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

Exclusion Criteria

• •1. Pathology seen on imaging tests obtained within the past 12 month that is clearly identified 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 be treated 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 to treat asthma)
• •7. Imaging (MRI, CT, x-ray) findings within the last 12 mon that contraindicate lead placement
• •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, bladder stimulators, etc.
• •12. Patient has previous experience with neuromodulation devices, including a failed trial
• •13. BMI \>40
• •14. 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.
• •15. Presence of other anatomic or comorbid conditions, or other medical, social, or psychologic 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
• •16. Failed psychologic evaluation
• •17. Suspicion or evidence of untreated mental illness, substance abuse, or drug-seeking behavior
• •18. Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation
• •19. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.