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

Christopher Gilmore*, Brian Ilfeld, Joshua Rosenow, Sean Li, Mehul Desai, Corey Hunter, Richard Rauck, Leonardo Kapural, Antoun Nader, John Mak, Steven Cohen, Nathan Crosby, Joseph Boggs

*Corresponding author for this work

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)637-645
Number of pages9
JournalRegional anesthesia and pain medicine
Volume44
Issue number6
DOIs
StatePublished - Jun 1 2019

Fingerprint

Neuralgia
Peripheral Nerves
Chronic Pain
Randomized Controlled Trials
Placebos
Pain
Therapeutics
Amputation
Femoral Nerve
Amputees
Sciatic Nerve
Lower Extremity
Safety
Research

Keywords

  • neuropathic pain
  • peripheral nerve stimulation
  • phantom pain
  • post-Amputation pain

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

Cite this

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. / Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain : A multicenter, randomized, placebo-controlled trial. In: Regional anesthesia and pain medicine. 2019 ; Vol. 44, No. 6. pp. 637-645.
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title = "Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: A multicenter, randomized, placebo-controlled trial",
abstract = "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.",
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Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain : A multicenter, randomized, placebo-controlled trial. / 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.

In: Regional anesthesia and pain medicine, Vol. 44, No. 6, 01.06.2019, p. 637-645.

Research output: Contribution to journalArticle

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

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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