Journal of Pain Research (Sep 2024)

Safety and Efficacy of Axon Therapy (SEAT Study), Utilizing Magnetic Peripheral Nerve Stimulation (mPNS) for Treatment of Neuropathic Pain

  • Kapural L,
  • Patel J,
  • Rosenberg JC,
  • Li S,
  • Amirdelfan K,
  • Bedder M

Journal volume & issue
Vol. Volume 17
pp. 3167 – 3174

Abstract

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Leonardo Kapural,1 Janus Patel,2 Jason Charles Rosenberg,3 Sean Li,4 Kasra Amirdelfan,5 Marshall Bedder6,7 1Carolinas Pain Institute, Winston Salem, NC, USA; 2Atrium Health, Wake Forest Baptist Pain Center-Premier, Winston Salem, NC, USA; 3South Carolina Pain and Spine Specialists, Murrels Inlet, SC, USA; 4National Spine and Pain Centers, Shrewsbury, NJ, USA; 5IPM Medical Group, Walnut Creek, CA, USA; 6Department of Surgery, Pain Medicine Service, Charlie Norwood Veterans Administration Medical Center, Augusta, GA, USA; 7Department of Psychiatry and Health Behavior, Addiction Medicine Service, Wellstar/Medical College of Georgia, Augusta, GA, USACorrespondence: Leonardo Kapural, Carolinas Pain Institute, Winston-Salem, NC, 27103, USA, Email [email protected]: Many of the current treatments for chronic neuropathic pain have variable effectiveness and known side effects. Given the prevalence of this type of intractable pain (3– 17% of general population), additional therapeutic non-invasive approaches are desired. Magnetic Peripheral Nerve Stimulation (mPNS) delivered at 0.5Hz provides an effective pain relief without side effects. The objective of this randomized, controlled, multi-site clinical trial was to compare long-term safety and efficacy of mPNS in patients with chronic, intractable, post-traumatic or post-surgical neuropathic pain to comprehensive Conventional Medical Management (CMM).Methods: A total of 65 patients with post-traumatic, post-surgical neuropathy were treated within a multicenter, randomized, clinical trial comparing the safety and effectiveness of mPNS + CMM to CMM alone. Patients were randomized 1:1 and followed through 90 days. The primary endpoint is a proportion of responders, 50% or greater reduction in pain at Day 90. The secondary endpoints included the European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) and Patient Global Impression of Change (PGIC).Results: At 3 months, 71% of subjects were considered responders (> 50% pain relief) in the mPNS + CMM group vs 13% of subjects in the CMM group. The mPNS + CMM group had a mean reduction in VAS scores at Day 90 of 3.8 points (> 50% reduction), while CMM showed less than a 1-point (0.7 point) mean reduction or ~10% reduction (p < 0.0001). The EQ-5D-3L score increased in the mPNS + CMM study group, whereas the CMM group showed no improvement in EQ-5D-3L at Day 90. PGIC responder rates were 80.6% and 4.3% at Day 90 for mPNS + CMM and CMM groups, respectively.Conclusion: mPNS + CMM was superior to CMM in a randomized prospective study when used for treatment of post-traumatic, post-surgical neuropathy. Due to the lack of other effective non-invasive treatments for neuropathic pain, mPNS should be considered much earlier in the treatment algorithm.Keywords: neuropathic pain, noninvasive, cost effective, pain relief, neuropathy

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