scholarly journals 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

2019 ◽  
Vol 45 (1) ◽  
pp. 44-51 ◽  
Author(s):  
Christopher A Gilmore ◽  
Brian M Ilfeld ◽  
Joshua M Rosenow ◽  
Sean Li ◽  
Mehul J Desai ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Peripheral Nerve ◽  
Nerve Stimulation ◽  
Short Form ◽  
Peripheral Nerve Stimulation ◽  
Pain Interference ◽  
Phantom Limb ◽  
Group 2 ◽  
Group 1

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.

scholarly journals One Year Follow-up of a Randomized, Double-Blind, Placebo-Controlled Trial of Percutaneous Peripheral Nerve Stimulation for Chronic Neuropathic Pain Following Amputation

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Joshua M Rosenow ◽  
Christopher Gilmore ◽  
Brian M Ilfeld ◽  
Sean Li ◽  
Mehul J Desai ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Pain Relief ◽  
Peripheral Nerve ◽  
Nerve Stimulation ◽  
Peripheral Nerve Stimulation ◽  
Pain Interference ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

Abstract INTRODUCTION Over 85% of patients experience residual limb (RLP) and/or phantom limb (PLP) pain following amputation. Peripheral nerve stimulation (PNS) is a non-opioid approach to relieve postamputation neuropathic pain. A recent multicenter, randomized, double-blind, placebo-controlled study using a novel percutaneous PNS system demonstrated clinically and statistically significant improvements in pain and pain interference with PNS compared to placebo (Gilmore et al, 2019). This work presents prospective 1-yr follow-up to assess durability of pain relief and functional improvements. METHODS Over 85% of patients experience residual limb (RLP) and/or phantom limb (PLP) pain following amputation. Peripheral nerve stimulation (PNS) is a non-opioid approach to relieve post-amputation neuropathic pain. A recent multicenter, randomized, double-blind, placebo-controlled study using a novel percutaneous PNS system demonstrated clinically and statistically significant improvements in pain and pain interference with PNS compared to placebo (Gilmore et al, 2019). This work presents prospective one-year follow-up to assess durability of pain relief and functional improvements. RESULTS A significantly greater proportion of subjects who completed the 12-mo visit reported = 50% pain relief on the BPI-SF (5/8, 63%; average pain relief = 73% among responders) compared to the placebo group at the time of crossover (0/14, 0%, P = .003; average pain relief = 23%). A majority of subjects also reported = 50% reductions in pain interference at 12 mo (5/8, 63%). Two of 13 (15%) subjects in the placebo group reported sustained improvements in pain interference (P = .06). Average reduction in pain interference among responders in the PNS group was 87%. CONCLUSION This work suggests that PNS delivered over 60 d may provide clinically significant and enduring pain relief, enabling improved function and potentially reducing the need for a permanently implanted system.

scholarly journals Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial

2019 ◽  
Vol 44 (6) ◽  
pp. 637-645 ◽  
Author(s):  
Christopher Gilmore ◽  
Brian Ilfeld ◽  
Joshua Rosenow ◽  
Sean Li ◽  
Mehul Desai ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Pain Relief ◽  
Peripheral Nerve ◽  
Nerve Stimulation ◽  
Peripheral Nerve Stimulation ◽  
Pain Interference ◽  
Controlled Study ◽  
Chronic Neuropathic Pain ◽  
Postamputation Pain

Background and objectivesChronic neuropathic pain is a common challenging condition following amputation. Recent research demonstrated the feasibility of percutaneously implanting fine-wire coiled peripheral nerve stimulation (PNS) leads in proximity to the sciatic and femoral nerves for postamputation pain. A multicenter, double-blinded, randomized, placebo-controlled study collected data on the safety and effectiveness of percutaneous PNS for chronic neuropathic pain following amputation.MethodsTwenty-eight lower extremity amputees with postamputation pain were enrolled. Subjects underwent ultrasound-guided implantation of percutaneous PNS leads and were randomized to receive PNS or placebo for 4 weeks. The placebo group then crossed over and all subjects received PNS for four additional weeks. The primary efficacy endpoint evaluated the proportion of subjects reporting ≥50% pain reduction during weeks 1–4.ResultsA significantly greater proportion of subjects receiving PNS (n=7/12, 58%, p=0.037) demonstrated ≥50% reductions in average postamputation pain during weeks 1–4 compared with subjects receiving placebo (n=2/14, 14%). Two subjects were excluded from efficacy analysis due to eligibility changes. Significantly greater proportions of PNS subjects also reported ≥50% reductions in pain (n=8/12, 67%, p=0.014) and pain interference (n=8/10, 80%, p=0.003) after 8 weeks of therapy compared with subjects receiving placebo (pain: n=2/14, 14%; pain interference: n=2/13, 15%). Prospective follow-up is ongoing; four of five PNS subjects who have completed 12-month follow-up to date reported ≥50% pain relief.ConclusionsThis work demonstrates that percutaneous PNS therapy may provide enduring clinically significant pain relief and improve disability in patients with chronic neuropathic postamputation pain.Trial registration numberNCT01996254.

scholarly journals Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Pain Following Amputation

2019 ◽  
Vol 184 (7-8) ◽  
pp. e267-e274 ◽  
Author(s):  
Steven P Cohen ◽  
Christopher A Gilmore ◽  
Richard L Rauck ◽  
Denise D Lester ◽  
Robert J Trainer ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Peripheral Nerve ◽  
Nerve Stimulation ◽  
Military Service ◽  
Phantom Limb Pain ◽  
Peripheral Nerve Stimulation ◽  
Service Members ◽  
Phantom Limb ◽  
Limb Pain ◽  
Military Service Members

Abstract Introduction Chronic pain and reduced function are significant problems for Military Service members and Veterans following amputation. Peripheral nerve stimulation (PNS) is a promising therapy, but PNS systems have traditionally been limited by invasiveness and complications. Recently, a novel percutaneous PNS system was developed to reduce the risk of complications and enable delivery of stimulation without surgery. Materials and Methods Percutaneous PNS was evaluated to determine if stimulation provides relief from residual and phantom limb pain following lower-extremity amputation. PNS leads were implanted percutaneously to deliver stimulation to the femoral and/or sciatic nerves. Patients received stimulation for up to 60 days followed by withdrawal of the leads. Results A review of recent studies and clinical reports found that a majority of patients (18/24, 75%) reported substantial (≥50%) clinically relevant relief of chronic post-amputation pain following up to 60 days of percutaneous PNS. Reductions in pain were frequently associated with reductions in disability and pain interference. Conclusions Percutaneous PNS can durably reduce pain, thereby enabling improvements in quality of life, function, and rehabilitation in individuals with residual or phantom limb pain following amputation. Percutaneous PNS may have additional benefit for Military Service members and Veterans with post-surgical or post-traumatic pain.

scholarly journals Peripheral Nerve Stimulation for Treatment of Painful Osteoarthritis of the Knee: A Case Report

2021 ◽  
pp. 201-204
Keyword(s):  
Case Report ◽  
Pain Relief ◽  
Peripheral Nerve ◽  
Knee Pain ◽  
Nerve Stimulation ◽  
Short Form ◽  
Pain Modulation ◽  
Peripheral Nerve Stimulation ◽  
Osteoarthritis Of The Knee ◽  
Osteoarthritic Knee

BACKGROUND: Osteoarthritic knee (OAk) pain is common, yet the standard of care often yields unsatisfactory pain relief. There remains a role for novel treatment options. Percutaneous motor peripheral nerve stimulation (mPNS) of the knee is a novel minimally invasive procedure that stimulates motor end points leading to muscle contraction associated with the painful joint. Pain relief is hypothesized to be achieved through central pain modulation. CASE REPORT: We report the case of a patient who experienced refractory osteoarthritic knee pain after 9 months of conservative care. Following 7 weeks of mPNS treatment, the patient achieved improvement in OAk pain relief and activities of daily living as measured by notable improvements in the Brief Pain Inventory-Short Form and Knee Injury and Osteoarthritis Outcome Score at 8- and 12-weeks postimplant. The Patient Global Impression of Change at the end of stimulation was much improved. CONCLUSION: Motor PNS may offer a safe and effective treatment alternative for chronic refractory pain related to OAk. KEY WORDS: Osteoarthritis, knee, pain, peripheral nerve stimulation

scholarly journals Mechanism of Peripheral Nerve Stimulation in Chronic Pain

Pain Medicine ◽  
2020 ◽  
Vol 21 (Supplement_1) ◽  
pp. S6-S12 ◽  
Author(s):  
Tiffany Lin ◽  
Akshat Gargya ◽  
Harmandeep Singh ◽  
Eellan Sivanesan ◽  
Amitabh Gulati
Keyword(s):  
Chronic Pain ◽  
Literature Review ◽  
Peripheral Nerve ◽  
Nerve Stimulation ◽  
Peripheral Nerve Stimulation ◽  
Cochrane Library ◽  
Gate Control Theory ◽  
Comprehensive Literature Review ◽  
Gate Control ◽  
Chronic Pain Conditions

Abstract Introduction With the advancement of technology, peripheral nerve stimulation (PNS) has been increasingly used to treat various chronic pain conditions. Its origin is based on the gate control theory postulated by Wall and Melzack in 1965. However, the exact mechanism behind PNS’ analgesic effect is largely unknown. In this article, we performed a comprehensive literature review to overview the PNS mechanism of action. Design A comprehensive literature review on the mechanism of PNS in chronic pain. Methods Comprehensive review of the available literature on the mechanism of PNS in chronic pain. Data were derived from database searches of PubMed, Scopus, and the Cochrane Library and manual searches of bibliographies and known primary or review articles. Results Animal, human, and imaging studies have demonstrated the peripheral and central analgesic mechanisms of PNS by modulating the inflammatory pathways, the autonomic nervous system, the endogenous pain inhibition pathways, and involvement of the cortical and subcortical areas. Conclusions Peripheral nerve stimulation exhibits its neuromodulatory effect both peripherally and centrally. Further understanding of the mechanism of PNS can help guide stimulation approaches and parameters to optimize the use of PNS.

A case report of wireless peripheral nerve stimulation for complex regional pain syndrome type-I of the upper extremity: 1 year follow up

2019 ◽  
Vol 19 (4) ◽  
pp. 829-835 ◽  
Author(s):  
Daniel Herschkowitz ◽  
Jana Kubias
Keyword(s):  
Case Report ◽  
Minimally Invasive ◽  
Peripheral Nerve ◽  
Upper Extremity ◽  
Nerve Stimulation ◽  
Pain Syndrome ◽  
Peripheral Nerve Stimulation ◽  
Type I ◽  
First Case

Abstract Background Complex regional pain syndrome (CRPS) is a chronic disabling painful disorder with limited options to achieve therapeutic relief. CRPS type I which follows trauma, may not show obvious damage to the nervous structures and remains dubious in its pathophysiology and also its response to conservative treatment or interventional pain management is elusive. Spinal cord and dorsal root ganglion stimulation (SCS, DRGS) provide good relief, mainly for causalgia or CRPS I of lower extremities but not very encouraging for upper extremity CRPS I. we reported earlier, a case of CRPS I of right arm treated successfully by wireless peripheral nerve stimulation (WPNS) with short term follow up. Here we present 1-year follow-up of this patient. Objective To present the first case of WPNS for CRPS I with a year follow up. The patient had minimally invasive peripheral nerve stimulation (PNS), without implantable pulse generator (IPG) or its accessories. Case report This was a case of refractory CRPS I after blunt trauma to the right forearm of a young female. She underwent placement of two Stimwave electrodes (Leads: FR4A-RCV-A0 with tines, Generation 1 and FR4A-RCV-B0 with tines, Generation 1) in her forearm under intraoperative electrophysiological and ultrasound guidance along radial and median nerves. This WPNS required no IPG. At high frequency (HF) stimulation (HF 10 kHz/32 μs, 2.0 mA), patient had shown remarkable relief in pain, allodynia and temperature impairment. At 5 months she started driving without opioid consumption, while allodynia disappeared. At 1 year follow up she was relieved of pain [visual analogue scale (VAS) score of 4 from 7] and Kapanji Index (Score) improved to 7–8. Both hands look similar in color and temperature. She never made unscheduled visits to the clinic or visited emergency room for any complications related to the WPNS. Conclusions CRPS I involving upper extremity remain difficult to manage with conventional SCS or DRGS because of equipment related adverse events. Minimally invasive WPNS in this case had shown consistent relief without any complications or side effects related to the wireless technology or the technique at the end of 1 year. Implications This is the first case illustration of WPNS for CRPS I, successfully treated and followed up for 1 year.

scholarly journals Fully Implantable Peripheral Nerve Stimulation for Hemiplegic Shoulder Pain: A Multi-Site Case Series With Two-Year Follow-Up

2017 ◽  
Vol 21 (3) ◽  
pp. 290-295 ◽  
Author(s):  
Richard D. Wilson ◽  
Maria E. Bennett ◽  
Vu Q.C. Nguyen ◽  
William C. Bock ◽  
Michael W. O'Dell ◽  
...  
Keyword(s):  
Peripheral Nerve ◽  
Shoulder Pain ◽  
Nerve Stimulation ◽  
Case Series ◽  
Peripheral Nerve Stimulation

scholarly journals Novel technique for trialing peripheral nerve stimulation: ultrasonography-guided StimuCath trial

2017 ◽  
Vol 42 (3) ◽  
pp. E5 ◽  
Author(s):  
Chandan G. Reddy ◽  
Oliver E. Flouty ◽  
Marshall T. Holland ◽  
Leigh A. Rettenmaier ◽  
Mario Zanaty ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Pain Relief ◽  
Peripheral Nerve ◽  
Nerve Stimulation ◽  
Relative Effectiveness ◽  
Peripheral Nerve Stimulation ◽  
Insurance Companies ◽  
Peripheral Nerve Stimulator ◽  
Vas Score

OBJECTIVE Peripheral nerve stimulation (PNS) has been used for the treatment of neuropathic pain for many decades. Despite the specific indications for PNS, clinicians often have difficulty screening for candidates likely to have a good or fair outcome. Given the expense of a permanent implant, most insurance companies will not pay for the implant without a successful PNS trial. And since PNS has only recently been approved by the US Food and Drug Administration, many insurance companies will not pay for a conventional trial of PNS. The objective of this study is to describe a short low-cost method for trialing and screening patients for peripheral nerve stimulator implantation. Additionally, this study demonstrates the long-term efficacy of PNS in the treatment of chronic neuropathic pain and the relative effectiveness of this novel screening method. METHODS The records of all patients who had undergone trialing and implantation of a PNS system for chronic refractory pain at the authors' institution over a 1-year period (August 1, 2012–July 31, 2013) were examined in this retrospective case series. The search revealed 17 patients, 13 who had undergone a novel in-office ultrasonography-guided StimuCath screening technique and 4 who had undergone a traditional week-long screening procedure. All 17 patients experienced a successful PNS trial and proceeded to permanent PNS system implantation. Patients were followed up for a mean duration of 3.0 years. Visual analog scale (VAS) pain scores were used to assess pain relief in the short-term (< 6 weeks), at 1 year, and at the last follow-up. Final outcome was also characterized as good, fair, poor, or bad. RESULTS Of these 17 patients, 10 were still using their stimulator at the last follow-up, with 8 of them obtaining good relief (classified as ≥ 50% pain relief, with an average 81% reduction in the VAS score) and 2 patients attaining fair relief (< 50% relief but still using stimulation therapy). Among the remaining 7 patients, the stimulator had been explanted in 4 and there had been no relief in 3. Excluding explanted cases, follow-up ranged from 14 to 46 months, with an average of 36 months. Patients with good or fair relief had experienced pain prior to implantation for an average of 5.1 years (range 1.8–15.2 years). A longer duration of pain trended toward a poorer outcome (bad outcome 7.6 years vs good outcome 4.1 years, p = 0.03). Seven (54%) of the 13 patients with the shorter trial experienced a good or fair outcome with an average 79% reduction in the VAS score; however, all 4 of the bad outcome cases came from this group. Three (75%) of the 4 patients with the longer trial experienced a good or fair outcome at the last follow-up, with an average 54% reduction in the VAS score. There was no difference between the trialing methods and the proportion of favorable (good or fair) outcomes (p = 0.71). CONCLUSIONS Short, ultrasonography-guided StimuCath trials were feasible in screening patients for permanent implantation of PNS, with efficacy similar to the traditional week-long screening noted at the 3-year follow-up.

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