Percutaneous 60-day peripheral nerve stimulation implant provides sustained relief of chronic pain following amputation: 12-month follow-up of a randomized, double-blind, placebo-controlled trial

Christopher A. Gilmore, Brian M. Ilfeld, Joshua M. Rosenow, Sean Li, Mehul J. Desai, Corey W. Hunter, Richard L. Rauck, Antoun Nader, John Mak, Steven P. Cohen, Nathan D. Crosby, Joseph W. Boggs

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction Peripheral nerve stimulation (PNS) has historically been used to treat chronic pain, but generally requires implantation of a permanent system for sustained relief. A recent study found that a 60-day PNS treatment decreases post-amputation pain, and the current work investigates longer-term outcomes out to 12 months in the same cohort. Methods As previously reported, 28 traumatic lower extremity amputees with residual and/or phantom limb pain were randomized to receive 8 weeks of PNS (group 1) or 4 weeks of placebo followed by a crossover 4 weeks of PNS (group 2). Percutaneous leads were implanted under ultrasound guidance targeting the femoral and sciatic nerves. During follow-up, changes in average pain and pain interference were assessed using the Brief Pain Inventory-Short Form and comparing with baseline. Results Significantly more participants in group 1 reported ≥50% reductions in average weekly pain at 12 months (67%, 6/9) compared with group 2 at the end of the placebo period (0%, 0/14, p=0.001). Similarly, 56% (5/9) of participants in group 1 reported ≥50% reductions in pain interference at 12 months, compared with 2/13 (15%, p=0.074) in group 2 at crossover. Reductions in depression were also statistically significantly greater at 12 months in group 1 compared with group 2 at crossover. Conclusions This work suggests that percutaneous PNS delivered over a 60-day period may provide significant carry-over effects including pain relief, potentially avoiding the need for a permanently implanted system while enabling improved function in patients with chronic pain. Trial registration number NCT01996254.

Original languageEnglish (US)
Pages (from-to)44-51
Number of pages8
JournalRegional anesthesia and pain medicine
Volume45
Issue number1
DOIs
StatePublished - Jan 1 2020

Keywords

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

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

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