<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/NCT03255733</url>
  </required_header>
  <id_info>
    <org_study_id>GTS-ITU Epicondylosis 01</org_study_id>
    <nct_id>NCT03255733</nct_id>
  </id_info>
  <brief_title>ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction</brief_title>
  <acronym>ITU</acronym>
  <official_title>Intense Therapeutic Ultrasound for Chronic, Subcutaneous Lateral Epicondylitis Musculoskeletal Pain Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guided Therapy Systems</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>More Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guided Therapy Systems</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effectiveness, safety and patient tolerance for the use of Intense&#xD;
      Therapeutic Ultrasound (ITU) for chronic, subcutaneous lateral Epicondylitis musculoskeletal&#xD;
      tissue pain reduction began in July 2015 and was completed in March 2017. The More&#xD;
      Foundation/The Core Institute: Single-blinded pivotal study for the treatment of chronic&#xD;
      lateral epicondylitis. A total 29 patients received 2 treatments, 4 weeks apart on&#xD;
      subcutaneous musculoskeletal tissues along with Standard of Care treatments as prescribed by&#xD;
      the Principal Investigator. Patients were followed for up to 6 months after the first&#xD;
      treatment receiving a physical exam at each follow-up visit (4, 8 and 12 weeks) and provided&#xD;
      feedback via Patient/Subject Reported Outcome Measure surveys specific to the treated anatomy&#xD;
      at each visit and via phone follow-up at 26 weeks after the first treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intense therapeutic ultrasound (ITU) is an established ultrasound based therapy in which&#xD;
      sound waves are concentrated and focused into selected musculoskeletal tissue, to produce&#xD;
      selective thermal coagulative changes over a small controlled area while leaving the&#xD;
      surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue&#xD;
      response cascade and promote collagen generation in the targeted anatomy resulting in pain&#xD;
      reduction.&#xD;
&#xD;
      ITU has been used clinically for treating the subcutaneous musculoskeletal tissue below&#xD;
      facial skin for the past decade and it has received CE Mark and FDA 510(k) clearance to&#xD;
      market for non-surgical brow and submental tissue lifting. Over 3 Million patients worldwide&#xD;
      have been treated using this technology. Clinical studies have shown that 85% of patients&#xD;
      receiving this treatment on facial skin tissue showed an improvement in facial lifting with&#xD;
      no significant pain, erythema, inflammation or scarring by creating the same coagulative&#xD;
      changes to the connective tissue under the skin. Histologically, it has been shown that ITU&#xD;
      induces the production of dermal collagen with thickening of the dermis and straightening of&#xD;
      the elastic fibers in the reticular dermis.&#xD;
&#xD;
      On-going research in laboratory studies has shown that ITU can improve healing of damaged&#xD;
      Achilles tendon in a rabbit model. Preliminary results showed an increase in precursor&#xD;
      markers for collagen regeneration (e.g. Vascular endothelial growth factor A (VEGFa), tumor&#xD;
      necrosis factor alpha (TNFα), Interleukin 1 beta (IL-1β), and Transforming growth factor beta&#xD;
      1 (TGFβ1)) and subsequent increase in collagen formation in injured rabbit tendons treated&#xD;
      with ITU compared to injured, untreated rabbit tendons.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2015</start_date>
  <completion_date type="Actual">March 13, 2017</completion_date>
  <primary_completion_date type="Actual">March 13, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patients age 18 - 85, previously diagnosed with Chronic Lateral Epicondylitis, with symptoms exceeding 90 days, and where Standard of Care treatments have failed to resolve the symptoms.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Investigator was blinded to the Patient Reported Outcome Measure Survey details and analysis.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients Reporting at Least 25% Overall Pain Reduction</measure>
    <time_frame>12 weeks after 1st Treatment</time_frame>
    <description>Percentage of Patients Reporting at least 25% pain reduction compared to baseline, using Universal Visual Analog Scale (VAS) Pain Score. VAS is a 10-point Pain Scale, where 0 = No Pain, 1 = Slight Pain and 10 = the Patients Worst Imaginable Pain. Scales in between represent 10% increments of Pain ( Range 1 - 10).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities</measure>
    <time_frame>12 weeks after 1st Treatment</time_frame>
    <description>Average Percentage of Pain Change as Reported using Patient-Rated Tennis Elbow Evaluation Survey, compared to baseline. Range (± 100%)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Tennis Elbow</condition>
  <arm_group>
    <arm_group_label>Intense Therapeutic Ultrasound Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intense Therapeutic Ultrasound Treatment</intervention_name>
    <arm_group_label>Intense Therapeutic Ultrasound Treatment</arm_group_label>
    <other_name>Guided Therapy Systems, Ardent Sound, GTS, ITU</other_name>
    <other_name>Actisound</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic Pain (&gt;90 days) from previously diagnosed Lateral Epicondylitis, where&#xD;
             &quot;Standard of Care&quot; regimens failed to relief pain in the affected anatomy.&#xD;
&#xD;
          -  No History of surgery to the affected anatomy.&#xD;
&#xD;
          -  No alternative treatment procedures within the last 90 days.&#xD;
&#xD;
          -  Unilateral Pain&#xD;
&#xD;
          -  Willingness to complete treatment and post treatment regimen as described.&#xD;
&#xD;
          -  Patients who have provided written and verbal informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients currently enrolled in any other non-conservative, device, or Investigational&#xD;
             New Device (IND) clinical trial, or who have participated in a clinical study&#xD;
             involving the Common Extensor Tendon, thirty days prior to study initiation;&#xD;
&#xD;
          -  Patients who have participated in any other clinical study involving an&#xD;
             investigational product 30 days prior to enrollment that, in the opinion of the&#xD;
             Principal Investigator, could affect the outcome of this study;&#xD;
&#xD;
          -  Patients who have received previous treatment in the symptomatic limb (not including&#xD;
             conservative treatment);&#xD;
&#xD;
          -  At the Principal Investigator's discretion, any patient that should be excluded based&#xD;
             on their current condition or medical history.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John A Kearney, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The More Foundataion</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The More Foundation</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>White WM, Makin IR, Barthe PG, Slayton MH, Gliklich RE. Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation. Arch Facial Plast Surg. 2007 Jan-Feb;9(1):22-9. doi: 10.1001/archfaci.9.1.22.</citation>
    <PMID>17224484</PMID>
  </reference>
  <reference>
    <citation>Alam M, White LE, Martin N, Witherspoon J, Yoo S, West DP. Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. J Am Acad Dermatol. 2010 Feb;62(2):262-9. doi: 10.1016/j.jaad.2009.06.039.</citation>
    <PMID>20115948</PMID>
  </reference>
  <reference>
    <citation>Gliklich RE, White WM, Slayton MH, Barthe PG, Makin IR. Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast Surg. 2007 Mar-Apr;9(2):88-95. doi: 10.1001/archfaci.9.2.88.</citation>
    <PMID>17372061</PMID>
  </reference>
  <reference>
    <citation>Laubach HJ, Makin IR, Barthe PG, Slayton MH, Manstein D. Intense focused ultrasound: evaluation of a new treatment modality for precise microcoagulation within the skin. Dermatol Surg. 2008 May;34(5):727-34. doi: 10.1111/j.1524-4725.2008.34196.x.</citation>
    <PMID>18429926</PMID>
  </reference>
  <reference>
    <citation>Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.</citation>
    <PMID>12696985</PMID>
  </reference>
  <reference>
    <citation>Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.</citation>
    <PMID>24049221</PMID>
  </reference>
  <reference>
    <citation>DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.</citation>
    <PMID>12851352</PMID>
  </reference>
  <reference>
    <citation>Rompe JD, Overend TJ, MacDermid JC. Validation of the Patient-rated Tennis Elbow Evaluation Questionnaire. J Hand Ther. 2007 Jan-Mar;20(1):3-10; quiz 11. doi: 10.1197/j.jht.2006.10.003.</citation>
    <PMID>17254903</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <results_first_submitted>August 21, 2017</results_first_submitted>
  <results_first_submitted_qc>October 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 17, 2017</results_first_posted>
  <last_update_submitted>October 19, 2017</last_update_submitted>
  <last_update_submitted_qc>October 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Lateral Epicondylitis</keyword>
  <keyword>Tennis Elbow</keyword>
  <keyword>Intense Therapeutic Ultrasound (ITU)</keyword>
  <keyword>Guided Therapy Systems (GTS)</keyword>
  <keyword>Ardent Sound, Inc.</keyword>
  <keyword>Actisound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Pain</mesh_term>
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 4, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03255733/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 2, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03255733/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 2, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03255733/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intense Therapeutic Ultrasound Treatment</title>
          <description>Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intense Therapeutic Ultrasound Treatment</title>
          <description>Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="29"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients Reporting at Least 25% Overall Pain Reduction</title>
        <description>Percentage of Patients Reporting at least 25% pain reduction compared to baseline, using Universal Visual Analog Scale (VAS) Pain Score. VAS is a 10-point Pain Scale, where 0 = No Pain, 1 = Slight Pain and 10 = the Patients Worst Imaginable Pain. Scales in between represent 10% increments of Pain ( Range 1 - 10).</description>
        <time_frame>12 weeks after 1st Treatment</time_frame>
        <population>Percentage of Patients reporting at least 25% improvement in Pain at 12 Weeks after the first treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Intense Therapeutic Ultrasound Treatment</title>
            <description>Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Reporting at Least 25% Overall Pain Reduction</title>
          <description>Percentage of Patients Reporting at least 25% pain reduction compared to baseline, using Universal Visual Analog Scale (VAS) Pain Score. VAS is a 10-point Pain Scale, where 0 = No Pain, 1 = Slight Pain and 10 = the Patients Worst Imaginable Pain. Scales in between represent 10% increments of Pain ( Range 1 - 10).</description>
          <population>Percentage of Patients reporting at least 25% improvement in Pain at 12 Weeks after the first treatment</population>
          <units>percentage of patients with less pain</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities</title>
        <description>Average Percentage of Pain Change as Reported using Patient-Rated Tennis Elbow Evaluation Survey, compared to baseline. Range (± 100%)</description>
        <time_frame>12 weeks after 1st Treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intense Therapeutic Ultrasound Treatment</title>
            <description>Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities</title>
          <description>Average Percentage of Pain Change as Reported using Patient-Rated Tennis Elbow Evaluation Survey, compared to baseline. Range (± 100%)</description>
          <units>percentage of reported pain change</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-58" lower_limit="-100" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 Years</time_frame>
      <desc>Any self-reported adverse event occurring after the first treatment</desc>
      <group_list>
        <group group_id="E1">
          <title>Intense Therapeutic Ultrasound Treatment</title>
          <description>Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>While the protocol involved Chronic patients, who had already failed Standard of Care regimens, it is a limitation for this investigational study to have no control group.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Rich Amodei, RDMS</name_or_title>
      <organization>Guided Therapy Systems</organization>
      <phone>480-649-8587</phone>
      <email>r.amodei@guidedtherapy.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03255733
org study id: GTS-ITU Epicondylosis 01
nct id: NCT03255733
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
This study evaluates the effectiveness, safety and patient tolerance for the use of Intense
      Therapeutic Ultrasound (ITU) for chronic, subcutaneous lateral Epicondylitis musculoskeletal
      tissue pain reduction began in July 2015 and was completed in March 2017. The More
      Foundation/The Core Institute: Single-blinded pivotal study for the treatment of chronic
      lateral epicondylitis. A total 29 patients received 2 treatments, 4 weeks apart on
      subcutaneous musculoskeletal tissues along with Standard of Care treatments as prescribed by
      the Principal Investigator. Patients were followed for up to 6 months after the first
      treatment receiving a physical exam at each follow-up visit (4, 8 and 12 weeks) and provided
      feedback via Patient/Subject Reported Outcome Measure surveys specific to the treated anatomy
      at each visit and via phone follow-up at 26 weeks after the first treatment.
Intense therapeutic ultrasound (ITU) is an established ultrasound based therapy in which
      sound waves are concentrated and focused into selected musculoskeletal tissue, to produce
      selective thermal coagulative changes over a small controlled area while leaving the
      surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue
      response cascade and promote collagen generation in the targeted anatomy resulting in pain
      reduction.

      ITU has been used clinically for treating the subcutaneous musculoskeletal tissue below
      facial skin for the past decade and it has received CE Mark and FDA 510(k) clearance to
      market for non-surgical brow and submental tissue lifting. Over 3 Million patients worldwide
      have been treated using this technology. Clinical studies have shown that 85% of patients
      receiving this treatment on facial skin tissue showed an improvement in facial lifting with
      no significant pain, erythema, inflammation or scarring by creating the same coagulative
      changes to the connective tissue under the skin. Histologically, it has been shown that ITU
      induces the production of dermal collagen with thickening of the dermis and straightening of
      the elastic fibers in the reticular dermis.

      On-going research in laboratory studies has shown that ITU can improve healing of damaged
      Achilles tendon in a rabbit model. Preliminary results showed an increase in precursor
      markers for collagen regeneration (e.g. Vascular endothelial growth factor A (VEGFa), tumor
      necrosis factor alpha (TNFα), Interleukin 1 beta (IL-1β), and Transforming growth factor beta
      1 (TGFβ1)) and subsequent increase in collagen formation in injured rabbit tendons treated
      with ITU compared to injured, untreated rabbit tendons.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients age 18 - 85, previously diagnosed with Chronic Lateral Epicondylitis, with symptoms exceeding 90 days, and where Standard of Care treatments have failed to resolve the symptoms.
primary purpose: Treatment
masking: None (Open Label)
masking description: Investigator was blinded to the Patient Reported Outcome Measure Survey details and analysis.
measure: Percentage of Patients Reporting at Least 25% Overall Pain Reduction
time frame: 12 weeks after 1st Treatment
description: Percentage of Patients Reporting at least 25% pain reduction compared to baseline, using Universal Visual Analog Scale (VAS) Pain Score. VAS is a 10-point Pain Scale, where 0 = No Pain, 1 = Slight Pain and 10 = the Patients Worst Imaginable Pain. Scales in between represent 10% increments of Pain ( Range 1 - 10).
measure: Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities
time frame: 12 weeks after 1st Treatment
description: Average Percentage of Pain Change as Reported using Patient-Rated Tennis Elbow Evaluation Survey, compared to baseline. Range (± 100%)
arm group label: Intense Therapeutic Ultrasound Treatment
arm group type: Experimental
description: Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.
intervention type: Device
intervention name: Intense Therapeutic Ultrasound Treatment
arm group label: Intense Therapeutic Ultrasound Treatment
other name: Guided Therapy Systems, Ardent Sound, GTS, ITU
other name: Actisound
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: John A Kearney, MD
role: Principal Investigator
affiliation: The More Foundataion
facility: 
country: United States
citation: White WM, Makin IR, Barthe PG, Slayton MH, Gliklich RE. Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation. Arch Facial Plast Surg. 2007 Jan-Feb;9(1):22-9. doi: 10.1001/archfaci.9.1.22.
PMID: 17224484
citation: Alam M, White LE, Martin N, Witherspoon J, Yoo S, West DP. Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. J Am Acad Dermatol. 2010 Feb;62(2):262-9. doi: 10.1016/j.jaad.2009.06.039.
PMID: 20115948
citation: Gliklich RE, White WM, Slayton MH, Barthe PG, Makin IR. Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast Surg. 2007 Mar-Apr;9(2):88-95. doi: 10.1001/archfaci.9.2.88.
PMID: 17372061
citation: Laubach HJ, Makin IR, Barthe PG, Slayton MH, Manstein D. Intense focused ultrasound: evaluation of a new treatment modality for precise microcoagulation within the skin. Dermatol Surg. 2008 May;34(5):727-34. doi: 10.1111/j.1524-4725.2008.34196.x.
PMID: 18429926
citation: Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.
PMID: 12696985
citation: Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.
PMID: 24049221
citation: DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.
PMID: 12851352
citation: Rompe JD, Overend TJ, MacDermid JC. Validation of the Patient-rated Tennis Elbow Evaluation Questionnaire. J Hand Ther. 2007 Jan-Mar;20(1):3-10; quiz 11. doi: 10.1197/j.jht.2006.10.003.
PMID: 17254903
responsible party type: Sponsor
mesh term: Musculoskeletal Pain
mesh term: Tennis Elbow
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: While the protocol involved Chronic patients, who had already failed Standard of Care regimens, it is a limitation for this investigational study to have no control group.
point of contact: 