SHS_262087 YUCO CNVR 17122
A Post-Market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation (HF10™ Therapy) Combined With Conventional Medical Management to Conventional Medical Management Alone in the Treatment of Chronic, Intractable, Neuropathic Limb Pain
• Have been clinically diagnosed with painful diabetic neuropathy (PDN) of the lower limbs.
• Average pain intensity of ≥ 5 out of 10 cm on the VAS in the lower extremities at enrollment.
• Have stable neurological status.
• Be on a stable analgesic regimen.
• Be 22 years of age or older at the time of enrollment.
• Be an appropriate candidate for the surgical procedures required in this study.
• Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English.
• Have a diagnosis of a lower limb mononeuropathy, have had a lower limb amputation, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.
• Have a BMI ≥ 40.
• Currently prescribed a daily opioid dosage > 120 mg morphine equivalents.
• Have a medical condition or pain in other area(s), not intended to be treated in this study.
• Have a current diagnosis of a progressive neurological disease such a multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury.
• Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, low platelet count, severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
• Have failed prior SCS, dorsal root ganglion (DRG) stimulation, or peripheral nerve stimulation (PNS) trials for chronic intractable pain.
• Have significant spinal stenosis, objective evidence of epidural scarring and/or any signs or symptoms of myelopathy.
• Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) resulting in a compromised epidural space.
• Be benefitting from an interventional procedure and/or surgery to treat lower limb pain.
• Have an existing drug pump and/or another active implantable device such as a pacemaker.
• Have either a metastatic malignant neoplasm or untreated local malignant neoplasm.
• Have a life expectancy of less than one year.
• Have a local infection at the anticipated surgical entry site or an active systemic infection.
• Be pregnant or plan to become pregnant during the study. Women of childbearing potential who are sexually active must use a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal.
Cong Yu, M.D.