<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/NCT03763513</url>
  </required_header>
  <id_info>
    <org_study_id>AYBU</org_study_id>
    <nct_id>NCT03763513</nct_id>
  </id_info>
  <brief_title>Investigation of Acute Effect of ESWT and ESWT+KT on Pain and Grip Strength</brief_title>
  <official_title>Investigation of Acute Effect of Extracorporeal Shock Wave Therapy and Extracorporeal Shock Wave Therapy+Kinesyotaping on Pain and Grip Strength in Patients/Athletes With Lateral Epicondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Yildirim Beyazıt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara Yildirim Beyazıt 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>
      The aim of this study was to investigate the acute effect of CT application in combination&#xD;
      with ESWT and ESWT on pain and grip strength in athletes/patients with lateral&#xD;
      epicondylitis.It is planned that at least 30 athletes aged 18-40 who are at the Ministry of&#xD;
      Youth and Sports, Ministry of Health, Ministry of Health Affairs and who have been diagnosed&#xD;
      with LE by specialist doctor.&#xD;
&#xD;
      After taking the information about birth dates, height, weight and dominant sides of the&#xD;
      athletes who are willing to participate in the study, pain intensities and hand grip&#xD;
      strengths will be evaluated. Then the athletes will be randomly divided into 2 groups&#xD;
      according to closed envelope method. First group ESWT application; 4 sessions will be held&#xD;
      for 4 weeks. The second group included ESWT + CT; 4 sessions will be held for 4 weeks. Pain&#xD;
      severity and hand grip strength will be evaluated again after treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lateral epicondylitis (LE); the most common cause of elbow pain. It is typically&#xD;
      characterized by pain around the lateral epicondyle during resistant wrist extension. This&#xD;
      condition has been reported to occur as a result of degenerative angiofibroblastic&#xD;
      hyperplasia of the wrist extensor tendons due to repetitive microtrauma. Although&#xD;
      conservative treatments are usually used in lateral epicondylitis, many of them do not have&#xD;
      sufficient evidence. In some cases, the healing phase lasts for months, which may be long&#xD;
      enough to affect quality of life and sport performance.&#xD;
&#xD;
      Extracorporeal shock wave therapy (ESWT) is used in musculoskeletal problems with a possible&#xD;
      mechanism of action, including hyperstimulation analgesia, neovascularization, and induction&#xD;
      of the healing process. However, this method is a painful method due to the shock wave&#xD;
      applied and may cause temporary redness in the area of application. This may cause the&#xD;
      subcutaneous fascia of the affected area to be affected by the application pressure.&#xD;
      Kinesiotaping (KT) is widely used in the treatment of various musculoskeletal problems. The&#xD;
      band, invented by the Japanese chiropractor Kenzo Kase in the 1970s, is a heat-sensitive&#xD;
      acrylic adhesive and an elastic woven cotton stripe with a maximum tensile strength of up to&#xD;
      about 40-60% of its total length. Many effects of KT have been hypothesised, including&#xD;
      improvement of feedback and correction of the articular alignment disorder. KT has an effect&#xD;
      on the skin and fascia. recovery will be provided faster.&#xD;
&#xD;
      The aim of this study is to compare the effects of ESWT application with ESWT + KT&#xD;
      application. In this study, our hypothesis is that ESWT + KT application will have more&#xD;
      effect on pain and muscle strength in LE patients than ESWT alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">July 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 1, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Level: visual analog scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>The pain level will evaluate By visual analog scale;min:0=no pain, maximum 10=irresistible pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>4 weeks</time_frame>
    <description>The muscle strength will evaluate by hand grip strength by dynamometer, is evaluating by mmHg bigger means stronger</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disability Level/Functionality</measure>
    <time_frame>4 weeks</time_frame>
    <description>By the DASH (Disability arm shoulder hand) questionaire, min =0, maks 100 the bigger point means worse functionality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pain</condition>
  <condition>Muscle Strength</condition>
  <condition>Lateral Epicondylitis</condition>
  <condition>Kinesio Taping</condition>
  <arm_group>
    <arm_group_label>ESWT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the first group:The group that will receive Extra corporeal shock wave therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESWT+KT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the second group:The group that will receive Extra corporeal shock wave therapy + Kinesiotaping application</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ESWT</intervention_name>
    <description>Extracorporeal Shock Wave Therapy=ESWT</description>
    <arm_group_label>ESWT</arm_group_label>
    <arm_group_label>ESWT+KT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesiotaping Application</intervention_name>
    <description>Kinesiotaping=KT (CT)</description>
    <arm_group_label>ESWT+KT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Lateral Epicondylitis Disease&#xD;
&#xD;
          -  has been doing professional sports for at least three years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having systemic problems,&#xD;
&#xD;
          -  Having health problems,&#xD;
&#xD;
          -  Has undergone any surgical operation in the upper extremity&#xD;
&#xD;
          -  Has suffered upper extremity injury in the last three months&#xD;
&#xD;
          -  Lack of inclusion criteria&#xD;
&#xD;
          -  Neurological and orthopedic problems of the upper extremity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara Yildirim Beyazıt University</investigator_affiliation>
    <investigator_full_name>Bihter Aslanyurek</investigator_full_name>
    <investigator_title>Reserach Assistant. PhD. PT. Bihter Akınoğlu</investigator_title>
  </responsible_party>
  <keyword>Tennis Elbow</keyword>
  <keyword>Taping</keyword>
  <keyword>Grip Strength</keyword>
  <keyword>Pain</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/NCT03763513
org study id: AYBU
nct id: NCT03763513
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate the acute effect of CT application in combination
      with ESWT and ESWT on pain and grip strength in athletes/patients with lateral
      epicondylitis.It is planned that at least 30 athletes aged 18-40 who are at the Ministry of
      Youth and Sports, Ministry of Health, Ministry of Health Affairs and who have been diagnosed
      with LE by specialist doctor.

      After taking the information about birth dates, height, weight and dominant sides of the
      athletes who are willing to participate in the study, pain intensities and hand grip
      strengths will be evaluated. Then the athletes will be randomly divided into 2 groups
      according to closed envelope method. First group ESWT application; 4 sessions will be held
      for 4 weeks. The second group included ESWT + CT; 4 sessions will be held for 4 weeks. Pain
      severity and hand grip strength will be evaluated again after treatment.
Lateral epicondylitis (LE); the most common cause of elbow pain. It is typically
      characterized by pain around the lateral epicondyle during resistant wrist extension. This
      condition has been reported to occur as a result of degenerative angiofibroblastic
      hyperplasia of the wrist extensor tendons due to repetitive microtrauma. Although
      conservative treatments are usually used in lateral epicondylitis, many of them do not have
      sufficient evidence. In some cases, the healing phase lasts for months, which may be long
      enough to affect quality of life and sport performance.

      Extracorporeal shock wave therapy (ESWT) is used in musculoskeletal problems with a possible
      mechanism of action, including hyperstimulation analgesia, neovascularization, and induction
      of the healing process. However, this method is a painful method due to the shock wave
      applied and may cause temporary redness in the area of application. This may cause the
      subcutaneous fascia of the affected area to be affected by the application pressure.
      Kinesiotaping (KT) is widely used in the treatment of various musculoskeletal problems. The
      band, invented by the Japanese chiropractor Kenzo Kase in the 1970s, is a heat-sensitive
      acrylic adhesive and an elastic woven cotton stripe with a maximum tensile strength of up to
      about 40-60% of its total length. Many effects of KT have been hypothesised, including
      improvement of feedback and correction of the articular alignment disorder. KT has an effect
      on the skin and fascia. recovery will be provided faster.

      The aim of this study is to compare the effects of ESWT application with ESWT + KT
      application. In this study, our hypothesis is that ESWT + KT application will have more
      effect on pain and muscle strength in LE patients than ESWT alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain Level: visual analog scale
time frame: 4 weeks
description: The pain level will evaluate By visual analog scale;min:0=no pain, maximum 10=irresistible pain
measure: Muscle Strength
time frame: 4 weeks
description: The muscle strength will evaluate by hand grip strength by dynamometer, is evaluating by mmHg bigger means stronger
measure: Disability Level/Functionality
time frame: 4 weeks
description: By the DASH (Disability arm shoulder hand) questionaire, min =0, maks 100 the bigger point means worse functionality
arm group label: ESWT
arm group type: Active Comparator
description: the first group:The group that will receive Extra corporeal shock wave therapy
arm group label: ESWT+KT
arm group type: Experimental
description: the second group:The group that will receive Extra corporeal shock wave therapy + Kinesiotaping application
intervention type: Device
intervention name: ESWT
description: Extracorporeal Shock Wave Therapy=ESWT
arm group label: ESWT
arm group label: ESWT+KT
intervention type: Other
intervention name: Kinesiotaping Application
description: Kinesiotaping=KT (CT)
arm group label: ESWT+KT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ankara Yildirim Beyazıt University
investigator full name: Bihter Aslanyurek
investigator title: Reserach Assistant. PhD. PT. Bihter Akınoğlu
mesh term: Tennis Elbow