<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/NCT01697358</url>
  </required_header>
  <id_info>
    <org_study_id>1665</org_study_id>
    <nct_id>NCT01697358</nct_id>
  </id_info>
  <brief_title>Spinal Cord Stimulation for Predominant Low Back Pain</brief_title>
  <acronym>PROMISE</acronym>
  <official_title>Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS)&#xD;
      using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management&#xD;
      (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed&#xD;
      back surgery syndrome (FBSS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study has a multi-center, prospective, randomized (1:1), open-label, parallel-group&#xD;
      design of two alternative treatments:&#xD;
&#xD;
        -  SCS group (SCS+OMM)&#xD;
&#xD;
        -  OMM group&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2013</start_date>
  <completion_date type="Actual">June 20, 2017</completion_date>
  <primary_completion_date type="Actual">March 12, 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Period I (from randomization to 6 months) is the randomized parallel group comparative phase. Day zero for the study is the point of randomization. The randomization ratio is 1:1 (SCS+OMM to OMM). For the SCS+OMM arm, the screening test and/or implant occurred after randomization. Period II (6 to 24 months) is the long-term observational follow-up phase.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups</measure>
    <time_frame>6 months post randomization</time_frame>
    <description>Compare the proportion of subjects with a ≥50% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥50% reduction in average low back pain were considered as responders.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups</measure>
    <time_frame>6 months post randomization</time_frame>
    <description>Compare change in low back pain intensity, as measured by the Numeric Pain Rating Scale (NPRS), from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in low back pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups</measure>
    <time_frame>6 months post randomization</time_frame>
    <description>Compare change in leg pain intensity, as measured by the NPRS, from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average leg pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in leg pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups</measure>
    <time_frame>6 months post randomization</time_frame>
    <description>ODI is a validated questionnaire of 10 subject-reported sections on the ability to perform activities of daily living. These 10 sections are pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and traveling. Each section was scored on a 0 to 5 scale with 0 indicating no limitation of function due to pain and 5 indicating major functional disability due to back pain. A raw ODI score was calculated from the total score of 10 sections (minimum is 0 and maximum is 50). This ODI raw score was then normalized to a scale of 0 to 100, with 0-20 categorized as minimal disability, 20-40 as moderate disability, 40-60 as severe disability, 60-80 as severely disabled, and 80-100 as bed-bound patients. The ODI was assessed at baseline and subsequent scheduled study visits. Change in functional disability is calculated as ODI at baseline - ODI at 6-month visit, with a positive change indicated as an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups</measure>
    <time_frame>6 months post randomization</time_frame>
    <description>The QoL scores were collected using the SF-36 questionnaire, which included the scores in the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The Physical Component Summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health using 1998 US population. Change in PCS is calculated as PCS at 6-month visit - PCS at baseline, with a positive change indicated as an improvement.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups</measure>
    <time_frame>6 months post randomization</time_frame>
    <description>This additional analysis was pre-specified to support the analysis of primary objective. The 30% responder which is defined in the following paragraph was considered as clinical relevant to the SCS therapy in back pain. Compare the proportion of subjects with a ≥30% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥30% reduction in average low back pain were considered as 30% responders.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">278</enrollment>
  <condition>Failed Back Surgery Syndrome</condition>
  <condition>Back Pain</condition>
  <condition>Pain in Leg, Unspecified</condition>
  <arm_group>
    <arm_group_label>SCS + OMM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OMM alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spinal Cord Stimulation (SCS)</intervention_name>
    <description>Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group.</description>
    <arm_group_label>SCS + OMM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Optimal Medical Management (OMM)</intervention_name>
    <description>The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.</description>
    <arm_group_label>OMM alone</arm_group_label>
    <arm_group_label>SCS + OMM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SCS candidate with the Specify 5-6-5 surgical lead&#xD;
&#xD;
          -  Has FBSS and does not require further surgery (defined as persistent or recurrent low&#xD;
             back and leg pain of at least 6 months duration following at least one decompression&#xD;
             and/or fusion procedure)&#xD;
&#xD;
          -  Average low back pain is ≥ 5 as assessed by the baseline NPRS&#xD;
&#xD;
          -  Average low back pain is greater than leg pain&#xD;
&#xD;
          -  Subject has persistent moderate to severe low back and leg pain despite other&#xD;
             treatments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug&#xD;
             delivery system, requires back surgery at the location related to his/her original&#xD;
             back pain complaint or experimental therapies&#xD;
&#xD;
          -  Most recent back surgery &lt; 6 months ago&#xD;
&#xD;
          -  Low back pain only (no leg pain)&#xD;
&#xD;
          -  Investigator suspects substance abuse that might confound the study results&#xD;
&#xD;
          -  Radiographic evidence of instability requiring fusion&#xD;
&#xD;
          -  Pain relieved completely by lying down&#xD;
&#xD;
          -  Life expectancy of &lt; 24 months&#xD;
&#xD;
          -  Subject is pregnant or planning to become pregnant during the course of the study&#xD;
&#xD;
          -  Subject is unable to undergo study assessments or complete questionnaires&#xD;
             independently&#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>Philippe Rigoard, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Poitiers</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pain Care LLC</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Neuroscience Center</name>
      <address>
        <city>Ocean Springs</city>
        <state>Mississippi</state>
        <zip>39564</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kozmary Center for Pain Management</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical College</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Medical College of Cornell University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021-9800</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Spine and Wellness Center</name>
      <address>
        <city>North Syracuse</city>
        <state>New York</state>
        <zip>13212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Neurosurgery Partners in Pain Management</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Spine Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WellSpan Interventional Pain Center</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Richmond Bone and Joint Clinic</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utah Spine Care</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCL St. Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ St. Maarten</name>
      <address>
        <city>Duffel</city>
        <zip>2570</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR Citadelle</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heilig Hart Ziekenhuis</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Neurosurgery: St. Augustinus Ziekenhuizen</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regina General Hospital</name>
      <address>
        <city>Regina</city>
        <zip>S4P 0W5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Las Américas</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>050025</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pablo Tobón Uribe</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Vicente Fundación</name>
      <address>
        <city>Rionegro</city>
        <state>Antioquia</state>
        <zip>054047</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Poitiers</name>
      <address>
        <city>Poitiers Cedex</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Städtisches Klinikum Görlitz gGmbH</name>
      <address>
        <city>Görlitz</city>
        <zip>02828</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Elisabeth Ziekenhuis Tilburg</name>
      <address>
        <city>Tilburg</city>
        <zip>5022 GC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <zip>47005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospital NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Radcliffe Hospital Oxford</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Colombia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <results_first_submitted>March 10, 2017</results_first_submitted>
  <results_first_submitted_qc>May 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 14, 2017</results_first_posted>
  <last_update_submitted>June 22, 2017</last_update_submitted>
  <last_update_submitted_qc>June 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FBSS</keyword>
  <keyword>post laminectomy syndrome</keyword>
  <keyword>SCS</keyword>
  <keyword>RCT</keyword>
  <keyword>back pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Failed Back Surgery Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be kept confidential by Medtronic and only be shared with study investigators following Medtronic approval of a data request form.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 278 subjects were recruited between January 2013 and August 2015 from 28 sites in Canada, Colombia, Europe, and US.</recruitment_details>
      <pre_assignment_details>A total of 60 subjects didn't meet the inclusion and/or exclusion criteria and discontinued from the study before randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SCS + OMM</title>
          <description>Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.</description>
        </group>
        <group group_id="P2">
          <title>OMM Alone</title>
          <description>Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period I: Randomization to 6 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="97"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period II: 6-24M Long-term Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="97"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Active subjects at the time of posting</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SCS + OMM</title>
          <description>Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.</description>
        </group>
        <group group_id="B2">
          <title>OMM Alone</title>
          <description>Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="110"/>
            <count group_id="B2" value="108"/>
            <count group_id="B3" value="218"/>
          </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="52.8" spread="12.5"/>
                    <measurement group_id="B2" value="55.1" spread="10.2"/>
                    <measurement group_id="B3" value="53.9" spread="11.5"/>
                  </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="68"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="132"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Colombia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups</title>
        <description>Compare the proportion of subjects with a ≥50% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥50% reduction in average low back pain were considered as responders.</description>
        <time_frame>6 months post randomization</time_frame>
        <population>Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>SCS + OMM</title>
            <description>Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.</description>
          </group>
          <group group_id="O2">
            <title>OMM Alone</title>
            <description>Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.</description>
          </group>
        </group_list>
        <measure>
          <title>Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups</title>
          <description>Compare the proportion of subjects with a ≥50% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥50% reduction in average low back pain were considered as responders.</description>
          <population>Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as non-responders.</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="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.036</p_value>
            <method>Z-test using unpooled standard deviation</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups</title>
        <description>Compare change in low back pain intensity, as measured by the Numeric Pain Rating Scale (NPRS), from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in low back pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.</description>
        <time_frame>6 months post randomization</time_frame>
        <population>Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.</population>
        <group_list>
          <group group_id="O1">
            <title>SCS + OMM</title>
            <description>Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.</description>
          </group>
          <group group_id="O2">
            <title>OMM Alone</title>
            <description>Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.</description>
          </group>
        </group_list>
        <measure>
          <title>Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups</title>
          <description>Compare change in low back pain intensity, as measured by the Numeric Pain Rating Scale (NPRS), from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in low back pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.</description>
          <population>Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.</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="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.9"/>
                    <measurement group_id="O2" value="0.3" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Regression, Linear</method>
            <method_desc>Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups</title>
        <description>Compare change in leg pain intensity, as measured by the NPRS, from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average leg pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in leg pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.</description>
        <time_frame>6 months post randomization</time_frame>
        <population>Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.</population>
        <group_list>
          <group group_id="O1">
            <title>SCS + OMM</title>
            <description>Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.</description>
          </group>
          <group group_id="O2">
            <title>OMM Alone</title>
            <description>Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.</description>
          </group>
        </group_list>
        <measure>
          <title>Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups</title>
          <description>Compare change in leg pain intensity, as measured by the NPRS, from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average leg pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in leg pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.</description>
          <population>Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.</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="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="2.1"/>
                    <measurement group_id="O2" value="-0.1" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Regression, Linear</method>
            <method_desc>Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups</title>
        <description>ODI is a validated questionnaire of 10 subject-reported sections on the ability to perform activities of daily living. These 10 sections are pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and traveling. Each section was scored on a 0 to 5 scale with 0 indicating no limitation of function due to pain and 5 indicating major functional disability due to back pain. A raw ODI score was calculated from the total score of 10 sections (minimum is 0 and maximum is 50). This ODI raw score was then normalized to a scale of 0 to 100, with 0-20 categorized as minimal disability, 20-40 as moderate disability, 40-60 as severe disability, 60-80 as severely disabled, and 80-100 as bed-bound patients. The ODI was assessed at baseline and subsequent scheduled study visits. Change in functional disability is calculated as ODI at baseline - ODI at 6-month visit, with a positive change indicated as an improvement.</description>
        <time_frame>6 months post randomization</time_frame>
        <population>Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.</population>
        <group_list>
          <group group_id="O1">
            <title>SCS + OMM</title>
            <description>Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.</description>
          </group>
          <group group_id="O2">
            <title>OMM Alone</title>
            <description>Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.</description>
          </group>
        </group_list>
        <measure>
          <title>Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups</title>
          <description>ODI is a validated questionnaire of 10 subject-reported sections on the ability to perform activities of daily living. These 10 sections are pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and traveling. Each section was scored on a 0 to 5 scale with 0 indicating no limitation of function due to pain and 5 indicating major functional disability due to back pain. A raw ODI score was calculated from the total score of 10 sections (minimum is 0 and maximum is 50). This ODI raw score was then normalized to a scale of 0 to 100, with 0-20 categorized as minimal disability, 20-40 as moderate disability, 40-60 as severe disability, 60-80 as severely disabled, and 80-100 as bed-bound patients. The ODI was assessed at baseline and subsequent scheduled study visits. Change in functional disability is calculated as ODI at baseline - ODI at 6-month visit, with a positive change indicated as an improvement.</description>
          <population>Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.</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="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" spread="14.7"/>
                    <measurement group_id="O2" value="1.8" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Regression, Linear</method>
            <method_desc>Variables included in the linear regression model are: baseline ODI, treatment group, and virtual center.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups</title>
        <description>The QoL scores were collected using the SF-36 questionnaire, which included the scores in the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The Physical Component Summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health using 1998 US population. Change in PCS is calculated as PCS at 6-month visit - PCS at baseline, with a positive change indicated as an improvement.</description>
        <time_frame>6 months post randomization</time_frame>
        <population>Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.</population>
        <group_list>
          <group group_id="O1">
            <title>SCS + OMM</title>
            <description>Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.</description>
          </group>
          <group group_id="O2">
            <title>OMM Alone</title>
            <description>Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.</description>
          </group>
        </group_list>
        <measure>
          <title>Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups</title>
          <description>The QoL scores were collected using the SF-36 questionnaire, which included the scores in the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The Physical Component Summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health using 1998 US population. Change in PCS is calculated as PCS at 6-month visit - PCS at baseline, with a positive change indicated as an improvement.</description>
          <population>Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.</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="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.27" spread="8.28"/>
                    <measurement group_id="O2" value="1.34" spread="6.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Regression, Linear</method>
            <method_desc>Variables included in the linear regression model are: baseline PCS, treatment group, and virtual center.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups</title>
        <description>This additional analysis was pre-specified to support the analysis of primary objective. The 30% responder which is defined in the following paragraph was considered as clinical relevant to the SCS therapy in back pain. Compare the proportion of subjects with a ≥30% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥30% reduction in average low back pain were considered as 30% responders.</description>
        <time_frame>6 months post randomization</time_frame>
        <population>As-treated - included all randomized subjects who provided data at 6-month visit, and analyzed based on the actual treatment the subjects received at 6-month visit.</population>
        <group_list>
          <group group_id="O1">
            <title>SCS + OMM</title>
            <description>Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.</description>
          </group>
          <group group_id="O2">
            <title>OMM Alone</title>
            <description>Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.</description>
          </group>
        </group_list>
        <measure>
          <title>Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups</title>
          <description>This additional analysis was pre-specified to support the analysis of primary objective. The 30% responder which is defined in the following paragraph was considered as clinical relevant to the SCS therapy in back pain. Compare the proportion of subjects with a ≥30% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥30% reduction in average low back pain were considered as 30% responders.</description>
          <population>As-treated - included all randomized subjects who provided data at 6-month visit, and analyzed based on the actual treatment the subjects received at 6-month visit.</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="79"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Z-test using unpooled standard deviation</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Randomization to 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SCS + OMM</title>
          <description>Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.</description>
        </group>
        <group group_id="E2">
          <title>OMM Alone</title>
          <description>Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>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="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vestibular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Implant site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Implant site infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Post laminectomy syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </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="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device extrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Device stimulation issue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Adjustment disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Drug abuse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA 19.1</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="4" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="108"/>
              </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>Restorative Therapies Group Clinical Trials</name_or_title>
      <organization>Medtronic Restorative Therapies Group - Pain Stim</organization>
      <email>medtronicneurotrials@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/NCT01697358
org study id: 1665
nct id: NCT01697358
lead sponsor: 
has dmc: No
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS)
      using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management
      (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed
      back surgery syndrome (FBSS).
The study has a multi-center, prospective, randomized (1:1), open-label, parallel-group
      design of two alternative treatments:

        -  SCS group (SCS+OMM)

        -  OMM group
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Period I (from randomization to 6 months) is the randomized parallel group comparative phase. Day zero for the study is the point of randomization. The randomization ratio is 1:1 (SCS+OMM to OMM). For the SCS+OMM arm, the screening test and/or implant occurred after randomization. Period II (6 to 24 months) is the long-term observational follow-up phase.
primary purpose: Treatment
masking: None (Open Label)
measure: Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups
time frame: 6 months post randomization
description: Compare the proportion of subjects with a ≥50% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥50% reduction in average low back pain were considered as responders.
measure: Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups
time frame: 6 months post randomization
description: Compare change in low back pain intensity, as measured by the Numeric Pain Rating Scale (NPRS), from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in low back pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.
measure: Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups
time frame: 6 months post randomization
description: Compare change in leg pain intensity, as measured by the NPRS, from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average leg pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in leg pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.
measure: Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups
time frame: 6 months post randomization
description: ODI is a validated questionnaire of 10 subject-reported sections on the ability to perform activities of daily living. These 10 sections are pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and traveling. Each section was scored on a 0 to 5 scale with 0 indicating no limitation of function due to pain and 5 indicating major functional disability due to back pain. A raw ODI score was calculated from the total score of 10 sections (minimum is 0 and maximum is 50). This ODI raw score was then normalized to a scale of 0 to 100, with 0-20 categorized as minimal disability, 20-40 as moderate disability, 40-60 as severe disability, 60-80 as severely disabled, and 80-100 as bed-bound patients. The ODI was assessed at baseline and subsequent scheduled study visits. Change in functional disability is calculated as ODI at baseline - ODI at 6-month visit, with a positive change indicated as an improvement.
measure: Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups
time frame: 6 months post randomization
description: The QoL scores were collected using the SF-36 questionnaire, which included the scores in the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The Physical Component Summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health using 1998 US population. Change in PCS is calculated as PCS at 6-month visit - PCS at baseline, with a positive change indicated as an improvement.
measure: Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups
time frame: 6 months post randomization
description: This additional analysis was pre-specified to support the analysis of primary objective. The 30% responder which is defined in the following paragraph was considered as clinical relevant to the SCS therapy in back pain. Compare the proportion of subjects with a ≥30% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥30% reduction in average low back pain were considered as 30% responders.
arm group label: SCS + OMM
arm group type: Active Comparator
description: Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan
arm group label: OMM alone
arm group type: Active Comparator
description: The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan
intervention type: Device
intervention name: Spinal Cord Stimulation (SCS)
description: Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group.
arm group label: SCS + OMM
intervention type: Drug
intervention name: Optimal Medical Management (OMM)
description: The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.
arm group label: OMM alone
arm group label: SCS + OMM
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe Rigoard, MD, PhD
role: Study Chair
affiliation: University of Poitiers
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country: Belgium
country: Canada
country: Colombia
country: France
country: Germany
country: Netherlands
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Failed Back Surgery Syndrome
sharing ipd: No
ipd description: Data will be kept confidential by Medtronic and only be shared with study investigators following Medtronic approval of a data request form.
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certain agreements: 
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