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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04479787
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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
Chronic Low-Back Pain Refractory Pain Neuropathic Pain Device: Spinal Cord Stimulation Other: Comprehensive Medical Management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 31, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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 Name: 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 Name: Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.




Primary Outcome Measures :
  1. The difference in responders between both groups [ Time Frame: 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 [ Time Frame: 6 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  4. 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)
  5. Patient has seronegative spondyloarthropathy (e.g. rheumatoid, lupus, psoriatic)
  6. Neurological deficit (e.g. foot drop)
  7. Prior lumbar spine surgery or sacroiliac joint fusion
  8. Patient has used a morphine equivalent daily dose of more than 50 MME in the last 30 days
  9. Patient is bed bound
  10. Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)
  11. Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicates lead placement
  12. Known allergic reaction to implanted materials
  13. Severe scoliotic deformity (>11 degrees in thoracic or lumbar spine)
  14. Patient has a history of, or existing intrathecal drug pump
  15. Patient has previous experience with neuromodulation devices, including a failed trial
  16. BMI > 40
  17. 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
  18. 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.
  19. Failed psychological evaluation
  20. Suspicion or evidence of untreated mental illness, or substance abuse
  21. Patient demonstrated 2 or more Waddell's signs of nonorganic behavior
  22. Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation
  23. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04479787


Contacts
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Contact: Todd Stirman 972-526-9625 Todd.stirman@abbott.com
Contact: Robyn Capobianco 512-286-4274 Robyn.capobianco@abbott.com

Locations
Show Show 20 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: James Yue, MD
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04479787    
Other Study ID Numbers: ABT-CIP-10343
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Neuralgia
Back Pain
Low Back Pain
Pain, Intractable
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases