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

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

Tracking Information

• First Submitted Date: July 17, 2020
• First Posted Date: July 21, 2020
• Last Update Posted Date: January 6, 2023
• Actual Study Start Date: July 31, 2020
• Actual Primary Completion Date: August 23, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Chronic Low-Back Pain
• Refractory Pain
• Neuropathic Pain

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 17, 2020): 270
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 31, 2024
• Actual Primary Completion Date: August 23, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04479787
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Abbott Medical Devices
• Original Responsible Party: Same as current
• Current Study Sponsor: Abbott Medical Devices
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: James Yue, MD

• PRS Account: Abbott Medical Devices
• Verification Date: January 2023