Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 12-month results from the COMFORT-randomized controlled trial
Authors' conclusion
These 12-month results are consistent with previously reported 6-month outcomes from this study, showing durability of peripheral nerve stimulation treatment with the micro-IPG system; subjects realized sustained large reduction in pain and improvement in patient-reported outcomes following treatment with this micro-IPG system.
Study context
- Population
- Patients with chronic peripheral neuropathic pain
- Comparison
- Active vs Control
Methodological detailsmulticentre, postmarket, crossover allowed after 3 months
- Multicentre
- Postmarket
- Crossover allowed after 3 months
Primary result
As reported in the abstract
Therapy response (≥50% pain reduction from baseline) and pain score · 12 months
- Responder rate
- 87%
- Average reduction in pain vs baseline (7.5±1.2 to 2.3±1.7)
- 69%
- Pain reduction vs baseline, P
- p<0.001
Further findings
Patient-reported outcomes · 12 months
- Statistical significance achieved for all patient-reported outcomes
- Majority used unique programming options and found device easy to use and comfortable to wear
Safety
Serious adverse device effects and pocket pain · 12 months
- No serious adverse device effects
- No reports of pocket pain
- Excellent safety profile
Original publication
Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 12-month results from the COMFORT-randomized controlled trial. Reg Anesth Pain Med. Published 20 November 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →