Journal Article

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

Hatheway, John, Khemlani, Vishal, Kapural, Leonardo, Kottalgi, Shilpa, Desai, Mehul J, Hersel, Alexander, Hah, Jennifer, Song, Jonathan, Heit, Gary, Engle, Mitchell, Gutierrez, Genaro, Ajakwe, Reginald, Trainor, Drew, Staats, Peter S, Makous, James, Moore, Gregory, Lynch, Paul

2025

Overview

BackgroundWe report the results from the first large, postmarket, multicentre, randomised controlled trial (RCT) evaluating peripheral nerve stimulation (PNS) for the treatment of chronic peripheral pain with a micro-implantable pulse generator (micro-IPG).MethodsSubjects meeting eligibility were randomised (2:1) to either the active arm receiving PNS and conventional medical management (CMM) or the control arm receiving CMM alone. Treatments were limited to the following areas: lower back, shoulder, knee and foot/ankle.ResultsAt 6 months, the active arm achieved an 88% responder rate with a 70% average reduction in pain. At the 3-month primary endpoint, the active arm achieved an 84% responder rate with an average pain reduction of 67% compared with the control arm, which achieved a 3% responder rate with an average pain reduction of 6%. Both responder rate and pain reduction in the active arm were significantly better than in the control arm (p<0.001). A majority of patient-reported outcomes also reached statistical significance. There have been no reports of pocket pain and no serious adverse device effects. 81% of subjects found the external wearable component of the PNS system to be comfortable.ConclusionsThis 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. This ongoing study will follow subjects for 3 years, the results of which will be reported as they become available.

• Publisher: BMJ Publishing Group Ltd,BMJ Publishing Group LTD
• Subject: Adult / Aged / Chronic and interventional pain / CHRONIC PAIN / Chronic Pain - diagnosis / Chronic Pain - therapy / Clinical medicine / Electric Stimulation Therapy - instrumentation / Electric Stimulation Therapy - methods / Electrodes, Implanted / Female / Humans / Implantable Neurostimulators / Male / Middle Aged / Morphine / Neuralgia / Neuralgia - diagnosis / Neuralgia - physiopathology / Neuralgia - therapy / Pain Management / Pain Management - instrumentation / Pain Management - methods / Pain Measurement - methods / Patient safety / Peripheral Nerve Injuries / Physical therapy / Population / Standard of care / Statistical analysis / Time Factors / Treatment Outcome