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

被引:69
作者
Gilmore, Christopher A. [1 ]
Ilfeld, Brian M. [2 ]
Rosenow, Joshua M. [3 ]
Li, Sean [4 ]
Desai, Mehul J. [5 ]
Hunter, Corey W. [6 ]
Rauck, Richard L. [1 ]
Nader, Antoun [7 ]
Mak, John [4 ]
Cohen, Steven P. [8 ]
Crosby, Nathan D. [9 ]
Boggs, Joseph W. [9 ]
机构
[1] Ctr Clin Res, Winston Salem, NC 27103 USA
[2] Univ Calif San Diego, Anesthesiol, La Jolla, CA 92093 USA
[3] Northwestern Univ, Dept Neurol Surg, Chicago, IL 60611 USA
[4] Premier Pain Ctr, Shrewsbury, NJ USA
[5] Int Spine Pain & Performance Ctr, Washington, DC USA
[6] Ainsworth Inst Pain Management, New York, NY USA
[7] Northwestern Univ, Dept Anesthesiol, Chicago, IL 60611 USA
[8] Johns Hopkins Sch Med, Pain Med Div, Anesthesiol, Baltimore, MD USA
[9] SPR Therapeut, Cleveland, OH USA
关键词
HEMIPLEGIC SHOULDER PAIN; SPINAL-CORD STIMULATION; NEUROSTIMULATION; REORGANIZATION;
D O I
10.1136/rapm-2019-100937
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
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.
引用
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页码:44 / 51
页数:8
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