<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/NCT02986074</url>
  </required_header>
  <id_info>
    <org_study_id>SJM-CIP-10126</org_study_id>
    <nct_id>NCT02986074</nct_id>
  </id_info>
  <brief_title>CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies</brief_title>
  <acronym>CRISP</acronym>
  <official_title>CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St Thomas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seacroft Hospital, Leeds</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant&#xD;
      based on anatomical landmarks with standard surgical implantation technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary purpose of this study is to compare the therapeutic efficacy of the conventional,&#xD;
      paresthesia mapping-based burst spinal cord stimulation (SCS) implantation strategy to a more&#xD;
      novel, anatomic midline-based approach that has the potential to streamline the workflow&#xD;
      associated with the SCS treatment continuum.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">August 19, 2019</completion_date>
  <primary_completion_date type="Actual">August 19, 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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS) for Back Pain at SCS Trial</measure>
    <time_frame>after 2 weeks of SCS trial</time_frame>
    <description>Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS) for Back Pain at 3 Months</measure>
    <time_frame>3 months after activation of permanent SCS implant</time_frame>
    <description>Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS) for Back Pain at 6 Months</measure>
    <time_frame>6 months after activation of permanent SCS implant</time_frame>
    <description>Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS) for Back Pain at 12 Months</measure>
    <time_frame>12 months after activation of permanent SCS implant</time_frame>
    <description>Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D at SCS Trial</measure>
    <time_frame>after 2 weeks of SCS trial</time_frame>
    <description>Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D at 3 Month</measure>
    <time_frame>3 months after activation of permanent SCS implant</time_frame>
    <description>Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D at 6 Month</measure>
    <time_frame>6 months after activation of permanent SCS implant</time_frame>
    <description>Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D at 12 Month</measure>
    <time_frame>12 months after activation of permanent SCS implant</time_frame>
    <description>Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ODI at SCS Trial</measure>
    <time_frame>first SCS trial assessment (up to two weeks after electrodes implantation)</time_frame>
    <description>questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ODI at 3 Months</measure>
    <time_frame>3 months after activation of permanent SCS implant</time_frame>
    <description>questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ODI at 6 Months</measure>
    <time_frame>6 months after activation of permanent SCS implant</time_frame>
    <description>questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ODI at 12 Months</measure>
    <time_frame>12 months after activation of permanent SCS implant</time_frame>
    <description>questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction Questionnaire</measure>
    <time_frame>3 month follow up</time_frame>
    <description>questionnaire regarding patient satisfaction with the therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction Questionnaire</measure>
    <time_frame>6 month follow up</time_frame>
    <description>questionnaire regarding patient satisfaction with the therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction Questionnaire</measure>
    <time_frame>12 month follow up</time_frame>
    <description>questionnaire regarding patient satisfaction with the therapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Anatomical midline lead first</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects in this group will receive stimulation first using an anatomical midline placed lead and subsequently using a paresthesia mapping placed lead</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paresthesia mapping lead first</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects in this group will receive stimulation first using a paresthesia mapping placed lead and subsequently using an anatomical midline placed lead</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Paresthesia mapping lead evaluation first</intervention_name>
    <description>Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using paresthesia mapping in the first part of the SCS trial and using the lead implanted using anatomical midline placement in the second part of the SCS trial</description>
    <arm_group_label>Paresthesia mapping lead first</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anatomical midline lead evaluation first</intervention_name>
    <description>Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using anatomical midline in the first part of the SCS trial and using the lead implanted using paresthesia mapping placement in the second part of the SCS trial</description>
    <arm_group_label>Anatomical midline lead first</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is able to provide informed consent to participate in the study;&#xD;
&#xD;
          -  Subject is 18 years of age or older;&#xD;
&#xD;
          -  Subject has failed to respond to at least 6 months of conventional treatment including&#xD;
             pharmacological treatment, physical therapy, epidural injections and/or radiofrequency&#xD;
             therapy as per NICE Tag 0159;&#xD;
&#xD;
          -  FBSS subjects with predominant low back pain;&#xD;
&#xD;
          -  Subject has a lower back pain intensity of at least 6.0 out of 10.0 on the VAS at&#xD;
             baseline;&#xD;
&#xD;
          -  Subject is on stable pain medications with a total opioid equivalent of 120 mgs a day&#xD;
             or less for at least 28 days prior to enrolling in this study, and is willing to stay&#xD;
             on those medications with no dose adjustments until activation of the permanently&#xD;
             implanted SCS device;&#xD;
&#xD;
          -  Subject's medical record has been evaluated by the Investigator to ensure that the&#xD;
             subject is a good candidate for a neurostimulation system;&#xD;
&#xD;
          -  Subject is willing to cooperate with the study requirements including compliance with&#xD;
             the regimen and completion of all office visits;&#xD;
&#xD;
          -  Female candidates of child-bearing potential agree to commit to the use of an&#xD;
             effective method of contraception (including but not limited to sterilization, barrier&#xD;
             devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or&#xD;
             abstinence) for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with significant scoliosis even if surgically corrected&#xD;
&#xD;
          -  Subject is currently participating in a clinical investigation that includes an active&#xD;
             treatment arm;&#xD;
&#xD;
          -  Subject has been implanted with or participated in a trial period for a&#xD;
             neurostimulation system;&#xD;
&#xD;
          -  Subject has an infusion pump;&#xD;
&#xD;
          -  Subject has evidence of an active disruptive psychological or psychiatric disorder as&#xD;
             determined as per standard of care;&#xD;
&#xD;
          -  Subject has a current diagnosis of a coagulation disorder, bleeding diathesis,&#xD;
             progressive peripheral vascular disease or uncontrolled diabetes mellitus;&#xD;
&#xD;
          -  Subject has a current diagnosis of a progressive neurological disease as determined by&#xD;
             the Investigator;&#xD;
&#xD;
          -  Subject is immunocompromised;&#xD;
&#xD;
          -  Subject has an existing medical condition that is likely to require repetitive MRI&#xD;
             evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma,&#xD;
             tumor);&#xD;
&#xD;
          -  Subject has history of cancer requiring active treatment in the last 12 months;&#xD;
&#xD;
          -  Subject has an existing medical condition that is likely to require the use of&#xD;
             diathermy in the future;&#xD;
&#xD;
          -  Subject has documented history of allergic response to titanium or silicone;&#xD;
&#xD;
          -  Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or&#xD;
             substance dependency in the 6 months prior to baseline data collection;&#xD;
&#xD;
          -  Female candidates of child bearing potential that are pregnant (confirmed by positive&#xD;
             urine/blood pregnancy test).&#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>Lalit Venkatesan, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Abbott Medical Devices</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seacroft Hospital</name>
      <address>
        <city>Leeds</city>
        <state>Yorkshire And The Humber</state>
        <zip>LS14 6UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Thomas Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <results_first_submitted>March 3, 2020</results_first_submitted>
  <results_first_submitted_qc>April 6, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 3, 2021</results_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</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>Paresthesia</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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>May 5, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT02986074/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>60 patients were enrolled and screened for eligibility between October 2016 and June 2018 in hospitals in London and Leeds U.K.</recruitment_details>
      <pre_assignment_details>55 of 60 subjects were randomized. Of those not randomized 3 did not meet inclusion criteria, 1 withdrew consent and 1 was withdrawn by the investigator because his diabetes become uncontrolled increasing the risk associated with SCS implant</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Anatomical Positioning Lead First</title>
          <description>subjects in this group will receive stimulation first using an anatomical midline placed lead and subsequently using a paresthesia mapping placed lead&#xD;
Anatomical midline lead evaluation first: Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using anatomical midline in the first part of the SCS trial and using the lead implanted using paresthesia mapping placement in the second part of the SCS trial</description>
        </group>
        <group group_id="P2">
          <title>Paresthesia Mapping Lead First</title>
          <description>subjects in this group will receive stimulation first using a paresthesia mapping placed lead and subsequently using an anatomical midline placed lead&#xD;
Paresthesia mapping lead evaluation first: Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using paresthesia mapping in the first part of the SCS trial and using the lead implanted using anatomical midline placement in the second part of the SCS trial</description>
        </group>
        <group group_id="P3">
          <title>Follow up Using Paresthesia Mapping Lead Stimulation</title>
          <description>Subjects that were successful at SCS trial, expressed preference for stimulation delivered using the lead implanted with the paresthesia mapping approach and received permanent implant, were followed up for 12 months while receiving stimulation delivered using the lead implanted with the paresthesia mapping approach</description>
        </group>
        <group group_id="P4">
          <title>Follow up Using Anatomical Placement Lead Stimulation</title>
          <description>Subjects that were successful at SCS trial, expressed preference for stimulation delivered using the lead implanted with the anatomical positioning approach and received permanent implant, were followed up for 12 months while receiving stimulation delivered using the lead implanted with the anatomical positioning approach</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Trial Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Second Trial Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Follow up Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>3 Month Follow up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6 Month Follow up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>system explant</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Subjects</title>
          <description>All subjects who were enrolled in the study</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="55"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Gender was not reported for two subjects</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="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </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>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale (VAS) for Back Pain at SCS Trial</title>
        <description>Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)</description>
        <time_frame>after 2 weeks of SCS trial</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale (VAS) for Back Pain at SCS Trial</title>
          <description>Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32" spread="25.9"/>
                    <measurement group_id="O2" value="30.5" spread="25.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analog Scale (VAS) for Back Pain at 3 Months</title>
        <description>Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)</description>
        <time_frame>3 months after activation of permanent SCS implant</time_frame>
        <population>one in the paresthesia mapping lead group had missing data</population>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale (VAS) for Back Pain at 3 Months</title>
          <description>Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)</description>
          <population>one in the paresthesia mapping lead group had missing data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.5" spread="28.1"/>
                    <measurement group_id="O2" value="24.6" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analog Scale (VAS) for Back Pain at 6 Months</title>
        <description>Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)</description>
        <time_frame>6 months after activation of permanent SCS implant</time_frame>
        <population>Two subjects had missing data in the paresthesia mapping lead group, one patient had missing data in the anatomically positioned lead group</population>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale (VAS) for Back Pain at 6 Months</title>
          <description>Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)</description>
          <population>Two subjects had missing data in the paresthesia mapping lead group, one patient had missing data in the anatomically positioned lead group</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" spread="24.5"/>
                    <measurement group_id="O2" value="35.2" spread="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analog Scale (VAS) for Back Pain at 12 Months</title>
        <description>Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)</description>
        <time_frame>12 months after activation of permanent SCS implant</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale (VAS) for Back Pain at 12 Months</title>
          <description>Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" spread="24.5"/>
                    <measurement group_id="O2" value="31.8" spread="26.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D at SCS Trial</title>
        <description>Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)</description>
        <time_frame>after 2 weeks of SCS trial</time_frame>
        <population>Data missing for one patient in the anatomically positioned lead group and one patient for the paresthesia mapping lead group</population>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D at SCS Trial</title>
          <description>Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)</description>
          <population>Data missing for one patient in the anatomically positioned lead group and one patient for the paresthesia mapping lead group</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.68" spread="0.17"/>
                    <measurement group_id="O2" value="0.65" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D at 3 Month</title>
        <description>Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)</description>
        <time_frame>3 months after activation of permanent SCS implant</time_frame>
        <population>Two subjects had missing data in the paresthesia mapping lead group, one patient had missing data in the anatomically positioned lead group</population>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D at 3 Month</title>
          <description>Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)</description>
          <population>Two subjects had missing data in the paresthesia mapping lead group, one patient had missing data in the anatomically positioned lead group</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="0.2"/>
                    <measurement group_id="O2" value="0.63" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D at 6 Month</title>
        <description>Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)</description>
        <time_frame>6 months after activation of permanent SCS implant</time_frame>
        <population>One patient had missing data in the anatomically positioned lead group</population>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D at 6 Month</title>
          <description>Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)</description>
          <population>One patient had missing data in the anatomically positioned lead group</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.62" spread="0.27"/>
                    <measurement group_id="O2" value="0.64" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D at 12 Month</title>
        <description>Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)</description>
        <time_frame>12 months after activation of permanent SCS implant</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D at 12 Month</title>
          <description>Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" spread="0.22"/>
                    <measurement group_id="O2" value="0.67" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ODI at SCS Trial</title>
        <description>questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)</description>
        <time_frame>first SCS trial assessment (up to two weeks after electrodes implantation)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>ODI at SCS Trial</title>
          <description>questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.2" spread="17.1"/>
                    <measurement group_id="O2" value="41.8" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ODI at 3 Months</title>
        <description>questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)</description>
        <time_frame>3 months after activation of permanent SCS implant</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>ODI at 3 Months</title>
          <description>questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.8" spread="22.6"/>
                    <measurement group_id="O2" value="37.3" spread="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ODI at 6 Months</title>
        <description>questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)</description>
        <time_frame>6 months after activation of permanent SCS implant</time_frame>
        <population>One patient had missing data in the anatomically positioned lead group</population>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>ODI at 6 Months</title>
          <description>questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)</description>
          <population>One patient had missing data in the anatomically positioned lead group</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.5" spread="23.5"/>
                    <measurement group_id="O2" value="36.9" spread="20.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ODI at 12 Months</title>
        <description>questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)</description>
        <time_frame>12 months after activation of permanent SCS implant</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>ODI at 12 Months</title>
          <description>questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.9" spread="21.5"/>
                    <measurement group_id="O2" value="39.4" spread="20.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction Questionnaire</title>
        <description>questionnaire regarding patient satisfaction with the therapy</description>
        <time_frame>3 month follow up</time_frame>
        <population>One patient had missing data in the paresthesia mapping lead group</population>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction Questionnaire</title>
          <description>questionnaire regarding patient satisfaction with the therapy</description>
          <population>One patient had missing data in the paresthesia mapping lead group</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="21"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neither satisfied or dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction Questionnaire</title>
        <description>questionnaire regarding patient satisfaction with the therapy</description>
        <time_frame>6 month follow up</time_frame>
        <population>four patients had missing data in the anatomically positioned lead group</population>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction Questionnaire</title>
          <description>questionnaire regarding patient satisfaction with the therapy</description>
          <population>four patients had missing data in the anatomically positioned lead group</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="17"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neither satisfied nor dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction Questionnaire</title>
        <description>questionnaire regarding patient satisfaction with the therapy</description>
        <time_frame>12 month follow up</time_frame>
        <population>One patient had missing data in the anatomically positioned lead group</population>
        <group_list>
          <group group_id="O1">
            <title>Anatomically Positioned Lead</title>
            <description>Stimulation delivered using the anatomical lead</description>
          </group>
          <group group_id="O2">
            <title>Paresthesia Mapping Lead</title>
            <description>Stimulation delivered using the paresthesia mapping lead</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction Questionnaire</title>
          <description>questionnaire regarding patient satisfaction with the therapy</description>
          <population>One patient had missing data in the anatomically positioned lead group</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="18"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neither satisfied nor dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through completion of the study, on average about 1 year</time_frame>
      <desc>Adverse events in this study were not collected per intervention as there were no primary safety endpoints and no investigational devices used in this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Anatomically Positioned Leads and Parasthesia Mapped Leads</title>
          <description>All subjects enrolled in the study</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="55"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>abdominal pain due to gall stones</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>difficulty urination and inability to weight bear on right leg</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>right leg numbness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>worsening of pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>photophobia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>system explant due to suspicion of infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>wound exploration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-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="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>IPG pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="55"/>
              </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>Yagna Pathak</name_or_title>
      <organization>Abbott</organization>
      <phone>+1-469-243-0088</phone>
      <email>yagna.pathak@abbott.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/NCT02986074
org study id: SJM-CIP-10126
nct id: NCT02986074
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant
      based on anatomical landmarks with standard surgical implantation technique.
The primary purpose of this study is to compare the therapeutic efficacy of the conventional,
      paresthesia mapping-based burst spinal cord stimulation (SCS) implantation strategy to a more
      novel, anatomic midline-based approach that has the potential to streamline the workflow
      associated with the SCS treatment continuum.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Visual Analog Scale (VAS) for Back Pain at SCS Trial
time frame: after 2 weeks of SCS trial
description: Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
measure: Visual Analog Scale (VAS) for Back Pain at 3 Months
time frame: 3 months after activation of permanent SCS implant
description: Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
measure: Visual Analog Scale (VAS) for Back Pain at 6 Months
time frame: 6 months after activation of permanent SCS implant
description: Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
measure: Visual Analog Scale (VAS) for Back Pain at 12 Months
time frame: 12 months after activation of permanent SCS implant
description: Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
measure: EQ-5D at SCS Trial
time frame: after 2 weeks of SCS trial
description: Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
measure: EQ-5D at 3 Month
time frame: 3 months after activation of permanent SCS implant
description: Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
measure: EQ-5D at 6 Month
time frame: 6 months after activation of permanent SCS implant
description: Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
measure: EQ-5D at 12 Month
time frame: 12 months after activation of permanent SCS implant
description: Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
measure: ODI at SCS Trial
time frame: first SCS trial assessment (up to two weeks after electrodes implantation)
description: questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
measure: ODI at 3 Months
time frame: 3 months after activation of permanent SCS implant
description: questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
measure: ODI at 6 Months
time frame: 6 months after activation of permanent SCS implant
description: questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
measure: ODI at 12 Months
time frame: 12 months after activation of permanent SCS implant
description: questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
measure: Satisfaction Questionnaire
time frame: 3 month follow up
description: questionnaire regarding patient satisfaction with the therapy
measure: Satisfaction Questionnaire
time frame: 6 month follow up
description: questionnaire regarding patient satisfaction with the therapy
measure: Satisfaction Questionnaire
time frame: 12 month follow up
description: questionnaire regarding patient satisfaction with the therapy
arm group label: Anatomical midline lead first
arm group type: Experimental
description: subjects in this group will receive stimulation first using an anatomical midline placed lead and subsequently using a paresthesia mapping placed lead
arm group label: Paresthesia mapping lead first
arm group type: Experimental
description: subjects in this group will receive stimulation first using a paresthesia mapping placed lead and subsequently using an anatomical midline placed lead
intervention type: Device
intervention name: Paresthesia mapping lead evaluation first
description: Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using paresthesia mapping in the first part of the SCS trial and using the lead implanted using anatomical midline placement in the second part of the SCS trial
arm group label: Paresthesia mapping lead first
intervention type: Device
intervention name: Anatomical midline lead evaluation first
description: Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using anatomical midline in the first part of the SCS trial and using the lead implanted using paresthesia mapping placement in the second part of the SCS trial
arm group label: Anatomical midline lead first
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lalit Venkatesan, Ph.D.
role: Study Director
affiliation: Abbott Medical Devices
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Paresthesia
mesh term: Chronic Pain
sharing ipd: Yes
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 