scholarly journals Mechanistically Informed Non-Invasive Peripheral Nerve Stimulation for Peripheral Neuropathic Pain: A Randomised Double-Blind Sham-Controlled Trial

2021 ◽  
Author(s):  
Selina Johnson ◽  
Anne Marshall ◽  
Dyfrig Hughes ◽  
Emily Holmes ◽  
Florian Henrich ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Peripheral Nerve ◽  
Nerve Stimulation ◽  
Controlled Trial ◽  
Peripheral Nerve Stimulation ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Non Invasive

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 Peripheral Nerve Stimulation of the Lateral Femoral Cutaneous and Superior Gluteal Nerves for Treating Proximal Neuropathy Hip Pain

2020 ◽  
pp. 221-224
Author(s):  
Niek Vanquathem
Keyword(s):  
Drug Delivery ◽  
Spinal Cord ◽  
Neuropathic Pain ◽  
Peripheral Nerve ◽  
Nerve Stimulation ◽  
Spinal Cord Stimulation ◽  
Hip Pain ◽  
Peripheral Nerve Stimulation ◽  
Peripheral Neuropathic Pain ◽  
Intrathecal Drug Delivery

Background: Chronic postoperative hip pain is estimated to occur in 10% to 35% of patients undergoing total hip replacement. Proximal peripheral neuropathic pain of the lateral femoral cutaneous and superior gluteal nerves has proven to be a difficult disorder to treat. Opioids are often ineffective in the treatment of neuropathic pain. Interventional methods such as peripheral nerve stimulation are minimally invasive options capable of relieving neuropathic pain. Stimulators powered by an implantable pulse generator (IPG), however, may not be suitable for peripheral nerve stimulation because of difficulty finding an appropriate pocket site. The introduction of wireless peripheral nerve stimulation has improved the ability to offer this modality. Case Presentation: We present a case of proximal peripheral neuropathic pain of the lateral femoral cutaneous and superior gluteal nerves that failed all other treatment modalities including spinal cord stimulation and intrathecal drug delivery. Two quadripolar, tined, wireless electrode arrays were positioned over the lateral femoral cutaneous and superior gluteal nerves. A stimulation scheme with a pulse rate of 1.5 kHz and pulse width of 30 μs at 2.0 mA was tested and found effective. Conclusion: This patient had proximal neuropathic hip pain and failed a variety of chronic pain treatment options, including conventional IPG-based spinal cord stimulation and an intrathecal drug delivery system. She was successfully treated with a wireless peripheral nerve stimulation system. Key words: Hip pain, lateral femoral cutaneous nerve, peripheral nerve stimulator, peripheral neuropathy, superior gluteal nerve

scholarly journals Mechanistically Informed Non-invasive Peripheral Nerve Stimulation for Peripheral Neuropathic Pain: a Randomised Double-blind Sham-controlled Trial.

2021 ◽  
Author(s):  
selina johnson ◽  
Anne Marshall ◽  
Dyfrig Hughes ◽  
Emily Holmes ◽  
Florian Henrich ◽  
...  
Keyword(s):  
Peripheral Nerve ◽  
Nerve Stimulation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Population ◽  
Mechanistic Study ◽  
Controlled Clinical Trial ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Non Invasive

Abstract Background: Induction of long-term synaptic depression (LTD) is proposed as a treatment mechanism for chronic pain but remains untested in clinical populations. Two interlinked studies; 1. A patient-assessor blinded, randomised, sham-controlled clinical trial and 2. an open-label mechanistic study, sought to examine therapeutic LTD for persons with chronic peripheral nerve injury pain. Methods: 1. Patients were randomised using a concealed, computer-generated schedule to either active or sham non-invasive low-frequency nerve stimulation (LFS), for 3 months (minimum 10 mins/day). The primary outcome was average pain intensity (0-10 Likert scale) recorded over one week, at three months, compared between study groups. 2. On trial completion, consenting subjects entered a mechanistic study assessing somatosensory changes in response to LFS. Results: 1. 76 patients were randomised (38 per group), with 65 (31 active, 34 sham) included in the intention to treat analysis. The primary outcome was not significant, pain scores were 0·3 units lower in active group (95% CI -1·0, 0·3; p=0·30) giving an effect size of 0·19 (Cohen’s D). Two non-device related serious adverse events were reported. 2. In the mechanistic study (n=19) primary outcomes of mechanical pain sensitivity (p=0.006) and dynamic mechanical allodynia (p=0.043) significantly improved indicating reduced mechanical hyperalgesia. Conclusions: Results from the RCT failed to reach significance. Results from the mechanistic study provide new evidence for effective induction of LTD in a clinical population. Taken together results add to mechanistic understanding of LTD and help inform future study design and approaches to treatment. Funding: National Institute for Health Research. ISRCTN53432663

scholarly journals Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Selina Johnson ◽  
Anne Marshall ◽  
Dyfrig Hughes ◽  
Emily Holmes ◽  
Florian Henrich ◽  
...  
Keyword(s):  
Peripheral Nerve ◽  
Nerve Stimulation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Population ◽  
Mechanistic Study ◽  
Controlled Clinical Trial ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Non Invasive

Abstract Background Induction of long-term synaptic depression (LTD) is proposed as a treatment mechanism for chronic pain but remains untested in clinical populations. Two interlinked studies; (1) A patient-assessor blinded, randomised, sham-controlled clinical trial and (2) an open-label mechanistic study, sought to examine therapeutic LTD for persons with chronic peripheral nerve injury pain. Methods (1) Patients were randomised using a concealed, computer-generated schedule to either active or sham non-invasive low-frequency nerve stimulation (LFS), for 3 months (minimum 10 min/day). The primary outcome was average pain intensity (0–10 Likert scale) recorded over 1 week, at 3 months, compared between study groups. (2) On trial completion, consenting subjects entered a mechanistic study assessing somatosensory changes in response to LFS. Results (1) 76 patients were randomised (38 per group), with 65 (31 active, 34 sham) included in the intention to treat analysis. The primary outcome was not significant, pain scores were 0.3 units lower in active group (95% CI − 1.0, 0.3; p = 0.30) giving an effect size of 0.19 (Cohen’s D). Two non-device related serious adverse events were reported. (2) In the mechanistic study (n = 19) primary outcomes of mechanical pain sensitivity (p = 0.006) and dynamic mechanical allodynia (p = 0.043) significantly improved indicating reduced mechanical hyperalgesia. Conclusions Results from the RCT failed to reach significance. Results from the mechanistic study provide new evidence for effective induction of LTD in a clinical population. Taken together results add to mechanistic understanding of LTD and help inform future study design and approaches to treatment. Trial registration ISRCTN53432663.

Long term clinical outcome of peripheral nerve stimulation in patients with chronic peripheral neuropathic pain

2009 ◽  
Vol 72 (4) ◽  
pp. 330-335 ◽  
Author(s):  
Frank Van Calenbergh ◽  
Jan Gybels ◽  
Koen Van Laere ◽  
Patrick Dupont ◽  
Leon Plaghki ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Clinical Outcome ◽  
Peripheral Nerve ◽  
Nerve Stimulation ◽  
Peripheral Nerve Stimulation ◽  
Peripheral Neuropathic Pain

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.

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