lateral epicondyle. Once the top strand was anchored, KT was applied along the side of elbow such that hole in the tape was over lateral epicondyle of the elbow. Two strands of tape followed the lateral forearm and ended at around beginning of the distal one third of forearm. Once the support was applied, KT was gently rubbed to activate the glue.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Counterforce elbow brace</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The counterforce brace was approximately 5cm wide with velcro attachment for adjustable girth. It had gel pack for extra support on extensor muscle mass. With the elbow extended, brace was applied 2.5cms below the lateral epicondyle. A feeling of comfortable compression, as reported by the patients was used to adjust the brace.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Kinesiotape</intervention_name>
    <description>Pre-cut kinesiotape for tennis elbow, spidertech.com, applied on wrist extensors starting above elbow and ending at distal one third of forearm</description>
    <arm_group_label>Kinesiotape (KT)</arm_group_label>
    <other_name>elastic tape, elastic therapeutic tape, kinesiotex tape</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Counterforce elbow brace</intervention_name>
    <description>Applied over the wrist extensor muscle mass, had velcro for adjustment, comfortable grip as reported by patient was used to adjust the brace</description>
    <arm_group_label>Counterforce elbow brace</arm_group_label>
    <other_name>elbow strap, forearm brace, forearm strap</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age (18-70 years)&#xD;
&#xD;
          2. Ability to provide written informed consent to participate&#xD;
&#xD;
          3. Were at least three weeks from onset of symptoms&#xD;
&#xD;
          4. Complaints of discomfort or pain at the lateral elbow region for a minimum of three&#xD;
             weeks and tenderness with palpation of the lateral epicondyle&#xD;
&#xD;
          5. Provocation of lateral elbow pain with one of the following test - resisted middle&#xD;
             finger extension, resisted wrist extension or passive stretch of wrist extensors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of surgery on affected elbow&#xD;
&#xD;
          2. History of cortisone injections on the affected elbow in the past 4 weeks&#xD;
&#xD;
          3. Any physical or mental limitations that precluded performance of the study testing&#xD;
&#xD;
          4. Allergy to adhesive tapes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joy C Macdermid, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University, Canada</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pritika Gogia, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hand and Upper Limb Centre, St. Joseph's Health Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 4, 2013</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Joy MacDermid</investigator_full_name>
    <investigator_title>Co-Director HULC Clinical Research lab</investigator_title>
  </responsible_party>
  <keyword>tennis elbow, treatment, lateral epicondylitis, immediate effects</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_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/NCT02235818
org study id: HSREB103099
nct id: NCT02235818
lead sponsor: 
has dmc: No
The purpose of this study was to compare the immediate efficacy of Counterforce brace versus
      kinesiotaping on patients with lateral epicondylosis/tennis elbow with respect to a
      repetitive physical task. The investigators hypothesized that there would be difference in
      the outcomes with respect to interventions and activity. Patient came for one hour long
      Single occasion testing session and were not followed up after the testing was complete.
This was a cross over randomized control trial. Thirty patients with clinical diagnosis of
      lateral epicondylosis/tennis elbow were recruited from a local community and were tested on
      single occasion (one time testing session) before and after a five minute upper extremity
      repetitive task first with control and then brace and kinesiotape assigned in cross-over
      design. The testing session was one hour long and there was no follow up of patients
      following the testing. The patients were recruited between Jan-June 2013.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain free grip strength
time frame: initial visit
description: Pain free grip strength was recorded with J-tech medical dynamometer before and after five minutes of repetitive physical exposure with first control (no intervention) and then brace and kinesiotape assigned randomly in cross-over fashion.
measure: Pressure Pain Threshold
time frame: initial visit
description: Pressure Pain Threshold was recorded with J-tech medical Algometer before and after five minutes of repetitive physical exposure with first control (no intervention) and then brace and kinesiotape assigned randomly in cross-over fashion.
measure: Pain levels
time frame: initial visit
description: Pain levels were recorded with Numeric Pain Rating scale before and after five minutes of repetitive physical exposure with first control (no intervention) and then brace and kinesiotape assigned randomly in cross-over fashion.
arm group label: Kinesiotape (KT)
arm group type: Active Comparator
description: Kinesiotape was used only on the affected side as per the manufacturer instructions. With the elbow extended, wrist fully flexed and fingers pointed down 24, KT was applied with slight stretch (10-15%) and paper off tension to the lateral arm beginning just above the bony portion of lateral epicondyle. Once the top strand was anchored, KT was applied along the side of elbow such that hole in the tape was over lateral epicondyle of the elbow. Two strands of tape followed the lateral forearm and ended at around beginning of the distal one third of forearm. Once the support was applied, KT was gently rubbed to activate the glue.
arm group label: Counterforce elbow brace
arm group type: Active Comparator
description: The counterforce brace was approximately 5cm wide with velcro attachment for adjustable girth. It had gel pack for extra support on extensor muscle mass. With the elbow extended, brace was applied 2.5cms below the lateral epicondyle. A feeling of comfortable compression, as reported by the patients was used to adjust the brace.
intervention type: Device
intervention name: Kinesiotape
description: Pre-cut kinesiotape for tennis elbow, spidertech.com, applied on wrist extensors starting above elbow and ending at distal one third of forearm
arm group label: Kinesiotape (KT)
other name: elastic tape, elastic therapeutic tape, kinesiotex tape
intervention type: Device
intervention name: Counterforce elbow brace
description: Applied over the wrist extensor muscle mass, had velcro for adjustment, comfortable grip as reported by patient was used to adjust the brace
arm group label: Counterforce elbow brace
other name: elbow strap, forearm brace, forearm strap
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Joy C Macdermid, PT, PhD
role: Principal Investigator
affiliation: Western University, Canada
last name: Pritika Gogia, MSc
role: Principal Investigator
affiliation: Western University, Canada
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Joy MacDermid
investigator title: Co-Director HULC Clinical Research lab
mesh term: Tennis Elbow