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

*Corresponding author for this work

Research output: Contribution to journalArticle

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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

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Keywords

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

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

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