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

Nevro Corp4 sites in 1 country430 target enrollmentJuly 20, 2017

ConditionsPainful Diabetic Neuropathy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Painful Diabetic Neuropathy
Sponsor: Nevro Corp
Enrollment: 430
Locations: 4
Primary Endpoint: Composite of Safety and Effectiveness
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10™ 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.

Registry

clinicaltrials.gov

Start Date

July 20, 2017

End Date

December 1, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nevro Corp

Responsible Party

Sponsor

Eligibility Criteria

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.
•Be willing and able to comply with study-related requirements, procedures, and scheduled visits.

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 ≥
•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.

Outcomes

Primary Outcomes

Composite of Safety and Effectiveness

Time Frame: 3 months

Difference between treatment groups in responder rates in subjects without a clinically meaningful neurological deficit compared with baseline. Responder is defined as a subject who has at least 50% reduction in lower limb pain from Baseline as measured by a 10 cm Visual Analog Scale (VAS).