Design of a Multicenter, Randomized Controlled Trial for the Treatment of Peripheral Neuropathic Pain (COMFORT Study) with a Micro-Implantable Pulse Generator.
John HathewayAlexander Perry HerselJonathan SongMitchell P EngleGenaro GutierrezVishal KhemlaniLeonardo KapuralGregory MooreReginald Chinaedu AjakweDrew M TrainorJennifer M HahPeter StaatsPaul LynchJames MakousGary HeitShilpa KottalgiMehul J DesaiPublished in: Journal of pain research (2024)
The COMFORT study, described here, has the potential to demonstrate the efficacy and safety of the Nalu Neurostimulation System in the treatment of peripheral neuropathy. Results of this study will be the first Level-I evidence, out to 36 months, validating the use of this PNS system in the treatment of chronic pain. This study is designed to enroll the largest cohort, to date, of subjects comparing PNS+CMM vs CMM alone.