<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/NCT03834090</url>
  </required_header>
  <id_info>
    <org_study_id>2015/369</org_study_id>
    <nct_id>NCT03834090</nct_id>
  </id_info>
  <brief_title>Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in Lateral Epicondylitis</brief_title>
  <official_title>Comparison of the Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in the Treatment of Lateral Epicondylitis: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</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>
      No consensus has yet been built on the treatment of lateral epicondylitis (LE) due to the&#xD;
      lack of evidence. Although conflicting results are present, radial extracorporeal shock wave&#xD;
      therapy (rESWT) has increasingly been used in the treatment of tendinopathy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ESWT and exercise have beneficial effects on the management of tendinopathies owing to their&#xD;
      various mechanisms that showed therapeutic efficacy. Owing to its positive outcomes,&#xD;
      extracorporeal shock wave therapy (ESWT) has recently been used in the treatment of&#xD;
      musculoskeletal system diseases such as plantar fasciitis, Achilles tendinopathy, calcific&#xD;
      rotator cuff tendinopathies, and patellar tendinopathy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2015</start_date>
  <completion_date type="Actual">January 15, 2016</completion_date>
  <primary_completion_date type="Actual">August 15, 2015</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 Patient-rated Tennis Elbow Evaluation score</measure>
    <time_frame>Change from Baseline at 1 month and 3 months after treatment.</time_frame>
    <description>The Patient-rated Tennis Elbow Evaluation is a specific questionnaire designed for the evaluation of the disease-specific pain and function/disability in LE. The scores were calculated separately and as the total PRTEE score, where 0 represented the best score, and 100 represented the worst score. The PRTEE consists of a pain scale with 5 items questioning pain during rest and specific activities (0 represents 'no pain' and 10 represents 'the highest pain'), and a function/disability scale with 10 items evaluating difficulties experienced during specific and daily activities (0 represents 'no difficulty' and 10 represents 'the highest difficulty)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change Visual Analogue Scale score</measure>
    <time_frame>Change from Baseline at 1 month and 3 months after treatment.</time_frame>
    <description>The self-evaluation of pain severity during rest and activity in the previous week was calculated using a 10-cm VAS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Roles and Maudsley Score</measure>
    <time_frame>Change from Baseline at 1 month and 3 months after treatment.</time_frame>
    <description>The Roles and Maudsley score was used to evaluate pain and activity limitation as classified in four categories: 1 point = excellent, &quot;no pain, complete movement, and complete activity;&quot; 2 points = good, &quot;discomfort from time to time, complete movement, and complete activity;&quot; 3 points = fair, &quot;discomfort after long-duration activity;&quot; and 4 points = poor, &quot;pain that restricts activity&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Grip Strength score</measure>
    <time_frame>Change from Baseline at 1 month and 3 months after treatment.</time_frame>
    <description>Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Lateral Epicondylitis</condition>
  <arm_group>
    <arm_group_label>rESWT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the group receiving rESWT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>supervised exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the group receiving supervised exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>rESWT</intervention_name>
    <description>rESWT was administered once per week for 3 weeks using a ShockMaster 500 device with 1.8 bar pneumatic pressure, 10 Hz frequency, with 2000 pulses.</description>
    <arm_group_label>rESWT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supervised exercises</intervention_name>
    <description>A program including post-isometric relaxation, and progressive resistance exercise (eccentric wrist extension) on the wrist extensors</description>
    <arm_group_label>supervised exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The diagnosis of LE was made in the clinical examination, and the diagnosis was&#xD;
             confirmed with the Southampton Diagnostic Criteria of &quot;the presence of epicondyle&#xD;
             pain, and epicondyle pain and tenderness on resisted extension of the wrist.&#xD;
&#xD;
          -  Patients with symptoms lasting longer than 3 months&#xD;
&#xD;
          -  with average pain in the previous week detected as 3 or above on a 10-cm visual&#xD;
             analogue scale (VAS)&#xD;
&#xD;
          -  who were aged over 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pain in the proximal part of the affected extremity (e.g. shoulder pain, neck pain)&#xD;
&#xD;
          -  abnormal neurogenic symptoms (e.g. radicular pain, numbness) on the affected extremity&#xD;
&#xD;
          -  presence of posterior interosseous nerve entrapment&#xD;
&#xD;
          -  congenital or acquired upper extremity deformities that might affect grip strength&#xD;
&#xD;
          -  systemic musculoskeletal system or neurologic disorders&#xD;
&#xD;
          -  systemic rheumatologic disease or systemic infection&#xD;
&#xD;
          -  presence of malignancy, coagulation disorders, and anticoagulant use&#xD;
&#xD;
          -  inserted cardiac pacemaker&#xD;
&#xD;
          -  history of surgical treatment on the elbow of the affected extremity&#xD;
&#xD;
          -  pregnancy.&#xD;
&#xD;
          -  patients who were administered other treatments such as physical therapy or steroid&#xD;
             injections in the last 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>MUSTAFA CORUM</investigator_full_name>
    <investigator_title>Principal Investigator</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>
  <!-- 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/NCT03834090
org study id: 2015/369
nct id: NCT03834090
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
No consensus has yet been built on the treatment of lateral epicondylitis (LE) due to the
      lack of evidence. Although conflicting results are present, radial extracorporeal shock wave
      therapy (rESWT) has increasingly been used in the treatment of tendinopathy
ESWT and exercise have beneficial effects on the management of tendinopathies owing to their
      various mechanisms that showed therapeutic efficacy. Owing to its positive outcomes,
      extracorporeal shock wave therapy (ESWT) has recently been used in the treatment of
      musculoskeletal system diseases such as plantar fasciitis, Achilles tendinopathy, calcific
      rotator cuff tendinopathies, and patellar tendinopathy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change Patient-rated Tennis Elbow Evaluation score
time frame: Change from Baseline at 1 month and 3 months after treatment.
description: The Patient-rated Tennis Elbow Evaluation is a specific questionnaire designed for the evaluation of the disease-specific pain and function/disability in LE. The scores were calculated separately and as the total PRTEE score, where 0 represented the best score, and 100 represented the worst score. The PRTEE consists of a pain scale with 5 items questioning pain during rest and specific activities (0 represents 'no pain' and 10 represents 'the highest pain'), and a function/disability scale with 10 items evaluating difficulties experienced during specific and daily activities (0 represents 'no difficulty' and 10 represents 'the highest difficulty)
measure: Change Visual Analogue Scale score
time frame: Change from Baseline at 1 month and 3 months after treatment.
description: The self-evaluation of pain severity during rest and activity in the previous week was calculated using a 10-cm VAS scale
measure: Change Roles and Maudsley Score
time frame: Change from Baseline at 1 month and 3 months after treatment.
description: The Roles and Maudsley score was used to evaluate pain and activity limitation as classified in four categories: 1 point = excellent, "no pain, complete movement, and complete activity;" 2 points = good, "discomfort from time to time, complete movement, and complete activity;" 3 points = fair, "discomfort after long-duration activity;" and 4 points = poor, "pain that restricts activity".
measure: Change Grip Strength score
time frame: Change from Baseline at 1 month and 3 months after treatment.
description: Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer
arm group label: rESWT
arm group type: Experimental
description: the group receiving rESWT
arm group label: supervised exercises
arm group type: Active Comparator
description: the group receiving supervised exercises
intervention type: Device
intervention name: rESWT
description: rESWT was administered once per week for 3 weeks using a ShockMaster 500 device with 1.8 bar pneumatic pressure, 10 Hz frequency, with 2000 pulses.
arm group label: rESWT
intervention type: Other
intervention name: Supervised exercises
description: A program including post-isometric relaxation, and progressive resistance exercise (eccentric wrist extension) on the wrist extensors
arm group label: supervised exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: MUSTAFA CORUM
investigator title: Principal Investigator
mesh term: Tennis Elbow