<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/NCT02258295</url>
  </required_header>
  <id_info>
    <org_study_id>2014813CTIL</org_study_id>
    <nct_id>NCT02258295</nct_id>
  </id_info>
  <brief_title>Hyaluronate Injection for Lateral Epicondylitis</brief_title>
  <official_title>Hyaluronate Injection for Lateral Epicondylitis: A Double-blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shaare Zedek Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shaare Zedek Medical Center</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>
      This proposal is a prospective, randomized, double-blinded study to evaluate the efficacy of&#xD;
      hyaluronic acid (HA) injections for chronic lateral epicondylitis (LE). HA has traditionally&#xD;
      been used to treat knee osteoarthritis. There are a small number of studies in the literature&#xD;
      that suggest that HA injections can be very effective for tendinosis. Although LE has been&#xD;
      studied with literally hundreds of articles published, very little treatment has proven to be&#xD;
      efficacious. This study will investigate the effectiveness of hyaluronate in treatment of&#xD;
      chronic LE. This will include a two arm study with one formulation of HA tested against&#xD;
      saline injections as the control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomized and blinded into one of the two arms. Patients will receive 3&#xD;
      injections total spaced over a 4 week period. After the injections are completed, patients&#xD;
      will return for evaluation at 3, 6 and 12 months from the initial injection. A total of 72&#xD;
      patients will be divided into the 2 groups. The questionnaires will be administered by a&#xD;
      research assistant blinded to the randomization. Three different outcomes measures will be&#xD;
      collected, all patient-oriented including the Patient Rated Tennis Elbow Evaluation (PRTEE),&#xD;
      Visual Analog Score (VAS) for pain while at rest and with maximum grip, and the short form&#xD;
      Disabilities of the Arm, Shoulder and Hand (quickDASH).&#xD;
&#xD;
      The primary outcome measure will be the VAS for pain at 3 months from the initial injection.&#xD;
      All measures will be evaluated at baseline then again at 12 months from the initial&#xD;
      injection.&#xD;
&#xD;
      HA formulation will be Intragel (IBSA) which include 2cc with a concentration of 16mg per&#xD;
      2cc. The molecular weight with Intragel averaging 800-1200 kiloDaltons.&#xD;
&#xD;
      The syringes will be coded and the injections blinded. The injections will be given 1cm&#xD;
      distal to the lateral epicondyle at the site of maximum tenderness. The needle will be&#xD;
      introduced to the depth of the bone then withdrawn 1-2mm. The injection will be given in two&#xD;
      locations in and around the point of maximum tenderness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <phase>Phase 3</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 (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Score (VAS) for pain with maximum grip.</measure>
    <time_frame>3 months from baseline.</time_frame>
    <description>For the (visual analogue score) VAS pain score, patients will be asked to rate their pain after performing a maximum grip using a Jamar hydraulic dynamometer. They will score their pain using the VAS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Rated Tennis Elbow Evaluation (PRTEE): Change from Baseline to value at 12</measure>
    <time_frame>Baseline then 3,6 and 12 months from baseline.</time_frame>
    <description>This is a 15 question validated survey, specific to tennis elbow. It is composed of a pain and function measure. The best score of 0 represents no pain and maximum function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Score (VAS) for pain at rest.</measure>
    <time_frame>Baseline then 3, 6, and 12 months from baseline.</time_frame>
    <description>For this VAS pain score, patients will be asked to rate their pain using the following standard question: &quot;How much pain do you feel when doing an activity that involves gripping such as shaking hands, opening a jar or carrying something?&quot;. They will then score their level of pain using the VAS.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quick - Disabilities of the Arm, Shoulder and Hand (QuickDASH)</measure>
    <time_frame>Baseline then 3, 6, and 12 months from baseline.</time_frame>
    <description>The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Tennis Elbow</condition>
  <arm_group>
    <arm_group_label>Intragel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intragel (IBSA) has an average size of 800-1200 kDaltons. Intragel will give given with a concentration of 16mg/2cc. Each injection (2cc) injection will be given at baseline, then 2 weeks and 4 weeks from the baseline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Saline injections will be given similar to the active hyaluronic injections. Each injection (2cc) will be given at baseline, then 2 weeks and 4 weeks from the baseline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intragel</intervention_name>
    <description>Intragel has an average molecular weight of 800-1200 kDaltons.</description>
    <arm_group_label>Intragel</arm_group_label>
    <other_name>Sinovial</other_name>
    <other_name>hyaluronate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Saline</description>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Included will be patients older than 18 years with lateral epicondylitis. The criteria&#xD;
             for diagnosis will include pain and tenderness at the lateral epicondyle worse with&#xD;
             resisted wrist or finger extension (with the elbow in the extended position).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Excluded will be patients with history of prior elbow surgery, history of fracture or&#xD;
             dislocation, known inflammatory or autoimmune disorders, or known hypersensitivity to&#xD;
             HA.&#xD;
&#xD;
          -  Exclusion will also include a known allergy to birds, feathers or egg products. If the&#xD;
             patient has complaints of pain or tenderness on exam in the area of the radial neck,&#xD;
             then a component of radial tunnel syndrome will be assumed and these patients will be&#xD;
             excluded from study.&#xD;
&#xD;
          -  Patients that are pregnant will be excluded.&#xD;
&#xD;
          -  Patients with medial epicondylitis&#xD;
&#xD;
          -  Prior elbow surgery&#xD;
&#xD;
          -  Elbow steroid injection in the past 3 months&#xD;
&#xD;
          -  Inflammatory condition, like rheumatoid arthritis or lupus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gershon Zinger, MD MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shaare Zedek Medical Center, Jerusalem Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91031</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Petrella RJ, Cogliano A, Decaria J, Mohamed N, Lee R. Management of Tennis Elbow with sodium hyaluronate periarticular injections. Sports Med Arthrosc Rehabil Ther Technol. 2010 Feb 2;2:4. doi: 10.1186/1758-2555-2-4.</citation>
    <PMID>20205851</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 14, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lateral Humeral Epicondylitis</keyword>
  <keyword>Tendinitis</keyword>
  <keyword>Tendinosis</keyword>
  <keyword>Athletic Injuries</keyword>
  <keyword>Elbow Joint</keyword>
  <keyword>Sports Medicine</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/NCT02258295
org study id: 2014813CTIL
nct id: NCT02258295
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This proposal is a prospective, randomized, double-blinded study to evaluate the efficacy of
      hyaluronic acid (HA) injections for chronic lateral epicondylitis (LE). HA has traditionally
      been used to treat knee osteoarthritis. There are a small number of studies in the literature
      that suggest that HA injections can be very effective for tendinosis. Although LE has been
      studied with literally hundreds of articles published, very little treatment has proven to be
      efficacious. This study will investigate the effectiveness of hyaluronate in treatment of
      chronic LE. This will include a two arm study with one formulation of HA tested against
      saline injections as the control.
Patients will be randomized and blinded into one of the two arms. Patients will receive 3
      injections total spaced over a 4 week period. After the injections are completed, patients
      will return for evaluation at 3, 6 and 12 months from the initial injection. A total of 72
      patients will be divided into the 2 groups. The questionnaires will be administered by a
      research assistant blinded to the randomization. Three different outcomes measures will be
      collected, all patient-oriented including the Patient Rated Tennis Elbow Evaluation (PRTEE),
      Visual Analog Score (VAS) for pain while at rest and with maximum grip, and the short form
      Disabilities of the Arm, Shoulder and Hand (quickDASH).

      The primary outcome measure will be the VAS for pain at 3 months from the initial injection.
      All measures will be evaluated at baseline then again at 12 months from the initial
      injection.

      HA formulation will be Intragel (IBSA) which include 2cc with a concentration of 16mg per
      2cc. The molecular weight with Intragel averaging 800-1200 kiloDaltons.

      The syringes will be coded and the injections blinded. The injections will be given 1cm
      distal to the lateral epicondyle at the site of maximum tenderness. The needle will be
      introduced to the depth of the bone then withdrawn 1-2mm. The injection will be given in two
      locations in and around the point of maximum tenderness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Visual Analogue Score (VAS) for pain with maximum grip.
time frame: 3 months from baseline.
description: For the (visual analogue score) VAS pain score, patients will be asked to rate their pain after performing a maximum grip using a Jamar hydraulic dynamometer. They will score their pain using the VAS.
measure: Patient Rated Tennis Elbow Evaluation (PRTEE): Change from Baseline to value at 12
time frame: Baseline then 3,6 and 12 months from baseline.
description: This is a 15 question validated survey, specific to tennis elbow. It is composed of a pain and function measure. The best score of 0 represents no pain and maximum function.
measure: Visual Analogue Score (VAS) for pain at rest.
time frame: Baseline then 3, 6, and 12 months from baseline.
description: For this VAS pain score, patients will be asked to rate their pain using the following standard question: "How much pain do you feel when doing an activity that involves gripping such as shaking hands, opening a jar or carrying something?". They will then score their level of pain using the VAS.
measure: Quick - Disabilities of the Arm, Shoulder and Hand (QuickDASH)
time frame: Baseline then 3, 6, and 12 months from baseline.
description: The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
arm group label: Intragel
arm group type: Experimental
description: Intragel (IBSA) has an average size of 800-1200 kDaltons. Intragel will give given with a concentration of 16mg/2cc. Each injection (2cc) injection will be given at baseline, then 2 weeks and 4 weeks from the baseline.
arm group label: Saline
arm group type: Active Comparator
description: Saline injections will be given similar to the active hyaluronic injections. Each injection (2cc) will be given at baseline, then 2 weeks and 4 weeks from the baseline.
intervention type: Drug
intervention name: Intragel
description: Intragel has an average molecular weight of 800-1200 kDaltons.
arm group label: Intragel
other name: Sinovial
other name: hyaluronate
intervention type: Drug
intervention name: Saline
description: Saline
arm group label: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gershon Zinger, MD MS
role: Principal Investigator
affiliation: Shaare Zedek Medical Center, Jerusalem Israel
facility: 
country: Israel
citation: Petrella RJ, Cogliano A, Decaria J, Mohamed N, Lee R. Management of Tennis Elbow with sodium hyaluronate periarticular injections. Sports Med Arthrosc Rehabil Ther Technol. 2010 Feb 2;2:4. doi: 10.1186/1758-2555-2-4.
PMID: 20205851
responsible party type: Sponsor
mesh term: Tennis Elbow