![]() ![]() The study was prospectively registered on in November 2013.Ĭonsenting patients were assessed for eligibility and randomized at six enrolling sites in the USA. This multicenter, randomized, double-blinded, placebo-controlled, partial-crossover study was designed to collect data regarding the safety and effectiveness of percutaneous PNS for chronic neuropathic pain in amputees. The primary hypothesis was that percutaneous PNS provides clinically significant pain relief in a statistically significantly greater proportion of subjects than the placebo control group. 18 Due to the need for data from a randomized study to validate and quantify potential benefits, the present multicenter, randomized, double-blinded, placebo-controlled, partial-crossover study was conducted to collect data on the safety and effectiveness of percutaneous PNS for chronic neuropathic pain in amputees. Nine subjects who proceeded to a 2-week stimulation home trial reported an average 72% reduction in RLP and 81% reduction in PLP, and improvements in functional measures like pain interference (81%–83% reductions in RLP and PLP interference). 18 In a series of 16 subjects, 14 (88%) obtained clinically significant relief of RLP and/or PLP. 17–21 The availability of such a system provides additional therapeutic options for the treatment of pain.Ī previous study demonstrated the feasibility of percutaneously implanting fine-wire coiled PNS leads in proximity to the sciatic and femoral nerves in amputees with neuropathic pain. The system uses a percutaneous fine-wire coiled lead designed to reduce lead migration and has been reported to have a significantly lower risk of infection than other neurostimulation electrodes. 15 16 A PNS system whose leads may be implanted under ultrasound guidance to provide pain relief for chronic and acute pain indications is now Food and Drug Administration-cleared. Unmet treatment needs for dedicated peripheral neuromodulation applications have resulted in the introduction of new devices and techniques that allow for percutaneous, ultrasound-guided lead implantation 10 14 and the development of a PNS system designed specifically for use in the periphery to overcome many of the challenges associated with previous techniques. This practice was consequently limited by the complexity, cost, and invasiveness of surgical lead implantation, and risk of nerve damage, lead migration, or failure. 8–10 Historically, PNS leads were designed to be located near or in contact with nerves, often using devices adapted from SCS. 2 3 6 7 Peripheral nerve stimulation (PNS) has been used effectively for neuropathic pain, including in cases of postamputation pain. Many therapies have been employed, including opioid and non-opioid oral analgesics, nerve blocks, spinal cord stimulation (SCS), and physical and psychological therapies, but few controlled trials demonstrate consistent and effective pain management. Neuropathic pain in amputees has historically been a complex and challenging condition to treat. 3 Chronic neuropathic pain in amputees can also decrease function and quality of life, leading to significantly increased risk of depression. 2 3 The prevalence of persistent pain has been reported as high as 74% for RLP and 85% for PLP, and many amputees report a combination of RLP and PLP. 1 Postamputation pain includes residual limb pain (RLP) and phantom limb pain (PLP), each having significant neuropathic components. There are approximately two million amputees in the USA, with nearly 200 000 amputations performed annually. 9 SPR Therapeutics, Cleveland, Ohio, USAĭr Christopher Gilmore, Center for Clinical Research, NC 27103, USA Ĭhronic neuropathic pain is a common and challenging condition following amputation.8 Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.7 Department of Anesthesiology, Northwestern University, Chicago, Illinois, USA.6 Ainsworth Institute of Pain Management, New York City, New York, USA.5 International Spine, Pain & Performance Center, Washington, District of Columbia, USA.4 Premier Pain Centers, Shrewsbury, New Jersey, USA. ![]() 3 Department of Neurological Surgery, Northwestern University, Chicago, Illinois, USA.2 Anesthesiology, University of California, San Diego, La Jolla, California, USA.1 Center for Clinical Research, Winston-Salem, North Carolina, USA. ![]()
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