<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/NCT04479787</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-CIP-10343</org_study_id>
    <nct_id>NCT04479787</nct_id>
  </id_info>
  <brief_title>Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)</brief_title>
  <official_title>Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the efficacy of BurstDR dorsal column stimulation,&#xD;
      compared with conventional medical management, in improving pain and back-related physical&#xD;
      function in subjects suffering with chronic, refractory axial low back pain with a&#xD;
      neuropathic component, who have not had lumbar spine surgery and for whom surgery is not an&#xD;
      option.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, multi-center, randomized, controlled clinical study with an optional crossover&#xD;
      component. The study is designed to evaluate the efficacy of BurstDR SCS in the treatment of&#xD;
      chronic axial low back pain with a neuropathic component, compared to conventional medical&#xD;
      management (CMM).&#xD;
&#xD;
      Subjects will be followed in-clinic at 1,3, 6, 9, 12, 18 and 24 months and via phone call or&#xD;
      optional clinic visit at 15- and 21-months. The primary endpoint will be assessed at the&#xD;
      6-month follow-up visit. Upon completion of the 6-month follow-up visit, subjects who are&#xD;
      dissatisfied with therapy and receiving inadequate improvement with their treatment&#xD;
      assignment will be allowed to cross-over to the other treatment arm, if desired.&#xD;
&#xD;
      The study will enroll up to 270 patients at up to 30 sites. Subjects will be randomized in a&#xD;
      3:2 fashion to yield approximately 200 evaluable subjects for the primary endpoint analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 31, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Actual">August 23, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference in responders between both groups</measure>
    <time_frame>6 Months</time_frame>
    <description>Improvement in pain, defined as a ≥ 50% decrease on NRS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison between both groups</measure>
    <time_frame>6 Months</time_frame>
    <description>Change in ODI from baseline, and the percentage of change in NRS from baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">270</enrollment>
  <condition>Chronic Low-Back Pain</condition>
  <condition>Refractory Pain</condition>
  <condition>Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>Spinal Cord Stimulation (SCS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Medical Management (CMM)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CMM consists of an array of therapies including, but not limited to structured physical therapy, medications, injections, and complementary and alternative medicine (e.g. acupuncture, massage therapy)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spinal Cord Stimulation</intervention_name>
    <description>Utilization of BURSTDR stimulation</description>
    <arm_group_label>Spinal Cord Stimulation (SCS)</arm_group_label>
    <other_name>Proclaim XR IPG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Medical Management</intervention_name>
    <description>Assessing type of CMM, location and frequency.</description>
    <arm_group_label>Conventional Medical Management (CMM)</arm_group_label>
    <other_name>Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient must be willing and able to provide written informed consent prior to any&#xD;
             clinical investigation-related procedure.&#xD;
&#xD;
          2. Age ≥ 18 years&#xD;
&#xD;
          3. Patient has chronic (at least 6 months), refractory axial low back pain with a&#xD;
             neuropathic component and is not a candidate for spine surgery&#xD;
&#xD;
          4. Patient has back pain for ≥ 6 months inadequately responsive to supervised&#xD;
             conservative care&#xD;
&#xD;
          5. Patient has not had spine surgery for back or leg pain&#xD;
&#xD;
          6. Patient is a candidate for spinal cord stimulation&#xD;
&#xD;
          7. Low back pain ≥ 6 on Numerical Rating Scale&#xD;
&#xD;
          8. Oswestry Disability Index score of ≥ 30%&#xD;
&#xD;
          9. Willing and able to comply with the instructions for use, operate the study device,&#xD;
             and comply with this Clinical Investigation Plan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pathology seen on imaging tests obtained within the past 12 months that is clearly&#xD;
             identified and is likely the cause of the CLBP, that can be addressed with surgery.&#xD;
&#xD;
          2. Primary complaint of leg pain, or leg pain is greater than back pain&#xD;
&#xD;
          3. Back pain is due to any of the following:&#xD;
&#xD;
               -  spinal instability defined as &gt; 2 mm translation on radiographic imaging&#xD;
&#xD;
               -  visceral causes (e.g., endometriosis or fibroids)&#xD;
&#xD;
               -  vascular causes (e.g., aortic aneurysm)&#xD;
&#xD;
               -  spinal infection (e.g., osteomyelitis)&#xD;
&#xD;
               -  inflammation or damage to the spinal cord (e.g. arachnoiditis or syringomyelia)&#xD;
&#xD;
               -  tumor or spinal metastases&#xD;
&#xD;
          4. Has widespread pain (e.g. fibromyalgia) or pain in other area(s), not intended to be&#xD;
             treated in this study (e.g. neck pain, shoulder pain)&#xD;
&#xD;
          5. Patient has seronegative spondyloarthropathy (e.g. rheumatoid, lupus, psoriatic)&#xD;
&#xD;
          6. Neurological deficit (e.g. foot drop)&#xD;
&#xD;
          7. Prior lumbar spine surgery or sacroiliac joint fusion&#xD;
&#xD;
          8. Patient has used a morphine equivalent daily dose of more than 50 MME in the last 30&#xD;
             days&#xD;
&#xD;
          9. Patient is bed bound&#xD;
&#xD;
         10. Patients with regular intake of systemic steroids (except inhaled steroids used to&#xD;
             treat asthma)&#xD;
&#xD;
         11. Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicates lead&#xD;
             placement&#xD;
&#xD;
         12. Known allergic reaction to implanted materials&#xD;
&#xD;
         13. Severe scoliotic deformity (&gt;11 degrees in thoracic or lumbar spine)&#xD;
&#xD;
         14. Patient has a history of, or existing intrathecal drug pump&#xD;
&#xD;
         15. Patient has previous experience with neuromodulation devices, including a failed trial&#xD;
&#xD;
         16. BMI &gt; 40&#xD;
&#xD;
         17. Patient is enrolled, or intends to participate, in another clinical drug and/or device&#xD;
             study or registry that may interfere with the results of this study, as determined by&#xD;
             Abbott personnel&#xD;
&#xD;
         18. Presence of other anatomic or comorbid conditions, or other medical, social, or&#xD;
             psychological conditions that, in the investigator's opinion, could limit the&#xD;
             subject's ability to participate in the clinical investigation or to comply with&#xD;
             follow-up requirements of the clinical investigation results.&#xD;
&#xD;
         19. Failed psychological evaluation&#xD;
&#xD;
         20. Suspicion or evidence of untreated mental illness, or substance abuse&#xD;
&#xD;
         21. Patient demonstrated 2 or more Waddell's signs of nonorganic behavior&#xD;
&#xD;
         22. Patient is in current litigation for back pain/injury, or is currently receiving&#xD;
             worker's compensation&#xD;
&#xD;
         23. Pregnant or nursing subjects and those who plan pregnancy during the clinical&#xD;
             investigation follow-up period.&#xD;
&#xD;
               -  Female subjects of child-bearing potential must have a negative pregnancy test&#xD;
                  done within 7 days prior to enrollment/baseline visit per site standard test.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Yue, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Barrow Brain &amp; Spine</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner University Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spanish Hills Interventional Pain Specialists</name>
      <address>
        <city>Camarillo</city>
        <state>California</state>
        <zip>93010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Pain &amp; Spinal Diagnostics Medical Group</name>
      <address>
        <city>Carlsbad</city>
        <state>California</state>
        <zip>92009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Napa Valley Orthopedic Medical Group</name>
      <address>
        <city>Napa</city>
        <state>California</state>
        <zip>94558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connecticut Orthopedic Specialists</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Spine, Pain &amp; Performance Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Orthopedic Institute</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anesthesia Pain Care Consultants</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axis Spine Center</name>
      <address>
        <city>Coeur d'Alene</city>
        <state>Idaho</state>
        <zip>83815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Anesthesia Associates</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60657</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northshore University Health System</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana Spine Group</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Goodman Campbell Brain &amp; Spine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>45133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas University Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis Pain Consultants</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Pain Care</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nevada Advanced Pain Specialists</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Spine</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spinal Diagnostics</name>
      <address>
        <city>Tualatin</city>
        <state>Oregon</state>
        <zip>97062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Interventional Pain &amp; Spine</name>
      <address>
        <city>Exton</city>
        <state>Pennsylvania</state>
        <zip>19341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Orthopedics and Neurosurgical Associates</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Burkhart Research Institute for Orthopaedics</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Spine &amp; Nerve Center of St Francis Hospital</name>
      <address>
        <city>Charleston</city>
        <state>West Virginia</state>
        <zip>25301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Low Back Pain</keyword>
  <keyword>Spinal Cord Stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Pain, Intractable</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04479787
org study id: ABT-CIP-10343
nct id: NCT04479787
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The objective of this study is to evaluate the efficacy of BurstDR dorsal column stimulation,
      compared with conventional medical management, in improving pain and back-related physical
      function in subjects suffering with chronic, refractory axial low back pain with a
      neuropathic component, who have not had lumbar spine surgery and for whom surgery is not an
      option.
A prospective, multi-center, randomized, controlled clinical study with an optional crossover
      component. The study is designed to evaluate the efficacy of BurstDR SCS in the treatment of
      chronic axial low back pain with a neuropathic component, compared to conventional medical
      management (CMM).

      Subjects will be followed in-clinic at 1,3, 6, 9, 12, 18 and 24 months and via phone call or
      optional clinic visit at 15- and 21-months. The primary endpoint will be assessed at the
      6-month follow-up visit. Upon completion of the 6-month follow-up visit, subjects who are
      dissatisfied with therapy and receiving inadequate improvement with their treatment
      assignment will be allowed to cross-over to the other treatment arm, if desired.

      The study will enroll up to 270 patients at up to 30 sites. Subjects will be randomized in a
      3:2 fashion to yield approximately 200 evaluable subjects for the primary endpoint analysis.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The difference in responders between both groups
time frame: 6 Months
description: Improvement in pain, defined as a ≥ 50% decrease on NRS
measure: Comparison between both groups
time frame: 6 Months
description: Change in ODI from baseline, and the percentage of change in NRS from baseline
arm group label: Spinal Cord Stimulation (SCS)
arm group type: Active Comparator
description: An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator
arm group label: Conventional Medical Management (CMM)
arm group type: Active Comparator
description: CMM consists of an array of therapies including, but not limited to structured physical therapy, medications, injections, and complementary and alternative medicine (e.g. acupuncture, massage therapy)
intervention type: Device
intervention name: Spinal Cord Stimulation
description: Utilization of BURSTDR stimulation
arm group label: Spinal Cord Stimulation (SCS)
other name: Proclaim XR IPG
intervention type: Other
intervention name: Conventional Medical Management
description: Assessing type of CMM, location and frequency.
arm group label: Conventional Medical Management (CMM)
other name: Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James Yue, MD
role: Principal Investigator
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country: United States
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Pain, Intractable
sharing ipd: No