Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 3-month and 6-month results from the COMFORT-randomised controlled trial
Authors' conclusion
This study successfully reached its primary endpoint-the active arm achieved a statistically significant superior responder rate as compared with the control arm at 3 months. These RCT results demonstrated that PNS, with this micro-IPG, is efficacious and safe.
Study context
- Population
- Patients with chronic peripheral (neuropathic) pain of the lower back, shoulder, knee or foot/ankle
- Comparison
- Peripheral nerve stimulation (PNS) with micro-implantable pulse generator (micro-IPG) plus conventional medical management (CMM) vs CMM alone
- Primary endpoint
- Responder rate
- Follow-up
- 3 months
Methodological detailspostmarket, multicentre, 2:1 randomisation, Ongoing; subjects followed for 3 years
- Postmarket
- Multicentre
- 2:1 randomisation
- Ongoing; subjects followed for 3 years
Primary result
As reported in the abstract
Responder rate and average pain reduction
Responder rate and average pain reduction · 3 months
Average pain reduction
- Active vs Control: P < 0.001 — responder rate and pain reduction both significantly better
Further findings
| Outcome | Active |
|---|---|
| Responder rate and average pain reduction · 6 months | 88% |
| Average pain reduction | 70% |
Patient-reported outcomes
- A majority reached statistical significance
Comfort of external wearable component
- Subjects finding it comfortable
- 81%
Safety
- No reports of pocket pain
- No serious adverse device effects
Original publication
Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 3-month and 6-month results from the COMFORT-randomised controlled trial. Reg Anesth Pain Med. Published 31 May 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →