A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain

Inclusion Criteria:

1. Patients with PSPS type 1 and 2

2. Patients with predominant back pain

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

4. Age ≥18 y

5. Patients with SCS(BurstDR) stimulation in situ for more than 6 month and >50% painrelief. Patients have to be satisfied with their existing SCS therapy andpredominantly use a BurstDR stimulation program.

(Only responders to that therapy should be included, not patients who have notresponded to their therapy so far.) [GROUP 1]

6. Low back pain baseline score of ≥6 on NRS before spinal cord stimulation therapy anda MCID (Minimal clinically important difference) of >50% with SCS(BurstDRTM) trialstimulation. [GROUP 2]

7. 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 month that is clearlyidentified and is likely the cause of the CLBP, that can be addressed with surgery

2. Primary symptom of leg pain, or leg pain is greater than back pain

3. Back pain is due to any of the following: vascular causes (eg, aortic aneurysm),spinal infection (eg, osteomyelitis), inflammation or damage to the spinal cord (eg,arachnoiditis or syringomyelia), tumor or spinal metastases

4. Has widespread pain (eg, fibromyalgia) or pain in other area(s), not intended to betreated in this study (eg, neck pain, shoulder pain)

5. Patient has used a morphine equivalent daily dose of >50 MME in the last 30 days

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

7. Imaging (MRI, CT, x-ray) findings within the last 12 mon that contraindicate leadplacement

8. Known allergic reaction to implanted materials

9. Severe scoliotic deformity (>11◦ in thoracic or lumbar spine)

10. Patient has a history of or existing intrathecal drug pump

11. Patient with other existing implantable electrical devices, i.e. pacemakers, bladderstimulators, etc.

12. Patient has previous experience with neuromodulation devices, including a failedtrial

13. BMI >40

14. 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.

15. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychologic 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

16. Failed psychologic evaluation

17. Suspicion or evidence of untreated mental illness, substance abuse, or drug-seekingbehavior

18. Patient is in current litigation for back pain/injury, or is currently receivingworker's compensation

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