Study of Peripheral Nerve Stimulation with Conventional Care for Adults Experiencing Chronic Neuropathic Pain

What this Trial Is About

Researchers are studying adults with chronic neuropathic pain in areas such as the upper extremities, lower back, pelvis, or lower extremities. The trial compares two groups one receiving conventional medical management CMM alone and the other receiving CMM combined with peripheral nerve stimulation PNS therapy. This randomized controlled trial aims to evaluate treatment outcomes and response rates between these approaches to better understand pain relief mechanisms. Participants receive either conventional care or one of two FDA-approved peripheral nerve stimulation devices. The SPR SPRINT PNS System is a wearable stimulator delivering electrical pulses for 60 days, controlled by a wireless remote. The Nalu PNS System uses a micro-implant powered by an external therapy disc and controlled via an app. Those in the CMM-only group continue with their standard care. The study observes these treatments over a three-month period. During the study, participants keep a 3-day pain diary to measure average pain intensity, focusing on achieving at least 50% pain relief. Researchers also track early trial response rates within 15 days. Participants complete online assessments and follow activity restrictions around treatment times. The study includes safety monitoring and aims to understand the effectiveness of combining peripheral nerve stimulation with conventional therapies for chronic neuropathic pain.

Mechanisms of Stimulation for Pain Alleviation