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

Inclusion Criteria:

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

2. Age ≥ 18 years

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

4. Patient has back pain for ≥ 6 months inadequately responsive to supervisedconservative 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 clearlyidentified 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 betreated 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 30days

9. Patient is bed bound

10. Patients with regular intake of systemic steroids (except inhaled steroids used totreat asthma)

11. Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicateslead 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 failedtrial

16. BMI > 40

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

18. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-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 receivingworker's compensation

23. Pregnant or nursing subjects and those who plan pregnancy during the clinicalinvestigation follow-up period.

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