Tsunami DRG High Frequency Stimulation Study

Chronic Back Pain Clinical Trial

Official title: A European, Prospective, Multi-Center, Double-Blind, Randomized, Controlled, Clinical Trial Investigating the Effects of High Frequency Wireless Spinal Cord Stimulation (SCS) Over Exiting Nerve Roots in the Treatment of Chronic Back Pain

Status Active, not recruiting

Clinical Trial Summary

Prospective, double blinded, randomized, clinical study investigating the effects of high frequency SCS over exiting nerve roots at T9 for the treatment of chronic back or back and leg pain.

Clinical Trial Description

All subjects will have two permanent stimulators placed over the exiting nerve roots at T9 at the implant visit. The stimulators can easily be removed for non-responders. High frequency stimulation is typically programmed below sensory threshold. This type of stimulation lends itself to a placebo-controlled trial. For this study subjects will be randomized 1:1 at enrollment into a high frequency or sham group. Neither the subjects nor experimenters will be made aware of their randomization assignment for at least the first month of the trial. Subjects belonging to both groups will be unblinded to their assignment at the 1-month or a later visit (including unscheduled visit) if they have a VAS > 30 mms. Subjects belonging to the sham group will be reprogrammed with HF stimulation at this point. Subjects belonging to the HF stimulation group will keep stimulating with HF. Subjects reporting a VAS < 30 mms will continue to be blinded. ;

Related Conditions & MeSH terms

• Back Pain
• Chronic Back and Leg Pain
• Chronic Back Pain

• NCT number: NCT03312010
• Study type: Interventional
• Source: Stimwave Technologies
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2018
• Completion date: December 1, 2022