At a glance
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Efficacy of Sub-Threshold Dorsal Root Ganglion (DRG) Stimulation Versus Sham in Established Responders: A Randomised, Double-Blind, Two-Period Crossover Trial
In Brief
A clinical study evaluating Subtreshhold DRG-S and Sham for Neuropathic Pain and 5 related conditions. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The goal of this clinical trial is to learn if sub-threshold dorsal root ganglion (DRG) stimulation provides pain relief beyond placebo in adults with chronic neuropathic pain who already have an implanted DRG stimulator. The main questions it aims to answer are: * Does sub-threshold DRG stimulation reduce daily pain intensity compared with sham stimulation? * How does sub-threshold stimulation affect sleep, mood, and daily activity? Researchers will compare active sub-threshold DRG stimulation to sham (device switched off) to see if stimulation has a genuine effect on pain and wellbeing. Participants will: * Be randomly assigned to receive either active sub-threshold DRG stimulation or sham stimulation for 5 days, followed by the opposite condition for another 5 days. * Complete short electronic diaries twice daily about their pain, sleep, mood, and activity. * Attend study visits for safety checks and assessments.
Study Details
Timeline
Interventions
Continuous electrical stimulation delivered through an implanted DRG neurostimulator. Amplitude is set individually to 80% of each participant's perception threshold, ensuring no paresthesia is produced. Frequency and pulse width remain unchanged from the participant's established therapeutic settings. This sub-threshold programming distinguishes the intervention from suprathreshold (paresthesia-based) DRG stimulation used in earlier studies.
The implanted DRG stimulator remains switched off for the entire 5-day period. Device interrogation logs are masked to maintain blinding. No electrical stimulation is delivered, allowing a placebo-controlled comparison with active sub-threshold stimulation.