• Reg Anesth Pain Med · Nov 2019

    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, and Joseph W Boggs.
    • Center for Clinical Research, Winston-Salem, North Carolina, USA cgilmore@ccrpain.com.
    • Reg Anesth Pain Med. 2019 Nov 17.

    IntroductionPeripheral 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.MethodsAs 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.ResultsSignificantly 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.ConclusionsThis 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 NumberNCT01996254.© American Society of Regional Anesthesia & Pain Medicine 2019. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.

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