SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA) (NOVA)

This is an interventional treatment trial for Chronic Back Pain Read More

Inclusion Criteria:

1. Be a candidate for SCS system (trial and implant) per labeled indication (back pain with or without leg pain)
2. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment
3. Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment
4. Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
5. Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent.
6. Be 18 years of age or older at the time of enrollment
7. Be on a stable pain medication regimen, as determined by the study investigator, for at least 30 days prior to enrolling in this study
8. Be willing to not increase pain medications from baseline through the 3-Month Visit
9. Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria:

1. Had previous lumbar spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
2. Has a medical, anatomical, and/or psycho-social condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator
3. Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and or neurological disorders, as determined by the Investigator
4. Be concurrently participating in another clinical study
5. Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator and/or drug delivery pump, etc.
6. Has a pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
7. Has mechanical spine instability as determined by the Investigator
8. Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat back and/or leg pain, which is providing significant pain relief
9. Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator
10. Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim
11. Be pregnant (determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control.)