Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study

Hatheway, John; Mangal, Vipul; Fishman, Michael; Kim, Phillip S.; Shah, Binit J.; Vogel, Rainer S; Galan, Vincent; Severyn, Steven; Weaver, Tristan; Provenzano, David; Chang, Eric H.; Verdolin, Michael H.; Howes, G. G.; Villarreal, Armando; Falowski, Steven; Hendrickson, K; Stromberg, Katherine; Davies, Lachlan; Johanek, Lisa M.; Kelly, M. J.

doi:10.1111/ner.13324

Cited by 12 publications

(3 citation statements)

References 36 publications

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“…The efficacy of using the Evolve workflow involving stimulating at 1 kHz with a pulse width from 90–220 µs was demonstrated in the Vectors study. 60 Differential Target Multiplexed (DTM) SCS uses electrical signals and multiple anatomical targets to target neurons and glial cells differently to balance neuro-glial interaction and optimize neuromodulation outcomes. The DTM RCT 61 showed a superior effect on back pain and leg pain treatment using DTM SCS versus tonic stimulation.…”

Section: Results: Consensus Statements and Evidencementioning

confidence: 99%

Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation: A Proposal for Standardization in Fellowship and Training Programs

Pritzlaff,

Goree,

Hagedorn

et al. 2023

JPR

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The need to be competent in neuromodulation is and should be a prerequisite prior to completing a fellowship in interventional pain medicine. Unfortunately, many programs lack acceptable candidates for these advanced therapies, and fellows may not receive adequate exposure to neuromodulation procedures. The American Society of Pain and Neuroscience (ASPN) desires to create a consensus of experts to set a minimum standard of competence for neurostimulation procedures, including spinal cord stimulation (SCS), dorsal root ganglion stimulation (DRG-S), and peripheral nerve stimulation (PNS). The executive board of ASPN accepted nominations for colleagues with excellence in the subject matter of neuromodulation and physician education. This diverse group used peer-reviewed literature and, based on grading of evidence and expert opinion, developed critical consensus guides for training that all accredited fellowship programs should adopt. For each consensus point, transparency and recusal were used to eliminate bias, and an author was nominated for evidence grading oversight and bias control. Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation sets a standard for neuromodulation training in pain fellowship training programs. The consensus panel has determined several recommendations to improve care in the United States for patients undergoing neuromodulation. As neuromodulation training in the United States has evolved dramatically, these therapies have become ubiquitous in pain medicine. Unfortunately, fellowship programs and the Accreditation Council for Graduate Medical Education (ACGME) pain program requirements have not progressed training to match the demands of modern advancements. PEAK sets a new standard for fellowship training and presents thirteen practice areas vital for physician competence in neuromodulation.

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Section: Results: Consensus Statements and Evidencementioning

confidence: 99%

Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation: A Proposal for Standardization in Fellowship and Training Programs

Pritzlaff,

Goree,

Hagedorn

et al. 2023

JPR

View full text Add to dashboard Cite

show abstract

“…SCS is widely used for treating chronic intractable pain [ 7 ], and randomized controlled trials (RCTs) comparing SCS with conservative treatment and repeated surgery for low back pain and leg pain due to FBSS have shown the advantage of SCS [ 8 – 10 ]. While conventional paresthesia-based SCS with low-frequency stimulation is still commonly used, recently introduced stimulation methods, such as burst SCS [ 11 , 12 ], 10 kHz high-frequency therapy [ 13 , 14 ], high-dose SCS [ 15 , 16 ], high-density SCS [ 17 , 18 ], closed-loop SCS [ 19 , 20 ], and differential target multiplexed programming [ 21 , 22 ], have been reported to be equally or more effective than paresthesia-based SCS. Also, spinal cord stimulator implantation using anatomical placement in which electrodes are placed mainly in the T9/10 intervertebral space has comparable therapeutic efficacy with paresthesia-based SCS but shorter operative time [ 23 ].…”

Section: Introductionmentioning

confidence: 99%

Efficacy of Spinal Cord Stimulation for Failed Back Surgery Syndrome in Elderly Patients: A Retrospective Study

Higashiyama¹,

Tamura²,

Sugawara³

2023

Pain Research and Management

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Objectives. Failed back surgery syndrome (FBSS) refers to a condition where symptoms such as low back pain, leg pain, and numbness persist or recur after lumbar surgery; it has been reported to occur in 10%–40% of patients who have undergone lumbar surgery. Spinal cord stimulation (SCS) has been reported useful for low back and leg pain due to FBSS. In this study, we studied the efficacy and safety of SCS for FBSS in older adults. Methods. Among FBSS patients who underwent an SCS trial between November 2017 and December 2020, those with at least 50% pain reduction during the trial phase who requested spinal cord stimulator implantation underwent implantation of a stimulator under local anesthesia. The patients were divided into two groups: patients aged <75 years (<75-year-old group) and patients aged ≥75 years (≥75-year-old group). The male/female ratio, symptom duration, operative duration, visual analog scale (VAS) scores before and after one year of surgery, responder rate (RR), complications one year after surgery, and stimulator removal rate were analyzed. Results. There were 27 cases in the <75-year-old group and 46 in the ≥75-year-old group, with no significant differences in male/female ratio, duration of pain, or operative time between the two groups. VAS scores for low back pain, leg pain, and overall pain one year after surgery were improved significantly from respective preoperative scores in both groups P < 0.001 . There were no significant differences in low back pain VAS, leg pain VAS, overall pain VAS, RR, complications one year after surgery, or stimulator removal rate between the two groups. Conclusion. SCS reduced pain effectively in both <75-year-old and ≥75-year-old groups with no differences in complications. Therefore, spinal cord stimulator implantation was considered a viable option for FBSS treatment in older adults because it can be performed under local anesthesia and is associated with a low incidence of complications.

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“… 11 Besides Con-SCS, new SCS paradigms like High-Frequency (HF) and Differential Target Multiplexed (DTM)-SCS have recently emereged. 12 , 13 A clinical study has been performed using HF SCS in PDPN patients which showed promising result. 14 DTM-SCS could potentially further improve pain reduction and responder rates.…”

Section: Introductionmentioning

confidence: 99%

Conventional, high frequency and differential targeted multiplexed spinal cord stimulation in experimental painful diabetic peripheral neuropathy: Pain behavior and role of the central inflammatory balance

de Geus,

Franken,

Joosten

2023

Mol Pain

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Spinal cord stimulation (SCS) is a last resort treatment for pain relief in painful diabetic peripheral neuropathy (PDPN) patients. However, the effectivity of SCS in PDPN is limited. New SCS paradigms such as high frequency (HF) and differential target multiplexed (DTM) might improve responder rates and efficacy of SCS-induced analgesia in PDPN patients, and are suggested to modulate the inflammatory balance and glial response in the spinal dorsal horn. The aim of this study was to research the effects of Con-, HF- and DTM-SCS on pain behavior and the spinal inflammatory balance in an animal model of PDPN. Streptozotocin-induced PDPN animals were stimulated for 48 hours with either Con-SCS (50Hz), HF-SCS (1200Hz) or DTM-SCS (combination of Con- and HF-SCS). Mechanical hypersensitivity was assessed using Von Frey (VF) test and the motivational aspects of pain were assessed using the mechanical conflict avoidance system (MCAS). The inflammatory balance and glial response were analyzed in the dorsal spinal cord based on RNA expression of pro- and anti-inflammatory cytokines (Tnf-α, Il-1ß, Il-4, Il-10), a microglia marker (Itgam), an astrocyte marker (Gfap), a T-cell marker (Cd3d), microglia proliferation markers (Irf8, Adgre1) and P2X4, p13-MAPK, BDNF signaling markers (P2x4, Mapk14, Bdnf). The results show that Con-, HF-, and DTM-SCS significantly decreased hypersensitivity after 48 hours of stimulation compared to Sham-SCS in PDPN animals, but at the same time did not affect escape latency in the MCAS. At the molecular level, Con-SCS resulted in a significant increase in spinal pro-inflammatory cytokine Tnf-α after 48 hours compared to DTM-SCS and Sham-SCS. In summary, Con-SCS showed a shift of the inflammatory balance towards a pro-inflammatory state whilst HF- and DTM-SCS shifted the balance towards an anti-inflammatory state. These findings suggest that the underlying mechanism of Con-SCS induced pain relief in PDPN differs from that induced by HF- and DTM-SCS.

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Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study

Cited by 12 publications

References 36 publications

Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation: A Proposal for Standardization in Fellowship and Training Programs

Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation: A Proposal for Standardization in Fellowship and Training Programs

Efficacy of Spinal Cord Stimulation for Failed Back Surgery Syndrome in Elderly Patients: A Retrospective Study

Conventional, high frequency and differential targeted multiplexed spinal cord stimulation in experimental painful diabetic peripheral neuropathy: Pain behavior and role of the central inflammatory balance

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