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.
- peripheral nerve stimulation
- neuropathic pain
- phantom pain
- post-amputation pain
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Presented at Data from this study were presented at the 2018 Napa Pain Conference in Napa, California, in August 16–19, 2018, and at the Military Health System Research Symposium in Kissimmee, Florida, in August 20–23, 2018.
Contributors CG, RR, LK, SC, NC, and JB contributed to the design of the study. CG, BI, JR, SL, MD, CH, AN, and JM collected the data. CG, BI, JR, SL, MD, CH, RR, LK, AN, JM, SC, NC, and JB contributed to drafting and revision of the manuscript.
Funding The study was funded by the Department of Defense (CDMRP/PRORP W81XWH-12-2-0132) and SPR Therapeutics.
Competing interests CG, JR, MD, RR, and LK have consulted for SPR Therapeutics. The institutions of CG, BI, SL, MD, JM, RR, and LK have received funding from SPR Therapeutics for other clinical studies. NC and JB are employees of SPR Therapeutics.
Patient consent for publication Not required.
Ethics approval The study was approved by the FDA under an Investigational Device Exemption and was conducted in accordance with relevant sections of the US Code of Federal Regulations, the Declaration of Helsinki, and the ICH guidelines for good clinical practice. The study protocol and written informed consent were approved by each study site’s institutional review board and the US Army Medical Research and Materiel Command Human Research Protection Office.
Provenance and peer review Not commissioned; externally peer reviewed.
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