COMFORT Trial: Peripheral Nerve Stimulation Provides Durable Pain Relief

The COMFORT trial shows durable analgesia at 24 months with permanently implanted micro-IPG peripheral nerve stimulation, delivering sustained pain relief for chronic peripheral neuropathic pain; 85% of participants achieved ≥50% pain reduction.

The multicenter, randomized COMFORT study preplanned a 24-month follow-up and used participant-reported Numeric Rating Scale (NRS) scores as its primary pain endpoint. Of 131 randomized participants, the modified intention-to-treat population numbered 68, and 46 completed 24 months, supporting conclusions about therapeutic durability in the assessed population.

Active peripheral nerve stimulation produced large absolute and relative pain reductions: the reported 24-month outcomes showed a mean NRS drop from 7.5 ± 1.2 to 2.4 ± 1.7 (a 67% relative reduction; absolute mean change −5.1) with an 85% responder rate using the predefined ≥50% threshold. The magnitude of change meets common thresholds for clinically meaningful benefit.

Secondary validated patient-reported outcomes also improved: measures of disability (ODI), mood (BDI), and quality of life (EQ-5D-5L) all demonstrated statistically significant, clinically meaningful gains (all P<.001). These improvements reflect reduced functional limitation, better emotional well-being, and practical gains in activity tolerance and task participation—points that help set realistic expectations during counseling.

Safety through 24 months recorded no serious device-related adverse events. Device- or procedure-related events were limited, and 96% of participants reported being satisfied or very satisfied with therapy. The overall safety profile was favorable and supports inclusion of device-related risk–benefit information in referral discussions.

Key Takeaways:

• Permanent micro‑IPG peripheral nerve stimulation produced sustained analgesia at 24 months with an 85% ≥50% responder rate and an absolute mean NRS reduction of 5.1 points.
• Validated secondary measures of disability, mood, and quality of life improved significantly and meaningfully, supporting functional gains beyond pain reduction.
• No serious device‑related adverse events were reported through 24 months; minor device‑or procedure‑related events were infrequent and rarely required device removal or revision.