xml: <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/NCT05972889</url>
    </required_header>
    <id_info>
      <org_study_id>ZMI-2023-NexWave-vs-Sham</org_study_id>
      <nct_id>NCT05972889</nct_id>
    </id_info>
    <brief_title>Randomized Blinded Evaluation of the Effects of TENS and IFC Compared to a Sham Device and SOC in Patients With Non-Specific CLBP</brief_title>
    <official_title>Randomized Blinded Evaluation of the Effects of Transcutaneous Electrical Nerve Stimulation and Interferential Current Compared to a Sham Device and Standard of Care in Patients With Non-Specific Chronic Lower Back Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zynex Medical, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zynex Medical, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, sham-controlled, randomized, single-blinded, multi-center study&#xD;
        comparing two different modes of the NexWave device, transcutaneous electrical nerve&#xD;
        stimulation (TENS) and interferential current (IFC), with an identical non-functioning&#xD;
        NexWave sham device or self-defined standard of care for improvement of pain intensity of&#xD;
        non-specific CLBP.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 28, 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analogue Scale Pain Rating - NexWave vs. Sham</measure>
      <time_frame>Four weeks</time_frame>
      <description>VAS pain rating between baseline and four weeks for NexWave subjects as compared to sham device subjects.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual Analogue Scale Pain Rating - NexWave vs. Control</measure>
      <time_frame>Four weeks</time_frame>
      <description>VAS pain rating between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Oswestry Disability Index (ODI) - NexWave vs. Sham</measure>
      <time_frame>Four weeks</time_frame>
      <description>ODI scores between baseline and four weeks for NexWave subjects as compared to sham device subjects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oswestry Disability Index (OD) - NexWave vs. Control</measure>
      <time_frame>Four weeks</time_frame>
      <description>ODI scores between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.</description>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">336</enrollment>
    <condition>Non-Specific Chronic Lower Back Pain</condition>
    <arm_group>
      <arm_group_label>Device TENS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Device IFC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham TENS</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham IFC</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Subjects continue with current standard of care only for 4 weeks with the option to crossover to the NexWave Device group for an additional 4 weeks (up to 8 total weeks).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>NexWave</intervention_name>
      <description>Device subjects receive designated treatment mode twice daily for up to 8 weeks.</description>
      <arm_group_label>Device IFC</arm_group_label>
      <arm_group_label>Device TENS</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham</intervention_name>
      <description>Sham subjects provided with Sham Device and treatment instructions identical to that of NexWave Device Arm for their designated Sham Arm. Sham subjects participate for 4 weeks with the option to crossover to the NexWave Device Arm for an additional 4 weeks (up to 8 weeks total).</description>
      <arm_group_label>Sham IFC</arm_group_label>
      <arm_group_label>Sham TENS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ages 18-70, or older if specified by law&#xD;
  &#xD;
            -  Non-specific chronic lower back pain defined as:&#xD;
  &#xD;
                 1. Having lasted ≥3 months in duration&#xD;
  &#xD;
                 2. Current Visual Analogue Scale (VAS) pain rating ≥50 out of 100 (or an equivalent&#xD;
                    of 5 out of 10 on a 10-point scale)&#xD;
  &#xD;
                 3. No radiating pain below the knee&#xD;
  &#xD;
                 4. ≥75% back or buttock pain rather than lower extremity pain&#xD;
  &#xD;
            -  Subjects who are willing and capable of providing informed consent&#xD;
  &#xD;
            -  Subjects who are willing and capable of participating in all testing and questionnaire&#xD;
               requirements associated with the clinical study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any prior home use of the NexWave or any TENS/IFC device&#xD;
  &#xD;
            -  Any history of lumbar spine surgery or spinal fractures&#xD;
  &#xD;
            -  Subjects with a history of rheumatic disease&#xD;
  &#xD;
            -  Subjects with spine disorders, deformities, or severe spinal conditions such as&#xD;
               scoliosis and kyphosis, Pott's disease, disc protrusion, or others that can be&#xD;
               attributed to specific causes of back pain&#xD;
  &#xD;
            -  Subjects currently prescribed and adherent to opioid therapy&#xD;
  &#xD;
            -  Current implanted cardiac pacemakers, defibrillators, cardiac pumps, spinal&#xD;
               stimulators, or other implanted electronic devices&#xD;
  &#xD;
            -  Active psychiatric or uncontrolled mood disorders including subjects on antipsychotic&#xD;
               medication, diagnosis of bipolar disorder or schizophrenia, or uncontrolled anxiety or&#xD;
               clinical depression&#xD;
  &#xD;
            -  Subjects with a known history of allergic reactions to medical adhesives or any&#xD;
               condition that could affect placement of the electrodes&#xD;
  &#xD;
            -  Women of childbearing potential who are pregnant or who are planning to become&#xD;
               pregnant during the anticipated study period&#xD;
  &#xD;
            -  Subjects with health conditions that in the Investigator's medical opinion would&#xD;
               prevent participation in the study, interfere with assessment or therapy,&#xD;
               significantly raise the risk of study participation, or modify outcome data or its&#xD;
               interpretation&#xD;
  &#xD;
            -  Subjects who are currently enrolled in another investigational study that would&#xD;
               directly interfere with the current study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kristin Andrud, PhD</last_name>
      <phone>(800) 495-6670</phone>
      <phone_ext>3457</phone_ext>
      <email>kandrud@zynex.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Center for Clinical Research, LLC</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27103</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jill Brewer</last_name>
        <phone>336-765-6181</phone>
        <phone_ext>146</phone_ext>
        <email>JBrewer@ccrpain.com</email>
      </contact>
      <investigator>
        <last_name>James North, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>TENS</keyword>
    <keyword>IFC</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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972889
  org study id: ZMI-2023-NexWave-vs-Sham
  nct id: NCT05972889
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This is a prospective, sham-controlled, randomized, single-blinded, multi-center study
        comparing two different modes of the NexWave device, transcutaneous electrical nerve
        stimulation (TENS) and interferential current (IFC), with an identical non-functioning
        NexWave sham device or self-defined standard of care for improvement of pain intensity of
        non-specific CLBP.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Visual Analogue Scale Pain Rating - NexWave vs. Sham
  time frame: Four weeks
  description: VAS pain rating between baseline and four weeks for NexWave subjects as compared to sham device subjects.
  measure: Visual Analogue Scale Pain Rating - NexWave vs. Control
  time frame: Four weeks
  description: VAS pain rating between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.
  measure: Oswestry Disability Index (ODI) - NexWave vs. Sham
  time frame: Four weeks
  description: ODI scores between baseline and four weeks for NexWave subjects as compared to sham device subjects.
  measure: Oswestry Disability Index (OD) - NexWave vs. Control
  time frame: Four weeks
  description: ODI scores between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.
  arm group label: Device TENS
  arm group type: Experimental
  arm group label: Device IFC
  arm group type: Experimental
  arm group label: Sham TENS
  arm group type: Sham Comparator
  arm group label: Sham IFC
  arm group type: Sham Comparator
  arm group label: Control
  arm group type: No Intervention
  description: Subjects continue with current standard of care only for 4 weeks with the option to crossover to the NexWave Device group for an additional 4 weeks (up to 8 total weeks).
  intervention type: Device
  intervention name: NexWave
  description: Device subjects receive designated treatment mode twice daily for up to 8 weeks.
  arm group label: Device IFC
  arm group label: Device TENS
  intervention type: Device
  intervention name: Sham
  description: Sham subjects provided with Sham Device and treatment instructions identical to that of NexWave Device Arm for their designated Sham Arm. Sham subjects participate for 4 weeks with the option to crossover to the NexWave Device Arm for an additional 4 weeks (up to 8 weeks total).
  arm group label: Sham IFC
  arm group label: Sham TENS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Kristin Andrud, PhD
  phone: (800) 495-6670
  phone ext: 3457
  email: kandrud@zynex.com
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: No