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

Inclusion Criteria

• Be a candidate for SCS system (trial and implant) per labeled indication (back pain with or without leg pain)
• 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
• Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment
• 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.
• Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent.
• Be 18 years of age or older at the time of enrollment
• Be on a stable pain medication regimen, as determined by the study investigator, for at least 30 days prior to enrolling in this study
• Be willing to not increase pain medications from baseline through the 3-Month Visit
• Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria

• Had previous lumbar spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
• Has a medical, anatomical, and/or psycho-social condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator
• 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
• Be concurrently participating in another clinical study
• Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator and/or drug delivery pump, etc.
• 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
• Has mechanical spine instability as determined by the Investigator
• 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
• Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator
• Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim
• 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.)