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Long-Term Clinical Outcomes (24 Months) of Peripheral Nerve Stimulation in the Treatment of Chronic Pain - COMFORT RCT

Year: 2026

Type: article

Abstract: Purpose: Few Randomized Controlled Trials (RCTs) have evaluated Peripheral Nerve Stimulation (PNS) for the treatment of chronic pain.Here, we report the 24-month results of the ongoing COMFORT multicenter, post-market RCT evaluating a micro-Implantable Pulse Generator (IPG) system.This device is FDA-cleared for the treatment of chronic peripheral pain.Methods: Eligible subjects were consented and randomized into one of two study arms -the Active Arm received PNS and Conventional Medical Management (CMM), and the Control Arm received CMM, alone.Outcomes were captured in the form of NRS pain scores and functional measures.Subjects who achieved ≥50% pain reduction with the PNS therapy were considered therapy responders.Results: The responder rate at 24 months was 85%, and it was 82% at 18 months.The average pain reduction as compared to baseline pain scores was 67% at 24 months (7.5±1.2 to 2.4±1.7;p<0.001) and 65% at 18 months (7.5±1.2 to 2.6±1.7;p<0.001).All patient-reported outcomes achieved statistical significance.No serious adverse device effects were reported, indicating a strong safety profile.Comfort and ease-of-use outcomes were favorable.Conclusions: The 18-and 24-month results are consistent with the previously reported 12-month outcomes from the COMFORT study.These data demonstrate that PNS therapy, delivered by the micro-IPG, reliably produces significant and durable improvements in net health outcomes.

Source: Chronic Pain & Management

DOI: 10.29011/2576-957x.100079