Implantable Peripheral Nerve Stimulation Shows Durable Pain Relief at 24 Months

Peripheral nerve stimulation (PNS) delivered via a micro-implantable pulse generator (micro-IPG) produced sustained and clinically meaningful improvements in pain and function in people with chronic peripheral neuropathic pain, according to long-term results from the randomized controlled COMFORT study (NCT05287373).

The multicenter, post-market COMFORT study included 131 participants who were randomized to receive conventional medical management with or without the addition of active PNS therapy via the permanently implanted Nalu Neurostimulation System (Nalu Medical, Carlsbad, CA; Boston Scientific, Marlborough, MA). After a crossover period, long-term outcomes were assessed in a modified intention-to-treat population of 68 individuals, with 46 participants receiving 24 months of follow-up. Pain intensity was measured using participant-reported Numeric Rating Scale (NRS) scores alongside validated participant-reported assessments of mood and quality of life.

Key findings at 24 months included:

• Eighty-five percent of participants (n=39) showed at least a 50% reduction in pain, with 28% classified as high responders who achieved ≥80% pain reduction.
• Mean pain scores improved by 67% from baseline, decreasing from 7.5 ± 1.2 to 2.4 ± 1.7 (P<.001).
• Significant pain relief was observed across treated regions, with responder rates (≥50% reduction) of 85% for low back pain, 89% for knee pain, 100% for shoulder pain, and 60% for foot/ankle pain.
• All secondary patient-reported outcomes—including disability (ODI), depression (BDI), and quality of life (EQ-5D-5L)—showed statistically significant and clinically meaningful improvements (all P<.001).
• No serious adverse device-related events were reported, and 96% of participants reported being satisfied or very satisfied with the therapy.

Source: Engle MP, Hersel A, Gutierrez G, Khemlani V, Kapural L, et al. (2026) Long-Term Clinical Outcomes (24 Months) of Peripheral Nerve Stimulation in the Treatment of Chronic Pain - COMFORT RCT. Chron Pain Manag 10: 179. https://doi.org/10.29011/2576-957X.100079