TY - JOUR T1 - Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial JF - Regional Anesthesia & Pain Medicine JO - Reg Anesth Pain Med DO - 10.1136/rapm-2018-100109 SP - rapm-2018-100109 AU - Christopher Gilmore AU - Brian Ilfeld AU - Joshua Rosenow AU - Sean Li AU - Mehul Desai AU - Corey Hunter AU - Richard Rauck AU - Leonardo Kapural AU - Antoun Nader AU - John Mak AU - Steven Cohen AU - Nathan Crosby AU - Joseph Boggs Y1 - 2019/04/05 UR - http://rapm.bmj.com/content/early/2019/04/05/rapm-2018-100109.abstract N2 - Background and objectives Chronic 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.Methods Twenty-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.Results A 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.Conclusions This 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 number NCT01996254. ER -