<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/NCT03267810</url>
  </required_header>
  <id_info>
    <org_study_id>20160951</org_study_id>
    <secondary_id>90SI5023</secondary_id>
    <nct_id>NCT03267810</nct_id>
  </id_info>
  <brief_title>TENS Trial to Prevent Neuropathic Pain in SCI</brief_title>
  <acronym>TENS</acronym>
  <official_title>Randomized, Double-blinded, Controlled Trial of Early-intervention TENS for the Reduction of the Prevalence and Severity of Chronic Neuropathic Pain During the First Year After Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Disability, Independent Living, and Rehabilitation Research</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to: 1) test whether transcutaneous electrical nerve&#xD;
      stimulation (TENS) after spinal cord injury can reduce the onset of post-injury neuropathic&#xD;
      pain; and 2) to learn more about this kind of pain and who is at risk for suffering from this&#xD;
      type of pain after spinal cord injury. Neuropathic pain is a type of pain that occurs in&#xD;
      about 50% of people with spinal cord injury. This type of pain is usually described as&#xD;
      &quot;burning&quot; or &quot;tingling,&quot; and is present around the level of injury and/or in areas below the&#xD;
      level of injury. The investigators' goal is to try a non-drug treatment (TENS) that may help&#xD;
      prevent this pain from occurring. Pain symptoms will be compared between the study&#xD;
      participants who receive active TENS and the study participants who receive a sham TENS&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty with recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">March 4, 2022</completion_date>
  <primary_completion_date type="Actual">March 4, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Percentage of Subjects Who Develop Chronic Neuropathic Pain.</measure>
    <time_frame>12 months</time_frame>
    <description>as defined by a score of ≥2 on the Spinal Cord Injury Pain Inventory (SCIPI), a self-report scale of symptoms. SCIPI has a total score ranging from 0 to 4 with scores of &gt;=2 screening positive for Neuropathic Pain in people with spinal cord injury</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropathic Pain Symptom Inventory (NPSI) Scores</measure>
    <time_frame>12 months</time_frame>
    <description>NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>12 months</time_frame>
    <description>Number of participants reporting adverse events related to study treatment as evaluated by physician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Interference With Function</measure>
    <time_frame>12 months</time_frame>
    <description>Self-report composite rating scale of interference of pain with activities, mood, and sleep. This scale has a total score ranging from 0 to 30, with a higher score indicating greater pain interference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>12 months</time_frame>
    <description>Patient Health Questionnaire - 9 (PHQ-9) has a total score ranging from 0 to 27, with a higher score indicating greater depressive symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Active TENS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham TENS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TENS</intervention_name>
    <description>TENS: TENS 7000 - : TENS applies low-level electrical current via four pads, 2 pads affixed paraspinally, at the level of the spinal cord injury, and 2 affixed on the ventral side to areas within the dermatome corresponding to the level of injury. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session</description>
    <arm_group_label>Active TENS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham TENS</intervention_name>
    <description>Inactive electrodes - for two 15 minute trials, neither high nor low frequency.</description>
    <arm_group_label>Sham TENS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18;&#xD;
&#xD;
          -  Traumatic spinal cord injury;&#xD;
&#xD;
          -  Date of injury occurring within four months of study enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than four months since date of injury;&#xD;
&#xD;
          -  Contraindications for the study intervention, transcutaneous electrical nerve&#xD;
             stimulation (TENS),88 including:&#xD;
&#xD;
          -  Implanted electronic device such as a pacemaker;&#xD;
&#xD;
          -  Cardiovascular problems;&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Epilepsy;&#xD;
&#xD;
          -  Cancer;&#xD;
&#xD;
          -  Persons with a spinal cord injury at the C2 level, as placement of TENS electrodes on&#xD;
             the neck is not recommended;&#xD;
&#xD;
          -  Cognitive dysfunction which limits the ability of the participant to adequately&#xD;
             understand procedures and risks.&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnant Women&#xD;
&#xD;
        Special populations:&#xD;
&#xD;
          -  Adults unable to consent: excluded from study&#xD;
&#xD;
          -  Individuals -who are not yet adults: individuals who are less than 18 years old will&#xD;
             be excluded from the study&#xD;
&#xD;
          -  Pregnant women: Women who are known to be pregnant will not be recruited into the&#xD;
             study. A pregnancy test will be administered to females prior to enrollment in TENS&#xD;
             (or sham) treatment. Women who become pregnant before or during the 8-week TENS&#xD;
             treatment period will be discontinued from the study. Women who become pregnant after&#xD;
             the 8-week TENS treatment portion of the study will continue to be enrolled, and&#xD;
             followed according to protocol guidelines (no information will be collected&#xD;
             specifically on the pregnancy or fetus).&#xD;
&#xD;
          -  Prisoners: excluded from study&#xD;
&#xD;
          -  Neonates: not applicable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Felix, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <results_first_submitted>May 31, 2023</results_first_submitted>
  <results_first_submitted_qc>May 31, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 22, 2023</results_first_posted>
  <last_update_submitted>July 1, 2023</last_update_submitted>
  <last_update_submitted_qc>July 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Elizabeth Felix</investigator_full_name>
    <investigator_title>Research Professor</investigator_title>
  </responsible_party>
  <keyword>Neuropathic Pain</keyword>
  <keyword>Transcutaneous Electrical Nerve Stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 18, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03267810/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Active TENS</title>
          <description>Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.&#xD;
TENS: TENS 7000 - : TENS will apply low-level electrical current via four pads, two applied paraspinally at the level of spinal cord injury, and two applied on the ventral side of the body within the dermatome corresponding to the level of injury . 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session</description>
        </group>
        <group group_id="P2">
          <title>Sham TENS</title>
          <description>Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.&#xD;
Sham TENS: Inactive electrodes - for two 15 minute trials, neither high nor low frequency.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active TENS</title>
          <description>Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.&#xD;
TENS: TENS 7000 - : TENS applies low-level electrical current via four pads, 2 pads affixed paraspinally, at the level of the spinal cord injury, and 2 affixed on the ventral side to areas within the dermatome corresponding to the level of injury. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session</description>
        </group>
        <group group_id="B2">
          <title>Sham TENS</title>
          <description>Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.&#xD;
Sham TENS: Inactive electrodes - for two 15 minute trials, neither high nor low frequency.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age in years at entry into study</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.38" spread="13.27"/>
                    <measurement group_id="B2" value="38.15" spread="17.13"/>
                    <measurement group_id="B3" value="35.77" spread="15.21"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </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="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Percentage of Subjects Who Develop Chronic Neuropathic Pain.</title>
        <description>as defined by a score of ≥2 on the Spinal Cord Injury Pain Inventory (SCIPI), a self-report scale of symptoms. SCIPI has a total score ranging from 0 to 4 with scores of &gt;=2 screening positive for Neuropathic Pain in people with spinal cord injury</description>
        <time_frame>12 months</time_frame>
        <population>Analyses were performed were on all participants enrolled in each arm using the &quot;last observation carried forward&quot; process.</population>
        <group_list>
          <group group_id="O1">
            <title>Active TENS</title>
            <description>Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.&#xD;
TENS: TENS 7000 - : TENS will apply low-level electrical current via four pads affixed to the lower back area. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session</description>
          </group>
          <group group_id="O2">
            <title>Sham TENS</title>
            <description>Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.&#xD;
Sham TENS: Inactive electrodes - for two 15 minute trials, neither high nor low frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Subjects Who Develop Chronic Neuropathic Pain.</title>
          <description>as defined by a score of ≥2 on the Spinal Cord Injury Pain Inventory (SCIPI), a self-report scale of symptoms. SCIPI has a total score ranging from 0 to 4 with scores of &gt;=2 screening positive for Neuropathic Pain in people with spinal cord injury</description>
          <population>Analyses were performed were on all participants enrolled in each arm using the &quot;last observation carried forward&quot; process.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Neuropathic Pain Symptom Inventory (NPSI) Scores</title>
        <description>NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain</description>
        <time_frame>12 months</time_frame>
        <population>Analyses were performed were on all participants enrolled in each arm using the &quot;last observation carried forward&quot; process.</population>
        <group_list>
          <group group_id="O1">
            <title>Active TENS</title>
            <description>Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.&#xD;
TENS: TENS 7000 - : TENS will apply low-level electrical current via four pads affixed to the lower back area. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session</description>
          </group>
          <group group_id="O2">
            <title>Sham TENS</title>
            <description>Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.&#xD;
Sham TENS: Inactive electrodes - for two 15 minute trials, neither high nor low frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Neuropathic Pain Symptom Inventory (NPSI) Scores</title>
          <description>NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain</description>
          <population>Analyses were performed were on all participants enrolled in each arm using the &quot;last observation carried forward&quot; process.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" lower_limit="0" upper_limit="33"/>
                    <measurement group_id="O2" value="14" lower_limit="0" upper_limit="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>Number of participants reporting adverse events related to study treatment as evaluated by physician</description>
        <time_frame>12 months</time_frame>
        <population>Analyses were performed were on all participants enrolled in each arm using the &quot;last observation carried forward&quot; process.</population>
        <group_list>
          <group group_id="O1">
            <title>Active TENS</title>
            <description>Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.&#xD;
TENS: TENS 7000 - : TENS will apply low-level electrical current via four pads, two applied paraspinally at the level of spinal cord injury, and two applied on the ventral side of the body within the dermatome corresponding to the level of injury . 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session</description>
          </group>
          <group group_id="O2">
            <title>Sham TENS</title>
            <description>Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.&#xD;
Sham TENS: Inactive electrodes - for two 15 minute trials</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>Number of participants reporting adverse events related to study treatment as evaluated by physician</description>
          <population>Analyses were performed were on all participants enrolled in each arm using the &quot;last observation carried forward&quot; process.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Interference With Function</title>
        <description>Self-report composite rating scale of interference of pain with activities, mood, and sleep. This scale has a total score ranging from 0 to 30, with a higher score indicating greater pain interference.</description>
        <time_frame>12 months</time_frame>
        <population>Analyses were performed were on all participants enrolled in each arm using the &quot;last observation carried forward&quot; process.</population>
        <group_list>
          <group group_id="O1">
            <title>Active TENS</title>
            <description>Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.&#xD;
TENS: TENS 7000 - : TENS will apply low-level electrical current via four pads, two applied paraspinally at the level of spinal cord injury, and two applied on the ventral side of the body within the dermatome corresponding to the level of injury . 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session</description>
          </group>
          <group group_id="O2">
            <title>Sham TENS</title>
            <description>Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.&#xD;
Sham TENS: Inactive electrodes - for two 15 minute trials, neither high nor low frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Interference With Function</title>
          <description>Self-report composite rating scale of interference of pain with activities, mood, and sleep. This scale has a total score ranging from 0 to 30, with a higher score indicating greater pain interference.</description>
          <population>Analyses were performed were on all participants enrolled in each arm using the &quot;last observation carried forward&quot; process.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="11"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depressive Symptoms</title>
        <description>Patient Health Questionnaire - 9 (PHQ-9) has a total score ranging from 0 to 27, with a higher score indicating greater depressive symptoms</description>
        <time_frame>12 months</time_frame>
        <population>Analyses were performed were on all participants enrolled in each arm using the &quot;last observation carried forward&quot; process.</population>
        <group_list>
          <group group_id="O1">
            <title>Active TENS</title>
            <description>Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.&#xD;
TENS: TENS 7000 - : TENS will apply low-level electrical current via four pads, two applied paraspinally at the level of spinal cord injury, and two applied on the ventral side of the body within the dermatome corresponding to the level of injury . 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session</description>
          </group>
          <group group_id="O2">
            <title>Sham TENS</title>
            <description>Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.&#xD;
Sham TENS: Inactive electrodes - for two 15 minute trials, neither high nor low frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Depressive Symptoms</title>
          <description>Patient Health Questionnaire - 9 (PHQ-9) has a total score ranging from 0 to 27, with a higher score indicating greater depressive symptoms</description>
          <population>Analyses were performed were on all participants enrolled in each arm using the &quot;last observation carried forward&quot; process.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="3" upper_limit="8"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Active TENS</title>
          <description>Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.&#xD;
TENS: TENS 7000 - : TENS applies low-level electrical current via four pads, 2 pads affixed paraspinally, at the level of the spinal cord injury, and 2 affixed on the ventral side to areas within the dermatome corresponding to the level of injury. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session</description>
        </group>
        <group group_id="E2">
          <title>Sham TENS</title>
          <description>Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.&#xD;
Sham TENS: Inactive electrodes - for two 15 minute trials, neither high nor low frequency.</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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>episode of severe nerve pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>increased pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>prolonged dysesthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>broken foot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Elizabeth Felix</name_or_title>
      <organization>University of Miami</organization>
      <phone>305-243-4497</phone>
      <email>efelix@med.miami.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/NCT03267810
org study id: 20160951
secondary id: 90SI5023
nct id: NCT03267810
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this research study is to: 1) test whether transcutaneous electrical nerve
      stimulation (TENS) after spinal cord injury can reduce the onset of post-injury neuropathic
      pain; and 2) to learn more about this kind of pain and who is at risk for suffering from this
      type of pain after spinal cord injury. Neuropathic pain is a type of pain that occurs in
      about 50% of people with spinal cord injury. This type of pain is usually described as
      "burning" or "tingling," and is present around the level of injury and/or in areas below the
      level of injury. The investigators' goal is to try a non-drug treatment (TENS) that may help
      prevent this pain from occurring. Pain symptoms will be compared between the study
      participants who receive active TENS and the study participants who receive a sham TENS
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: The Percentage of Subjects Who Develop Chronic Neuropathic Pain.
time frame: 12 months
description: as defined by a score of ≥2 on the Spinal Cord Injury Pain Inventory (SCIPI), a self-report scale of symptoms. SCIPI has a total score ranging from 0 to 4 with scores of >=2 screening positive for Neuropathic Pain in people with spinal cord injury
measure: Neuropathic Pain Symptom Inventory (NPSI) Scores
time frame: 12 months
description: NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain
measure: Number of Participants With Adverse Events
time frame: 12 months
description: Number of participants reporting adverse events related to study treatment as evaluated by physician
measure: Pain Interference With Function
time frame: 12 months
description: Self-report composite rating scale of interference of pain with activities, mood, and sleep. This scale has a total score ranging from 0 to 30, with a higher score indicating greater pain interference.
measure: Depressive Symptoms
time frame: 12 months
description: Patient Health Questionnaire - 9 (PHQ-9) has a total score ranging from 0 to 27, with a higher score indicating greater depressive symptoms
arm group label: Active TENS
arm group type: Experimental
description: Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.
arm group label: Sham TENS
arm group type: Sham Comparator
description: Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.
intervention type: Device
intervention name: TENS
description: TENS: TENS 7000 - : TENS applies low-level electrical current via four pads, 2 pads affixed paraspinally, at the level of the spinal cord injury, and 2 affixed on the ventral side to areas within the dermatome corresponding to the level of injury. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session
arm group label: Active TENS
intervention type: Other
intervention name: Sham TENS
description: Inactive electrodes - for two 15 minute trials, neither high nor low frequency.
arm group label: Sham TENS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth Felix, PhD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Elizabeth Felix
investigator title: Research Professor
mesh term: Spinal Cord Injuries
mesh term: Neuralgia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 