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ACTIVE NOT RECRUITING
NCT05777317
NA

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

Sponsor: Nevro Corp

View on ClinicalTrials.gov

Summary

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.

Official title: PDN-SENSORY: A Multi-Center Randomized Controlled Trial to Evaluate Pain and Neurological Function With 10 kHz SCS in Treatment of Painful Diabetic Neuropathy

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

143

Start Date

2023-04-24

Completion Date

2026-08-31

Last Updated

2024-11-06

Healthy Volunteers

No

Interventions

DEVICE

10 kHz SCS

Spinal cord stimulation programmed to a frequency of 10 kHz

OTHER

CMM alone

Conventional medical management alone

Locations (2)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Touchstone Interventional Pain Center

Medford, Oregon, United States