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