TY - JOUR
T1 - Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain
T2 - A multicenter, randomized, placebo-controlled trial
AU - Gilmore, Christopher
AU - Ilfeld, Brian
AU - Rosenow, Joshua
AU - Li, Sean
AU - Desai, Mehul
AU - Hunter, Corey
AU - Rauck, Richard
AU - Kapural, Leonardo
AU - Nader, Antoun
AU - Mak, John
AU - Cohen, Steven
AU - Crosby, Nathan
AU - Boggs, Joseph
N1 - Funding Information:
The study was funded with a grant from the US Department of Defense, and enrollment was completed with 28 subjects at the close of the grant funding period. Prospective follow-up is ongoing and will continue until 1 year after the final subject
Funding Information:
Funding The study was funded by the Department of Defense (CDMRP/PRORP W81XWH-12-2-0132) and SPR Therapeutics.
Publisher Copyright:
© American Society of Regional Anesthesia & Pain Medicine 2019. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.
PY - 2019/6/1
Y1 - 2019/6/1
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.
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.
KW - neuropathic pain
KW - peripheral nerve stimulation
KW - phantom pain
KW - post-Amputation pain
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UR - http://www.scopus.com/inward/citedby.url?scp=85066353412&partnerID=8YFLogxK
U2 - 10.1136/rapm-2018-100109
DO - 10.1136/rapm-2018-100109
M3 - Article
C2 - 30954936
AN - SCOPUS:85066353412
SN - 1098-7339
VL - 44
SP - 637
EP - 645
JO - Regional anesthesia and pain medicine
JF - Regional anesthesia and pain medicine
IS - 6
ER -