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

Painful Diabetic Neuropathy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05777317
Study type Interventional
Source Nevro Corp
Contact Don Middlebrook
Phone 650-433-2218
Email don.middlebrook@nevro.com
Status Recruiting
Phase N/A
Start date April 24, 2023
Completion date August 31, 2026
View Details
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