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

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ClinicalTrials.gov Identifier: NCT04479787
Recruitment Status : Active, not recruiting
First Posted : July 21, 2020
Last Update Posted : January 6, 2023
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE July 17, 2020
First Posted Date  ICMJE July 21, 2020
Last Update Posted Date January 6, 2023
Actual Study Start Date  ICMJE July 31, 2020
Actual Primary Completion Date August 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2023)
The difference in responders between both groups [ Time Frame: 6 Months ]
Improvement in pain, defined as a ≥ 50% decrease on NRS
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2020)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2023)
Comparison between both groups [ Time Frame: 6 Months ]
Change in ODI from baseline, and the percentage of change in NRS from baseline
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2020)
Proportion of patients who elect to cross-over after the Primary Outcome [ Time Frame: 6 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)
Official Title  ICMJE Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)
Brief Summary 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.
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Low-Back Pain
  • Refractory Pain
  • Neuropathic Pain
Intervention  ICMJE
  • Device: Spinal Cord Stimulation
    Utilization of BURSTDR stimulation
    Other Name: Proclaim XR IPG
  • Other: Conventional Medical Management
    Assessing type of CMM, location and frequency.
    Other Name: Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.
Study Arms  ICMJE
  • Active Comparator: Spinal Cord Stimulation (SCS)
    An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator
    Intervention: Device: Spinal Cord Stimulation
  • Active Comparator: Conventional 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)
    Intervention: Other: Conventional Medical Management
Publications * O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 17, 2020)
270
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2024
Actual Primary Completion Date August 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04479787
Other Study ID Numbers  ICMJE ABT-CIP-10343
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Abbott Medical Devices
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Abbott Medical Devices
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Yue, MD
PRS Account Abbott Medical Devices
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP