Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery

Inclusion Criteria: * Be a candidate for SCS system (trial and implant) * Have been diagnosed with chronic, refractory axial low back pain with or without lower limb pain, with a neuropathic component as assessed by the investigator, 6 months refractory to conventional therapy 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 regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study * Be willing and able to comply with study-related requirements, procedures, and visits Exclusion Criteria: * Had a previous spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) * Has a medical, anatomical, and/or psychosocial 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 pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, 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 lit…