<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/NCT03284411</url>
  </required_header>
  <id_info>
    <org_study_id>MDT17046</org_study_id>
    <nct_id>NCT03284411</nct_id>
  </id_info>
  <brief_title>Spinal Cord Stimulation (SCS) Dosing Study</brief_title>
  <official_title>Spinal Cord Stimulation (SCS) Dosing Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedtronicNeuro</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedtronicNeuro</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study characterized the effects of amplitude on subject satisfaction and pain relief in&#xD;
      subjects being treated by SCS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This feasibility study assessed the following outcomes:&#xD;
&#xD;
        -  Patient satisfaction&#xD;
&#xD;
        -  VAS pain scores&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">March 15, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SCS Therapy Satisfaction</measure>
    <time_frame>8 weeks</time_frame>
    <description>To characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: &quot;Overall how satisfied or unsatisfied are you with this therapy?&quot;. The response choices were as follows: &quot;very satisfied&quot;, &quot;somewhat satisfied&quot;, &quot;neutral&quot;, &quot;somewhat unsatisfied&quot;, &quot;very unsatisfied&quot;. Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response &quot;very satisfied&quot;, &quot;somewhat satisfied&quot;, or &quot;neutral&quot;, otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)</measure>
    <time_frame>8 weeks</time_frame>
    <description>To characterize the effect of four different amplitude settings on baseline pain relief. During each follow-up period the VAS pain score was recorded once a day, on a multi-day diary, where subjects rated their pain by making a vertical slash mark through the 0-10 cm line that best described their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS pain score represented worse pain. The average VAS pain scores from the last 3 days of the diary prior to the scheduled visit was used for analysis. Each subject was considered to have maintained their baseline pain if there was less than a 2 point increase in their average pain score at the follow-up period. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained the subject's pain relief. The frequency and percentage of subjects' that maintained their average baseline VAS pain score were reported at each amplitude level.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Back Pain</condition>
  <condition>Leg Pain</condition>
  <arm_group>
    <arm_group_label>Spinal Cord Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject was programmed to 4 different amplitude settings: 80%, 60%, 40% and 20% of perception threshold amplitude</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spinal Cord Stimulation</intervention_name>
    <description>Programming</description>
    <arm_group_label>Spinal Cord Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 22 years of age or older&#xD;
&#xD;
          2. Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month&#xD;
&#xD;
          3. Has approproate SCS settings&#xD;
&#xD;
          4. Willing and able to provide signed and dated informed consent&#xD;
&#xD;
          5. Capable of comprehending and consenting in English&#xD;
&#xD;
          6. Capable of getting into the supine and sitting positions&#xD;
&#xD;
          7. Willing and able to comply with all study procedures and visits&#xD;
&#xD;
          8. On stable (no change in dose, route, or frequency) prescribed pain medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Implanted with leads for peripheral nerve stimulation or an implantable intrathecal&#xD;
             drug delivery system&#xD;
&#xD;
          2. Had a pain-related surgery in the previous 1 month of enrollment or the intent to&#xD;
             undergo surgery during the period of the study&#xD;
&#xD;
          3. Implanted with quadripolar lead&#xD;
&#xD;
          4. Currently enrolled or planning to enroll in a potentially confounding clinical study&#xD;
             during the course of the study&#xD;
&#xD;
          5. Pregnant or is of child-bearing potential and unwilling to use a medically acceptable&#xD;
             form of birth control during the study&#xD;
&#xD;
          6. Has untreated major psychiatric comorbidity&#xD;
&#xD;
          7. Has serious drug-related behavioral issues&#xD;
&#xD;
          8. Has unresolved major issues of secondary gain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arizona Pain Doctors</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Pain and Wellness Center</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Scientific Innovations</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Goodman Campbell Brain and Spine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kentuckiana Pain Specialists</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drez One, LLC</name>
      <address>
        <city>Somerset</city>
        <state>Kentucky</state>
        <zip>42503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Brain &amp; Spine</name>
      <address>
        <city>Cape Girardeau</city>
        <state>Missouri</state>
        <zip>63701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Spine Care</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Pain Care, Inc.</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <results_first_submitted>March 3, 2020</results_first_submitted>
  <results_first_submitted_qc>March 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 18, 2020</results_first_posted>
  <last_update_submitted>April 6, 2020</last_update_submitted>
  <last_update_submitted_qc>April 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03284411/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03284411/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Spinal Cord Stimulation</title>
          <description>Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of their perception threshold amplitude).&#xD;
Spinal Cord Stimulation: Programming</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </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>Spinal Cord Stimulation</title>
          <description>Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of their perception threshold).&#xD;
Spinal Cord Stimulation: Programming</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.1" spread="11.9"/>
                  </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="23"/>
                  </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 (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>SCS Therapy Satisfaction</title>
        <description>To characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: &quot;Overall how satisfied or unsatisfied are you with this therapy?&quot;. The response choices were as follows: &quot;very satisfied&quot;, &quot;somewhat satisfied&quot;, &quot;neutral&quot;, &quot;somewhat unsatisfied&quot;, &quot;very unsatisfied&quot;. Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response &quot;very satisfied&quot;, &quot;somewhat satisfied&quot;, or &quot;neutral&quot;, otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulation</title>
            <description>Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of perception threshold).&#xD;
Spinal Cord Stimulation: Programming</description>
          </group>
        </group_list>
        <measure>
          <title>SCS Therapy Satisfaction</title>
          <description>To characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: &quot;Overall how satisfied or unsatisfied are you with this therapy?&quot;. The response choices were as follows: &quot;very satisfied&quot;, &quot;somewhat satisfied&quot;, &quot;neutral&quot;, &quot;somewhat unsatisfied&quot;, &quot;very unsatisfied&quot;. Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response &quot;very satisfied&quot;, &quot;somewhat satisfied&quot;, or &quot;neutral&quot;, otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Baseline</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>80% perception threshold</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60% perception threshold</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40% perception threshold</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>20% perception threshold</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)</title>
        <description>To characterize the effect of four different amplitude settings on baseline pain relief. During each follow-up period the VAS pain score was recorded once a day, on a multi-day diary, where subjects rated their pain by making a vertical slash mark through the 0-10 cm line that best described their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS pain score represented worse pain. The average VAS pain scores from the last 3 days of the diary prior to the scheduled visit was used for analysis. Each subject was considered to have maintained their baseline pain if there was less than a 2 point increase in their average pain score at the follow-up period. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained the subject's pain relief. The frequency and percentage of subjects' that maintained their average baseline VAS pain score were reported at each amplitude level.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulation</title>
            <description>Each subject was programmed to 4 different amplitude settings (80, 60, 40, 20 percent of perception threshold).&#xD;
Spinal Cord Stimulation: Programming</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)</title>
          <description>To characterize the effect of four different amplitude settings on baseline pain relief. During each follow-up period the VAS pain score was recorded once a day, on a multi-day diary, where subjects rated their pain by making a vertical slash mark through the 0-10 cm line that best described their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS pain score represented worse pain. The average VAS pain scores from the last 3 days of the diary prior to the scheduled visit was used for analysis. Each subject was considered to have maintained their baseline pain if there was less than a 2 point increase in their average pain score at the follow-up period. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained the subject's pain relief. The frequency and percentage of subjects' that maintained their average baseline VAS pain score were reported at each amplitude level.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Baseline</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>80% perception threshold</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60% perception threshold</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40% perception threshold</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>20% perception threshold</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from enrollment to study discontinuation with an average of 2.2 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Spinal Cord Stimulation</title>
          <description>Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of their perception threshold)&#xD;
Spinal Cord Stimulation: Programming</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="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <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="5" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Inadequate analgesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device stimulation issue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </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>SCS Dosing Clinical Research Study Team</name_or_title>
      <organization>Medtronic</organization>
      <phone>800-633-8766</phone>
      <email>rs.scsdosing@medtronic.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/NCT03284411
org study id: MDT17046
nct id: NCT03284411
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study characterized the effects of amplitude on subject satisfaction and pain relief in
      subjects being treated by SCS.
This feasibility study assessed the following outcomes:

        -  Patient satisfaction

        -  VAS pain scores
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: SCS Therapy Satisfaction
time frame: 8 weeks
description: To characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: "Overall how satisfied or unsatisfied are you with this therapy?". The response choices were as follows: "very satisfied", "somewhat satisfied", "neutral", "somewhat unsatisfied", "very unsatisfied". Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response "very satisfied", "somewhat satisfied", or "neutral", otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level.
measure: Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)
time frame: 8 weeks
description: To characterize the effect of four different amplitude settings on baseline pain relief. During each follow-up period the VAS pain score was recorded once a day, on a multi-day diary, where subjects rated their pain by making a vertical slash mark through the 0-10 cm line that best described their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS pain score represented worse pain. The average VAS pain scores from the last 3 days of the diary prior to the scheduled visit was used for analysis. Each subject was considered to have maintained their baseline pain if there was less than a 2 point increase in their average pain score at the follow-up period. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained the subject's pain relief. The frequency and percentage of subjects' that maintained their average baseline VAS pain score were reported at each amplitude level.
arm group label: Spinal Cord Stimulation
arm group type: Experimental
description: Each subject was programmed to 4 different amplitude settings: 80%, 60%, 40% and 20% of perception threshold amplitude
intervention type: Device
intervention name: Spinal Cord Stimulation
description: Programming
arm group label: Spinal Cord Stimulation
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Back Pain
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 