<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/NCT03756012</url>
  </required_header>
  <id_info>
    <org_study_id>Expanded Long Pulse</org_study_id>
    <nct_id>NCT03756012</nct_id>
  </id_info>
  <brief_title>Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation</brief_title>
  <official_title>Multi-Center Evaluation of Clinical Outcomes of Pulse Widths &lt;500 μsec and &gt;1000 μsec During a Temporary Spinal Cord Stimulation Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kettering Health Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ohio Pain Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kettering Health Network</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>
      The purpose of this study is to evaluate the effect of pulse widths &lt;500 μsec and &gt;1000 μsec&#xD;
      on clinical outcomes during a temporary SCS trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a prospective, multi-center, two-arm, randomized, crossover design to&#xD;
      be conducted at up to 10 sites. The study will enroll up to 100 subjects in order to include&#xD;
      up to 10 subjects in the study per site. Subjects selected to participate in the trial have&#xD;
      back and/or leg pain, have been evaluated as a candidate for SCS and have agreed to undergo a&#xD;
      temporary SCS trial using the Algovita® system with percutaneous leads. Each subject will be&#xD;
      followed during the trial period of approximately 7+/-2 days. The study will end when the&#xD;
      last subject has completed the trial period and exited. The expected enrollment period for&#xD;
      this study is approximately six months. After exit from the clinical study, subjects will&#xD;
      continue to be followed by their physician per usual care. All device and procedure-related&#xD;
      AEs will be collected and reported per the study protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2018</start_date>
  <completion_date type="Actual">October 2, 2019</completion_date>
  <primary_completion_date type="Actual">October 2, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of Pulse Widths on Pain Clinical Outcomes</measure>
    <time_frame>For 7 days following intervention</time_frame>
    <description>To evaluate the effect of conventional pulse widths &lt;500 μsec and pulse widths &gt;1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Targeted Pain</measure>
    <time_frame>For 7 days following intervention</time_frame>
    <description>To evaluate the effect of conventional pulse widths &lt;500μsecand pulse widths and &gt;1000μsecon clinical outcomes during temporary trial as measured by the number of participants that reported significant change in targeted pain compared to baseline using the NRS at the end of the trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Paesthesia</measure>
    <time_frame>For 7 days following intervention</time_frame>
    <description>At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Research Participant Program Preference</measure>
    <time_frame>For 7 days following intervention</time_frame>
    <description>At the end of the trial period, subjects will be asked to select their favorite program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Pain Relief</measure>
    <time_frame>For 7 days following intervention</time_frame>
    <description>At the end of the trial period, subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following ordinal scale; Excellent, Very Good, Good, Fair or Poor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Research Participant Pain Relief Satisfaction</measure>
    <time_frame>For 7 days following intervention</time_frame>
    <description>At the end of the trial period, subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following ordinal scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>≥ 50% Pain Relief</measure>
    <time_frame>For 7 days following intervention</time_frame>
    <description>Number of patients who achieved ≥ 50% pain relief during the trial (from either arm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of AEs</measure>
    <time_frame>For 7 days following intervention</time_frame>
    <description>Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Back Pain</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Low Pulse Width (&lt;500 μsec)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Spinal Cord Stimulation System will be programmed to pulse widths &lt;500 μsec.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Pulse Width (&gt;1000 μsec)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Spinal Cord Stimulation System will be programmed to pulse widths &gt;1000 μsec</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Algovita Spinal Cord Stimulation System</intervention_name>
    <description>The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
    <arm_group_label>High Pulse Width (&gt;1000 μsec)</arm_group_label>
    <arm_group_label>Low Pulse Width (&lt;500 μsec)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be eligible for SCS therapy according to the Algovita® SCS system Indications for Use&#xD;
             statement&#xD;
&#xD;
          -  be undergoing a SCS trial using Algovita® SCS system&#xD;
&#xD;
          -  sign a valid, Institutional Review Board (IRB)-approved informed consent form.&#xD;
&#xD;
          -  be 18 years of age or older when written informed consent is obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  be contraindicated for an Algovita® SCS system&#xD;
&#xD;
          -  have a cognitive impairment or exhibits any characteristic, that would limit the study&#xD;
             candidate's ability to assess pain relief or complete study assessments&#xD;
&#xD;
          -  have a life expectancy of less than 2 years&#xD;
&#xD;
          -  be participating in another clinical study that would confound data analysis&#xD;
&#xD;
          -  have a coexisting pain condition that might confound pain ratings&#xD;
&#xD;
          -  have a significant psychiatric disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Ohio Pain Clinic</name>
      <address>
        <city>Centerville</city>
        <state>Ohio</state>
        <zip>45458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <results_first_submitted>December 9, 2020</results_first_submitted>
  <results_first_submitted_qc>February 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 8, 2021</results_first_posted>
  <last_update_submitted>February 15, 2021</last_update_submitted>
  <last_update_submitted_qc>February 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kettering Health Network</investigator_affiliation>
    <investigator_full_name>Amol Soin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</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>March 9, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03756012/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>patients received both doses</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Total Patient Population</title>
          <description>This was a case series and all patients received both algorithms; pulse widths &lt;500 µsec and &gt;1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </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>Total Patient Population</title>
          <description>This was a case series and all patients received both algorithms; pulse widths &lt;500 µsec and &gt;1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.&#xD;
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" lower_limit="18" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Effect of Pulse Widths on Pain Clinical Outcomes</title>
        <description>To evaluate the effect of conventional pulse widths &lt;500 μsec and pulse widths &gt;1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps.</description>
        <time_frame>For 7 days following intervention</time_frame>
        <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patient Population</title>
            <description>This was a case series and all patients received both algorithms; pulse widths &lt;500 µsec and &gt;1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.&#xD;
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Pulse Widths on Pain Clinical Outcomes</title>
          <description>To evaluate the effect of conventional pulse widths &lt;500 μsec and pulse widths &gt;1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps.</description>
          <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Patient subjectively felt coverage was larger with wide pulse width program</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patient subjectively felt coverage was larger with conventional pulse width program</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Targeted Pain</title>
        <description>To evaluate the effect of conventional pulse widths &lt;500μsecand pulse widths and &gt;1000μsecon clinical outcomes during temporary trial as measured by the number of participants that reported significant change in targeted pain compared to baseline using the NRS at the end of the trial period.</description>
        <time_frame>For 7 days following intervention</time_frame>
        <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patient Population</title>
            <description>This was a case series and all patients received both algorithms; pulse widths &lt;500 µsec and &gt;1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.&#xD;
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Targeted Pain</title>
          <description>To evaluate the effect of conventional pulse widths &lt;500μsecand pulse widths and &gt;1000μsecon clinical outcomes during temporary trial as measured by the number of participants that reported significant change in targeted pain compared to baseline using the NRS at the end of the trial period.</description>
          <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Patient reported no significant change in pain scores/pain relief</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patient reported significant change in pain scores/pain relief</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Paesthesia</title>
        <description>At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.</description>
        <time_frame>For 7 days following intervention</time_frame>
        <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patient Population</title>
            <description>This was a case series and all patients received both algorithms; pulse widths &lt;500 µsec and &gt;1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.&#xD;
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Paesthesia</title>
          <description>At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.</description>
          <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Larger coverage area with wide pulse width</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Larger coverage area with conventional pulse width</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Research Participant Program Preference</title>
        <description>At the end of the trial period, subjects will be asked to select their favorite program.</description>
        <time_frame>For 7 days following intervention</time_frame>
        <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patient Population</title>
            <description>This was a case series and all patients received both algorithms; pulse widths &lt;500 µsec and &gt;1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.</description>
          </group>
        </group_list>
        <measure>
          <title>Research Participant Program Preference</title>
          <description>At the end of the trial period, subjects will be asked to select their favorite program.</description>
          <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Preferred wide pulse width</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>preferred conventional pulse width</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Pain Relief</title>
        <description>At the end of the trial period, subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following ordinal scale; Excellent, Very Good, Good, Fair or Poor</description>
        <time_frame>For 7 days following intervention</time_frame>
        <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patient Population</title>
            <description>This was a case series and all patients received both algorithms; pulse widths &lt;500 µsec and &gt;1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.&#xD;
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Pain Relief</title>
          <description>At the end of the trial period, subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following ordinal scale; Excellent, Very Good, Good, Fair or Poor</description>
          <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Excellent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fair</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Poor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Research Participant Pain Relief Satisfaction</title>
        <description>At the end of the trial period, subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following ordinal scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied</description>
        <time_frame>For 7 days following intervention</time_frame>
        <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patient Population</title>
            <description>This was a case series and all patients received both algorithms; pulse widths &lt;500 µsec and &gt;1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.&#xD;
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
        </group_list>
        <measure>
          <title>Research Participant Pain Relief Satisfaction</title>
          <description>At the end of the trial period, subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following ordinal scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied</description>
          <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neither Satisfied nor Unsatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unsatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very Unsatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>≥ 50% Pain Relief</title>
        <description>Number of patients who achieved ≥ 50% pain relief during the trial (from either arm)</description>
        <time_frame>For 7 days following intervention</time_frame>
        <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patient Population</title>
            <description>This was a case series and all patients received both algorithms; pulse widths &lt;500 µsec and &gt;1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.&#xD;
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
        </group_list>
        <measure>
          <title>≥ 50% Pain Relief</title>
          <description>Number of patients who achieved ≥ 50% pain relief during the trial (from either arm)</description>
          <population>Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Achieved &gt;/= 50% pain relief during the trial (from either arm)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Did not achieve &gt;/= 50% pain relief during the trial (from either arm)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of AEs</title>
        <description>Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit.</description>
        <time_frame>For 7 days following intervention</time_frame>
        <population>was not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patient Population</title>
            <description>This was a case series and all patients received both algorithms; pulse widths &lt;500 µsec and &gt;1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.&#xD;
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of AEs</title>
          <description>Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit.</description>
          <population>was not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 10 days post-implant</time_frame>
      <desc>Adverse Events were not collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Total Patient Population</title>
          <description>This was a case series and all patients received both algorithms; pulse widths &lt;500 µsec and &gt;1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.&#xD;
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.&#xD;
Adverse Events were not collected. Study was ended prematurely and results were only provided for total population instead of separate arms since subjects received both interventions.</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="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Amol Soin</name_or_title>
      <organization>Ohio Pain Clinic</organization>
      <phone>937-434-2226</phone>
      <email>drsoin@ohiopainclinic.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/NCT03756012
org study id: Expanded Long Pulse
nct id: NCT03756012
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to evaluate the effect of pulse widths <500 μsec and >1000 μsec
      on clinical outcomes during a temporary SCS trial.
The proposed study is a prospective, multi-center, two-arm, randomized, crossover design to
      be conducted at up to 10 sites. The study will enroll up to 100 subjects in order to include
      up to 10 subjects in the study per site. Subjects selected to participate in the trial have
      back and/or leg pain, have been evaluated as a candidate for SCS and have agreed to undergo a
      temporary SCS trial using the Algovita® system with percutaneous leads. Each subject will be
      followed during the trial period of approximately 7+/-2 days. The study will end when the
      last subject has completed the trial period and exited. The expected enrollment period for
      this study is approximately six months. After exit from the clinical study, subjects will
      continue to be followed by their physician per usual care. All device and procedure-related
      AEs will be collected and reported per the study protocol.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Effect of Pulse Widths on Pain Clinical Outcomes
time frame: For 7 days following intervention
description: To evaluate the effect of conventional pulse widths <500 μsec and pulse widths >1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps.
measure: Change in Targeted Pain
time frame: For 7 days following intervention
description: To evaluate the effect of conventional pulse widths <500μsecand pulse widths and >1000μsecon clinical outcomes during temporary trial as measured by the number of participants that reported significant change in targeted pain compared to baseline using the NRS at the end of the trial period.
measure: Distribution of Paesthesia
time frame: For 7 days following intervention
description: At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.
measure: Research Participant Program Preference
time frame: For 7 days following intervention
description: At the end of the trial period, subjects will be asked to select their favorite program.
measure: Quality of Pain Relief
time frame: For 7 days following intervention
description: At the end of the trial period, subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following ordinal scale; Excellent, Very Good, Good, Fair or Poor
measure: Research Participant Pain Relief Satisfaction
time frame: For 7 days following intervention
description: At the end of the trial period, subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following ordinal scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied
measure: ≥ 50% Pain Relief
time frame: For 7 days following intervention
description: Number of patients who achieved ≥ 50% pain relief during the trial (from either arm)
measure: Rate of AEs
time frame: For 7 days following intervention
description: Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit.
arm group label: Low Pulse Width (<500 μsec)
arm group type: Active Comparator
description: Spinal Cord Stimulation System will be programmed to pulse widths <500 μsec.
arm group label: High Pulse Width (>1000 μsec)
arm group type: Active Comparator
description: Spinal Cord Stimulation System will be programmed to pulse widths >1000 μsec
intervention type: Device
intervention name: Algovita Spinal Cord Stimulation System
description: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
arm group label: High Pulse Width (>1000 μsec)
arm group label: Low Pulse Width (<500 μsec)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Kettering Health Network
investigator full name: Amol Soin
investigator title: Principal Investigator
mesh term: Back Pain
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 