Center for Clinical Research, Winston-Salem, North Carolina, USA
Anesthesiology, University of California, San Diego, La Jolla, California, USA.
Reg Anesth Pain Med. 2019 Jun;44(6):637-645. doi: 10.1136/rapm-2018-100109. Epub 2019 Apr 5.
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.
慢性神经病理性疼痛是截肢后常见的棘手病症。最近的研究表明，经皮植入细金属丝螺旋状周围神经刺激（PNS）导线靠近坐骨神经和股神经治疗截肢后疼痛是可行的。一项多中心、双盲、随机、安慰剂对照研究收集了经皮 PNS 治疗截肢后慢性神经病理性疼痛的安全性和有效性数据。
28 例截肢后伴有疼痛的下肢截肢患者入组。受试者接受超声引导下经皮 PNS 导线植入，并随机接受 PNS 或安慰剂治疗 4 周。安慰剂组随后交叉，所有受试者接受 PNS 治疗 4 周。主要疗效终点评估 1-4 周内报告疼痛缓解≥50%的受试者比例。
接受 PNS（n=7/12，58%）的受试者在 1-4 周内平均截肢后疼痛缓解≥50%的比例明显高于接受安慰剂（n=2/14，14%）。由于入选标准改变，有 2 名受试者被排除在疗效分析之外。接受 PNS 的受试者报告疼痛（n=8/12，67%）和疼痛干扰（n=8/10，80%）缓解≥50%的比例也明显高于接受安慰剂的受试者（疼痛：n=2/14，14%；疼痛干扰：n=2/13，15%）。正在进行前瞻性随访；截至目前，完成 12 个月随访的 5 名 PNS 受试者中有 4 名报告疼痛缓解≥50%。
这项工作表明，经皮 PNS 治疗可能为慢性神经病理性截肢后疼痛患者提供持久的临床显著疼痛缓解和改善残疾状况。
NCT01996254。
