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Objective: To investigate the predictive value of thoracic sympathetic ganglion block (TSGB) in response to ketamine infusion therapy (KIT) and spinal-cord stimulation (SCS) in patients with chronic upper-extremity pain including complex regional pain syndrome (CRPS)., Design: Retrospective., Setting: Tertiary hospital single-center., Subjects: Patients who underwent TSGB receiving KIT or SCS within a 3-year window., Methods: Positive TSGB outcomes were defined as ≥2 0-10 Numerical Rating Scale (NRS) score reduction at 2 weeks post-procedure. Positive KIT and SCS outcomes were determined by ≥2 NRS score reduction at 2-4 weeks post-KIT and ≥4 NRS score reduction at 2-4 weeks post-SCS implantation, respectively., Results: Among 207 patients who underwent TSGB, 38 received KIT and 34 underwent SCS implantation within 3 years post-TSGB; 33 patients receiving KIT and 32 patients receiving SCS were included. Among 33 patients who received KIT, 60.6% (n = 20) reported a ≥ 2 0-10 NRS pain-score reduction. Positive response to TSGB occurred in 70.0% (n = 14) KIT responders, significantly higher than that in 30.8% (n = 4) KIT non-responders. Multivariable analysis revealed a positive association between positive responses to TSGB and KIT (OR 7.004, 95% CI 1.26-39.02). Among 32 patients who underwent SCS implantation, 68.8% (n = 22) experienced short-term effectiveness. Positive response to TSGB was significantly higher in SCS responders (45.5%, n = 10) than in non-responders (0.0%). However, there were no associations between pain reduction post-TSGB and that post-KIT or post-SCS., Conclusions: A positive response to TSGB is a potential predictor for positive KIT and SCS outcomes among patients with chronic upper-extremity pain, including CRPS., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: Different types of spinal cord stimulation (SCS) have been evaluated for the management of chronic nonsurgical refractory back pain (NSRBP). A direct comparison between the different types of SCS or between closed-loop SCS with conventional medical management (CMM) for patients with NSRBP has not been previously conducted, and therefore, their relative effectiveness and cost-effectiveness remain unknown. The aim of this study was to perform a systematic review, network meta-analysis (NMA) and economic evaluation of closed-loop SCS compared with fixed-output SCS and CMM for patients with NSRBP., Methods: Databases were searched to September 8, 2023. Randomized controlled trials of SCS for NSRBP were included. The results of the studies were combined using fixed-effect NMA models. A cost-utility analysis was performed from the perspective of the UK National Health Service with results reported as incremental cost per quality-adjusted life-year (QALY)., Results: Closed-loop SCS resulted in statistically and clinically significant reductions in pain intensity (mean difference [MD] 32.72 [95% CrI 15.69-49.78]) and improvements in secondary outcomes (Oswestry Disability Index [ODI] and health-related quality of life [HRQoL]) compared with fixed-output SCS at 6-month follow-up. Compared with CMM, both closed-loop and fixed-output SCS resulted in statistically and clinically significant reductions in pain intensity (closed-loop SCS vs. CMM MD 101.58 [95% CrI 83.73-119.48]; fixed-output SCS versus CMM MD 68.86 [95% CrI 63.43-74.31]) and improvements in secondary outcomes (ODI and HRQoL). Cost-utility analysis showed that closed-loop SCS dominates fixed-output SCS and CMM, and fixed-output SCS also dominates CMM., Discussion: Current evidence showed that closed-loop and fixed-output SCS provide more benefits and cost-savings compared with CMM for patients with NSRBP., Competing Interests: This work was supported by Saluda Medical. S.E. reports consultancy fees from Medtronic, and Mainstay Medical outside the submitted work. He has received department research funding from the National Institute of Health Research, Saluda Medical and Medtronic. S.N. reports consultancy fees from Saluda Medical. A.B. MTech Access was commissioned by Saluda Medical to participate in this project. N.A.M. reports receiving grants from Neuros, Mesoblast, and Vivex Biologics, as well as consulting as a medical monitor for Saluda Medical, Nevro, Vivex Biologics, Mainstay, Sollis Therapeutics, and Vertos outside the submitted work. C.G. reports consulting fees and stock options received from Mainstay, personal fees from Mainstay, Saluda Medical, Persica, and Iliad outside the submitted work, research funded by Sollis, expert witness testimony fees, and serves as Editor-in-Chief of Pain Practice. B.B. reports an educational grant from Saluda Medical and consultancy fees from Salvia Bioelectronics, Medtronic and Abbott outside the submitted work. P.S.S. has received consultancy fees from Medtronic, Saluda Medical, Nalu, and Biotronic outside the submitted work, and has stock options from Saluda Medical and Nalu. M.M. reports no conflicts of interest. N.S., A.L., and R.V.D. are employees of Saluda Medical. R.V.D. has previously received consultancy fees from Mainstay Medical, Medtronic, and Saluda Medical outside the submitted work., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Spinal Cord Stimulation (SCS) may provide pain relief in patients with therapy-refractory Persistent Spinal Pain Syndrome Type II (PSPS-T2). Despite the evidence that SCS can reduce disability and reduce pain medication usage, only 25% of the patients is able to completely omit pain medication usage after 12 months of SCS. To tackle the high burden of patients who consume a lot of pain medication, tapering programs could be initiated before starting a trajectory with SCS. The current objective is to examine whether a pain medication tapering program before SCS alters disability in PSPS-T2 patients compared to no tapering program., Methods and Design: A three-arm, parallel-group multicenter randomized controlled trial will be conducted including 195 patients who will be randomized (1:1:1) to either (a) a standardized pain medication tapering program, (b) a personalized pain medication tapering program, or (c) no tapering program before SCS implantation, all with a follow-up period until 12 months after implantation. The primary outcome is disability. The secondary outcomes are pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication usage, psychological constructs, sleep, symptoms of central sensitization, and healthcare expenditure., Discussion: Within the PIANISSIMO project we propose a way to reduce the risks of adverse events, medication-induced hyperalgesia, tolerance, and dependence by providing pain medication tapering before SCS. Due to the lack of a commonly accepted in-hospital tapering approach, two different tapering programs will be evaluated in this study. If pain medication tapering programs are deemed to be more effective than no tapering on disability, this would add to the evidence towards an improved patient-centered care model in this patient group and set a clear path to advocate for pain medication tapering before SCS as the new standard treatment guideline for these patients., Trial Registration: ClinicalTrials.gov NCT05861609. Registered on May 17, 2023., Competing Interests: Lisa Goudman is a postdoctoral research fellow funded by the Research Foundation Flanders (FWO), Belgium (project number 12ZF622N). Maarten Moens has received speaker fees from Medtronic, Nevro and Saluda Medical. STIMULUS received independent research grants from Medtronic. There are no other conflicts of interest to declare., (Copyright: © 2024 Moens et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: The International Neuromodulation Society (INS) has recognized a need to establish best practices for optimizing implantable devices and salvage when ideal outcomes are not realized. This group has established the Neurostimulation Appropriateness Consensus Committee (NACC)® to offer guidance on matters needed for both our members and the broader community of those affected by neuromodulation devices., Materials and Methods: The executive committee of the INS nominated faculty for this NACC® publication on the basis of expertise, publications, and career work on the issue. In addition, the faculty was chosen in consideration of diversity and inclusion of different career paths and demographic categories. Once chosen, the faculty was asked to grade current evidence and along with expert opinion create consensus recommendations to address the lapses in information on this topic., Results: The NACC® group established informative and authoritative recommendations on the salvage and optimization of care for those with indwelling devices. The recommendations are based on evidence and expert opinion and will be expected to evolve as new data are generated for each topic., Conclusions: NACC® guidance should be considered for any patient with less-than-optimal outcomes with a stimulation device implanted for treating chronic pain. Consideration should be given to these consensus points to salvage a potentially failed device before explant., Competing Interests: Conflict of Interest Timothy R. Deer consults for Abbott, Saluda, Painteq, Cornorloc, Spinal Simplicity, Spinethera, Nervonik, Biotronik, and SPR Therapeutics. Dawood Sayed reports personal fees from Abbott, Medtronic, Flowonix, Nevro, and Boston Scientific, outside the submitted work. David M. Dickerson reports research support from SPR Therapeutics and Abbott; consulting fees from Abbott, Vertos, SPR, and Biotronik; speaker’s fees from Abbott, Vertos, Biotronik, and SPR Therapeutics; and meeting and travel support from Vertos, SPR, and Abbott. He is a committee chair for the North American Neuromodulation Society and the American Society of Anesthesiologists, and a board member of the Midwest Pain Society. He serves as a clinical advisory member for National Median Arcuate Ligament Syndrome Advisory and National Rx and Drug Abuse Summit. Erika A. Petersen reports research support from Mainstay, Medtronic, Nalu, Neuros Medical, Nevro Corp, ReNeuron, SPR, and Saluda, in addition to personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Nalu, Neuros Medical, Nevro, Presidio Medical, Saluda, and Vertos, outside the submitted work. She holds stock options from SynerFuse and neuro42. Michael A. Fishman reports honoraria from Abbott, Biotronik, Medtronic, and Mainstay Medical; consults and advises for Biowave, Biotronik, Medtronic, and Thermaquil; conducts funded research for Abbott, Biowave, Biotronik, and Medtronic; receives royalties/patent from Brixton Biosciences, Medtronic, and Vyrsa (acq Nevro); and has stock options from Brixton Biosciences and Thermaquil, an equity position in Celeri Health, and ownership in Brixton Biosciences. James Fitzgerald reports personal fees from Medtronic and Abbott, and grants from Abbott, outside the submitted work. Ganesan Baranidharan reports grants and personal fees from Nevro Corporation, Abbott, and Boston Scientific; and personal fees from Nalu Medical, outside the submitted work. Dirk De Ridder reports other from Abbott during the conduct of the study, and he has a patent pending with Abbott. Krishnan V. Chakravarthy reports other from Medtronic, Mainstay Medical, Vertos, NXTSTIM, Accufix Medical, Newrom Biomedical, and Douleur Therapeutics, outside the submitted work. Corey W. Hunter reports other from Saluda Medical Pty Ltd; grants, personal fees, and other from Abbott; and grants from Biotronik, outside the submitted work. Eric Buchser reports personal fees from Medtronic, Switzerland, outside the submitted work. Chris Gilligan reports other from Mainstay Medical and Sollis Therapeutics; and personal fees from Medtronic, Saluda, and Abbott, outside the submitted work. Simon Thomson reports consulting agreements with Boston Scientific Neuromodulation, Galvani Bioelectronics, Mainstay Medical, and Saluda Medical. Jessica Jameson reports personal fees from Nevro, Boston Scientific, and Abbott, outside the submitted work. Thomas T. Simopoulos reports personal consultant fees from Nevro Corp, outside the submitted work. Robert M. Levy is an uncompensated consultant for Nalu, Saluda Medical, and Mainstay Medical; and has stock options from Nalu and Saluda Medical obtained before 2019 and not exercisable through the duration of his term as International Neuromodulation Society president and editor-in-chief of the journal Neuromodulation: Technology at the Neural Interface. The remaining authors reported no conflict of interest., (Copyright © 2024. Published by Elsevier Inc.)

Introduction: For over 60 years, spinal cord stimulation has endured as a therapy through innovation and novel developments. Current practice of neuromodulation requires proper patient selection, risk mitigation and use of innovation. However, there are tangible and intangible challenges in physiology, clinical science and within society., Areas Covered: We provide a narrative discussion regarding novel topics in the field especially over the last decade. We highlight the challenges in the patient care setting including selection, as well as economic and socioeconomic challenges. Physician training challenges in neuromodulation is explored as well as other factors related to the use of neuromodulation such as novel indications and economics. We also discuss the concepts of technology and healthcare data., Expert Opinion: Patient safety and durable outcomes are the mainstay goal for neuromodulation. Substantial work is needed to assimilate data for larger and more relevant studies reflecting a population. Big data and global interconnectivity efforts provide substantial opportunity to reinvent our scientific approach, data analysis and its management to maximize outcomes and minimize risk. As improvements in data analysis become the standard of innovation and physician training meets demand, we expect to see an expansion of novel indications and its use in broader cohorts.

Introduction: Spinal neurostimulation is a therapy for otherwise intractable chronic pain. Spinal neurostimulation includes stimulation of the spinal cord (SCS), dorsal root ganglion (DRGS), and dorsal root entry zone (DREZS). New paresthesia-free neurostimulation paradigms may rely on different mechanisms of action from those of conventional tonic neurostimulation. The aim of this systematic review is to assess the existing knowledge on the effect of spinal neurostimulation on somatosensory processing in patients with chronic pain. We therefore reviewed the existing literature on the effect of various spinal neurostimulation paradigms on the supraspinal somatosensory evoked response (SER)., Materials and Methods: Multiple scientific data bases were searched for studies that assessed the effect of spinal neurostimulation on the supraspinal SER, evoked by painful or nonpainful peripheral stimuli in patients with chronic pain. We found 205 studies, of which 24 were included. Demographic data, study design, and study outcome were extracted., Results: Of the 24 included studies, 23 used electroencephalography to assess the SER; one study used magnetoencephalography. Fifteen studies evaluated tonic SCS; six studies (also) evaluated paresthesia-free paradigms; three studies evaluated the effect of tonic DRGS or DREZS. Sixteen studies used nonpainful stimuli to elicit the SER, 14 observed a decreased SER amplitude. Ten studies used painful stimuli to elicit the SER, yielding mixed results., Discussion: The included studies suggest that both paresthesia-based and paresthesia-free spinal neurostimulation paradigms can decrease (part of) the SER elicited by a nonpainful peripheral stimulus. The observed SER amplitude reduction likely is the effect of various spinal and supraspinal mechanisms of spinal neurostimulation that also contribute to pain relief., Conclusions: Spinal neurostimulation modulates the processing of a peripherally applied nonpainful stimulus. For painful stimuli, the results are not conclusive. It is not yet clear whether paresthesia-free neurostimulation affects the SER differently from paresthesia-based neurostimulation., Competing Interests: Conflict of Interest Frank J.P.M. Huygen declares that he is supported in kind by Saluda Medical, receives consulting fees (payment to institution) from Boston Scientific, and receives personal fees from Abbott and Grünenthal. The remaining authors reported no conflict of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Spinal cord stimulation (SCS) has been reported to cause substantial pain relief and improved quality of life (QoL) in patients with persistent spinal pain syndrome (PSPS). Despite implantable pulse generator (IPG)-related inconveniences such as pain, shame, and discomfort affecting QoL and patient satisfaction, these are often neglected. Hence, the current study aims to determine the associations between patient satisfaction, IPG-related inconveniences, and preoperative counseling in a homogeneous group of patients with PSPS receiving SCS with IPG implantation in the gluteal or abdominal area., Materials and Methods: Retrospective data on sample characteristics were gathered from the EPIC (electronic health record software) digital patient data base. Prospective data on patient satisfaction were obtained with a questionnaire that covered various topics such as shame, pain, disturbances in daily/intense activities, night rest and/or sleep, discomfort caused by clothing, and preoperative counseling. The exact location of the IPG and its scar were determined with photo analysis. Thereafter, the site of IPG placement was classified into separate quadrants within the gluteal and abdominal area. Patient satisfaction was defined as accepting the current location of the IPG without having the wish to undergo revision surgery., Results: In total, 81 participants (50.9 ± 10 years) were included in this analysis, with patient satisfaction observed in 61 patients (75.3%). Among satisfied patients, more extensive preoperative counseling concerning IPG pain and discomfort was reported compared with patients who were not satisfied (p < 0.001). When comparing the two groups, significant differences were found in shame (8/81, 9.9%), IPG site pain (21/81, 25.9%), disturbance of activities (42/81, 51.9%), and clothing-related discomfort (42/81, 51.9%)., Conclusions: On the basis of the current results, shared decision-making and comprehensive preoperative provision of information are recommended to optimize patient satisfaction regarding IPG pain, discomfort, and inconveniences. Although many patients experience these disadvantages despite successful SCS for pain related to PSPS, most of them accept this if they have received adequate preoperative information about expectations., Competing Interests: Conflict of Interest The authors reported no conflict of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background and Objectives: As spinal cord stimulation (SCS) offers a therapy for increasing numbers of patients with chronic pain and spinal cord injury, it becomes increasingly important to better understand its somatotopy. In this prospective study, we investigate whether high-resolution SCS (HR-SCS) offers improved selectivity assessed through elicitation of evoked electromyography (EMG) responses as compared with commercial paddle leads., Methods: Vertical tripole configurations were used to elicit EMG responses in both types of paddles placed for standard-of-care indications between T6 and T10. In HR-SCS, evoked EMG responses in lower extremity/abdominal muscle groups were monitored at 6 to 8 mediolateral sites. All commercial paddle columns were tested. Percentage change in the maximum root mean square value was calculated at a group level. Heat maps were generated to identify responders for each muscle group. Responders were considered patients who had a >50% change in root mean square over baseline., Results: We demonstrated significantly greater motor responses across medial and lateral contacts and greater responder rates consistently at the T6 and T9 levels with HR-SCS as compared with commercial paddles in 18 patients. Distal muscle groups (gastrocnemius and tibialis anterior) and proximal muscle groups (biceps femoris and quadriceps) were selectively activated at both levels., Conclusion: We demonstrate that HR-SCS has greater selectivity in eliciting evoked EMG responses in an intraoperative setting. HR-SCS offers recruitment of muscle groups at lateral contacts concurrently with medial contacts. We provide data that HR-SCS may provide higher spatial resolution, which has the potential to allow for personalization of care and treatment of pain syndromes/symptoms which to date have not been effectively treated., (Copyright © Congress of Neurological Surgeons 2024. All rights reserved.)

Objectives: The aim of this study was to present key technologic and regulatory milestones in spinal cord stimulation (SCS) for managing chronic pain on a narrative timeline with visual representation, relying on original sources to the extent possible., Materials and Methods: We identified technical advances in SCS that facilitated and enhanced treatment on the basis of scientific publications and approvals from the United States (US) Food and Drug Administration (FDA). We presented milestones limited to first use in key indications and in the context of new technology validation. We focused primarily on pain management, but other indications (eg, motor disorder in multiple sclerosis) were included when they affected technology development., Results: We developed a comprehensive visual and narrative timeline of SCS technology and US FDA milestones. Since its conception in the 1960s, the science and technology of SCS neuromodulation have continuously evolved. Advances span lead design (from paddle-type to percutaneous, and increased electrode contacts) and stimulator technology (from wireless power to internally powered and rechargeable, with miniaturized components, and programmable multichannel devices), with expanding stimulation program flexibility (such as burst and kilohertz stimulation frequencies), as well as usage features (such as remote programming and magnetic resonance imaging conditional compatibility)., Conclusions: This timeline represents the evolution of SCS technology alongside expanding FDA-approved indications for use., Competing Interests: Conflict of Interest Scott Lempka serves as a scientific advisory board member for Abbott Neuromodulation, CereGate, and Presidio Medical, Inc; and holds stock or stock options with CereGate, Hologram Consultants, LLC, Neuronoff, Inc, and Presidio Medical, Inc. Marom Bikson has received payment for expert testimony from Axonics and Wave Neuroscience. Richard North holds royalties or licenses with Abbott and several patents. The remaining authors reported no conflict of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aimed to determine agreement between reported percentage pain reduction (RPPR) and calculated percentage pain reduction (CPPR) in patients with percutaneous spinal cord stimulation (SCS) implants, and to correlate RPPR and CPPR with patient satisfaction. We also sought to determine which patient-reported outcome measures are most improved in patients with SCS., Materials and Methods: Fifty patients with percutaneous spinal cord stimulator implants with a mean follow-up of 51.1 months were interviewed and surveyed to assess their pain level, impression of degree of pain relief, satisfaction with the therapy, and desire to have the device again. Baseline pain level was obtained from their preimplant records., Results: Overall, RPPR was found to be 53.3%, whereas CPPR was 44.4%. Of all patients, 21 reported <50% pain reduction; however, most of these (12/21, 57%) were satisfied with the outcome of therapy. In terms of individual improvement in outcomes, activities of daily life was the most improved measure at 82%, followed by mood, sleep, medication use, and health care utilization at 74%, 62%, 50%, and 48%, respectively., Conclusions: RPPR appears to be a complex outcome measure that may not agree with CPPR. Overall RPPR is greater than the CPPR. On the basis of our data, these independently valid measures should not be used interchangeably. A 50% pain reduction threshold is not a requisite for patient satisfaction and desire to have the device again. Activities of daily living was the most improved measure in this cohort, followed by mood, sleep, medication usage, and decrease in health care utilization., Competing Interests: Conflict of Interest Thomas Simopoulos reports presentation fees from Nevro and Boston Scientific. The remaining authors reported no conflict of interest., (Copyright © 2023 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this economic analysis was to evaluate the cost-effectiveness of differential target multiplexed spinal cord stimulation (DTM-SCS) for treating chronic intractable low back pain, compared with conventional spinal cord stimulation (C-SCS) and conservative medical management (CMM), by updating and expanding the inputs for a previously published cross-industry model., Materials and Methods: This model comprised a 12-month decision-tree phase followed by a long-term Markov model. Costs and outcomes were calculated from a UK National Health Service perspective, over a base-case horizon of 15 years and up to a maximum of 40 years. All model inputs were derived from published literature or other deidentified sources and updated to reflect recent clinical trials and costs. Deterministic and one-way sensitivity analyses were performed to calculate costs and quality-adjusted life-years (QALYs) across the 15-year time horizon and to explore the impact of individual parameter variability on the cost-effectiveness results. Probabilistic sensitivity analysis was undertaken to explore the impact of joint parameter uncertainty on the results., Results: DTM-SCS was the most cost-effective option from a payer perspective. Compared with CMM alone, DTM-SCS was associated with an incremental cost-effectiveness ratio (ICER) of £6101 per QALY gained (incremental net benefit [INB] = £21,281). The INB for C-SCS compared with CMM was lower than for DTM-SCS, at £8551. For the comparison of DTM-SCS and C-SCS, an ICER of £897 per QALY gained was calculated, with a 99.5% probability of cost-effectiveness at a £20,000 per QALY threshold., Conclusions: Among patients with low back pain treated over a 15-year follow-up period, DTM-SCS and C-SCS are cost-effective compared with CMM, from both payer and societal perspectives. DTM-SCS is associated with a lower ICER than that of C-SCS. Wider uptake of DTM-SCS in the UK health care system is warranted to manage chronic low back pain., Competing Interests: Conflict of Interest Ashish Gulve reports a relationship with Medtronic Inc that includes consulting or advisory and speaking and lecture fees. Vivek Mehta reports a relationship with Medtronic Inc that includes consulting or advisory and funding grants; a relationship with Boston Scientific Corp that includes consulting or advisory and funding grants; a relationship with Pfizer Inc that includes consulting or advisory; and a relationship with Mainstay Medical that includes consulting or advisory and funding grants. David A. Provenzano reports a relationship with Avanos Medical Inc that includes consulting or advisory and funding grants; a relationship with Medtronic Inc that includes consulting or advisory and funding grants; a relationship with Nevro Corp that includes consulting or advisory and funding grants; a relationship with SI-BONE Inc that includes consulting or advisory; a relationship with Stimgenics that includes funding grants; and a relationship with Abbott that includes funding grants. Ashish Gulve, Vivek Mehta, and David A. Provenzano did not receive any funding from Medtronic or other sources related to this research; however, they did receive funding from Medtronic for engagements unrelated to the present research submission. Simon Eggington, Shanti Scheffler, Nicolas C. Gasquet, and Christine N. Ricker are or were full-time employees of Medtronic at the time of this research., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Dorsal root ganglion stimulation (DRG-S) is a novel therapy to treat chronic pain. It has shown efficacy when delivered intermittently, suggesting a delayed washout effect exists. To measure the washout period, and to determine whether there are differences in washout times among different types of treated pain, we measured the time for pain to return at the end of the patients' one-week DRG stimulation trials., Materials and Methods: Patients who completed a successful DRG-S trial were included. The times until 25% (t25) and 90% (t90) of baseline pain level returned were recorded. The patients were divided into neuropathic, nociceptive, and mixed pain groups for subgroup comparison. t25 and t90 were plotted in the entire cohort and subgroups using reverse Kaplan-Meier plots (failure curves) and compared using a log-rank test., Results: In total, 29 consecutive patients were included. Median t25 and t90 times were 7.1 and 19.5 hours, respectively. Median (interquartile range) times were longest for the nociceptive pain group (n = 17) and shortest for the neuropathic pain group (n = 6), with the mixed-pain group (n = 6) in between (t25: 7.1 [1.7-19.4], 3.40 [1.4-8.4], and 5.7 [0.8-17.6]; t90, 22.0 [10.7-71.0], 7.6 [3.6-19.8], and 20.9 [14.2-31.2], respectively). t90 times differed significantly by pain type (p = 0.040)., Conclusions: This study showed a prolonged washout period after cessation of DRG-S therapy. Washout times vary according to pain type. The observed effects are possibly due to long-term depression of pain signaling and could allow the implementation of alternative stimulation strategies with DRG-S. Further investigations evaluating DRG-S washout times are warranted., Competing Interests: Conflict of Interest Kenneth B. Chapman reports a relationship with Abbott that includes funding grants. The remaining authors reported no conflict of interest., (Copyright © 2024 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Objectives: Spinal cord stimulation (SCS) is a surgical treatment for severe, chronic, neuropathic pain. It is based on one to two lead(s) implanted in the epidural space, stimulating the dorsal column. It has long been assumed that when deactivating SCS, there is a variable interval before the patient perceives the return of the pain, a phenomenon often termed echo or carryover effect. Although the carryover effect has been problematized as a source of error in crossover studies, no experimental investigation of the effect has been published. This open, prospective, international multicenter study aimed to systematically document, quantify, and investigate the carryover effect in SCS., Materials and Methods: Eligible patients with a beneficial effect from their SCS treatment were instructed to deactivate their SCS device in a home setting and to reactivate it when their pain returned. The primary outcome was duration of carryover time defined as the time interval from deactivation to reactivation. Central clinical parameters (age, sex, indication for SCS, SCS treatment details, pain score) were registered and correlated with carryover time using nonparametric tests (Mann-Whitney/Kruskal-Wallis) for categorical data and linear regression for continuous data., Results: In total, 158 patients were included in the analyses. A median carryover time of five hours was found (interquartile range 2.5;21 hours). Back pain as primary indication for SCS, high-frequency stimulation, and higher pain score at the time of deactivation were correlated with longer carryover time., Conclusions: This study confirms the existence of the carryover effect and indicates a remarkably high degree of interindividual variation. The results suggest that the magnitude of carryover may be correlated to the nature of the pain condition and possibly stimulation paradigms., Clinical Trial Registration: The Clinicaltrials.gov registration number for the study is NCT03386058., Competing Interests: Conflict of Interest Bart Billet serves as a consultant for Abbott, Saluda, Bioelectronics, and Medtronic. Helga Angela Gulisano has received lecture fees from Medtronic. Jens Christian Hedemann Sørensen has received consulting fees from Novo Nordic and has a patent application for wireless brain-computer interface and stock options with Cenexum ApS and Neurizon ApS. Kaare Meier has received speaker’s fees from Abbott and has coownership of data base company Neurizon. Kliment Gatzinsky has received honoraria from Boston Scientific for lectures and serves on the advisory boards for Medtronic and Boston Scientific. Thomas Ruland reports consulting fees from Abbott. The remaining authors report no conflict of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of our meta-analysis was to systematically assess the enduring effectiveness and safety of high-frequency spinal stimulation (HF-SCS) in the management of chronic pain., Methods: We developed a comprehensive literature search strategy to identify clinical trials investigating the efficacy of high-frequency spinal stimulation for chronic pain. The search was conducted in multiple databases, including Web of Science, Cochrane, PubMed, and Embase, covering the period from 2004 to 2023. The inclusion and exclusion criteria established for this study were applied to screen the eligible literature by carefully reviewing abstracts and, when necessary, examining the full text of selected articles. To assess the quality of the included studies, we utilized the Risk of Bias assessment tool provided by the Cochrane Collaboration. The PRISMA method was followed for the selection of articles, and the quality of the articles was evaluated using the risk assessment table for bias provided by the Cochrane Collaboration. Meta-analysis of the selected studies was performed using Review Manager 5.4 and STATA 16.0. Effect sizes for continuous data were reported as mean differences (MD) or standardized mean differences (SMD), while categorical data were analyzed using relative risks (RR)., Results: According to our predefined literature screening criteria, a total of seven English-language randomized controlled trials (RCTs) were included in the meta-analysis. The findings from the meta-analysis demonstrated that HF-SCS exhibited superior efficacy in the long-term treatment of chronic pain when compared with the control group (RR=2.44, 95% CI: 1.20-4.96, P =0.01). Furthermore, HF-SCS demonstrated a statistically significant improvement in the Oswestry Disability Index score (mean difference MD=3.77, 95% CI: 1.17-6.38, P =0.005). However, for pain assessment (standardized mean difference SMD=-0.59, 95% CI: -1.28 to 0.10, P =0.09), Patient Global Impression of Improvement (PGI-I) score (MD=0.11, 95% CI: -0.66 to 0.88, P =0.78 for 6 months; MD=0.02, 95% CI: -0.42 to 0.43, P =0.97 for 12 mo), Clinical Global Impression of Improvement (CGI-I) score (MD=-0.58, 95% CI: -1.62 to 0.43, P =0.27 for 6 mo; MD=-0.23, 95% CI: -0.94 to 0.48, P =0.52 for 12 mo), and occurrence of adverse effects (odds ratio [OR]=0.77, 95% CI: 0.23-2.59, P =0.67), HF-SCS did not show statistically sufficient effects compared with the control group., Conclusions: The findings from our comprehensive review and meta-analysis offer encouraging data about the prolonged efficacy and safety of HF-SCS in chronic pain management on some but not all outcomes. Recognizing the constraints of the existing evidence is crucial. Additional clinical trials, meticulously planned and stringent, are essential to bolster the current body of evidence and reach more conclusive findings., Competing Interests: The authors declare no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: MuscleSCS is a new technique that combines spinal cord stimulation (SCS) with muscle stimulation to relieve pain., Objectives: In this clinical study, we wanted to use rod electrodes to investigate the MuscleSCS method's effectiveness in the treatment of chronic lower back pain. One of our hypotheses was that the combined use of MuscleSCS and BurstDRTM would further improve the treatment., Study Design: A prospective, single-center, single-blinded, randomized crossover study., Setting: A university medical center., Methods: Patients with chronic lower back pain had previously (one to 10 years ago) received an SCS system (Octrode™). In this study, they were randomly treated for 2 weeks each with BurstDRTM stimulation alone, MuscleSCS stimulation alone, or a combination of BurstDRTM stimulation and MuscleSCS stimulation. Thereafter, the patients were treated for another 6 weeks with one of the 3 methods (crossover possible). Pain ratings on the visual analog scale (VAS) were recorded and compared. A Pain Disability Index (PDI) questionnaire was used at the baseline and at 3 months., Results: We included 24 patients in this study (11 women, mean age 62.3 yrs.) The values of the second week of the stimulation were the only ones used for the calculations. The first week of the stimulation was used as a wash-out period.The combined application of BurstDRTM and MuscleSCS stimulation was associated with the best results (P = 0.032). PDI scores did not improve during this treatment. No serious adverse events occurred during this study. Seventy-one and a half percent of the patients experienced an improvement in their pain as a result of the additional MuscleSCS stimulation., Limitations: In this study, only one fixed contact setting (3 & 4) was used to ensure uniform conditions for all patients and the ability to compare the different treatment modes., Conclusion: This study showed that the combined application of SCS (BurstDRTM) and additional MuscleSCS stimulation using a rod electrode could significantly improve outcomes for patients suffering from chronic back pain.

Purpose of Review: Since the advent of spinal cord stimulation (SCS), advances in technology have allowed for improvement and treatment of various conditions, especially chronic pain. Additionally, as the system has developed, the ability to provide different stimulation waveforms for patients to treat different conditions has improved. The purpose and objective of the paper is to discuss basics of waveforms and present the most up-to-date literature and research studies on the different types of waveforms that currently exist. During our literature search, we came across over sixty articles that discuss the various waveforms we intend to evaluate., Recent Findings: There are several publications on several waveforms used in clinical practice, but to our knowledge, this is the only educational document teaching on waveforms which provides essential knowledge. There is a gap of knowledge related to understanding wave forms and how they work., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objectives: Although studies have described inequities in spinal cord stimulation (SCS) receipt, there is a lack of information to inform system-level changes to support health care equity. This study evaluated whether Black patients exhaust more treatment options than do White patients, before receiving SCS., Materials and Methods: This retrospective cohort study included claims data of Black and non-Latinx White patients who were active-duty service members or military retirees who received a persistent spinal pain syndrome (PSPS) diagnosis associated with back surgery within the US Military Health System, January 2017 to January 2020 (N = 8753). A generalized linear model examined predictors of SCS receipt within two years of diagnosis, including the interaction between race and number of pain-treatment types received., Results: In the generalized linear model, Black patients (10.3% [8.7%, 12.0%]) were less likely to receive SCS than were White patients (13.6% [12.7%, 14.6%]) The interaction term was significant; White patients who received zero to three different types of treatments were more likely to receive SCS than were Black patients who received zero to three treatments, whereas Black and White patients who received >three treatments had similar likelihoods of receiving a SCS., Conclusions: In a health care system with intended universal access, White patients diagnosed with PSPS tried fewer treatment types before receiving SCS, whereas the number of treatment types tried was not significantly related to SCS receipt in Black patients. Overall, Black patients received SCS less often than did White patients. Findings indicate the need for structured referral pathways, provider evaluation on equity metrics, and top-down support., Competing Interests: Conflict of Interest The authors reported no conflict of interest., (Published by Elsevier Inc.)

Introduction: The evidence for spinal cord stimulation (SCS) has been criticized for the absence of blinded, parallel randomized controlled trials (RCTs) and limited evaluations of the long-term effects of SCS in RCTs. The aim of this study was to determine whether evoked compound action potential (ECAP)-controlled, closed-loop SCS (CL-SCS) is associated with better outcomes when compared with fixed-output, open-loop SCS (OL-SCS) 36 months following implant., Methods: The EVOKE study was a multicenter, participant-blinded, investigator-blinded, and outcome assessor-blinded, randomized, controlled, parallel-arm clinical trial that compared ECAP-controlled CL-SCS with fixed-output OL-SCS. Participants with chronic, intractable back and leg pain refractory to conservative therapy were enrolled between January 2017 and February 2018, with follow-up through 36 months. The primary outcome was a reduction of at least 50% in overall back and leg pain. Holistic treatment response, a composite outcome including pain intensity, physical and emotional functioning, sleep, and health-related quality of life, and objective neural activation was also assessed., Results: At 36 months, more CL-SCS than OL-SCS participants reported ≥50% reduction (CL-SCS=77.6%, OL-SCS=49.3%; difference: 28.4%, 95% CI 12.8% to 43.9%, p<0.001) and ≥80% reduction (CL-SCS=49.3%, OL-SCS=31.3%; difference: 17.9, 95% CI 1.6% to 34.2%, p=0.032) in overall back and leg pain intensity. Clinically meaningful improvements from baseline were observed at 36 months in both CL-SCS and OL-SCS groups in all other patient-reported outcomes with greater levels of improvement with CL-SCS. A greater proportion of patients with CL-SCS were holistic treatment responders at 36-month follow-up (44.8% vs 28.4%), with a greater cumulative responder score for CL-SCS patients. Greater neural activation and accuracy were observed with CL-SCS. There were no differences between CL-SCS and OL-SCS groups in adverse events. No explants due to loss of efficacy were observed in the CL-SCS group., Conclusion: This long-term evaluation with objective measurement of SCS therapy demonstrated that ECAP-controlled CL-SCS resulted in sustained, durable pain relief and superior holistic treatment response through 36 months. Greater neural activation and increased accuracy of therapy delivery were observed with ECAP-controlled CL-SCS than OL-SCS., Trial Registration Number: NCT02924129., Competing Interests: Competing interests: NM reports personal fees from Saluda Medical for acting as independent medical monitor for the EVOKE study during the conduct of the study; he reports receiving grants from Neuros and Mesoblast, as well as consulting as a medical monitor for Nevro, Vivex, Mainstay, and Vertos outside the submitted work. RL is an uncompensated consultant for Nalu, Saluda Medical, and Mainstay Medical and has stock options from Nalu and Saluda Medical obtained before 2019, not exercisable through the duration of his term as International Neuromodulation Society President and editor-in-chief of the journal Neuromodulation: Technology at the Neural Interface. TD reports personal fees from Saluda Medical during the conduct of the study; consultancy for Axonics, Abbott, Nalu, Vertos, SpineThera, Mainstay, Cornerloc, Ethos, SPR Therapeutics, Medtronic, Boston Scientific, PainTeq, Tissue Tech, Spinal Simplicity, and Avanos outside the submitted work. He is a minor equity holder for Saluda Medical, Nalu, SpineThera, Stimgenics, Vertiflex, Vertos, and Bioness and an advisory board member for Abbott, Vertos, Nalu, SPR Therapeutics, and Tissue Tech. LK reports receiving grants from Nevro, Neuros, Avanos, Medtronic, Neuralace, and Xalud Therapeutics and financial support from Nevro, Avanos, and Saluda Medical outside the submitted work. SL reports receiving grants and personal fees from Saluda Medical during the conduct of the study; he reports grants from Avanos, Boston Scientific, Nalu Medical, SPR Therapeutics, Averitas Pharma, Biotronik, SGX Therapeutics, and PainTeq, as well as consultancy for Abbott, Avanos, Boston Scientific, Nevro, SPR Therapeutics, Averitas Pharma, Biotronik, Nalu Medical, and PainTeq, outside the submitted work, as well as holding stock options for Nalu Medical. KA reports consultancy for Medtronic, Nevro, Boston Scientific, Nalu, Presidio, Biotronik, Mesoblast, Vivex Laboratories outside the submitted work. JP reports research and consulting fees from Saluda Medical during the conduct of the study; consultancy for Abbott, Medtronic, Saluda Medical, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil outside the submitted work; has received grant and research support from: Abbott, Flowonix, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil outside the submitted work; and is a shareholder of Vertos, SPR Therapeutics, Painteq, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, and Anesthetic Gas Reclamation. CH reports grants from Saluda Medical during the conduct of the study; consultancy fees from Genecentrix outside the submitted work. SC reports grants from Cleveland Clinic during the conduct of the study; and grants from Vertos, Mainstay, and Vivex outside the submitted work. SMF reports consulting fees from Abbott, Medtronic, Saluda, VertiFlex, Vertos, Surgentec, CornerLoc, Mainstay and Relievant outside the submitted work, has received grant for research funding from Mainstay, Relievant, Medtronic, Abbott, VertiFlex, Saluda, Nalu, CornerLoc, Aurora, Biotronik, and Stimgenics outside the submitted work, and has an equity position in SynerFuse, Aurora Spine, Thermaquil. SPR Therapeutics, Saluda, CornerLoc, PainTEQ, Stimgenics, Anesthetic Gas Reclamation, Neural Integrative Solutions, SpineThera, and Celeri Health. CG reports clinical trial funding from Saluda Medical during the conduct of the study; reports personal fees and other from SPR, and personal fees from Nevro, Nalu, Biotronik, and Boston Scientific outside the submitted work. PSS has received consultancy fees from Medtronic, Saluda Medical, Nalu, and Biotronic outside the submitted work, and has stock options from Saluda Medical and Nalu. JS reports personal fees from Nevro during the conduct of the study and personal fees from Saluda Medical and Boston Scientific outside the submitted work. TM reports research fees from Saluda Medical during the conduct of the study and personal fees from Nevro outside the submitted work. JC reports personal fees from Saluda Medical during the conduct of the study; personal fees from Abbott, Boston Scientific, Nevro, Medtronic, Mainstay, SPR Therapeutics, CornerLoc, PillNurse, Biotronik, and Vivex outside the submitted work; and stock from Mainstay, CornerLoc, and PillNurse. EP has received research support from Mainstay, Medtronic, Neuros Medical, Nevro Corp, ReNeuron, SPR, and Saluda Medical outside the submitted work, as well as personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Nalu, Neuros Medical, Nevro, Presidio Medical, Saluda Medical, and Vertos outside the submitted work. She holds stock options from SynerFuse and neuro42. JMH reports consulting fees from Abbott, Boston Scientific, Nevro, and Saluda Medical outside the submitted work. RR reports grants from SPR, Nalu and Nevro outside the submitted work,l fees from Presidio, and grants and personal fees from Boston Scientific and Saluda Medical outside the submitted work. JWK is an advisory board member for Boston Scientific, Medtronic, Abbott, and Saluda Medical. GB reports consulting fees from Medtronic, Boston Scientific, and Saluda Medical outside the submitted work, and has a consulting agreement and is on the advisory board for Nevro Corp, Nalu Medical Inc, Abbott, and Boston Scientific. RST reports consulting fees from Medtronic, Nevro and Saluda Medical outside the submitted work. LP reports personal fees from Saluda Medical; is a member of the data monitoring board of Saluda Medical during the conduct of the study; and reports personal consulting fees from Medtronic and Nalu outside the submitted work. Members of the EVOKE study group report being employees of Saluda Medical. No other disclosures were reported., (© American Society of Regional Anesthesia & Pain Medicine 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)

Objective: To examine if the use of an antibacterial envelope (TYRX) decreases the rate of postoperative infection in chronic pain patients undergoing treatment with spinal cord stimulation (SCS) involving device implantation., Methods: Single-center retrospective cohort study comparing postoperative infections rates in non-TYRX recipients from 2018 to 2020 with recipients of a TYRX antibacterial envelope from 2020 to 2021. Infection was registered if a patient received any form of antibiotic treatment after hospital discharge within a follow-up period of 100 days., Results: A total of 198 patients were included: 100 in the TYRX group and 98 in the non-TYRX group. There were no significant differences between the 2 groups regarding age, body mass index (BMI), smoking, diabetes, and use of immunosuppression. The overall infection rate was 5.6%. The infection rate was 4% in the TYRX group and 7.1% in the non-TYRX group (P = 0.6). However, the 4 cases of postoperative infection in the TYRX group could be effectively managed with oral antibiotics alone, whereas 6 out of the 7 patients in the non-TYRX group required intravenous antibiotics. Moreover, device explantation was necessary in 3 of these patients suggesting the event of more severe infections in the non-TYRX group (P = 0.014)., Conclusions: The TYRX antibacterial envelope displayed infection rates reducing capabilities, along with a clear tendency to reduce revision surgeries and system removals due to infections., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Introduction: Chronic pain patients may experience impairments in multiple health-related domains. The design and interpretation of clinical trials of chronic pain interventions, however, remains primarily focused on treatment effects on pain intensity. This study investigates a novel, multidimensional holistic treatment response to evoked compound action potential-controlled closed-loop versus open-loop spinal cord stimulation as well as the degree of neural activation that produced that treatment response., Methods: Outcome data for pain intensity, physical function, health-related quality of life, sleep quality and emotional function were derived from individual patient level data from the EVOKE multicenter, participant, investigator, and outcome assessor-blinded, parallel-arm randomized controlled trial with 24 month follow-up. Evaluation of holistic treatment response considered whether the baseline score was worse than normative values and whether minimal clinical important differences were reached in each of the domains that were impaired at baseline. A cumulative responder score was calculated to reflect the total minimal clinical important differences accumulated across all domains. Objective neurophysiological data, including spinal cord activation were measured., Results: Patients were randomized to closed-loop (n=67) or open-loop (n=67). A greater proportion of patients with closed-loop spinal cord stimulation (49.3% vs 26.9%) were holistic responders at 24-month follow-up, with at least one minimal clinical important difference in all impaired domains (absolute risk difference: 22.4%, 95% CI 6.4% to 38.4%, p=0.012). The cumulative responder score was significantly greater for closed-loop patients at all time points and resulted in the achievement of more than three additional minimal clinical important differences at 24-month follow-up (mean difference 3.4, 95% CI 1.3 to 5.5, p=0.002). Neural activation was three times more accurate in closed-loop spinal cord stimulation (p<0.001 at all time points)., Conclusion: The results of this study suggest that closed-loop spinal cord stimulation can provide sustained clinically meaningful improvements in multiple domains and provide holistic improvement in the long-term for patients with chronic refractory pain., Trial Registration Number: NCT02924129., Competing Interests: Competing interests: LK reports receiving grants from Nevro, Neuros, Avanos, Medtronic, Neuralace, and Xalud Therapeutics and financial support from Nevro, Avanos, and Saluda Medical. NM reports receiving grants from Neuros and Mesoblast, as well as consulting as a medical monitor for Saluda Medical, Nevro, Vivex, Mainstay, and Vertos. SC reports receiving grants from Saluda Medical, Vertos, Mainstay, and Vivex. CG reports personal fees and other from SPR, and personal fees from Nevro, Nalu, Biotronik, Boston Scientific, Saluda Medical, and Shiratronics. JP serves as a consultant for Abbott, Medtronic, Saluda Medical, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil; has received grant and research support from: Abbott, Flowonix, Saluda Medical, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil; and is a shareholder of Vertos, SPR Therapeutics, Painteq, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, and Anesthetic Gas Reclamation. SL reports receiving grants from Avanos, Boston Scientific, Nalu Medical, SPR Therapeutics, Saluda Medical, Averitas Pharma, Biotronik, SGX Therapeutics, and PainTeq, as well as serving as a consultant for Abbott, Avanos, Boston Scientific, Nevro, SPR Therapeutics, Averitas Pharma, Biotronik, Nalu Medical, PainTeq, and Saluda Medical, as well as holding stock options for Nalu Medical. CH has received consultancy fees from Saluda Medical and Genecentrix. PSS has received consultancy fees from Medtronic, Saluda Medical, Nalu, and Biotronic and has stock options from Saluda Medical and Nalu. RST reports consultancy fees from Medtronic, Nevro and Saluda Medical. SE reports consultancy fees from Medtronic, Mainstay Medical, Boston Scientific, and Abbott. He has received department research funding from the National Institute of Health Research, Medtronic and Nevro. JWK is an advisory board member for Boston Scientific, Medtronic, Abbott, and Saluda Medical. ST has received consultancy fees from Boston Scientific, Mainstay Medical, and Saluda Medical. He has received department research funding from the National Institute for Health Research, Boston Scientific, Saluda Medical, and Mainstay Medical. EP has received research support from Mainstay, Medtronic, Neuros Medical, Nevro Corp, ReNeuron, SPR, and Saluda Medical, as well as personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Nalu, Neuros Medical, Nevro, Presidio Medical, Saluda Medical, and Vertos. She holds stock options from SynerFuse and neuro42. DS is a consultant for Abbott, Medtronic, Nevro, SPR, Vertos, PainTEQ, and Saluda Medical and has received research funding from and holds minority equity in Vertos. TD is a consultant for Abbott, Vertos, SpineThera, Saluda Medical, Cornerloc, SPR Therapeutics, PainTeq, Spinal Simplicity, and Biotronik. He has minor equity in form of stock options for Vertos, Saluda Medical, Cornerloc, Nalu, PainTeq, and Spinal Simplicity, and minor equity in common stock for SpineThera, and Ethos. He is an advisory board member or participates on a data safety monitoring board for Abbott, Vertos, SPR Therapeutics, and Biotronik. AA reports consultancy fees from Boston Scientific. AL, NS and RD are employees of Saluda Medical. RD has previously received consultancy fees from Mainstay Medical, Medtronic Ltd, and Saluda Medical. RL is an uncompensated consultant for Nalu, Saluda Medical, and Mainstay Medical and has stock options from Nalu and Saluda Medical obtained before 2019, not exercisable through the duration of his term as International Neuromodulation Society President and editor-in-chief of the journal Neuromodulation: Technology at the Neural Interface., (© American Society of Regional Anesthesia & Pain Medicine 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)

Neuropathic pain is a chronic condition representing a significant burden for society. It is estimated 1 out of 10 people over the age of 30 that in the US have been diagnosed with neuropathic pain. Most of the available treatments for neuropathic pain have moderate efficacy over time which limit their use; therefore, other therapeutic approaches are needed for patients. Spinal cord stimulation is an established and cost-effective modality for treating severe chronic pain. In this article we will review the current approved indications for the use of spinal cord stimulation in the US and the novel therapeutic options which are now available using this therapy., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: The use of spinal cord stimulation (SCS) therapy to treat chronic pain continues to rise. Optimal patient selection remains one of the most important factors for SCS success. However, despite increased utilization and the existence of general indications, predicting which patients will benefit from neuromodulation remains one of the main challenges for this therapy. Therefore, this study aims to identify the variables that may correlate with nonresponders to high-frequency (10 kHz) SCS to distinguish the subset of patients less likely to benefit from this intervention., Materials and Methods: This was a retrospective single-center observational study of patients who underwent 10 kHz SCS implant. Patients were divided into nonresponders and responders groups. Demographic data and clinical outcomes were collected at baseline and statistical analysis was performed for all continuous and categorical variables between the two groups to calculate statistically significant differences., Results: The study population comprised of 237 patients, of which 67.51% were responders and 32.49% were nonresponders. There was a statistically significant difference of high levels of kinesiophobia, high self-perceived disability, greater pain intensity, and clinically relevant pain catastrophizing at baseline in the nonresponders compared to the responders. A few variables deemed potentially relevant, such as age, gender, history of spinal surgery, diabetes, alcohol use, tobacco use, psychiatric illness, and opioid utilization at baseline were not statistically significant., Conclusion: Our study is the first in the neuromodulation literature to raise awareness to the association of high levels of kinesiophobia preoperatively in nonresponders to 10 kHz SCS therapy. We also found statistically significant differences with greater pain intensity, higher self-perceived disability, and clinically relevant pain catastrophizing at baseline in the nonresponders relative to responders. It may be appropriate to screen for these factors preoperatively to identify patients who are less likely to respond to SCS. If these modifiable risk factors are present, it might be prudent to consider a pre-rehabilitation program with pain neuroscience education to address these factors prior to SCS therapy, to enhance successful outcomes in neuromodulation., (© 2023 The Authors. Pain Practice published by Wiley Periodicals LLC on behalf of World Institute of Pain.)

Purpose of Review: This literature review critically examines existing studies on cervical spinal cord stimulation (cSCS) for the treatment of chronic pain. The objective is to evaluate the current evidence, identify knowledge gaps, and collate data to inform clinical decision-making and suggest future research avenues. The review covers indications, contraindications, surgical and anesthetic approaches, trials, efficacy, and complications of cSCS., Recent Findings: Recent advancements highlight the evolving role of cSCS in chronic pain management. New neuromodulation techniques involve optimal placement of leads based on the pain's innervation level, maximizing therapeutic outcomes. Contemporary studies underscore the broadening benefits of cSCS, including enhanced functional abilities and sleep quality. However, alongside these innovations come challenges; emerging data bring attention to complications such as hardware issues and infections. Significantly, modern research emphasizes the crucial role of accurate patient selection, factoring in prior therapy responses and comprehensive evaluations. cSCS emerges as a promising tool for chronic pain management, with benefits beyond mere pain relief. As surgical techniques, patient selection criteria, and postoperative care refine, the potential of cSCS expands to benefit a broader patient demographic. However, further comprehensive research is necessary to enhance its application, validate its role earlier in treatment, and ultimately ameliorate the lives of those with chronic pain., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Spinal cord stimulation (SCS) is a well-established treatment option for chronic pain. Pain over the implantable pulse generator, or pocket pain, is an incompletely understood risk of SCS implantation which may limit the efficacy of treatment and patient quality of life. The goal of this narrative review is to analyze the literature to gain a more thorough understanding of the incidence and risk factors for the development of pocket pain to help guide treatment options and minimize its occurrence in the future., Methods: A literature review was conducted investigating the development of pocket pain in patients with SCS for the management of a variety of pain conditions., Results: In total, 305 articles were included in the original database search and 50 met the criteria for inclusion. The highest level of evidence for papers that specifically investigated pocket pain was level III. Four retrospective, observational analyses included pocket pain as a primary outcome. The remainder of the included studies listed pocket pain as an adverse event of SCS implantation., Conclusions: There is a relative dearth of primary literature that examines the incidence, characteristics, and health economic implications of pocket pain in patients with SCS. This highlights the need for large-scale, high-quality prospective or randomized controlled trials examining pocket pain. This may ultimately help prevent and reduce pocket pain leading to improved efficacy of treatment and greater patient quality of life., (© 2023 World Institute of Pain.)

Background: The prevalence of sacroiliac joint pain (SIJP) is estimated to be 10-30% in patients with chronic low back pain. Numerous conservative and surgical treatment modalities for SIJP have been described with limited evidence regarding long-term pain relief. Spinal cord stimulation (SCS) is a well-established technique to treat patients with chronic low back pain. However, the effect on patients with SIJP is not consistent. Therefore, peripheral nerve stimulation (PNS) for chronic SIJP was implemented in experimental trials. Clinical data on PNS for SIJP is still lacking. The authors present a case series and a protocol for a prospective, multicenter study to determine the effect of PNS in patients with chronic intractable SIJP., Method: A multicenter, prospective randomized controlled trial was designed. Patients with chronic intractable SIJP will be recruited and randomized in a 4:3 ratio to either the peripheral nerve stimulation group or to the best medical treatment group. A total of 90 patients are planned to be enrolled (52 in the PNS group and 38 in the BMT group). Patients in the intervention group receive a percutaneous implantation of a unilateral or bilateral lead which is externalized for a trial phase for 3-14 days. After trial phase only patients with at least 50% reduction of pain receive an impulse generator for permanent stimulation. Regular visits for participants are planned on day 0, after 3 months (± 30 days), 6 months (± 30 days), and 12 months (± 60 days). The primary outcome measurements is the difference in Numeric Pain Rating Scale (NRS) between baseline and after 6 months. Secondary outcomes is improvement of pain associated disability (ODI) and improvement of health-related quality of life after 6 and 12 months., Discussion: We have described the protocol for a prospective, multicenter, randomized trial evaluating the influence of PNS on patients with chronic sacroiliac joint syndrome. We believe that PNS on patients with chronic sacroiliac joint syndrome will show promising results regarding pain relief and quality of life in comparison to BMT after 12 months. The design of this trial promises high evidence in comparison to the data to date., Trial Registration: ClinicalTrials.gov, NCT05357300. Registered on April 26, 2022., (© 2024. The Author(s).)

Dorsal root ganglion stimulation (DRG-S) is a relatively new neuromodulation technique that has shown promising results in the treatment of chronic pain conditions. We present a case of a difficult lead extraction during the explantation of a DRG-S device. The lead was unable to be removed despite multiple attempts until a sheath and stylet were used to facilitate extraction. As DRG-S utilization becomes more widespread, DRG-S device explantation will inevitably become more common. The technique described in this report may be beneficial in certain cases of difficult DRG-S lead extraction., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 International Anesthesia Research Society.)

Chronic pain involves a structured and individualized development of neurophysiological and biological responses. The final expression in each patient correlates with diverse expressions of mediators and activations of different transmission and modulation pathways, as well as alterations in the structure and function of the brain, all of which develop according to the pain phenotype. Still today, the selection process for the ideal candidate for spinal cord stimulation (SCS) is based on results from test and functional variables analysis as well as pain evaluation. In addition to the difficulties in the initial selection of patients and the predictive analysis of the test phase, which undoubtedly impact on the results in the middle and long term, the rate of explants is one of the most important concerns, in the analysis of suitability of implanted candidates. A potential for useful integration of genome analysis and lymphocyte expression in the daily practice of neurostimulation, for pain management is presented. Structural and functional quantitative information provided by imaging biomarkers will allow establishing a clinical decision support system that improve the effectiveness of the SCS implantation, optimizing human, economic and psychological resources. A correct programming of the neurostimulator, as well as other factors associated with the choice of leads and their position in the epidural space, are the critical factors for the effectiveness of the therapy. Using a model of SCS based on mathematical methods and computational simulation, the effect of different factors of influence on clinical practice studied, as several configurations of electrodes, position of these, and programming of polarities, in order to draw conclusions of clinical utility in neuroestimulation therapy., Competing Interests: Competing interests: None declared., (© American Society of Regional Anesthesia & Pain Medicine 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Spinal cord stimulation (SCS) is a modern neuromodulation technique extensively proven to be an effective modality for treatment of chronic neuropathic pain. It has been mainly studied for complex regional pain syndrome (CRPS) and failed back surgery syndrome (FBSS) and recent data almost uniformly establishes its statistically significant positive therapeutic results. It has also been compared with other available treatment modalities across various studies. However, long term data on maintenance of its efficacious potential remains less explored. Few studies have reported data on long follow-up times (>= 12 months) and have compared its efficacy with other treatment options for chronic pain, respectively. Our study pools and analyzes the available data and compares SCS with other treatment options. It also analyzes the efficacy of SCS in long term management of patients with chronic pain., Evidence Acquisition: We reviewed all the data available on MEDLINE, Embase and Cochrane CENTRAL using a search strategy designed to fit our pre-set inclusion and exclusion criteria. Both single-arm and double-arm studies were included. The primary outcome was defined as decrease of visual analogue scale (VAS) by >50% at 6, 12 and/or 24 months after SCS., Evidence Synthesis: According to the pooled data of double-arm studies, SCS has unanimously proven its superiority over other treatment options at 6 months follow-up; however it fails to prove statistically significant difference in results at longer treatment intervals. Dorsal root ganglion stimulation, a relatively recent technique with the same underlying physiologic mechanisms as SCS, showed far more promising results than SCS. Single-arm studies show around 70% patients experiencing greater than 50% reduction in their VAS scores at 6 and 12 months., Conclusions: SCS is a viable option for management of chronic neuropathic pain secondary to FBSS and CRPS. However, data available for its long term efficacy remains scarce and show no further statistically significant results.

Objective: This case series retrospectively reviewed the outcomes in patients implanted with combined, synchronous dorsal root ganglion stimulation (DRGS) and spinal cord stimulation (SCS) connected to a single implantable pulse generator (IPG) in a tertiary referral neuromodulation centre in the United Kingdom., Methods: Twenty-six patients underwent a trial of DRGS+SCS for treating focal neuropathic pain between January 2016 and December 2019, with a follow-up in February 2022. A Transgrade approach was employed for DRGS. Patients were provided with 3 possible stimulation programs: DRGS-only, SCS-only, or DRGS+SCS. Patients were assessed for pain intensity, patients' global impression of change (PGIC), preferred lead(s) and complications., Results: Twenty patients were successful and went on for full implantation. The most common diagnosis was Complex Regional Pain Syndrome. After an average of 3.1 years follow-up, 1 patient was lost to follow-up, and 2 were non-responders. Of the remaining 17 patients, 16 (94%) continued to report a PGIC of 7. The average pain intensity at Baseline was 8.5 on an NRS scale of 0-10. At the last follow-up, the average NRS reduction overall was 78.9% with no statistical difference between those preferring DRGS+SCS (n = 9), SCS-only (n = 3) and DRGS-only (n = 5). The combination of DRGS+SCS was preferred by 53% at the last follow-up. There were no serious neurological complications., Conclusions: This retrospective case series demonstrates the potential effectiveness of combined DRGS+SCS with sustained analgesia observed at an average follow-up of over 3 years. Implanting combined DRGS+SCS may provide programming flexibility and therapeutic alternatives., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Treatment of persistent spinal pain syndrome (PSPS) is challenging. Chronic pain associated with PSPS can lead to an impaired ability to work., Objective: To obtain information on whether receiving a disability pension (DP) affects pain and pain treatments in retiring working-age PSPS patients. Neuropathic pain medication and antidepressant use were considered as an indicator of neuropathic pain., Methods: The study group comprised 129 consecutive PSPS patients with spinal cord stimulation (SCS) devices implanted at Kuopio University Hospital Neurosurgery between January 1, 1996, and December 31, 2014. Purchase data of gabapentinoids, tricyclic antidepressants, and serotonin-norepinephrine reuptake inhibitors from January 1995 to March 2016, as well as the data on working ability, were retrieved from national registries., Results: The data showed that 28 of 129 (21.7%) SCS permanent patients had a DP, and 27 had a sufficient follow-up time (two years before and one year after DP). Most patients (61%) used neuropathic pain medications during the follow-up, while 44% used antidepressants. Most patients (70%, n  = 19) retired because of dorsopathies. The dose of gabapentinoids started to increase before the DP; after the DP, the doses started to increase again after the decrease but remained at a lower level., Conclusions: Neuropathic pain medication and antidepressant use suggest that pain continues after the DP-that is, pensioners continue to experience inconvenient chronic pain. Resources for patient care are therefore needed after the DP. However, the DP reduces the dose increase of gabapentinoids; the dose is higher immediately before retirement than at the end of the follow-up., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2024 Hanna Kaijankoski et al.)

Background: The increased availability of web-based medical information has encouraged patients with chronic pain to seek health care information from multiple sources, such as consultation with health care providers combined with web-based information. The type and quality of information that is available on the web is very heterogeneous, in terms of content, reliability, and trustworthiness. To date, no studies have evaluated what information is available about neuromodulation on the web for patients with chronic pain., Objective: This study aims to explore the type, quality, and content of web-based information regarding spinal cord stimulation (SCS) for chronic pain that is freely available and targeted at health care consumers., Methods: The social listening tool Awario was used to search Facebook (Meta Platforms, Inc), Twitter (Twitter, Inc), YouTube (Google LLC), Instagram (Meta Platforms, Inc), blogs, and the web for suitable hits with "pain" and "neuromodulation" as keywords. Quality appraisal of the extracted information was performed using the DISCERN instrument. A thematic analysis through inductive coding was conducted., Results: The initial search identified 2174 entries, of which 630 (28.98%) entries were eventually withheld, which could be categorized as web pages, including news and blogs (114/630, 18.1%); Reddit (Reddit, Inc) posts (32/630, 5.1%); Vimeo (Vimeo, Inc) hits (38/630, 6%); or YouTube (Google LLC) hits (446/630, 70.8%). Most posts originated in the United States (519/630, 82.4%). Regarding the content of information, 66.2% (383/579) of the entries discussed (fully discussed or partially discussed) how SCS works. In total, 55.6% (322/579) of the entries did not elaborate on the fact that there may be >1 potential treatment choice and 47.7% (276/579) did not discuss the influence of SCS on the overall quality of life. The inductive coding revealed 4 main themes. The first theme of pain and the burden of pain (1274/8886, 14.34% coding references) explained about pain, pain management, individual impact of pain, and patient experiences. The second theme included neuromodulation as a treatment approach (3258/8886, 36.66% coding references), incorporating the background on neuromodulation, patient-centered care, SCS therapy, and risks. Third, several device-related aspects (1722/8886, 19.38% coding references) were presented. As a final theme, patient benefits and testimonials of treatment with SCS (2632/8886, 29.62% coding references) were revealed with subthemes regarding patient benefits, eligibility, and testimonials and expectations., Conclusions: Health care consumers have access to web-based information about SCS, where details about the surgical procedures, the type of material, working mechanisms, risks, patient expectations, testimonials, and the potential benefits of this therapy are discussed. The reliability, trustworthiness, and correctness of web-based sources should be carefully considered before automatically relying on the content., (©Maarten Moens, Leen Van Doorslaer, Maxime Billot, Edgard Eeckman, Manuel Roulaud, Philippe Rigoard, Maaike Fobelets, Lisa Goudman. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 30.01.2024.)

Background: Neuromodulation is a standard and well-accepted treatment for chronic refractory neuropathic pain. There has been progressive innovation in the field over the last decade, particularly in areas of spinal cord stimulation (SCS) and dorsal root ganglion stimulation. Improved outcomes using proprietary waveforms have become customary in the field, leading to an unprecedented expansion of these products and a plethora of options for the management of pain. Although advances in waveform technology have improved our fundamental understanding of neuromodulation, a scoping review describing new energy platforms and their associated clinical effects and outcomes is needed. The authors submit that understanding electrophysiological neuromodulation may be important for clinical decision-making and programming selection for personalized patient care., Objective: This review aims to characterize ways differences in mechanism of action and clinical outcomes of current spinal neuromodulation products may affect contemporary clinical decision-making while outlining a possible path for the future SCS., Study Design: The study is a scoping review of the literature about newer generation SCS waveforms., Materials and Methods: A literature report was performed on PubMed and chapters to include articles on spine neuromodulation mechanism of action and efficacy., Results: A total of 8469 studies were identified, 75 of which were included for the scoping review after keywords defining recent waveform technology were added., Conclusions: Clinical data suggest that neuromodulation remains a promising tool in the treatment of chronic pain. The evidence for SCS for treating chronic pain seems compelling; however, more long-term and comparative data are needed for a comparison of waveforms when it comes to the etiology of pain. In addition, an exploration into combination waveform therapy and waveform cycling may be paramount for future clinical studies and the development of new technologies., Competing Interests: Conflict of Interest Sayed E. Wahezi is a consultant for Boston Scientific and receives research funding from Vertos, Boston Scientific, and Abbott. Dr. Wahezi has filed for a neuromodulation patent during the production of this manuscript. Corey W. Hunter is a consultant for Abbott, Averitas, Biotronik, Boston Scientific, Mainstay, Nalu, PainTEQ, Saluda, SKK, and Vivex and holds stock and/or stock options with Mainstay, Nalu, PainTEQ, Spine Biopharma, and Vivex. Magdalena Anitescu reports consulting fees from Boston Scientific and Medtronic. Lynn Kohan reports consulting fees from Avanos. The remaining authors have no conflict of interest to report., (Copyright © 2023 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Conflict of Interest The reSearch and TeachIng neuromodulation Uz bruSsel (STIMULUS) consortium received independent research grants from Medtronic. Lisa Goudman is a postdoctoral research fellow funded by the Research Foundation Flanders, Belgium (project number 12ZF622N).

Introduction: Neuromodulation has emerged as a promising therapy for the management of chronic pain, movement disorders, and other neurological conditions. Spinal cord stimulation (SCS) is a widely used form of neuromodulation that involves the delivery of electrical impulses to the spinal cord to modulate the transmission of pain signals to the brain. In recent years, there has been increasing interest in the use of automation systems to improve the efficacy and safety of SCS. This narrative review summarizes the status of Food and Drug Administration-approved autonomous neuromodulation devices including closed loop, feedforward, and feedback systems. The review discusses the advantages and disadvantages of each system and focuses specifically on the use of these systems for SCS. It is important for clinicians to understand the expanding role of automation in neuromodulation in order to select appropriate therapies founded on automation systems to the specific needs of the patient and the underlying condition., Conclusion: The review also provides insights into the current state of the art in neuromodulation automation systems and discusses potential future directions for research in this field., (© 2023 The Authors. Pain Practice published by Wiley Periodicals LLC on behalf of World Institute of Pain.)

Background: Ninety-Hz active-recharge spinal cord stimulation (SCS) applied at below sensory-threshold intensity, as used with fast-acting subperception therapy spinal cord stimulation, has been shown clinically to produce significant analgesia, but additional characterization is required to better understand the therapy. This preclinical study investigates the behavioral effect of multiple 90-Hz SCS variants in a rodent model of neuropathic pain, focusing on charge balance and the relationship between 90-Hz efficacy and stimulation intensity., Materials and Methods: Rats (n = 24) received a unilateral partial sciatic nerve ligation to induce neuropathic pain and were implanted with a quadripolar lead at T13. Mechanical hypersensitivity was assessed before, during, and after 60 minutes of SCS. After a prescreen with 50-Hz SCS 67% motor threshold ([MT], the positive control), rats underwent a randomized-crossover study including sham SCS and several 90-Hz SCS paradigms (at 40% MT or 60% MT, either using active or pseudopassive recharge) (experiment 1, n = 16). A second, identical experiment (experiment 2) was performed to supplement data with 90-Hz SCS at 20% and 80% MT (experiment 2, n = 8)., Results: Experiment 1: At 40% MT, 90-Hz active-recharge SCS produced a significantly larger recovery to baseline than did 90-Hz pseudopassive SCS at both tested intensities and sham SCS. Experiment 2: Only the 90-Hz SCS active recharge at 40% MT and 50-Hz SCS positive control caused mean recovery to baseline that was statistically better than that of sham SCS., Conclusions: The degree to which 90-Hz SCS reduced mechanical hypersensitivity during stimulation depended on the nature of charge balance, with 90-Hz active-recharge SCS generating better responses than did 90-Hz pseudopassive recharge SCS. In addition, our findings suggest that the amplitude of 90-Hz active-recharge SCS must be carefully configured for efficacy., Competing Interests: Conflict of Interest Tianhe C. Zhang and Rosana Esteller are employees of Boson Scientific Inc. Elbert A. Joosten is a consultant for Boston Scientific Inc. Lonne Heijmans reported no conflict of interest., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: Recent developments in spinal cord stimulation (SCS) programming have initiated new modalities of imperceptible stimulation. However, the boundaries of sensory perception are not well defined. The BEnchtop NEuromodulation Following endIng of Trial study aimed to create a map of perceptual threshold responses across a broad range of SCS parameters and programming to inform subperception therapy design., Materials and Methods: This multicenter study was conducted at seven US sites. A total of 43 patients with low back and/or leg pain who completed a percutaneous commercial SCS trial were enrolled. Test stimulation was delivered through trial leads for approximately 90 minutes before removal. SCS parameters, including amplitude, frequency, pulse width (PW), electrode configuration, cycling, and multifrequency stimulation were varied during testing. Paresthesia threshold (PT), comfort level (CL), perceptual coverage area, and paresthesia quality (through patient selection of keywords) were collected. Differences were evaluated with analysis of variance followed by post hoc multiple comparisons using t-tests with Bonferroni correction., Results: PT was primarily determined by PW and was insensitive to frequency for constant frequency stimulation (range: 20 Hz-10 kHz; F(1284) = 69.58, p < 0.0001). For all tests, CL was approximately 25% higher than PT. The dominant variable that influenced paresthesia quality was frequency. Sensations described as comfortable and tingling were most common for frequencies between 60 Hz and 2.4 kHz; unpleasant sensations were generally more common outside this range. Increasing distance between active electrodes from 7 mm to 14 mm, or cycling the SCS waveform at 1 Hz, decreased PT (p < 0.0001). Finally, PT for a low-frequency stimulus (ie, 60 Hz) was unaffected by mixing with a sub-PT high-frequency stimulus., Conclusions: In contrast to previous work investigating narrower ranges, PW primarily influenced PT, independently of frequency. Paresthesia quality was primarily influenced by pulse frequency. These findings advance our understanding of SCS therapy and may be used to improve future novel neuromodulation paradigms., Competing Interests: Conflict of Interest John Hatheway has received funding from Medtronic, Nalu, Biotronik, and Boston Scientific. Michael Yang has consulted for and participated in research sponsored by Boston Scientific and Nevro, as well as participated in research sponsored by Saluda. Michael Fishman was a former Director for North American Neuromodulation Society and has consulted for Abbott, Neuromodulation, Aurora Pain Care, Biotronik, Bridge Therapeutics, Brixton Biosciences, Institute for Musculoskeletal Education, Medtronic, and Saluda Medical; is the cofounder of Celéri Health and Occam’s Razor and holds stock for Celéri Health, Occam’s Razor, Aurora Spine, and Thermaquil; has conducted research with Abbott, Biotronik, Boston Scientific, Foundation Fusion Solutions (Cornerloc), InterAxon, Medtronic, Nalu Medical, PainQX, Seikagaku, SGX Medical, and Thermaquil; is an employee of the Center for International Pain & Spine, and his spouse is an employee of Global Medical. Michael Verdolin has consulted for Medtronic, Vertiflex, and Boston Scientific. Tory McJunkin has consulted for Nevro and has conducted research with Nevro and Saluda. Steven Rosen has conducted research with Saluda and Boston Scientific and has consulted for Flowonix. Sean Slee and Andrew Kibler are paid employees of BIOTRONIK NRO, Inc, a subsidiary of BIOTRONIK SE & Co. KG. Kasra Amirdelfan has consulted for Medtronic, Boston Scientific, Nevro, Biotronik, and Nalu, and holds minor options for Nalu., (Copyright © 2023. Published by Elsevier Inc.)

Objectives: Psychologic screening is often included as a mandatory component of evaluation of the impact of psychopathology disorders on the predicted outcome of spinal cord stimulation (SCS) for patients with chronic pain due to persistent spinal pain syndrome type 2 (PSPS type 2). The conclusion of such screenings can influence the decision to offer SCS therapy to a patient. However, evidence on the impact of psychopathology on SCS outcomes is still scarce., Materials and Methods: To address this knowledge gap, we systematically reviewed the literature from 2009 to 2021 to explore the correlation between the presence of a psychopathological disorder and the predicted outcome of SCS in patients with PSPS type 2. The literature search was conducted using various online data bases with "failed back surgery syndrome," "psychopathology," and "spinal cord stimulation" used as essential keywords. The identified studies were organized in a Rayyan AI data base, and the quality was analyzed with the Critical Appraisal Skills Program tool., Results: Our search generated the identification of 468 original articles, of which two prospective and four retrospective studies met our inclusion criteria. These studies reported pain relief, a reduction of symptoms of anxiety and depression, and an improvement in rumination on the Pain Catastrophizing Scale in patients with PSPS type 2 after SCS therapy. The studies also found contradictory outcomes measured using the Oswestry Disability Index, and in terms of the impact of psychopathological disorder on the clinical outcome and revision rate of the SCS system., Conclusion: In this systematic review, we found no convincing evidence that the presence of a psychopathological disorder affects the predicted outcome of SCS therapy in patients with PSPS type 2., (Copyright © 2023 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Objectives: Chronic low back pain (CLBP) is one of the most common chronic pain conditions that cause both individual suffering and a burden to society. For these patients, several interventional treatment options such as surgery, blocks, radiofrequency, and spinal cord stimulation are available. Lately, dorsal root ganglion stimulation (DRG-S) also has been mentioned as an option by targeting bilateral T12 dorsal ganglia. In this study, we present the outcome of 11 patients with CLBP treated with bilateral T12 DRG-S., Materials and Methods: Thirteen patients with CLBP with and without leg pain were treated with bilateral T12 DRG-S. Three of the patients also received a third lumbar lead owing to leg pain. Eleven of the patients had >50% pain relief during the peri- or/and postoperative testing and received a fully implantable neurostimulator. Pain intensity, general health status, quality of life, pain catastrophizing, mental status, sleeping disorder, physical activity, and patient satisfaction were followed using numeric rating scale (NRS), Patient-Reported Outcomes Measurement Information System 29 version 2.1, Pain Catastrophizing Score, Generalized Anxiety Disorder 7-item scale, Patient Health Questionnaire Depression Module, Insomnia Severity Index, and Patient Satisfaction Questionnaire at baseline before implantation and at three months and six months. The results were analyzed on the basis of six domains: pain relief, sleeping disorder, social ability, mental status, physical activity, and satisfaction. To be identified as a responder, the patients should show a significant improvement in the pain relief domain together with at least two other domains. All responders also were given the opportunity to test 4-Hz DRG-S and compare it with traditional 20-Hz stimulation., Results: All 11 patients were identified as responders at six months. Five of the patients had >80% pain relief, with an average NRS score reduction of 71% for the whole group. Significant improvement could be observed in three domains for one patient, four domains for three patients, five domains for six patients, and six domains for one patient. Seven patients chose to try 4-Hz stimulation. All seven identified 4-Hz stimulation as at least as good as or better than 20-Hz stimulation and chose to continue with 4-Hz stimulation., Conclusions: Bilateral T12 DRG-S seems to be an effective treatment for chronic low back pain, with significant beneficial effect not only on pain but also on quality of life, pain catastrophizing, mental status, sleeping disorder, and physical activity. 4-Hz DRG-S gave a result comparable with or better than 20-Hz stimulation., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Chronic postsurgical pain is a considerable source of disabling neuropathic pain. Rates of knee replacement surgeries are increasing, and many patients report chronic postsurgical pain in their wake. When conventional therapies prove ineffective, neuromodulation options such as dorsal root ganglion stimulation (DRGS) may be used. However, little is known about the effect of DRGS on improvements in quantitative functional outcome parameters., Materials and Methods: In a prospective observational study at two pain centers, patients with chronic postsurgical knee pain underwent implantation with a DRGS system after an interdisciplinary multimodal pain program. Ratings of pain, mood, quality of life, and function were captured at baseline and through 12 months of treatment. Quantitative measures (range of motion, walking distance, and pain medication usage) were also recorded., Results: Visual analog scale ratings of pain decreased from 8.6 to 3.0 (p < 0.0001; N = 11), and other pain measures agreed. Quality of life on the 36-Item Short Form Health Survey questionnaire improved from 69.3 to 87.6 (p < 0.0001), whereas the improvement in depression ratings was nonsignificant. International Knee Documentation Committee questionnaire ratings of function improved from 27.7 to 51.7 (p < 0.0001), which aligned with other functional measures. On average, knee range of motion improved by 24.5°, and walking distance dramatically increased from 125 meters to 1481. Cessation of opioids, antidepressants, and/or anticonvulsants was achieved by 73% of participants., Conclusions: Both subjective-based questionnaire and quantitative examination-based variables were in broad agreement on the value of DRGS in improving functionality and chronic postsurgical pain in the knee. Although this finding is limited by the small sample size, this intervention may have utility in the many cases in which pain becomes problematic after orthopedic knee surgery., (Copyright © 2022 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Background and Objectives: In case of the ineffectiveness of pharmacological and non-pharmacological treatments in managing chronic neuropathic pain, spinal cord stimulation (SCS) with BurstDR™ stimulation may reduce pain and increase the quality of life. The term "burst" refers to a series of stimulation impulses that are compressed into small packets and separated by intervals of latency. Materials and Methods : A group of 30 consecutive patients who received the BurstDR™ stimulator using the minimally invasive percutaneous method was selected. Patients selected for our study underwent numerous spinal surgeries before SCS implantation. In the study, analgesics and co-analgesics and their doses used by patients before and 6 months after SCS implantation were examined and compared. Using the visual analogue scale (VAS), pain was compared before and after the procedure. Patients` quality of life was assessed using the Oswestry Disability Index (ODI). Results: We observed a significant reduction in opioid daily doses by an average of 32.4% (±36.1%) and a reduction in paracetamol daily doses by an average of 40% (±33.4%). There was a reduction in pregabalin doses as well. Ketoprofen daily dose reduction was 85.4 mg. The mean VAS difference before and after procedure was 3.9 (±2.3), and the mean difference in ODI was 12.9 (±9), which benefits operative treatment. The VAS and ODI results were statistically significant as well. Conclusions: According to our research, BurstDR™ stimulation improves the quality of life by reducing doses of analgesics and the level of pain.

Objectives: The purpose of this study was to evaluate analgesic and safety considerations for high thoracic and cervical dorsal root ganglion (DRG) neuromodulation for complex regional pain syndrome (CRPS). We hypothesized that DRG neuromodulation would provide sustained analgesia with complications like that of low thoracic or lumbar electrode implantation., Materials and Methods: A single-center, retrospective study was conducted of patients with CRPS I or II of the upper extremities, refractory to previous therapies, who were treated with DRG neuromodulation in the upper thoracic and cervical spine. The primary outcome was successful DRG therapy, defined as ≥ 50% pain relief on a Numeric Rating Scale (NRS) 0 to 10 pain scale at six months after implantation. A secondary outcome was a reduction in daily opioid use after DRG therapy., Results: After a DRG stimulation trial, 17 of 20 patients (85%) had ≥ 50% improvement in NRS pain and underwent a permanent pulse generator implant, with 100% endorsing ≥ 50% pain relief at six months. Mean NRS pain scores before DRG neuromodulation were 9.3 ± 1.1, with a mean reduction of 5.5 (95% CI, 4.5-6.6; p < 0.001) at six months. Ten patients were taking opioids at baseline; the median (interquartile range) dose was 45 mg (23 to 120) morphine equivalents (MME), which was reduced to 20 MME (15 to 40) at six months. The median reduction in daily MME use was -25 (95% CI, -100 to 20; p = 0.099). Six of 20 patients (30%) experienced a complication: three had lead migration; two experienced paresthesias; and one had a reduction in shoulder mobility. One patient had symptoms of a reversible spinal cord compression immediately after implant, requiring emergent electrode removal., Conclusions: DRG neuromodulation for patients with CRPS of the upper extremities produced clinically important analgesia and reduced opioid use for ≥ six months but was associated with one serious complication., (Copyright © 2023. Published by Elsevier Inc.)

Background: Neuromodulation has been successfully used globally to address severe refractory chronic pain for over five decades. Compared to the wide acceptance that it enjoys in United States and Europe, it is fairly underutilized in Asia, including India., Objectives: We conducted the first systematic nationwide survey to provide an overview of neuromodulation in the past 20 years to investigate the practice trends for severe refractory chronic pain and barriers for the uptake of neuromodulation therapies for pain in India., Design: A 20-point detailed questionnaire survey was sent out for online completion in August 2020 to practitioners in India involved in interventions for pain. The survey was completed by 112 practitioners (10% return rate). The response data collected were analyzed, tabulated, and presented as percentages., Results: The average duration of pain practice in India for the majority of respondents was less than a decade. About 70% of practitioners expressed that they manage severe refractory pain without neuromodulation. This survey confirms that neuromodulation is grossly underutilized for pain, comprising only 10% of total neuromodulation implants performed per annum in India. The most common indications were neuropathic pain (45%) and failed back surgery syndrome (42%). The respondents expressed the main barriers to be related to the cost (85%), lack of awareness (68%), and lack of good training (59%). More than 50% of respondents also expressed difficulty of access to neuromodulation therapies for pain and acceptance by patients., Conclusion: The younger generation of pain practitioners in India is becoming more aware and convinced about the role of neuromodulation to alleviate severe pain and suffering. An all-round approach combining improved training, awareness at various levels, more flexible options of newer technology and reimbursement approval can positively influence its use. This can be achieved with the collective efforts of physicians, insurers, industry, and focused academic activities of clinical societies., (Copyright © 2022 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)