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

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 number NCT01996254.

Percutaneous Peripheral Nerve Stimulation for Chronic Low Back Pain: Prospective Case Series With 1 Year of Sustained Relief Following Short‐Term Implant

“…78,79 Percutaneous PNS provides an opportunity as an earlier neurostimulation intervention that may preclude the need for opioids, denervation, surgery, and permanently implanted systems, particularly given evidence of long-term relief in patients with chronic pain. 80,81,[83][84][85][86][87][88][89][90][91][92][93][94][95][96][97] A recently published double-blinded randomized controlled trial (RCT) assessing the efficacy of percutaneous PNS in the treatment of chronic postamputation pain demonstrated significant and durable pain relief and improvement in quality of life with results sustained through 1 year. 97,81 The present investigation was designed as a prospective case series study to determine the feasibility of generating similar sustainable reductions in pain and disability and improvements in quality of life in patients with LBP using the same device.…”

Resurgence of peripheral nerve stimulation with innovation in device technologies

“…The article by Gilmore et al 7 in this issue emphasizes the renaissance of PNS in the 21st century. Beyond its application for pain treatment, electrical stimulation of peripheral nerves has demonstrated potential in neural regeneration 23.…”

“…Although their primary outcome of >50% pain relief at 4 weeks was met in the treatment arm, surprisingly the crossover patients did not have similar results 7. All leads were placed under ultrasound guidance, but stimulation testing was not performed for patients in the “placebo arm.” The results may justify lead testing in future studies to ensure optimal placement of the PNS lead.…”

“…In this issue of Regional Anesthesia & Pain Medicine , Gilmore et al 7 examine the use of PNS for the treatment of chronic neuropathic pain in amputees. The PNS device studied is approved by the Food and Drug Administration for up to 60 days of application in the back and/or extremities for the following indications: (1) symptomatic relief of chronic, intractable pain, or postsurgical and post-traumatic acute pain; (2) symptomatic relief of post-traumatic pain; and (3) symptomatic relief of postoperative pain 8.…”

“…Gilmore et al 7 present a multicenter, randomized, double-blinded, placebo-controlled, partial-crossover study that was carried out in an amputee population (N=28). All patients were implanted with PNS leads and were administered either active stimulation or placebo sham stimulation for the initial 4 weeks, with crossover of the placebo group after 4 weeks (weeks 5–8).…”