Altius direct electrical nerve stimulation for the treatment of lower extremity post-amputation pain: a device and literature review

INTRODUCTION Post-amputation pain (PAP), including residual limb pain (RLP) and phantom limb pain (PLP), can impair quality of life, although not all patients experience severe symptoms. Current treatments often provide incomplete relief.AREAS COVERED This review summarizes the treatment landscape, with emphasis on the Altius® high frequency alternating current (HFAC) nerve block therapy. A structured narrative review of PubMed, EMBASE, and ClinicalTrials.gov through 2026 for studies of electrical nerve stimulation in amputees. QUEST trial (NCT02221934, a multicenter, double-blind, randomized, active-sham-controlled study of Altius system) was analyzed. The FDA MAUDE database was queried for adverse events. HFAC reversibly blocks peripheral nerve conduction. In QUEST (n = 180), primary endpoint (≥50% pain reduction in ≥50% of sessions) was achieved at 30 minutes in 24.7% of HFAC versus 7.1% of sham subjects (p = 0.002). At 120 minutes, rates were 46.8% versus 22.2% (p = 0.001). Twelve-month follow-up (n = 146) showed sustained analgesia, improved quality of life, and reduced opioid use. Adverse events were mainly surgical; explant rates were 10–12%. MAUDE identified three reports (two infections, one lead fracture).EXPERT OPINION Altius HFAC provides clinically meaningful, statistically significant analgesia for chronic lower-limb PAP in patients selected by diagnostic nerve block response. Further comparative and long-term evaluation is required.