NCT03228420

Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 430 (actual)
• Sponsor: Nevro Corp · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DEVICE	Senza HF10 Therapy	Senza 10kHz Spinal Cord Stimulation
OTHER	CMM	Conventional Medical Management

Timeline

• Start date: 2017-07-20
• Primary completion: 2020-05-01
• Completion: 2022-12-01
• First posted: 2017-07-24
• Last updated: 2021-08-10
• Results posted: 2021-08-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study