Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial
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 postamputat...
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| Published in | Regional anesthesia and pain medicine Vol. 44; no. 6; pp. 637 - 645 |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| 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 | |
| Online Access | Get full text |
| ISSN | 1098-7339 1532-8651 1532-8651 |
| DOI | 10.1136/rapm-2018-100109 |
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| Abstract | 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. |
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| AbstractList | 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. 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 (painn=2/14, 14%; pain interferencen=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. 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. 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. 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. This work demonstrates that percutaneous PNS therapy may provide enduring clinically significant pain relief and improve disability in patients with chronic neuropathic postamputation pain. NCT01996254. 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.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.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.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.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.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.This work demonstrates that percutaneous PNS therapy may provide enduring clinically significant pain relief and improve disability in patients with chronic neuropathic postamputation pain.CONCLUSIONSThis work demonstrates that percutaneous PNS therapy may provide enduring clinically significant pain relief and improve disability in patients with chronic neuropathic postamputation pain.NCT01996254.TRIAL REGISTRATION NUMBERNCT01996254. |
| Author | Kapural, Leonardo Gilmore, Christopher Rosenow, Joshua Rauck, Richard Hunter, Corey Mak, John Crosby, Nathan Desai, Mehul Li, Sean Ilfeld, Brian Boggs, Joseph Nader, Antoun Cohen, Steven |
| AuthorAffiliation | Premier Pain Centers, Shrewsbury, New Jersey, USA Ainsworth Institute of Pain Management, New York City, New York, USA SPR Therapeutics, Cleveland, Ohio, USA Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA Department of Neurological Surgery, Northwestern University, Chicago, Illinois, USA Center for Clinical Research, Winston-Salem, North Carolina, USA International Spine, Pain & Performance Center, Washington, District of Columbia, USA Anesthesiology, University of California, San Diego, La Jolla, California, USA Department of Anesthesiology, Northwestern University, Chicago, Illinois, USA |
| AuthorAffiliation_xml | – name: International Spine, Pain & Performance Center, Washington, District of Columbia, USA – name: Department of Neurological Surgery, Northwestern University, Chicago, Illinois, USA – name: Anesthesiology, University of California, San Diego, La Jolla, California, USA – name: SPR Therapeutics, Cleveland, Ohio, USA – name: Department of Anesthesiology, Northwestern University, Chicago, Illinois, USA – name: Premier Pain Centers, Shrewsbury, New Jersey, USA – name: Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA – name: Ainsworth Institute of Pain Management, New York City, New York, USA – name: Center for Clinical Research, Winston-Salem, North Carolina, USA |
| Author_xml | – sequence: 1 givenname: Christopher surname: Gilmore fullname: Gilmore, Christopher organization: Center for Clinical Research, Winston-Salem, North Carolina, USA – sequence: 2 givenname: Brian surname: Ilfeld fullname: Ilfeld, Brian organization: Anesthesiology, University of California, San Diego, La Jolla, California, USA – sequence: 3 givenname: Joshua surname: Rosenow fullname: Rosenow, Joshua organization: Department of Neurological Surgery, Northwestern University, Chicago, Illinois, USA – sequence: 4 givenname: Sean surname: Li fullname: Li, Sean organization: Premier Pain Centers, Shrewsbury, New Jersey, USA – sequence: 5 givenname: Mehul surname: Desai fullname: Desai, Mehul organization: International Spine, Pain & Performance Center, Washington, District of Columbia, USA – sequence: 6 givenname: Corey surname: Hunter fullname: Hunter, Corey organization: Ainsworth Institute of Pain Management, New York City, New York, USA – sequence: 7 givenname: Richard surname: Rauck fullname: Rauck, Richard organization: Center for Clinical Research, Winston-Salem, North Carolina, USA – sequence: 8 givenname: Leonardo surname: Kapural fullname: Kapural, Leonardo organization: Center for Clinical Research, Winston-Salem, North Carolina, USA – sequence: 9 givenname: Antoun surname: Nader fullname: Nader, Antoun organization: Department of Anesthesiology, Northwestern University, Chicago, Illinois, USA – sequence: 10 givenname: John surname: Mak fullname: Mak, John organization: Premier Pain Centers, Shrewsbury, New Jersey, USA – sequence: 11 givenname: Steven surname: Cohen fullname: Cohen, Steven organization: Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA – sequence: 12 givenname: Nathan surname: Crosby fullname: Crosby, Nathan organization: SPR Therapeutics, Cleveland, Ohio, USA – sequence: 13 givenname: Joseph surname: Boggs fullname: Boggs, Joseph organization: SPR Therapeutics, Cleveland, Ohio, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30954936$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | American Society of Regional Anesthesia & Pain Medicine 2019. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ. Copyright © 2019 by American Society of Regional Anesthesia and Pain Medicine. 2019 American Society of Regional Anesthesia & Pain Medicine 2019. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, an indication of whether changes were made, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2019 American Society of Regional Anesthesia & Pain Medicine 2019. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, an indication of whether changes were made, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| DOI | 10.1136/rapm-2018-100109 |
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| Keywords | phantom pain neuropathic pain post-amputation pain peripheral nerve stimulation |
| Language | English |
| License | This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, an indication of whether changes were made, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. American Society of Regional Anesthesia & Pain Medicine 2019. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ. |
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| PublicationTitle | Regional anesthesia and pain medicine |
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| Snippet | Background and objectivesChronic neuropathic pain is a common challenging condition following amputation. Recent research demonstrated the feasibility of... BACKGROUND AND OBJECTIVESChronic neuropathic pain is a common challenging condition following amputation. Recent research demonstrated the feasibility of... Chronic neuropathic pain is a common challenging condition following amputation. Recent research demonstrated the feasibility of percutaneously implanting... |
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| SubjectTerms | 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 |
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| Title | Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial |
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