<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/NCT03800927</url>
  </required_header>
  <id_info>
    <org_study_id>OA-04</org_study_id>
    <nct_id>NCT03800927</nct_id>
  </id_info>
  <brief_title>Long-Duration Ultrasound for Knee Osteoarthritis</brief_title>
  <official_title>Multi Week Long-Duration Ultrasound for Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ZetrOZ, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ZetrOZ, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will measure the 24-week pain relief from long-duration ultrasound on the symptoms&#xD;
      of knee arthritis pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Participants will receive active and sham devices for the first 12-weeks. Responders to treatment will continue with 12 weeks of additional active treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain Units on a Numeric Rating Scale (NRS)</measure>
    <time_frame>Average of first week (start of study) to average measure at 24 weeks (end of study)</time_frame>
    <description>NRS on the scale of 1 - 10, 1 being minimum and 10 being maximum, Change was calculate from base line</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Function</measure>
    <time_frame>First week (start of study) to 24 weeks (end of study)</time_frame>
    <description>WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in the scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0-10, 0 is no pain 10 is worst pain possible for a range of 0 - 50 points. The stiffness category consists of two scores from 0-10, 0 is no stiffness 10 is worst stiffness possible for a range of 0 - 20 points. The function score consists of 17 scores from 0-10, 0 is normal function and 10 is severely limited function, for a range of 0 - 170 points. Categories were multiplied by 10 for analysis. Total score is the sum of pain, stiffness, and function scores (range of 0 - 2400)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strengthen</measure>
    <time_frame>First week (start of study) to 24 weeks (end of study)</time_frame>
    <description>Strength measurement with force meter (Newtons)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion</measure>
    <time_frame>First week (start of study) to 24 weeks (end of study)</time_frame>
    <description>Range of Motion measurement with motion machine (Degrees)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Osteo Arthritis Knee</condition>
  <arm_group>
    <arm_group_label>Sham Ultrasound Device</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No ultrasound treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Ultrasound Device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Long duration ultrasound</intervention_name>
    <description>Low-intensity long duration ultrasound treatment</description>
    <arm_group_label>Active Ultrasound Device</arm_group_label>
    <arm_group_label>Sham Ultrasound Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are you between 18 and 80 years of age (inclusive)?&#xD;
&#xD;
          -  Can you speak, read, and write in English?&#xD;
&#xD;
          -  Do you have knee pain that has lasted at least 3 months?&#xD;
&#xD;
          -  Are you willing and able to self-administer the ultrasound device daily within your&#xD;
             place of residence or during normal daily activity?&#xD;
&#xD;
          -  Are you willing to keep all pain medications stable and discuss with the investigator&#xD;
             any needs to change medications during the study period? This may include drugs&#xD;
             administered topically, orally, transdermally, or by injection.&#xD;
&#xD;
          -  Are you willing to document usage of any medications during the study period?&#xD;
&#xD;
          -  Do you agree to discontinue all other interventional treatment modalities on the lower&#xD;
             back during the study? (e.g., transcutaneous electric nerve stimulation [TENS],&#xD;
             electronic muscle stimulation, traditional ultrasound, massage therapy, chiropractic&#xD;
             services)&#xD;
&#xD;
          -  On a Numeric Rating Scale (NRS) of 0 (no pain) to 10 (pain as bad as you can imagine),&#xD;
             how would you rate your average pain over the past week? Pain must be ≥4 for the&#xD;
             subject to be enrolled in this study. This criterion will be assessed by self-report&#xD;
             at Visit 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have you participated in a clinical trial for an investigational drug and/or agent&#xD;
             within 30 days prior to screening?&#xD;
&#xD;
          -  Are you pregnant?&#xD;
&#xD;
          -  Are you a prisoner?&#xD;
&#xD;
          -  Are you non-ambulatory (unable to walk)?&#xD;
&#xD;
          -  Do you have a pacemaker?&#xD;
&#xD;
          -  Do you have a malignancy in the treatment area?&#xD;
&#xD;
          -  Do you have an active infection, open sores, or wounds in the treatment area?&#xD;
&#xD;
          -  Do you have impaired sensation in the treatment area, such as caused by chemotherapy&#xD;
             or anesthesia?&#xD;
&#xD;
          -  Do you have a known neuropathy (disease of the brain or spinal nerves)?&#xD;
&#xD;
          -  Do you have a hereditary disposition (tendency) for excessive bleeding (hemorrhage)?&#xD;
&#xD;
          -  Do you have peripheral artery disease?&#xD;
&#xD;
          -  Does the subject display any condition which, in the judgment of the investigator,&#xD;
             would make participation in the study unacceptable including, but not limited to, the&#xD;
             subject's ability to understand and follow instructions?&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ralph Ortiz, MPH, DO</last_name>
    <role>Study Director</role>
    <affiliation>Medical Pain Consultants</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthopedic Foundation</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Pain Consultants</name>
      <address>
        <city>Dryden</city>
        <state>New York</state>
        <zip>13053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.samrecover.com</url>
    <description>Class II Medical Device</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>June 23, 2023</last_update_submitted>
  <last_update_submitted_qc>June 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03800927
org study id: OA-04
nct id: NCT03800927
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This study will measure the 24-week pain relief from long-duration ultrasound on the symptoms
      of knee arthritis pain.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Participants will receive active and sham devices for the first 12-weeks. Responders to treatment will continue with 12 weeks of additional active treatment.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in Pain Units on a Numeric Rating Scale (NRS)
time frame: Average of first week (start of study) to average measure at 24 weeks (end of study)
description: NRS on the scale of 1 - 10, 1 being minimum and 10 being maximum, Change was calculate from base line
measure: Function
time frame: First week (start of study) to 24 weeks (end of study)
description: WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in the scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0-10, 0 is no pain 10 is worst pain possible for a range of 0 - 50 points. The stiffness category consists of two scores from 0-10, 0 is no stiffness 10 is worst stiffness possible for a range of 0 - 20 points. The function score consists of 17 scores from 0-10, 0 is normal function and 10 is severely limited function, for a range of 0 - 170 points. Categories were multiplied by 10 for analysis. Total score is the sum of pain, stiffness, and function scores (range of 0 - 2400)
measure: Strengthen
time frame: First week (start of study) to 24 weeks (end of study)
description: Strength measurement with force meter (Newtons)
measure: Range of motion
time frame: First week (start of study) to 24 weeks (end of study)
description: Range of Motion measurement with motion machine (Degrees)
arm group label: Sham Ultrasound Device
arm group type: Placebo Comparator
description: No ultrasound treatment
arm group label: Active Ultrasound Device
arm group type: Active Comparator
description: Active treatment
intervention type: Device
intervention name: Long duration ultrasound
description: Low-intensity long duration ultrasound treatment
arm group label: Active Ultrasound Device
arm group label: Sham Ultrasound Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ralph Ortiz, MPH, DO
role: Study Director
affiliation: Medical Pain Consultants
facility: 
facility: 
country: United States
url: https://www.samrecover.com
description: Class II Medical Device
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No