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

Launched by MEDTRONICNEURO · May 29, 2024

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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 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.)

Trial Officials