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Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04479787
Collaborator
(none)
270
Enrollment
32
Locations
2
Arms
42
Anticipated Duration (Months)
8.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the efficacy of BurstDR dorsal column stimulation, compared with comprehensive 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Spinal Cord Stimulation
  • Other: Comprehensive Medical Management
 N/A

Detailed Description

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 comprehensive 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)
Actual Study Start Date :
Jul 31, 2020
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Spinal Cord Stimulation (SCS)

An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator

Device: Spinal Cord Stimulation
Utilization of BURSTDR stimulation
Other Names:
  • Proclaim XR IPG

    		•
    Active Comparator: Comprehensive Medical Management (CMM)

    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)

    Other: Comprehensive Medical Management
    Assessing type of CMM, location and frequency.
    Other Names:
  • Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The difference in responders between both groups [6 Months]

      Improvement in function, defined as a ≥ 13% decrease on ODI or score ≤ 20%, OR Improvement in pain, defined as a ≥ 50% decrease on NRS

    Secondary Outcome Measures

    1. Proportion of patients who elect to cross-over after the Primary Outcome [6 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Patient must be willing and able to provide written informed consent prior to any clinical investigation-related procedure.

    2. Age ≥ 18 years

    3. Patient has chronic (at least 6 months), refractory axial low back pain with a neuropathic component and is not a candidate for spine surgery

    4. Patient has back pain for ≥ 6 months inadequately responsive to supervised conservative care

    5. Patient has not had spine surgery for back or leg pain

    6. Patient is a candidate for spinal cord stimulation

    7. Low back pain ≥ 6 on Numerical Rating Scale

    8. Oswestry Disability Index score of ≥ 30%

    9. Willing and able to comply with the instructions for use, operate the study device, and comply with this Clinical Investigation Plan

    Exclusion Criteria:

    1. Pathology seen on imaging tests obtained within the past 12 months that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery.

    2. Primary complaint of leg pain, or leg pain is greater than back pain

    3. Back pain is due to any of the following:

    • spinal instability defined as > 2 mm translation on radiographic imaging

    • visceral causes (e.g., endometriosis or fibroids)

    • vascular causes (e.g., aortic aneurysm)

    • spinal infection (e.g., osteomyelitis)

    • inflammation or damage to the spinal cord (e.g. arachnoiditis or syringomyelia)

    • tumor or spinal metastases

    1. Has widespread pain (e.g. fibromyalgia) or pain in other area(s), not intended to be treated in this study (e.g. neck pain, shoulder pain)

    2. Patient has seronegative spondyloarthropathy (e.g. rheumatoid, lupus, psoriatic)

    3. Neurological deficit (e.g. foot drop)

    4. Prior lumbar spine surgery or sacroiliac joint fusion

    5. Patient has used a morphine equivalent daily dose of more than 50 MME in the last 30 days

    6. Patient is bed bound

    7. Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)

    8. Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicates lead placement

    9. Known allergic reaction to implanted materials

    10. Severe scoliotic deformity (>11 degrees in thoracic or lumbar spine)

    11. Patient has a history of, or existing intrathecal drug pump

    12. Patient has previous experience with neuromodulation devices, including a failed trial

    13. BMI > 40

    14. Patient is enrolled, or intends to participate, in another clinical drug and/or device study or registry that may interfere with the results of this study, as determined by Abbott personnel

    15. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.

    16. Failed psychological evaluation

    17. Suspicion or evidence of untreated mental illness, or substance abuse

    18. Patient demonstrated 2 or more Waddell's signs of nonorganic behavior

    19. Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation

    20. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.

    • Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to enrollment/baseline visit per site standard test.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barrow Brain & Spine Phoenix Arizona United States 85048
    2 Banner University Medical Center Tucson Arizona United States 85724
    3 Spanish Hills Interventional Pain Specialists Camarillo California United States 93010
    4 Coastal Pain & Spinal Diagnostics Medical Group Carlsbad California United States 92009
    5 Napa Valley Orthopedic Medical Group Napa California United States 94558
    6 Connecticut Orthopedic Specialists Hamden Connecticut United States 06518
    7 International Spine, Pain & Performance Center Washington District of Columbia United States 20037
    8 The Orthopedic Institute Gainesville Florida United States 32607
    9 Anesthesia Pain Care Consultants Tamarac Florida United States 33321
    10 Axis Spine Center Coeur d'Alene Idaho United States 83815
    11 Chicago Anesthesia Associates Chicago Illinois United States 60657
    12 Northshore University Health System Evanston Illinois United States 60201
    13 Indiana Spine Group Carmel Indiana United States 46032
    14 Goodman Campbell Brain & Spine Indianapolis Indiana United States 45133
    15 Kansas University Medical Center Kansas City Kansas United States 66160
    16 Brigham & Women's Hospital Boston Massachusetts United States 02115
    17 Mayo Clinic Rochester Minnesota United States 55905
    18 Saint Louis Pain Consultants Chesterfield Missouri United States 63017
    19 Advanced Pain Care Henderson Nevada United States 89052
    20 Nevada Advanced Pain Specialists Reno Nevada United States 89511
    21 Albany Medical Center Albany New York United States 12208
    22 Montefiore Medical Center Bronx New York United States 10461
    23 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
    24 OrthoNeuro New Albany Ohio United States 43054
    25 Summit Spine Portland Oregon United States 97225
    26 Spinal Diagnostics Tualatin Oregon United States 97062
    27 Center for Interventional Pain & Spine Exton Pennsylvania United States 19341
    28 Rhode Island Hospital Providence Rhode Island United States 02903
    29 Clinical Trials of South Carolina Charleston South Carolina United States 29406
    30 Carolina Orthopedics and Neurosurgical Associates Spartanburg South Carolina United States 29303
    31 Burkhart Research Institute for Orthopaedics San Antonio Texas United States 78216
    32 The Spine & Nerve Center of St Francis Hospital Charleston West Virginia United States 25301

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    • Principal Investigator: James Yue, MD,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT04479787
    Other Study ID Numbers:
    • ABT-CIP-10343
    First Posted:
    Jul 21, 2020
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Abbott Medical Devices
    Chronic Low Back Pain
    Spinal Cord Stimulation
    Additional relevant MeSH terms:
    Neuralgia
    Back Pain
    Low Back Pain
    Pain, Intractable

    Study Results

    No Results Posted as of Apr 7, 2022