<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/NCT04494841</url>
  </required_header>
  <id_info>
    <org_study_id>UsabilityDuoTherm</org_study_id>
    <secondary_id>4R44DA049631</secondary_id>
    <nct_id>NCT04494841</nct_id>
  </id_info>
  <brief_title>Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain</brief_title>
  <official_title>Addressing Feasibility of the DuoTherm in Acute and Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MMJ Labs LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sport and Spine Rehab Clinical Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>MMJ Labs LLC</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>
      Ten patients with acute or chronic low back pain will be invited to try a multimodal device&#xD;
      for 20 minutes. Pain will be recorded prior to and after use, and feedback on the device will&#xD;
      be elicited.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To facilitate data collection of a short-term intervention, the investigators chose to enroll&#xD;
      patients from a mixed physical therapy/chiropractic practice with demographic and economic&#xD;
      diversity in the metro Washington area. The neuromodulatory device will have patient&#xD;
      controlled frequencies at 50Hz, 100Hz, and 180Hz attached to a 12 x 22 cm metal plate&#xD;
      ergonomically curved to fit the low back. The device will be wearable with a neoprene belt on&#xD;
      both sides for patients to adjust pressure. The metal pocket in our device holds a 221g clay&#xD;
      pack capable of being frozen to 15F or heated to 110F or patient tolerance, with 30 minute&#xD;
      thermal capacity. A convenience sample of 10 patients at the clinic was invited to give&#xD;
      feedback on the prototype device after informed consent. Changes suggested were incorporated&#xD;
      and after informed consent a second group of ten gave will give feedback with the&#xD;
      production-ready device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2020</start_date>
  <completion_date type="Actual">February 18, 2021</completion_date>
  <primary_completion_date type="Actual">January 20, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Consecutive low back pain patients were offered to try a new device and give feedback on a prototype. Once the feedback was obtained, the changes were incorporated into a production-ready model and re-evaluated.</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain: Visual Analog Scale (VAS)</measure>
    <time_frame>Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation</time_frame>
    <description>Difference in 10 cm VAS printed on paper from 0 (no pain) to 10 (most pain) before and after use of the device, higher value indicates a greater pain reduction, 1.8 cm is considered clinically relevant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants' Choice in Thermal Options</measure>
    <time_frame>30 minutes</time_frame>
    <description>One of four options: hot, cold, none, both</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Would You Recommend</measure>
    <time_frame>After 30 minutes</time_frame>
    <description>Binary approval or disapproval of device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Pain Relief</measure>
    <time_frame>30 minutes</time_frame>
    <description>7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Low Back Sprain</condition>
  <condition>Low Back Pain, Recurrent</condition>
  <arm_group>
    <arm_group_label>DuoTherm VibraCool Back Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Duotherm VibraCool Back Device</intervention_name>
    <description>Low back plate belt with mechanicothermal and pressure intervention options.</description>
    <arm_group_label>DuoTherm VibraCool Back Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute or chronic low back pain as chief complaint&#xD;
&#xD;
          -  Capacity to understand all relevant risks and potential benefits of the study&#xD;
             (informed consent);&#xD;
&#xD;
          -  Willingness to communicate information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Radicular pain likely reflecting a surgical or mechanical problem&#xD;
&#xD;
          -  BMI greater than 30 (device won't fit)&#xD;
&#xD;
          -  Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)&#xD;
&#xD;
          -  Diabetic neuropathy rendering a patient unable to determine if the device is too hot&#xD;
&#xD;
          -  New neurologic deficits&#xD;
&#xD;
          -  Skin lesions over the low back area&#xD;
&#xD;
          -  Contraindication to any medication for pain management that would impact analgesic use&#xD;
             record&#xD;
&#xD;
          -  Inability to apply DuoTherm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Yes based on self-representation</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Baxter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MMJ Labs LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sport and Spine Rehab Clinic</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Stumbo SP, Yarborough BJ, McCarty D, Weisner C, Green CA. Patient-reported pathways to opioid use disorders and pain-related barriers to treatment engagement. J Subst Abuse Treat. 2017 Feb;73:47-54. doi: 10.1016/j.jsat.2016.11.003. Epub 2016 Nov 15.</citation>
    <PMID>28017184</PMID>
  </reference>
  <reference>
    <citation>Darnall BD, Colloca L. Optimizing Placebo and Minimizing Nocebo to Reduce Pain, Catastrophizing, and Opioid Use: A Review of the Science and an Evidence-Informed Clinical Toolkit. Int Rev Neurobiol. 2018;139:129-157. doi: 10.1016/bs.irn.2018.07.022. Epub 2018 Aug 6.</citation>
    <PMID>30146045</PMID>
  </reference>
  <reference>
    <citation>Davis CS, Lieberman AJ, Hernandez-Delgado H, Suba C. Laws limiting the prescribing or dispensing of opioids for acute pain in the United States: A national systematic legal review. Drug Alcohol Depend. 2019 Jan 1;194:166-172. doi: 10.1016/j.drugalcdep.2018.09.022. Epub 2018 Nov 3.</citation>
    <PMID>30445274</PMID>
  </reference>
  <reference>
    <citation>Ballard A, Khadra C, Adler S, Trottier ED, Le May S. Efficacy of the Buzzy Device for Pain Management During Needle-related Procedures: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Jun;35(6):532-543. doi: 10.1097/AJP.0000000000000690.</citation>
    <PMID>30829735</PMID>
  </reference>
  <reference>
    <citation>Lurie RC, Cimino SR, Gregory DE, Brown SHM. The effect of short duration low back vibration on pain developed during prolonged standing. Appl Ergon. 2018 Feb;67:246-251. doi: 10.1016/j.apergo.2017.10.007. Epub 2017 Nov 1.</citation>
    <PMID>29122196</PMID>
  </reference>
  <reference>
    <citation>Ueki S, Yamagami Y, Makimoto K. Effectiveness of vibratory stimulation on needle-related procedural pain in children: a systematic review. JBI Database System Rev Implement Rep. 2019 Jul;17(7):1428-1463. doi: 10.11124/JBISRIR-2017-003890.</citation>
    <PMID>31021972</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <results_first_submitted>August 10, 2022</results_first_submitted>
  <results_first_submitted_qc>October 20, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 21, 2022</results_first_posted>
  <last_update_submitted>October 20, 2022</last_update_submitted>
  <last_update_submitted_qc>October 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MMJ Labs LLC</investigator_affiliation>
    <investigator_full_name>Amy Lynn Baxter</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Medical Device</keyword>
  <keyword>Buzzy</keyword>
  <keyword>Vibration</keyword>
  <keyword>thermomechanical</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the clinical results reported in any publications, after deidentification, will be available for a period of 36 months after publication to achieve approved aims of any researcher who provides a methodologically sound proposal. Proposals should be directed to info@mmjlabs.com. To gain acccess, data requestors will need to sign a data access agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>36 months after publication</ipd_time_frame>
    <ipd_access_criteria>researchers providing approved methodologically sound proposals</ipd_access_criteria>
  </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>June 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT04494841/Prot_SAP_000.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>June 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT04494841/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>DuoTherm VibraCool Back Device</title>
          <description>Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.&#xD;
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>DuoTherm VibraCool Back Device</title>
          <description>Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.&#xD;
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.9" spread="11.0"/>
                  </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="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Pain: Visual Analog Scale (VAS)</title>
        <description>Difference in 10 cm VAS printed on paper from 0 (no pain) to 10 (most pain) before and after use of the device, higher value indicates a greater pain reduction, 1.8 cm is considered clinically relevant.</description>
        <time_frame>Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DuoTherm VibraCool Back Device</title>
            <description>Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.&#xD;
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain: Visual Analog Scale (VAS)</title>
          <description>Difference in 10 cm VAS printed on paper from 0 (no pain) to 10 (most pain) before and after use of the device, higher value indicates a greater pain reduction, 1.8 cm is considered clinically relevant.</description>
          <units>units on a scale (centimeters)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants' Choice in Thermal Options</title>
        <description>One of four options: hot, cold, none, both</description>
        <time_frame>30 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DuoTherm VibraCool Back Device</title>
            <description>Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.&#xD;
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants' Choice in Thermal Options</title>
          <description>One of four options: hot, cold, none, both</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hot</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cold</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Both</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Would You Recommend</title>
        <description>Binary approval or disapproval of device</description>
        <time_frame>After 30 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DuoTherm VibraCool Back Device</title>
            <description>Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.&#xD;
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options.</description>
          </group>
        </group_list>
        <measure>
          <title>Would You Recommend</title>
          <description>Binary approval or disapproval of device</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Approve</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Disapprove</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Pain Relief</title>
        <description>7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study</description>
        <time_frame>30 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DuoTherm VibraCool Back Device</title>
            <description>Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.&#xD;
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Pain Relief</title>
          <description>7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 hours</time_frame>
      <desc>20 patients will be evaluated for adverse events, mortality, or other not serious adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>DuoTherm VibraCool Back Device</title>
          <description>Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.&#xD;
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options.</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="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </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="20"/>
              </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 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>Dr. Amy Baxter</name_or_title>
      <organization>MMJ Labs</organization>
      <phone>1 877 805 2899</phone>
      <email>abaxter@mmjlabs.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/NCT04494841
org study id: UsabilityDuoTherm
secondary id: 4R44DA049631
nct id: NCT04494841
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Ten patients with acute or chronic low back pain will be invited to try a multimodal device
      for 20 minutes. Pain will be recorded prior to and after use, and feedback on the device will
      be elicited.
To facilitate data collection of a short-term intervention, the investigators chose to enroll
      patients from a mixed physical therapy/chiropractic practice with demographic and economic
      diversity in the metro Washington area. The neuromodulatory device will have patient
      controlled frequencies at 50Hz, 100Hz, and 180Hz attached to a 12 x 22 cm metal plate
      ergonomically curved to fit the low back. The device will be wearable with a neoprene belt on
      both sides for patients to adjust pressure. The metal pocket in our device holds a 221g clay
      pack capable of being frozen to 15F or heated to 110F or patient tolerance, with 30 minute
      thermal capacity. A convenience sample of 10 patients at the clinic was invited to give
      feedback on the prototype device after informed consent. Changes suggested were incorporated
      and after informed consent a second group of ten gave will give feedback with the
      production-ready device.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Consecutive low back pain patients were offered to try a new device and give feedback on a prototype. Once the feedback was obtained, the changes were incorporated into a production-ready model and re-evaluated.
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Change in Pain: Visual Analog Scale (VAS)
time frame: Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation
description: Difference in 10 cm VAS printed on paper from 0 (no pain) to 10 (most pain) before and after use of the device, higher value indicates a greater pain reduction, 1.8 cm is considered clinically relevant.
measure: Participants' Choice in Thermal Options
time frame: 30 minutes
description: One of four options: hot, cold, none, both
measure: Would You Recommend
time frame: After 30 minutes
description: Binary approval or disapproval of device
measure: Subjective Pain Relief
time frame: 30 minutes
description: 7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study
arm group label: DuoTherm VibraCool Back Device
arm group type: Experimental
description: Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.
intervention type: Device
intervention name: Duotherm VibraCool Back Device
description: Low back plate belt with mechanicothermal and pressure intervention options.
arm group label: DuoTherm VibraCool Back Device
criteria: 
gender: All
gender based: Yes
gender description: Yes based on self-representation
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Amy Baxter, MD
role: Principal Investigator
affiliation: MMJ Labs LLC
facility: 
country: United States
citation: Stumbo SP, Yarborough BJ, McCarty D, Weisner C, Green CA. Patient-reported pathways to opioid use disorders and pain-related barriers to treatment engagement. J Subst Abuse Treat. 2017 Feb;73:47-54. doi: 10.1016/j.jsat.2016.11.003. Epub 2016 Nov 15.
PMID: 28017184
citation: Darnall BD, Colloca L. Optimizing Placebo and Minimizing Nocebo to Reduce Pain, Catastrophizing, and Opioid Use: A Review of the Science and an Evidence-Informed Clinical Toolkit. Int Rev Neurobiol. 2018;139:129-157. doi: 10.1016/bs.irn.2018.07.022. Epub 2018 Aug 6.
PMID: 30146045
citation: Davis CS, Lieberman AJ, Hernandez-Delgado H, Suba C. Laws limiting the prescribing or dispensing of opioids for acute pain in the United States: A national systematic legal review. Drug Alcohol Depend. 2019 Jan 1;194:166-172. doi: 10.1016/j.drugalcdep.2018.09.022. Epub 2018 Nov 3.
PMID: 30445274
citation: Ballard A, Khadra C, Adler S, Trottier ED, Le May S. Efficacy of the Buzzy Device for Pain Management During Needle-related Procedures: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Jun;35(6):532-543. doi: 10.1097/AJP.0000000000000690.
PMID: 30829735
citation: Lurie RC, Cimino SR, Gregory DE, Brown SHM. The effect of short duration low back vibration on pain developed during prolonged standing. Appl Ergon. 2018 Feb;67:246-251. doi: 10.1016/j.apergo.2017.10.007. Epub 2017 Nov 1.
PMID: 29122196
citation: Ueki S, Yamagami Y, Makimoto K. Effectiveness of vibratory stimulation on needle-related procedural pain in children: a systematic review. JBI Database System Rev Implement Rep. 2019 Jul;17(7):1428-1463. doi: 10.11124/JBISRIR-2017-003890.
PMID: 31021972
responsible party type: Principal Investigator
investigator affiliation: MMJ Labs LLC
investigator full name: Amy Lynn Baxter
investigator title: Principal Investigator
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Yes
ipd description: Individual participant data that underlie the clinical results reported in any publications, after deidentification, will be available for a period of 36 months after publication to achieve approved aims of any researcher who provides a methodologically sound proposal. Proposals should be directed to info@mmjlabs.com. To gain acccess, data requestors will need to sign a data access agreement.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: 36 months after publication
ipd access criteria: researchers providing approved methodologically sound proposals
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 