John Hatheway, Alexander Perry Hersel, Jonathan Song, Mitchell P Engle, Genaro Gutierrez, Vishal Khemlani, Leonardo Kapural, Gregory Moore, Reginald Chinaedu Ajakwe, Drew M Trainor, Jennifer M Hah, Peter Staats, Paul Lynch, James Makous, Gary Heit, Shilpa Kottalgi, Mehul J Desai
BACKGROUND: Peripheral Nerve Stimulation (PNS) is an established therapy for chronic neuropathic pain of peripheral origin, typically following nerve injury. However, there is a paucity of Randomized Controlled Trials (RCTs) demonstrating the therapeutic benefits of PNS. The goals of the current study (COMFORT Study) are to document the safety and efficacy of the Nalu Neurostimulation in a PNS RCT, compared to conventional medical management (CMM). METHODS/DESIGN: This is a prospective, multicenter, RCT evaluating the treatment of neuropathic pain with PNS therapy...
2024: Journal of Pain Research