<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/NCT03816709</url>
  </required_header>
  <id_info>
    <org_study_id>HE19132</org_study_id>
    <nct_id>NCT03816709</nct_id>
  </id_info>
  <brief_title>Intramuscular Heating Rates of a Chattanooga Intelect XT Therapeutic Ultrasound</brief_title>
  <official_title>Intramuscular Heating Rates of a Chattanooga Intelect XT Therapeutic Ultrasound With 3 MHz, 1.0 W/cm2 at Three Depths up to 2.5 cm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North Dakota State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>North Dakota State University</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the rate of tissue temperature increase in the&#xD;
      triceps surae during an ultrasound treatment using the Chattanooga Intelect Legend XT. The&#xD;
      following parameters will be used: 3 MHz frequency, 1.0 W/cm2 intensity, 15 minute treatment&#xD;
      time. Thermocouples will be inserted at 1.0, 1.75, and 2.5 cm depths to determine the heating&#xD;
      rates. Most modality textbook recommendations for therapeutic ultrasound are based on studies&#xD;
      performed with the Omnisound ultrasound machine. Previous research has shown variations in&#xD;
      power output across manufacturers, producing differences in tissue temperature increases. No&#xD;
      information has been published regarding the heating rates of the Chattanooga Intelect Legend&#xD;
      XT machine for ultrasound treatments. By determining the heating rates for this machine,&#xD;
      clinicians will be better able to utilize the Chattanooga Intelect Legend XT to help reach&#xD;
      therapeutic goals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individual subjects will report to the research lab. They will be instructed to wear&#xD;
      appropriate shorts or pants that can be rolled up to expose the gastrocnemius (calf) muscle.&#xD;
      The subject will lay prone on the treatment table with the foot and lower leg off of the&#xD;
      treatment table in a relaxed, comfortable position. The following procedures will be&#xD;
      completed using universal precautions:&#xD;
&#xD;
        1. The investigator will prep the treatment area by having the subject flex the calf to&#xD;
           determine the proper location for the ultrasound treatment in the middle of the medial&#xD;
           gastrocnemius muscle belly at its largest girth.&#xD;
&#xD;
             1. A carpenter's square with markings along the vertical arm at the three experimental&#xD;
                depths (1.0, 1.75, 2.5 cm) will be used.&#xD;
&#xD;
             2. The horizontal arm of the carpenter's square will be covered in tape. The&#xD;
                carpenter's square is then placed just proximal to the treatment mark while the&#xD;
                level on the horizontal arm is used to maintain a level measure.&#xD;
&#xD;
             3. Marks will be made on the muscle belly parallel to the marks on the vertical axis&#xD;
                at 1.0, 1.75 and 2.5 cm depths.&#xD;
&#xD;
             4. A mark is also made on the horizontal arm tape in line with the treatment mark on&#xD;
                the medial gastrocnemius.&#xD;
&#xD;
        2. The Terason uSmart 3300 diagnostic ultrasound unit will be used to measure the adipose&#xD;
           thickness over the treatment area and look for abnormalities in the treatment and&#xD;
           thermocouple insertion areas. Aquasonic® 100 ultrasound gel will be placed on the 15L4&#xD;
           transducer. The transducer with gel will be placed over the mark of the treatment area.&#xD;
           Once the transducer is in place, the screen will be frozen and the skin and adipose&#xD;
           thickness will be measured using the caliper tool.&#xD;
&#xD;
        3. The thermocouples will be removed from the MetriCide after sterilizing for a minimum of&#xD;
           12 hours prior to insertion.&#xD;
&#xD;
             1. The distal aspect of the thermocouple will be wiped dry with sterile gauze.&#xD;
&#xD;
             2. A mark with a sharpie will be made on each thermocouple just past the length marked&#xD;
                on the horizontal arm of the carpenter's square. This allows the tip of each&#xD;
                thermocouple to be directly below the treatment site. A second mark will be made at&#xD;
                5 cm to make sure the thermocouple does not go too deep into the tissue.&#xD;
&#xD;
             3. The distal end of the thermocouple will be wiped clean again using a 70% isopropyl&#xD;
                alcohol wipe up to the marks and then the thermocouple will be wrapped in sterile&#xD;
                gauze until it is inserted.&#xD;
&#xD;
        4. The insertion areas will be shaved to remove any body hair (if necessary) and cleaned&#xD;
           using Betadine.&#xD;
&#xD;
           a. Once the Betadine dries, 70% isopropyl alcohol will be wiped over the insertion area&#xD;
           and given time to dry.&#xD;
&#xD;
        5. The subject will be instructed to take two deep breaths, while the researcher lightly&#xD;
           grasps the gastrocnemius to confirm muscle relaxation.&#xD;
&#xD;
             1. During the second exhalation, the 1.16 in needle catheter will be placed into the&#xD;
                subject's calf at the 1.0 cm depth insertion mark using the level to guide the&#xD;
                needle in. The needle will be removed leaving the catheter in the tissue.&#xD;
&#xD;
             2. The thermocouple will be threaded through the catheter to the appropriate depth&#xD;
                marked on the thermocouple and the catheter will be removed.&#xD;
&#xD;
             3. The thermocouple will be secured using medical tape to keep it from moving.&#xD;
&#xD;
             4. This procedure will be performed 3 times, with one thermocouple placed at each&#xD;
                respective depth: 1.0 cm, 1.75 cm, and 2.5 cm.&#xD;
&#xD;
        6. Each thermocouple will be attached to the Iso Thermex electronic thermometer (Columbus&#xD;
           Instruments, Columbus, OH), which will measure and record intramuscular temperatures&#xD;
           from the tips of the thermocouples.&#xD;
&#xD;
        7. An ultrasound treatment template will be applied at the treatment site and secured with&#xD;
           tape to maintain consistent treatment size.&#xD;
&#xD;
           a. This template will be twice the size of the transducer's Effective Radiating Area&#xD;
           (ERA).&#xD;
&#xD;
        8. A metronome will be utilized to consistently move the transducer at a rate of 4 cm/s .&#xD;
&#xD;
        9. The ultrasound treatment will begin once the intramuscular temperature has remained the&#xD;
           same for a minute.&#xD;
&#xD;
       10. Each subject will receive one ultrasound treatment at the following parameters: 3 MHz&#xD;
           frequency, 1.0 W/cm2 intensity, and 100% duty cycle using the Chattanooga Intelect®&#xD;
           Legend XT.&#xD;
&#xD;
           a. Termination of treatment will result when any of the following occur: i. A 15-minute&#xD;
           treatment time is obtained. ii. A 4°C temperature increase occurs at all three depths as&#xD;
           this has been shown as the necessary temperature change to increase tissue&#xD;
           extensibility.&#xD;
&#xD;
           iii. A 45°C temperature is reached at any depth, due to concern of tissue damage at high&#xD;
           temperatures.&#xD;
&#xD;
           iv. The subject experiences any pain or discomfort during the treatment.&#xD;
&#xD;
       11. Following the treatment, the ultrasound gel will be wiped from the leg, the template and&#xD;
           thermocouples will be removed, and the insertion sites will be cleaned with 70%&#xD;
           isopropyl alcohol wipes and covered with a band aid.&#xD;
&#xD;
       12. The subject will then be instructed on the possibility of minor soreness for the next&#xD;
           day or two and instructed on an icing schedule to decrease discomfort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2019</start_date>
  <completion_date type="Actual">May 11, 2020</completion_date>
  <primary_completion_date type="Actual">April 15, 2020</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heating Rate at 1 cm Depth</measure>
    <time_frame>Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 6 minutes)</time_frame>
    <description>A thermocouple was inserted at the 1 cm depth to determine the tissue temperatures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heating Rate at 1.75 cm Depth</measure>
    <time_frame>Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 8 minutes)</time_frame>
    <description>A thermocouple was inserted at the 1.75 cm depth to determine the tissue temperatures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heating Rate at 2.5 cm Depth</measure>
    <time_frame>Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which did not occur in the 15 minute treatment)</time_frame>
    <description>A thermocouple was inserted at the 2.5 cm depth to determine the tissue temperatures.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Ultrasound Therapy; Complications</condition>
  <arm_group>
    <arm_group_label>Therapeutic ultrasound treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All subjects received a therapeutic ultrasound treatment with the Chattanooga Intelect Legend XT machine with the following parameters: 3 MHz, 1.0 W/cm2, 15 minute treatment time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Therapeutic Ultrasound</intervention_name>
    <description>A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes.</description>
    <arm_group_label>Therapeutic ultrasound treatment</arm_group_label>
    <other_name>Ultrasound therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  males and females between the ages of 18 - 35 years old&#xD;
&#xD;
          -  able to speak English&#xD;
&#xD;
          -  have less than 1 cm of adipose over the left medial gastrocnemius muscle.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any current lower extremity injury&#xD;
&#xD;
          -  any lower extremity injuries within the last 6 months&#xD;
&#xD;
          -  open wounds&#xD;
&#xD;
          -  skin infections&#xD;
&#xD;
          -  impaired circulation&#xD;
&#xD;
          -  peripheral vascular disease&#xD;
&#xD;
          -  deep vein thrombosis&#xD;
&#xD;
          -  advanced arthritis&#xD;
&#xD;
          -  poor thermal regulation&#xD;
&#xD;
          -  anesthetic areas&#xD;
&#xD;
          -  neoplasms/tumors&#xD;
&#xD;
          -  thrombophlebitis&#xD;
&#xD;
          -  closed infections&#xD;
&#xD;
          -  any allergies or sensitivities to betadine&#xD;
&#xD;
          -  any abnormalities observed in the medial gastrocnemius muscle determined by diagnostic&#xD;
             ultrasound&#xD;
&#xD;
          -  1.0 cm or greater adipose over the left medial gastrocnemius muscle.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristy Shirley</last_name>
    <role>Study Director</role>
    <affiliation>NDSU IRB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Dakota State University</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58108-6050</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Gange KN, Kjellerson MC, Berdan CJ. The Dynatron Solaris(R) Ultrasound Machine: Slower Heating Than Textbook Recommendations at 3 MHz, 1.0 W/cm2. J Sport Rehabil. 2018 Jan 1;27(1):22-29. doi: 10.1123/jsr.2016-0173. Epub 2018 Jan 18.</citation>
    <PMID>27992304</PMID>
  </reference>
  <reference>
    <citation>Merrick MA, Bernard KD, Devor ST, Williams MJ. Identical 3-MHz ultrasound treatments with different devices produce different intramuscular temperatures. J Orthop Sports Phys Ther. 2003 Jul;33(7):379-85. doi: 10.2519/jospt.2003.33.7.379.</citation>
    <PMID>12918863</PMID>
  </reference>
  <reference>
    <citation>Draper DO, Castel JC, Castel D. Rate of temperature increase in human muscle during 1 MHz and 3 MHz continuous ultrasound. J Orthop Sports Phys Ther. 1995 Oct;22(4):142-50. doi: 10.2519/jospt.1995.22.4.142.</citation>
    <PMID>8535471</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <results_first_submitted>March 5, 2020</results_first_submitted>
  <results_first_submitted_qc>May 4, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 27, 2021</results_first_posted>
  <last_update_submitted>May 4, 2021</last_update_submitted>
  <last_update_submitted_qc>May 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>North Dakota State University</investigator_affiliation>
    <investigator_full_name>Kara Gange</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>heating rates</keyword>
  <keyword>therapeutic ultrasound</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Once the data has been analyzed to determine the heating rates, a manuscript including the heating rates will be submitted for publication.</ipd_description>
  </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>January 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03816709/Prot_005.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>January 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03816709/SAP_006.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>January 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03816709/ICF_007.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Twenty-five subjects were recruited through the Institution's Listserve from January-February, 2019.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Therapeutic Ultrasound Treatment</title>
          <description>All subjects received a therapeutic ultrasound treatment with the Chattanooga Intelect Legend XT machine with the following parameters: 3 MHz, 1.0 W/cm2, 15 minute treatment time.&#xD;
Therapeutic Ultrasound: A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </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="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>male and female 18-35 year olds with no injuries to the lower leg.</population>
      <group_list>
        <group group_id="B1">
          <title>Therapeutic Ultrasound Treatment</title>
          <description>All subjects received a therapeutic ultrasound treatment with the Chattanooga Intelect Legend XT machine with the following parameters: 3 MHz, 1.0 W/cm2, 15 minute treatment time.&#xD;
Therapeutic Ultrasound: A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>18-35 year olds</description>
          <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="25"/>
                  </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="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" 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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </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>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Heating Rate at 1 cm Depth</title>
        <description>A thermocouple was inserted at the 1 cm depth to determine the tissue temperatures.</description>
        <time_frame>Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 6 minutes)</time_frame>
        <population>Intent to treat population. All subjects received the Ultrasound treatment with a thermocouple recording tissue temperatures at the 1 cm depth.</population>
        <group_list>
          <group group_id="O1">
            <title>Therapeutic Ultrasound Treatment</title>
            <description>All subjects received a therapeutic ultrasound treatment with the Chattanooga Intelect Legend XT machine with the following parameters: 3 MHz, 1.0 W/cm2, 15 minute treatment time.&#xD;
Therapeutic Ultrasound: A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes at the depths of 1.0, 1.75, and 2.5 cm.</description>
          </group>
        </group_list>
        <measure>
          <title>Heating Rate at 1 cm Depth</title>
          <description>A thermocouple was inserted at the 1 cm depth to determine the tissue temperatures.</description>
          <population>Intent to treat population. All subjects received the Ultrasound treatment with a thermocouple recording tissue temperatures at the 1 cm depth.</population>
          <units>degrees Celcius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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="6.49" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heating Rate at 1.75 cm Depth</title>
        <description>A thermocouple was inserted at the 1.75 cm depth to determine the tissue temperatures.</description>
        <time_frame>Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 8 minutes)</time_frame>
        <population>Intent to treat. All subject received the Ultrasound treatment with a thermocouple at the 1.75 cm depth to determine tissue temperature</population>
        <group_list>
          <group group_id="O1">
            <title>Therapeutic Ultrasound Treatment</title>
            <description>All subjects received a therapeutic ultrasound treatment with the Chattanooga Intelect Legend XT machine with the following parameters: 3 MHz, 1.0 W/cm2, 15 minute treatment time.&#xD;
Therapeutic Ultrasound: A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes at the depths of 1.0, 1.75, and 2.5 cm.</description>
          </group>
        </group_list>
        <measure>
          <title>Heating Rate at 1.75 cm Depth</title>
          <description>A thermocouple was inserted at the 1.75 cm depth to determine the tissue temperatures.</description>
          <population>Intent to treat. All subject received the Ultrasound treatment with a thermocouple at the 1.75 cm depth to determine tissue temperature</population>
          <units>degrees Celcius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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="5.50" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heating Rate at 2.5 cm Depth</title>
        <description>A thermocouple was inserted at the 2.5 cm depth to determine the tissue temperatures.</description>
        <time_frame>Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which did not occur in the 15 minute treatment)</time_frame>
        <population>Intent to treat. All subjects received the Ultrasound treatment with a thermocouple at the 2.5 cm depth to determine tissue temperatures.</population>
        <group_list>
          <group group_id="O1">
            <title>Therapeutic Ultrasound Treatment</title>
            <description>All subjects received a therapeutic ultrasound treatment with the Chattanooga Intelect Legend XT machine with the following parameters: 3 MHz, 1.0 W/cm2, 15 minute treatment time.&#xD;
Therapeutic Ultrasound: A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes at the depths of 1.0, 1.75, and 2.5 cm.</description>
          </group>
        </group_list>
        <measure>
          <title>Heating Rate at 2.5 cm Depth</title>
          <description>A thermocouple was inserted at the 2.5 cm depth to determine the tissue temperatures.</description>
          <population>Intent to treat. All subjects received the Ultrasound treatment with a thermocouple at the 2.5 cm depth to determine tissue temperatures.</population>
          <units>degrees Celcius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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="3.07" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Therapeutic Ultrasound Treatment</title>
          <description>All subjects received a therapeutic ultrasound treatment with the Chattanooga Intelect Legend XT machine with the following parameters: 3 MHz, 1.0 W/cm2, 15 minute treatment time.&#xD;
Therapeutic Ultrasound: A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes at the depths of 1.0, 1.75, and 2.5 cm.</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="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </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="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Kara Gange, Associate Professor</name_or_title>
      <organization>North Dakota State University</organization>
      <phone>701-231-5777</phone>
      <email>kara.gange@ndsu.edu</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/NCT03816709
org study id: HE19132
nct id: NCT03816709
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to determine the rate of tissue temperature increase in the
      triceps surae during an ultrasound treatment using the Chattanooga Intelect Legend XT. The
      following parameters will be used: 3 MHz frequency, 1.0 W/cm2 intensity, 15 minute treatment
      time. Thermocouples will be inserted at 1.0, 1.75, and 2.5 cm depths to determine the heating
      rates. Most modality textbook recommendations for therapeutic ultrasound are based on studies
      performed with the Omnisound ultrasound machine. Previous research has shown variations in
      power output across manufacturers, producing differences in tissue temperature increases. No
      information has been published regarding the heating rates of the Chattanooga Intelect Legend
      XT machine for ultrasound treatments. By determining the heating rates for this machine,
      clinicians will be better able to utilize the Chattanooga Intelect Legend XT to help reach
      therapeutic goals.
Individual subjects will report to the research lab. They will be instructed to wear
      appropriate shorts or pants that can be rolled up to expose the gastrocnemius (calf) muscle.
      The subject will lay prone on the treatment table with the foot and lower leg off of the
      treatment table in a relaxed, comfortable position. The following procedures will be
      completed using universal precautions:

        1. The investigator will prep the treatment area by having the subject flex the calf to
           determine the proper location for the ultrasound treatment in the middle of the medial
           gastrocnemius muscle belly at its largest girth.

             1. A carpenter's square with markings along the vertical arm at the three experimental
                depths (1.0, 1.75, 2.5 cm) will be used.

             2. The horizontal arm of the carpenter's square will be covered in tape. The
                carpenter's square is then placed just proximal to the treatment mark while the
                level on the horizontal arm is used to maintain a level measure.

             3. Marks will be made on the muscle belly parallel to the marks on the vertical axis
                at 1.0, 1.75 and 2.5 cm depths.

             4. A mark is also made on the horizontal arm tape in line with the treatment mark on
                the medial gastrocnemius.

        2. The Terason uSmart 3300 diagnostic ultrasound unit will be used to measure the adipose
           thickness over the treatment area and look for abnormalities in the treatment and
           thermocouple insertion areas. Aquasonic® 100 ultrasound gel will be placed on the 15L4
           transducer. The transducer with gel will be placed over the mark of the treatment area.
           Once the transducer is in place, the screen will be frozen and the skin and adipose
           thickness will be measured using the caliper tool.

        3. The thermocouples will be removed from the MetriCide after sterilizing for a minimum of
           12 hours prior to insertion.

             1. The distal aspect of the thermocouple will be wiped dry with sterile gauze.

             2. A mark with a sharpie will be made on each thermocouple just past the length marked
                on the horizontal arm of the carpenter's square. This allows the tip of each
                thermocouple to be directly below the treatment site. A second mark will be made at
                5 cm to make sure the thermocouple does not go too deep into the tissue.

             3. The distal end of the thermocouple will be wiped clean again using a 70% isopropyl
                alcohol wipe up to the marks and then the thermocouple will be wrapped in sterile
                gauze until it is inserted.

        4. The insertion areas will be shaved to remove any body hair (if necessary) and cleaned
           using Betadine.

           a. Once the Betadine dries, 70% isopropyl alcohol will be wiped over the insertion area
           and given time to dry.

        5. The subject will be instructed to take two deep breaths, while the researcher lightly
           grasps the gastrocnemius to confirm muscle relaxation.

             1. During the second exhalation, the 1.16 in needle catheter will be placed into the
                subject's calf at the 1.0 cm depth insertion mark using the level to guide the
                needle in. The needle will be removed leaving the catheter in the tissue.

             2. The thermocouple will be threaded through the catheter to the appropriate depth
                marked on the thermocouple and the catheter will be removed.

             3. The thermocouple will be secured using medical tape to keep it from moving.

             4. This procedure will be performed 3 times, with one thermocouple placed at each
                respective depth: 1.0 cm, 1.75 cm, and 2.5 cm.

        6. Each thermocouple will be attached to the Iso Thermex electronic thermometer (Columbus
           Instruments, Columbus, OH), which will measure and record intramuscular temperatures
           from the tips of the thermocouples.

        7. An ultrasound treatment template will be applied at the treatment site and secured with
           tape to maintain consistent treatment size.

           a. This template will be twice the size of the transducer's Effective Radiating Area
           (ERA).

        8. A metronome will be utilized to consistently move the transducer at a rate of 4 cm/s .

        9. The ultrasound treatment will begin once the intramuscular temperature has remained the
           same for a minute.

       10. Each subject will receive one ultrasound treatment at the following parameters: 3 MHz
           frequency, 1.0 W/cm2 intensity, and 100% duty cycle using the Chattanooga Intelect®
           Legend XT.

           a. Termination of treatment will result when any of the following occur: i. A 15-minute
           treatment time is obtained. ii. A 4°C temperature increase occurs at all three depths as
           this has been shown as the necessary temperature change to increase tissue
           extensibility.

           iii. A 45°C temperature is reached at any depth, due to concern of tissue damage at high
           temperatures.

           iv. The subject experiences any pain or discomfort during the treatment.

       11. Following the treatment, the ultrasound gel will be wiped from the leg, the template and
           thermocouples will be removed, and the insertion sites will be cleaned with 70%
           isopropyl alcohol wipes and covered with a band aid.

       12. The subject will then be instructed on the possibility of minor soreness for the next
           day or two and instructed on an icing schedule to decrease discomfort.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Heating Rate at 1 cm Depth
time frame: Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 6 minutes)
description: A thermocouple was inserted at the 1 cm depth to determine the tissue temperatures.
measure: Heating Rate at 1.75 cm Depth
time frame: Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 8 minutes)
description: A thermocouple was inserted at the 1.75 cm depth to determine the tissue temperatures.
measure: Heating Rate at 2.5 cm Depth
time frame: Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which did not occur in the 15 minute treatment)
description: A thermocouple was inserted at the 2.5 cm depth to determine the tissue temperatures.
arm group label: Therapeutic ultrasound treatment
arm group type: Other
description: All subjects received a therapeutic ultrasound treatment with the Chattanooga Intelect Legend XT machine with the following parameters: 3 MHz, 1.0 W/cm2, 15 minute treatment time.
intervention type: Device
intervention name: Therapeutic Ultrasound
description: A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes.
arm group label: Therapeutic ultrasound treatment
other name: Ultrasound therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kristy Shirley
role: Study Director
affiliation: NDSU IRB
facility: 
country: United States
citation: Gange KN, Kjellerson MC, Berdan CJ. The Dynatron Solaris(R) Ultrasound Machine: Slower Heating Than Textbook Recommendations at 3 MHz, 1.0 W/cm2. J Sport Rehabil. 2018 Jan 1;27(1):22-29. doi: 10.1123/jsr.2016-0173. Epub 2018 Jan 18.
PMID: 27992304
citation: Merrick MA, Bernard KD, Devor ST, Williams MJ. Identical 3-MHz ultrasound treatments with different devices produce different intramuscular temperatures. J Orthop Sports Phys Ther. 2003 Jul;33(7):379-85. doi: 10.2519/jospt.2003.33.7.379.
PMID: 12918863
citation: Draper DO, Castel JC, Castel D. Rate of temperature increase in human muscle during 1 MHz and 3 MHz continuous ultrasound. J Orthop Sports Phys Ther. 1995 Oct;22(4):142-50. doi: 10.2519/jospt.1995.22.4.142.
PMID: 8535471
responsible party type: Principal Investigator
investigator affiliation: North Dakota State University
investigator full name: Kara Gange
investigator title: Associate Professor
sharing ipd: No
ipd description: Once the data has been analyzed to determine the heating rates, a manuscript including the heating rates will be submitted for publication.
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 