RT Journal Article
SR Electronic
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
FD BMJ Publishing Group Ltd
SP rapm-2018-100109
DO 10.1136/rapm-2018-100109
A1 Christopher Gilmore
A1 Brian Ilfeld
A1 Joshua Rosenow
A1 Sean Li
A1 Mehul Desai
A1 Corey Hunter
A1 Richard Rauck
A1 Leonardo Kapural
A1 Antoun Nader
A1 John Mak
A1 Steven Cohen
A1 Nathan Crosby
A1 Joseph Boggs
YR 2019
UL http://rapm.bmj.com/content/early/2019/04/05/rapm-2018-100109.abstract
AB 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.