Sub-threshold DRG Stimulation vs Sham in Established Responders
CompletedNot applicableNCT07170722
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
- Official title
- Efficacy of Sub-Threshold Dorsal Root Ganglion (DRG) Stimulation Versus Sham in Established Responders: A Randomised, Double-Blind, Two-Period Crossover Trial
- Conditions
- Neuropathic Pain
- Complex Regional Pain Syndromes (CRPS)
- Causalgia
- Chronic Pain
- Low Back Pain
- Pelvic Pain
- Interventions
- Device: Subtreshhold DRG-S
- Other: Sham
- Sponsor
- Umeå University
- Start date
- 2025-09-01
- Primary completion
- 2025-11-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Sweden
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Adults, age 18 years or older * Implanted with a dorsal root ganglion (DRG) stimulator for chronic neuropathic pain * Have experienced at least 50% reduction in pain for 3 months or longer on standard DRG therapy * Stable pain medication regimen for at least 4 weeks before enrollment * Able and willing to complete electronic diaries and attend study visits Exclusion Criteria: * Active infection or wound complication at the stimulator implant site * Significant psychiatric illness (for example, uncontrolled depression or psychosis) * Planned surgery, device reprogramming, or medication changes during the study period * Currently pregnant or breastfeeding * Occurrence of any adverse event that meets predefined withdrawal criteria during the study (such as intolerable pain or device-related complications)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07170722