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

Abstract

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.

Percutaneous Peripheral Nerve Stimulation for Chronic Low Back Pain: Prospective Case Series With 1 Year of Sustained Relief Following Short‐Term Implant

“…Although the results presented here are promising and consistent with previous studies of percutaneous PNS for other types of pain, 80,81,[83][84][85][86][87][88][89][90][91][92][93][94][95][96][97] this study has limitations, which should be considered in interpretation of the results. In particular, the population size was limited (n = 9) and did not include a control group or explore placebo effect; additional studies could help confirm these results in a larger population of patients, including studies that might compare the effects of percutaneous PNS to other standard interventional approaches used for patients with chronic LBP.…”

“…This is consistent with previously published studies and RCTs of percutaneous PNS in other pain indications (eg, neuropathic pain, chronic shoulder pain), where clinically significant reductions in pain and improvements in pain-related disability were also sustained long-term. 80,81,[83][84][85][86][87][88][89][90][91][92][93][94][95][96][97] Together, these studies reveal the potential for percutaneous PNS to be used as an alternative to existing treatment modalities for chronic pain, effectively reducing pain and opioid use, while reducing disability and invasiveness. This approach has the potential to significantly influence the care continuum for chronic back pain by providing the benefits of an effective neurostimulation therapy to patients earlier than has been previously possible.…”

“…77 An effective and less invasive system is needed that does not have the costs, risks, complications, and delayed care associated with previous therapies, 78,79 especially if such a system may permit short-term use to interrupt the cycle of chronic pain and provides longterm pain relief that prevents the recurrence of pain or the need for surgery or a permanent implant. 80,81 Percutaneous PNS consists of 1 or 2 fine-wire leads (Figure 1), which are implanted via a percutaneous introducer and connected to a miniature wearable stimulator that is programmed by the clinician and adjusted by the patient. The system enables delivery of electrical stimulation to nerves innervating the region of pain (eg, the low back), while avoiding the challenges associated with permanently implanted neurostimulation systems.…”

“…78,79 Percutaneous PNS provides an opportunity as an earlier neurostimulation intervention that may preclude the need for opioids, denervation, surgery, and permanently implanted systems, particularly given evidence of long-term relief in patients with chronic pain. 80,81,[83][84][85][86][87][88][89][90][91][92][93][94][95][96][97] A recently published double-blinded randomized controlled trial (RCT) assessing the efficacy of percutaneous PNS in the treatment of chronic postamputation pain demonstrated significant and durable pain relief and improvement in quality of life with results sustained through 1 year. 97,81 The present investigation was designed as a prospective case series study to determine the feasibility of generating similar sustainable reductions in pain and disability and improvements in quality of life in patients with LBP using the same device.…”

“…82 This approach of percutaneous PNS provides a unique opportunity to be used as an earlier neurostimulation intervention that may preclude the need for opioids, denervation, and permanently implanted neurostimulation systems, due to the less invasive nature of the intervention in conjunction with evidence of longterm relief in patients with many types of chronic pain. 80,81,[83][84][85][86][87][88][89][90][91][92][93][94][95][96][97] In addition to 2 previously published RCTs using this same device for the treatment of chronic shoulder pain, 86,94 a third double-blinded RCT was recently published and demonstrated successful relief of chronic neuropathic pain and improvement in quality of life, with results sustained through 1 year. 97…”