<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/NCT03774823</url>
  </required_header>
  <id_info>
    <org_study_id>CS1217</org_study_id>
    <nct_id>NCT03774823</nct_id>
  </id_info>
  <brief_title>RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury</brief_title>
  <official_title>Clinical Evaluation of the Safety and Efficacy of RF and PEMF for the Treatment of Soft Tissue Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Venus Concept</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Venus Concept</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will investigate whether the impact of PEMF and RF therapies is safe and&#xD;
      efficacious for the treatment of pain associated with soft tissue injuries as compared to&#xD;
      treatment with ultrasound, and to show the effects of PEMF and RF therapies on range of&#xD;
      motion and blood flow associated with soft tissue injuries as compared to ultrasound therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, controlled study of the safety and efficacy of a radiofrequency (RF)&#xD;
      and pulsed electromagnetic fields (PEMF) device compared to ultrasound (US) for the treatment&#xD;
      of pain associated with soft tissue injuries, and to show the comparative effects on blood&#xD;
      flow (BF) and range of motion (ROM). Total expected duration of the clinical study is&#xD;
      approximately 6 months (enrollment period of 4 months and a follow-up period of 3 weeks)&#xD;
      while individual participation will take three weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 13, 2018</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 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>
    <intervention_model_description>One group receives treatment with RF and PEMF while the second group receives treatment with ultrasound</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participant is not aware which group they will be randomized into upon entering the study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Reduction in BPI-SF Severity</measure>
    <time_frame>Day 10</time_frame>
    <description>Reduction in pain severity during daily activity at Visit 4 compared to Baseline as measured by the Brief Pain Inventory (Short Form) - Severity. BPI-SF assesses pain at its 'worst', 'least', 'average', and 'now' (current pain) and is rated on a scale of 0-10, where 0 represents 'No pain' and 10 represents 'Pain as bad as you can imagine'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Reduction in BPI-SF Interference Score</measure>
    <time_frame>Day 10</time_frame>
    <description>Reduction in pain interference during daily activity at Visit 4 compared to Baseline as measured by the BPI-SF Interference score. BPI-SF Interference score measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The 0-10 scale is also used for pain interference, where 0 represents 'does not interfere' and 10 represents 'completely interferes'. BPI pain interference is typically scored as the mean of the seven interference items.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Term Blood Perfusion</measure>
    <time_frame>Day 8</time_frame>
    <description>Change in tissue blood perfusion (BP) pre- and post-treatment at Baseline, Visit 3 as measured by perfusion imaging, measured in perfusion units (PU) where a positive value indicates an increase in blood perfusion and a negative value indicate a decrease in blood perfusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long Term Blood Perfusion</measure>
    <time_frame>Day 14</time_frame>
    <description>Change in tissue blood perfusion (BP) pre- and post-treatment at Baseline, Visit 6 as measured by perfusion imaging as measured by perfusion imaging, measured in perfusion units (PU) where a positive value indicates an increase in blood perfusion and a negative value indicate a decrease in blood perfusion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Reduction in BPI-SF Severity Score</measure>
    <time_frame>Day 14</time_frame>
    <description>Reduction in pain severity during daily activity at Visit 6 as measured by the BPI-SF Severity score. BPI-SF Severity score assesses pain at its 'worst', 'least', 'average', and 'now' (current pain) and is rated on a scale of 0-10, where 0 represents 'No pain' and 10 represents 'Pain as bad as you can imagine'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Reduction in BPI-SF Interference Score</measure>
    <time_frame>Day 14</time_frame>
    <description>Reduction in pain interference during daily activity at Visit 6 as measured by the BPI-SF Interference score. BPI-SF Interference score measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The 0-10 scale is also used for pain interference, where 0 represents 'does not interfere' and 10 represents 'completely interferes'. BPI pain interference is typically scored as the mean of the seven interference items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early Subject Satisfaction: 5-Point Likert Satisfaction Scale</measure>
    <time_frame>Day 8</time_frame>
    <description>Subjects' assessment of satisfaction with the treatment at Visit 4 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as:&#xD;
4 being very satisfied 3 being satisfied 2 having no opinion&#xD;
1 being unsatisfied 0 being very unsatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale</measure>
    <time_frame>Day 14</time_frame>
    <description>Subjects' assessment of satisfaction with the treatment at Visit 6 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as:&#xD;
4 being very satisfied 3 being satisfied 2 having no opinion&#xD;
1 being unsatisfied 0 being very unsatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Final Subject Satisfaction: 5-Point Likert Satisfaction Scale</measure>
    <time_frame>Day 21</time_frame>
    <description>Subjects' assessment of satisfaction with the treatment at Visit 7 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as:&#xD;
4 being very satisfied 3 being satisfied 2 having no opinion&#xD;
1 being unsatisfied 0 being very unsatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Discomfort</measure>
    <time_frame>Day 21</time_frame>
    <description>Subject's assessment of discomfort and pain with treatment as measured by a 10 cm visual analog scale (VAS). A line which ranges from 10 being the worst pain ever to 0 being no pain at all.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Day 21</time_frame>
    <description>Subjects experiencing a treatment-related adverse event (AE)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Soft Tissue Injuries</condition>
  <arm_group>
    <arm_group_label>Freeze Plus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will receive treatment using RF and PEMF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will receive treatment using ultrasound</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RF and PEMF</intervention_name>
    <description>RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
    <arm_group_label>Freeze Plus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
    <arm_group_label>Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to read, understand and provide written informed consent to receive treatment.&#xD;
&#xD;
          2. Healthy, adult male or female, 18 - 75 years of age.&#xD;
&#xD;
          3. Sustained recent (within 30 days), painful unilateral mild to moderate soft tissue&#xD;
             injury.&#xD;
&#xD;
          4. Seeking treatment for pain associated with mild to moderate soft tissue injury.&#xD;
&#xD;
          5. BMI score is greater than 18.5 and less than 29.9.&#xD;
&#xD;
          6. Able and willing to comply with the treatment and follow-up schedule and requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant, planning to become pregnant or nursing during the ocurse of the study.&#xD;
&#xD;
          2. Open wound or infection at site of soft tissue injury.&#xD;
&#xD;
          3. Evidence of severe injury, including fracture or nerve injury.&#xD;
&#xD;
          4. History of musculoskeletal disorders, including arthritis, tendonitis, bursitis,&#xD;
             ankylosing spondylitis.&#xD;
&#xD;
          5. Moderate to severe ligament tear.&#xD;
&#xD;
          6. Having a known anti-coagulative or thromboembolic condition or taking anticoagulation&#xD;
             medications one week prior to and during the treatment course (to allow inclusion,&#xD;
             temporary cessation of anticoagulant use as per the subject's physician discretion is&#xD;
             permitted).&#xD;
&#xD;
          7. History of immunosuppression/immune deficiency disorders (including HIV infection or&#xD;
             AIDS) or currently using immunosuppressive medications.&#xD;
&#xD;
          8. Having an anesthetic or corticosteroid injection within 4 weeks of study enrollment.&#xD;
&#xD;
          9. Having any active electrical implant anywhere in the body, such as a pacemaker or an&#xD;
             internal defibrillator.&#xD;
&#xD;
         10. Having a permanent implant in the treated areas, such as metal plates and screws or an&#xD;
             injected chemical substance.&#xD;
&#xD;
         11. History of any form of cancer or pre-malignancy in the treatment area.&#xD;
&#xD;
         12. Severe concurrent conditions, such as cardiac disorders, uncontrolled hypertension,&#xD;
             etc.&#xD;
&#xD;
         13. Patients with history of diseases stimulated by heat, such as recurrent herpes simplex&#xD;
             in the treatment area.&#xD;
&#xD;
         14. History of epidermal or dermal disorders (particularly if involving collagen or&#xD;
             microvascularity).&#xD;
&#xD;
         15. Poorly controlled endocrine disorders, such as diabetes.&#xD;
&#xD;
         16. Skin piercings in the treatment area.&#xD;
&#xD;
         17. Having a history of anxiety-depression syndromes.&#xD;
&#xD;
         18. Any condition which in the opinion of the investigator may jeopardize the patient's&#xD;
             safe participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Biro</last_name>
    <role>Study Director</role>
    <affiliation>Venus Concept</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kendall Sports Medicine and Rehabilitation Clinic</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <results_first_submitted>October 15, 2020</results_first_submitted>
  <results_first_submitted_qc>January 4, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 22, 2021</results_first_posted>
  <last_update_submitted>January 4, 2021</last_update_submitted>
  <last_update_submitted_qc>January 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RF/PEMF</keyword>
  <keyword>Ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Soft Tissue Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03774823/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Freeze Plus</title>
          <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
        </group>
        <group group_id="P2">
          <title>Ultrasound</title>
          <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Subjects seeking treatment for pain associated with mild to moderate soft tissue injury.</population>
      <group_list>
        <group group_id="B1">
          <title>Freeze Plus</title>
          <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
        </group>
        <group group_id="B2">
          <title>Ultrasound</title>
          <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Brief Pain Inventory (Short Form)</title>
          <description>The Brief Pain Inventory - Short Form (BPI-SF) is a self-administered questionnaire made up of the response to 2 components: a) BPI-SF Severity which is the severity of a patient's pain and b) BPI-SF Interference which is the impact of this pain on daily functioning. The patient is asked to rate severity and interference on a 10-point scale where 0 represents 'No pain/No interference' and 10 represents 'Pain/Interference as bad as you can imagine'.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>BPI-SF Severity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.56" spread="1.72"/>
                    <measurement group_id="B2" value="4.38" spread="2.06"/>
                    <measurement group_id="B3" value="5.47" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BPI-SF Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.75" spread="2.82"/>
                    <measurement group_id="B2" value="0.86" spread="0.62"/>
                    <measurement group_id="B3" value="2.81" spread="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Reduction in BPI-SF Severity</title>
        <description>Reduction in pain severity during daily activity at Visit 4 compared to Baseline as measured by the Brief Pain Inventory (Short Form) - Severity. BPI-SF assesses pain at its 'worst', 'least', 'average', and 'now' (current pain) and is rated on a scale of 0-10, where 0 represents 'No pain' and 10 represents 'Pain as bad as you can imagine'.</description>
        <time_frame>Day 10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Freeze Plus</title>
            <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Reduction in BPI-SF Severity</title>
          <description>Reduction in pain severity during daily activity at Visit 4 compared to Baseline as measured by the Brief Pain Inventory (Short Form) - Severity. BPI-SF assesses pain at its 'worst', 'least', 'average', and 'now' (current pain) and is rated on a scale of 0-10, where 0 represents 'No pain' and 10 represents 'Pain as bad as you can imagine'.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.75" spread="1.86"/>
                    <measurement group_id="O2" value="2.44" spread="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Reduction in BPI-SF Interference Score</title>
        <description>Reduction in pain interference during daily activity at Visit 4 compared to Baseline as measured by the BPI-SF Interference score. BPI-SF Interference score measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The 0-10 scale is also used for pain interference, where 0 represents 'does not interfere' and 10 represents 'completely interferes'. BPI pain interference is typically scored as the mean of the seven interference items.</description>
        <time_frame>Day 10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Freeze Plus</title>
            <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Reduction in BPI-SF Interference Score</title>
          <description>Reduction in pain interference during daily activity at Visit 4 compared to Baseline as measured by the BPI-SF Interference score. BPI-SF Interference score measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The 0-10 scale is also used for pain interference, where 0 represents 'does not interfere' and 10 represents 'completely interferes'. BPI pain interference is typically scored as the mean of the seven interference items.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.11" spread="2.96"/>
                    <measurement group_id="O2" value="0.25" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Short Term Blood Perfusion</title>
        <description>Change in tissue blood perfusion (BP) pre- and post-treatment at Baseline, Visit 3 as measured by perfusion imaging, measured in perfusion units (PU) where a positive value indicates an increase in blood perfusion and a negative value indicate a decrease in blood perfusion.</description>
        <time_frame>Day 8</time_frame>
        <population>One subject in the Freeze Plus arm and one subject in the Ultrasound arm did not have blood perfusion measured at visit 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Freeze Plus</title>
            <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
          </group>
        </group_list>
        <measure>
          <title>Short Term Blood Perfusion</title>
          <description>Change in tissue blood perfusion (BP) pre- and post-treatment at Baseline, Visit 3 as measured by perfusion imaging, measured in perfusion units (PU) where a positive value indicates an increase in blood perfusion and a negative value indicate a decrease in blood perfusion.</description>
          <population>One subject in the Freeze Plus arm and one subject in the Ultrasound arm did not have blood perfusion measured at visit 3.</population>
          <units>Perfusion units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.04" spread="2.62"/>
                    <measurement group_id="O2" value="-0.46" spread="6.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Long Term Blood Perfusion</title>
        <description>Change in tissue blood perfusion (BP) pre- and post-treatment at Baseline, Visit 6 as measured by perfusion imaging as measured by perfusion imaging, measured in perfusion units (PU) where a positive value indicates an increase in blood perfusion and a negative value indicate a decrease in blood perfusion.</description>
        <time_frame>Day 14</time_frame>
        <population>One subject in the Freeze Plus arm and one subject in the Ultrasound arm did not have blood perfusion measured at visit 6.</population>
        <group_list>
          <group group_id="O1">
            <title>Freeze Plus</title>
            <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
          </group>
        </group_list>
        <measure>
          <title>Long Term Blood Perfusion</title>
          <description>Change in tissue blood perfusion (BP) pre- and post-treatment at Baseline, Visit 6 as measured by perfusion imaging as measured by perfusion imaging, measured in perfusion units (PU) where a positive value indicates an increase in blood perfusion and a negative value indicate a decrease in blood perfusion.</description>
          <population>One subject in the Freeze Plus arm and one subject in the Ultrasound arm did not have blood perfusion measured at visit 6.</population>
          <units>Perfusion units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.43" spread="6.13"/>
                    <measurement group_id="O2" value="1.44" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Reduction in BPI-SF Severity Score</title>
        <description>Reduction in pain severity during daily activity at Visit 6 as measured by the BPI-SF Severity score. BPI-SF Severity score assesses pain at its 'worst', 'least', 'average', and 'now' (current pain) and is rated on a scale of 0-10, where 0 represents 'No pain' and 10 represents 'Pain as bad as you can imagine'.</description>
        <time_frame>Day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Freeze Plus</title>
            <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Reduction in BPI-SF Severity Score</title>
          <description>Reduction in pain severity during daily activity at Visit 6 as measured by the BPI-SF Severity score. BPI-SF Severity score assesses pain at its 'worst', 'least', 'average', and 'now' (current pain) and is rated on a scale of 0-10, where 0 represents 'No pain' and 10 represents 'Pain as bad as you can imagine'.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.81" spread="1.34"/>
                    <measurement group_id="O2" value="0.94" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Reduction in BPI-SF Interference Score</title>
        <description>Reduction in pain interference during daily activity at Visit 6 as measured by the BPI-SF Interference score. BPI-SF Interference score measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The 0-10 scale is also used for pain interference, where 0 represents 'does not interfere' and 10 represents 'completely interferes'. BPI pain interference is typically scored as the mean of the seven interference items.</description>
        <time_frame>Day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Freeze Plus</title>
            <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Reduction in BPI-SF Interference Score</title>
          <description>Reduction in pain interference during daily activity at Visit 6 as measured by the BPI-SF Interference score. BPI-SF Interference score measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The 0-10 scale is also used for pain interference, where 0 represents 'does not interfere' and 10 represents 'completely interferes'. BPI pain interference is typically scored as the mean of the seven interference items.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.43" spread="1.05"/>
                    <measurement group_id="O2" value="0.68" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Early Subject Satisfaction: 5-Point Likert Satisfaction Scale</title>
        <description>Subjects' assessment of satisfaction with the treatment at Visit 4 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as:&#xD;
4 being very satisfied 3 being satisfied 2 having no opinion&#xD;
1 being unsatisfied 0 being very unsatisfied</description>
        <time_frame>Day 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Freeze Plus</title>
            <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
          </group>
        </group_list>
        <measure>
          <title>Early Subject Satisfaction: 5-Point Likert Satisfaction Scale</title>
          <description>Subjects' assessment of satisfaction with the treatment at Visit 4 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as:&#xD;
4 being very satisfied 3 being satisfied 2 having no opinion&#xD;
1 being unsatisfied 0 being very unsatisfied</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="0.6"/>
                    <measurement group_id="O2" value="3.5" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale</title>
        <description>Subjects' assessment of satisfaction with the treatment at Visit 6 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as:&#xD;
4 being very satisfied 3 being satisfied 2 having no opinion&#xD;
1 being unsatisfied 0 being very unsatisfied</description>
        <time_frame>Day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Freeze Plus</title>
            <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
          </group>
        </group_list>
        <measure>
          <title>Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale</title>
          <description>Subjects' assessment of satisfaction with the treatment at Visit 6 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as:&#xD;
4 being very satisfied 3 being satisfied 2 having no opinion&#xD;
1 being unsatisfied 0 being very unsatisfied</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="0"/>
                    <measurement group_id="O2" value="3.5" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Final Subject Satisfaction: 5-Point Likert Satisfaction Scale</title>
        <description>Subjects' assessment of satisfaction with the treatment at Visit 7 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as:&#xD;
4 being very satisfied 3 being satisfied 2 having no opinion&#xD;
1 being unsatisfied 0 being very unsatisfied</description>
        <time_frame>Day 21</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Freeze Plus</title>
            <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
          </group>
        </group_list>
        <measure>
          <title>Final Subject Satisfaction: 5-Point Likert Satisfaction Scale</title>
          <description>Subjects' assessment of satisfaction with the treatment at Visit 7 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as:&#xD;
4 being very satisfied 3 being satisfied 2 having no opinion&#xD;
1 being unsatisfied 0 being very unsatisfied</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0"/>
                    <measurement group_id="O2" value="3.5" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Discomfort</title>
        <description>Subject's assessment of discomfort and pain with treatment as measured by a 10 cm visual analog scale (VAS). A line which ranges from 10 being the worst pain ever to 0 being no pain at all.</description>
        <time_frame>Day 21</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Freeze Plus</title>
            <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Discomfort</title>
          <description>Subject's assessment of discomfort and pain with treatment as measured by a 10 cm visual analog scale (VAS). A line which ranges from 10 being the worst pain ever to 0 being no pain at all.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.025" spread=".95"/>
                    <measurement group_id="O2" value="0.8" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events</title>
        <description>Subjects experiencing a treatment-related adverse event (AE)</description>
        <time_frame>Day 21</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Freeze Plus</title>
            <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Subjects experiencing a treatment-related adverse event (AE)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse data were collected for up to 21 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Freeze Plus</title>
          <description>Subjects in this arm will receive treatment using RF and PEMF&#xD;
RF and PEMF: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment</description>
        </group>
        <group group_id="E2">
          <title>Ultrasound</title>
          <description>Subjects in this arm will receive treatment using ultrasound&#xD;
Ultrasound: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area</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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </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>
    <point_of_contact>
      <name_or_title>Director, Clinical Affairs</name_or_title>
      <organization>Venus Concept Ltd.</organization>
      <phone>888-907-0115</phone>
      <email>mgronski@venusconcept.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/NCT03774823
org study id: CS1217
nct id: NCT03774823
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The study will investigate whether the impact of PEMF and RF therapies is safe and
      efficacious for the treatment of pain associated with soft tissue injuries as compared to
      treatment with ultrasound, and to show the effects of PEMF and RF therapies on range of
      motion and blood flow associated with soft tissue injuries as compared to ultrasound therapy.
This is a randomized, controlled study of the safety and efficacy of a radiofrequency (RF)
      and pulsed electromagnetic fields (PEMF) device compared to ultrasound (US) for the treatment
      of pain associated with soft tissue injuries, and to show the comparative effects on blood
      flow (BF) and range of motion (ROM). Total expected duration of the clinical study is
      approximately 6 months (enrollment period of 4 months and a follow-up period of 3 weeks)
      while individual participation will take three weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One group receives treatment with RF and PEMF while the second group receives treatment with ultrasound
primary purpose: Treatment
masking: Single (Participant)
masking description: Participant is not aware which group they will be randomized into upon entering the study
measure: Mean Reduction in BPI-SF Severity
time frame: Day 10
description: Reduction in pain severity during daily activity at Visit 4 compared to Baseline as measured by the Brief Pain Inventory (Short Form) - Severity. BPI-SF assesses pain at its 'worst', 'least', 'average', and 'now' (current pain) and is rated on a scale of 0-10, where 0 represents 'No pain' and 10 represents 'Pain as bad as you can imagine'.
measure: Mean Reduction in BPI-SF Interference Score
time frame: Day 10
description: Reduction in pain interference during daily activity at Visit 4 compared to Baseline as measured by the BPI-SF Interference score. BPI-SF Interference score measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The 0-10 scale is also used for pain interference, where 0 represents 'does not interfere' and 10 represents 'completely interferes'. BPI pain interference is typically scored as the mean of the seven interference items.
measure: Short Term Blood Perfusion
time frame: Day 8
description: Change in tissue blood perfusion (BP) pre- and post-treatment at Baseline, Visit 3 as measured by perfusion imaging, measured in perfusion units (PU) where a positive value indicates an increase in blood perfusion and a negative value indicate a decrease in blood perfusion.
measure: Long Term Blood Perfusion
time frame: Day 14
description: Change in tissue blood perfusion (BP) pre- and post-treatment at Baseline, Visit 6 as measured by perfusion imaging as measured by perfusion imaging, measured in perfusion units (PU) where a positive value indicates an increase in blood perfusion and a negative value indicate a decrease in blood perfusion.
measure: Mean Reduction in BPI-SF Severity Score
time frame: Day 14
description: Reduction in pain severity during daily activity at Visit 6 as measured by the BPI-SF Severity score. BPI-SF Severity score assesses pain at its 'worst', 'least', 'average', and 'now' (current pain) and is rated on a scale of 0-10, where 0 represents 'No pain' and 10 represents 'Pain as bad as you can imagine'.
measure: Mean Reduction in BPI-SF Interference Score
time frame: Day 14
description: Reduction in pain interference during daily activity at Visit 6 as measured by the BPI-SF Interference score. BPI-SF Interference score measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The 0-10 scale is also used for pain interference, where 0 represents 'does not interfere' and 10 represents 'completely interferes'. BPI pain interference is typically scored as the mean of the seven interference items.
measure: Early Subject Satisfaction: 5-Point Likert Satisfaction Scale
time frame: Day 8
description: Subjects' assessment of satisfaction with the treatment at Visit 4 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as:
4 being very satisfied 3 being satisfied 2 having no opinion
1 being unsatisfied 0 being very unsatisfied
measure: Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale
time frame: Day 14
description: Subjects' assessment of satisfaction with the treatment at Visit 6 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as:
4 being very satisfied 3 being satisfied 2 having no opinion
1 being unsatisfied 0 being very unsatisfied
measure: Final Subject Satisfaction: 5-Point Likert Satisfaction Scale
time frame: Day 21
description: Subjects' assessment of satisfaction with the treatment at Visit 7 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as:
4 being very satisfied 3 being satisfied 2 having no opinion
1 being unsatisfied 0 being very unsatisfied
measure: Assessment of Discomfort
time frame: Day 21
description: Subject's assessment of discomfort and pain with treatment as measured by a 10 cm visual analog scale (VAS). A line which ranges from 10 being the worst pain ever to 0 being no pain at all.
measure: Adverse Events
time frame: Day 21
description: Subjects experiencing a treatment-related adverse event (AE)
arm group label: Freeze Plus
arm group type: Experimental
description: Subjects in this arm will receive treatment using RF and PEMF
arm group label: Ultrasound
arm group type: Experimental
description: Subjects in this arm will receive treatment using ultrasound
intervention type: Device
intervention name: RF and PEMF
description: RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment
arm group label: Freeze Plus
intervention type: Device
intervention name: Ultrasound
description: Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area
arm group label: Ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrea Biro
role: Study Director
affiliation: Venus Concept
facility: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Soft Tissue Injuries
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 