Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial

• Published in: Regional anesthesia and pain medicine Vol. 44; no. 6; pp. 637 - 645
• Main Authors: Gilmore, Christopher, Ilfeld, Brian, Rosenow, Joshua, Li, Sean, Desai, Mehul, Hunter, Corey, Rauck, Richard, Kapural, Leonardo, Nader, Antoun, Mak, John, Cohen, Steven, Crosby, Nathan, Boggs, Joseph
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd 01.06.2019; Copyright by American Society of Regional Anesthesia and Pain Medicine; BMJ Publishing Group LTD
• Subjects: Adult; Amputation; Amputation, Surgical; Chronic pain; Clinical significance; Cross-Over Studies; Double-Blind Method; Electrodes; Female; Humans; Male; Middle Aged; Narcotics; Nervous system; Neuralgia - therapy; Neuromuscular electrical stimulation; neuropathic pain; Original article; Pain; Pain management; Pain, Postoperative; peripheral nerve stimulation; phantom pain; Placebo effect; post-amputation pain; Prospective Studies; Regional anesthesia; Skin; Transcutaneous Electric Nerve Stimulation; Ultrasonic imaging; Veins & arteries; United States > US; phantom pain; neuropathic pain; post-amputation pain; peripheral nerve stimulation
• ISSN: 1098-7339; 1532-8651; 1532-8651
• DOI: 10.1136/rapm-2018-100109

Background and objectivesChronic neuropathic pain is a common challenging condition following amputation. Recent research demonstrated the feasibility of percutaneously implanting fine-wire coiled peripheral nerve stimulation (PNS) leads in proximity to the sciatic and femoral nerves for postamputation pain. A multicenter, double-blinded, randomized, placebo-controlled study collected data on the safety and effectiveness of percutaneous PNS for chronic neuropathic pain following amputation.MethodsTwenty-eight lower extremity amputees with postamputation pain were enrolled. Subjects underwent ultrasound-guided implantation of percutaneous PNS leads and were randomized to receive PNS or placebo for 4 weeks. The placebo group then crossed over and all subjects received PNS for four additional weeks. The primary efficacy endpoint evaluated the proportion of subjects reporting ≥50% pain reduction during weeks 1–4.ResultsA significantly greater proportion of subjects receiving PNS (n=7/12, 58%, p=0.037) demonstrated ≥50% reductions in average postamputation pain during weeks 1–4 compared with subjects receiving placebo (n=2/14, 14%). Two subjects were excluded from efficacy analysis due to eligibility changes. Significantly greater proportions of PNS subjects also reported ≥50% reductions in pain (n=8/12, 67%, p=0.014) and pain interference (n=8/10, 80%, p=0.003) after 8 weeks of therapy compared with subjects receiving placebo (pain: n=2/14, 14%; pain interference: n=2/13, 15%). Prospective follow-up is ongoing; four of five PNS subjects who have completed 12-month follow-up to date reported ≥50% pain relief.ConclusionsThis work demonstrates that percutaneous PNS therapy may provide enduring clinically significant pain relief and improve disability in patients with chronic neuropathic postamputation pain.Trial registration numberNCT01996254.