Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain (NCT03228420) | Clinical Trial Compass
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Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain
United States430 participantsStarted 2017-07-20
Plain-language summary
This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10â„¢ therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy (Painful Diabetic Neuropathy or PDN). This study is a multi-center, prospective, randomized comparison of the two treatments.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Be willing and capable of giving informed consent.
Exclusion criteria
✕. 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.