Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy

The purpose of this post-market study is to evaluate changes in pain and neurological function with high frequency, 10 kHz spinal cord stimulation (SCS) therapy in patients with chronic, intractable lower limb pain associated with diabetic peripheral neuropathy, a condition known as painful diabetic neuropathy (PDN). This is a multi-center, prospective, randomized controlled study to evaluate improvement in pain and neurological function in PDN patients, with neurological function assessed via objective measures. Patients will be randomized to conventional medical management (CMM) or 10 kHz SCS plus CMM.

NCT Number	NCT05777317
Lead Sponsor	Nevro Corp
Conditions	Painful Diabetic Neuropathy
Enrollment	143 participants
Start Date	2023-04-24
Primary Completion	2026-03-13 (estimated)
Study Completion	2026-07 (estimated)
Updated on ClinicalTrials.gov	2026-06-29