NeuromodulationPub Date : 2025-02-01Epub Date: 2024-09-27DOI: 10.1016/j.neurom.2024.08.009
Lisa Goudman, Philippe Rigoard, Manuel Roulaud, Konstantin Slavin, Marc Russo, Maxime Billot, Maarten Moens
{"title":"The Opinion of Healthcare Professionals About a Proposed European Registry of Neuromodulation for Chronic Pain: An Online Survey.","authors":"Lisa Goudman, Philippe Rigoard, Manuel Roulaud, Konstantin Slavin, Marc Russo, Maxime Billot, Maarten Moens","doi":"10.1016/j.neurom.2024.08.009","DOIUrl":"10.1016/j.neurom.2024.08.009","url":null,"abstract":"<p><strong>Introduction: </strong>During the last decade, the complementary value of real-world data (through registries or medical records) and data from randomized clinical trials has been recognized as increasingly important. In the field of neuromodulation, only a few industry-independent nationwide neuromodulation registries are available. The interest in creating a European registry has increased but without a successful result. The goal of this online survey is to gain further insights into the need for and burden of a European registry for neuromodulation.</p><p><strong>Materials and methods: </strong>An online survey was developed and distributed during the 3rd Joint Congress of the International Neuromodulation Society European Chapters in September 2023 (Hamburg, Germany). Healthcare professionals were asked to indicate the need for a European registry, the items that should be collected, and the restrictions to access of a European registry.</p><p><strong>Results: </strong>In total, 125 respondents opened the link to the survey, of whom 104 completed (at least partly) the survey. Of the 104 responses, 91% indicated that there is a need for a European registry, whereas 6% indicated there is no need. The main reasons for establishing a registry on a European level were the possibility of collecting real-world evidence (84%), the potential to collect big data from European patients (82%), to evaluate safety in neuromodulation (70%), and the possibility of reporting yearly on European activity in neuromodulation (51%). Indications for neuromodulation, patient characteristics, and follow-up assessments were most often stated as items that should be collected. Access should not only be granted to implanters but also to nurses, the assessment team, and other physicians, as agreed on by 64%, 52%, and 51%, respectively.</p><p><strong>Discussion: </strong>More than 90% of the respondents believed that a European registry for neuromodulation is needed, mainly to obtain real-world (big) data about the effectiveness and safety of this therapy. This survey clearly pointed to the need for a European registry for which it seems key to ensure financial and logistical support, in addition to in-depth legal guidance in developing this registry.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":"362-368"},"PeriodicalIF":3.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142350819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NeuromodulationPub Date : 2025-02-01Epub Date: 2024-12-05DOI: 10.1016/j.neurom.2024.10.005
David A Provenzano, Esha A Vaidya, Jason S Kilgore
{"title":"Preoperative Magnetic Resonance Imaging Modifies Percutaneous Spinal Cord Stimulator Trial Progression and Planning.","authors":"David A Provenzano, Esha A Vaidya, Jason S Kilgore","doi":"10.1016/j.neurom.2024.10.005","DOIUrl":"10.1016/j.neurom.2024.10.005","url":null,"abstract":"<p><strong>Objective: </strong>Spinal cord stimulator (SCS) percutaneous lead placement has been effective in treating chronic limb, neck, and back pain. However, SCS lead placement poses a risk of neurologic injury, which may be attenuated with preprocedural magnetic resonance imaging (MRI) to identify potential spinal anatomical abnormalities (eg, central canal stenosis) that would either modify or prevent lead placement. However, a large-scale study of the clinical value of preoperative MRIs in percutaneous SCS lead placement is lacking.</p><p><strong>Materials and methods: </strong>A retrospective chart review of a single center identified patients who considered SCS percutaneous lead trials and had preprocedural MRIs. Patients' preprocedural MRIs were reviewed for spinal pathology and locations and severity of stenoses (mild, moderate, and severe) based on qualitative analysis that may affect lead placement. In addition, trial-related information and several demographic factors were analyzed with proportional analyses, logistic regressions, and relative risks (RR) to determine their association with stenosis.</p><p><strong>Results: </strong>Retrospective review identified 340 patients who considered an SCS trial with preprocedural MRIs. Preprocedural MRIs influenced SCS treatment for 7% of total patients (n = 25). Of these 25 patients, 60% (n = 15) had the trial technique altered, and 40% (n = 10) did not progress to trial owing to an MRI finding. Preprocedural MRIs were more likely to influence SCS trials for cervical cases than for thoracic/lumbar cases (RR = 4.6, 95% CI 2.2-9.5, p < 0.001). Clinical and demographic characteristics were associated with limited predictive capabilities for spinal stenosis. Specifically, logistic regression analyses revealed age group to be significantly (p ≤ 0.02) associated with moderate/severe cervical spinal stenosis and lumbar spinal stenosis, whereas only age was significantly (p ≤ 0.04) associated with moderate/severe thoracic spinal stenosis.</p><p><strong>Conclusion: </strong>Preprocedural MRIs did influence SCS trial progression. Given limited patient characteristics were significantly associated with a greater risk of stenosis at lead placement or entry zones, all patient populations should be considered for preprocedural MRIs examining lead entry and placement zones.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":"306-314"},"PeriodicalIF":3.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NeuromodulationPub Date : 2025-02-01Epub Date: 2024-05-16DOI: 10.1016/j.neurom.2024.03.007
Lizbeth A Leapo, Michael E Miller, Harry A Hoyen, Gilles C Pinault, Ronald J Triolo
{"title":"Implanted Pulse Generators in Lower Extremity Neuroprostheses: A 25-Year Review.","authors":"Lizbeth A Leapo, Michael E Miller, Harry A Hoyen, Gilles C Pinault, Ronald J Triolo","doi":"10.1016/j.neurom.2024.03.007","DOIUrl":"10.1016/j.neurom.2024.03.007","url":null,"abstract":"<p><strong>Objectives: </strong>Neuroprosthetic devices can improve quality of life by providing an alternative option for motor function lost after spinal cord injury, stroke, and other central nervous system disorders. The objective of this study is to analyze the outcomes of implanted pulse generators that our research group installed in volunteers with paralysis to assist with lower extremity function over a 25-year period, specifically, to determine survival rates and common modes of malfunction, reasons for removal or revision, and precipitating factors or external events that may have adversely influenced device performance.</p><p><strong>Materials and methods: </strong>Our implantable receiver-stimulator (IRS-8) and implantable stimulator-telemeter (IST-12 and IST-16) device histories were retrospectively reviewed through surgical notes, regulatory documentation, and manufacturing records from 1996 to 2021.</p><p><strong>Results: </strong>Most of the 65 devices (64.6%) implanted in 43 volunteers remain implanted and operational. Seven underwent explantation owing to infection; seven had internal failures, and six were physically broken by external events. Of the 22 devices explanted, 15 were successfully replaced to restore recipients' enhanced functionality. There were no instances of sepsis or major health complications. The five infections that followed all 93 IRS and IST lower extremity research surgeries during this period indicate a pooled infection rate of 5.4%. The Kaplan-Meier analysis of technical malfunctions between the implant date and most recent follow-up shows five-, ten-, and 20-year device survival rates of 92%, 84%, and 71%, respectively.</p><p><strong>Conclusions: </strong>Incidence of malfunction is similar to, whereas infection rates are slightly higher than, other commonly implanted medical devices. Future investigations will focus on infection prevention, modifying techniques on the basis of recipient demographics, lifestyle factors, and education, and integrating similar experience of motor neuroprostheses used in other applications.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":"331-340"},"PeriodicalIF":3.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140945169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NeuromodulationPub Date : 2025-02-01Epub Date: 2024-10-22DOI: 10.1016/j.neurom.2024.09.007
Marc A Russo, Willem Volschenk, Dominic Bailey, Danielle M Santarelli, Elizabeth Holliday, Daniel Barker, Jason Dizon, Brett Graham
{"title":"Twelve-Month Clinical Trial Results of a Novel, Dorsal Horn Dendrite Stimulation Waveform for Chronic Neuropathic Low Back Pain.","authors":"Marc A Russo, Willem Volschenk, Dominic Bailey, Danielle M Santarelli, Elizabeth Holliday, Daniel Barker, Jason Dizon, Brett Graham","doi":"10.1016/j.neurom.2024.09.007","DOIUrl":"10.1016/j.neurom.2024.09.007","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of this study was to evaluate the effectiveness and safety of a novel subperception spinal cord stimulation (SCS) waveform paradigm designed to target the dorsal horn dendrites for treating chronic neuropathic low back pain (LBP). The final 12-month results are reported here.</p><p><strong>Materials and methods: </strong>Twenty-seven participants were implanted with a commercial SCS system. Devices were programmed to deliver the waveform (frequency 100 Hz, pulse width 1000 μsec, T9-T10 disk bipole) at decreasing stimulation perception threshold amplitudes (80%, 60%, then 40%) over a 14-week period. Participants were blinded to the program settings. Participants then received their preferred program for further evaluation at 26 and 52 weeks after activation. Outcome measures included back pain score (visual analogue scale [VAS]), Brief Pain Inventory (BPI), EuroQol 5-Dimension 5-Level (EQ-5D-5L), 36-Item Short Form Health Survey (SF-36), treatment satisfaction, and clinician global impression of change (CGIC).</p><p><strong>Results: </strong>At 52 weeks (n = 24), the responder rate (≥50% pain relief) was 65.6%, and the high-responder rate (≥80% pain relief) was 56.5%. The mean change from baseline in pain VAS was -43.94 mm (95% CI -57.89, -30.00; p < 0.001) and mean pain relief was 64.69% ± 39.43%. BPI and SF-36 scores remained significantly improved (p ≤ 0.001). EQ-5D-5L index and EuroQoL-VAS further improved, and 87.0% of participants met the minimum clinically important difference for the EQ-5D-5L index. Treatment satisfaction was 83%, and 91% of participants had a CGIC rating of \"much improved\" or above. No serious study-related adverse events were reported.</p><p><strong>Conclusions: </strong>The 12-month trial results show sustained improvements in pain, quality of life, and health-related outcomes. This novel subperception dorsal horn dendrite SCS approach seems a safe and promising treatment option for patients with chronic neuropathic LBP. The open-source availability of this waveform on commercial SCS platforms allows widespread patient access. Further evaluation seems warranted.</p><p><strong>Clinical trial registration: </strong>The Clinicaltrials.gov registration number for the study is ACTRN12618000647235 (anzctr.org.au).</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":"263-273"},"PeriodicalIF":3.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142470918","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NeuromodulationPub Date : 2025-02-01Epub Date: 2024-07-09DOI: 10.1016/j.neurom.2024.06.004
Emilia Nejatbakhsh, Simon B Kristensen, Christian Scherer, Kaare Meier, Morten Blichfeldt-Eckhardt
{"title":"Does Spinal Cord Stimulation Improve Sleep Disturbances Independently of Pain Relief in Patients With Chronic Pain? An Explorative, Observational Study.","authors":"Emilia Nejatbakhsh, Simon B Kristensen, Christian Scherer, Kaare Meier, Morten Blichfeldt-Eckhardt","doi":"10.1016/j.neurom.2024.06.004","DOIUrl":"10.1016/j.neurom.2024.06.004","url":null,"abstract":"<p><strong>Objectives: </strong>Chronic pain poses a significant health challenge worldwide and is associated with both disability and reduced quality of life. Sleep disturbances are reported in 67% to 88% of patients with chronic pain. Pain and sleep affect each other reciprocally; we aimed to study this bidirectional relationship in patients treated with spinal cord stimulation (SCS) for chronic pain. Specifically, we investigated whether sleep improves after treatment with SCS and whether this improvement may be mediated by pain reduction.</p><p><strong>Materials and methods: </strong>An observational cohort study was conducted in patients with chronic neuropathic pain treated with SCS at a single neurosurgical department in Denmark. Outcomes were assessed preoperatively and at three, six, and 12 months postoperatively, and thereafter annually. Primary outcomes were pain intensity (numeric rating scale) and insomnia at first follow-up (Insomnia Severity Index). The association between sleep and pain was investigated using linear regression and mediation analysis.</p><p><strong>Results: </strong>Forty-three patients were included in the study. The mean insomnia score was reduced by 25% from 18.1 (SD 6.0) to 13.5 (SD 6.6) (p = 0.0001). Pain intensity was reduced 38% from 7.4 (SD 1.6) to 4.6 (SD 2.1) at the first follow-up (p ≤ 0.0001). Changes in pain and changes in insomnia scores were significantly but weakly associated (regression coefficient = 1.3, 95% CI [0.3; 2.2], p = 0.008, r<sup>2</sup> = 15.7%); and changes in pain score were not found to mediate changes in sleep score (β = -0.02, 95% CI [-0.15; 0.11], p = 0.76).</p><p><strong>Conclusions: </strong>We found that patients treated with SCS showed significant improvements in both insomnia and pain intensity at first follow-up. Improvements in insomnia and pain intensity were significantly but weakly associated, and improvements in pain intensity score did not mediate improvements in insomnia score. Thus, improvements in self-reported insomnia in patients treated with SCS for chronic pain may predominantly be caused by other factors than reduced pain intensity.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":"315-322"},"PeriodicalIF":3.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141559333","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NeuromodulationPub Date : 2025-02-01Epub Date: 2024-11-05DOI: 10.1016/j.neurom.2024.09.006
Ahmed J Awad, Molly M Murray, Justin L Morris, Peter A Pahapill
{"title":"The Retrograde Approach of Surgical Paddle-Lead Placement for Spinal Cord Stimulation.","authors":"Ahmed J Awad, Molly M Murray, Justin L Morris, Peter A Pahapill","doi":"10.1016/j.neurom.2024.09.006","DOIUrl":"10.1016/j.neurom.2024.09.006","url":null,"abstract":"<p><strong>Introduction: </strong>Standard anterograde placement of a surgical paddle lead (SPL) for spinal cord stimulation (SCS) can be challenging in patients with scarring from prior spine surgery, instrumentation obstructing the targeted level, or severe stenosis below the targeted level. One potential alternative is retrograde (caudal) insertion by performing laminotomies cephalad to the targeted levels. The literature is limited to only a small number of individual cases describing this technique. In this report, the authors present their experience over the last ten years of the retrograde insertion of SPLs for SCS.</p><p><strong>Materials and methods: </strong>This is a retrospective study of 298 consecutive surgical paddle implants performed by a single neurosurgeon from 2013 to 2023 in an academic medical center.</p><p><strong>Results: </strong>A total of 26 patients underwent retrograde insertion of SPLs. The average patient age was 61 years, with women comprising 58% of cases. Three different manufacturers were used. The retrograde approach was planned before surgery in 96% of cases. The indications for the retrograde approach were 1) scarring from current or prior SCS leads placed from below in the standard anterograde fashion (46%); 2) scarring from prior extensive spine surgery and/or instrumentation (42%); 3) anatomical considerations of scoliosis and stenosis below the targeted levels or the requirement of high cervical stimulation (8%); or 4) intraoperative decision due to extensive scarring during planned anterograde placement (4%). The targeted spinal regions were thoracic (88%) or cervical (12%). There was one case of lead migration that required revision surgery. There were no paddle-lead fractures or deep surgical site infections.</p><p><strong>Conclusions: </strong>The retrograde insertion of SPLs is a low-risk and feasible procedure that can be performed with minimal risk of lead migration, fracture, or deep surgical site infection. The retrograde strategy can be used in SPL trials or permanent placements.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":"323-330"},"PeriodicalIF":3.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142584012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NeuromodulationPub Date : 2025-02-01Epub Date: 2024-11-25DOI: 10.1016/j.neurom.2024.10.006
Peter D Vu, Steven Mach, Saba Javed
{"title":"Neurostimulation for the Treatment of Cancer-Induced Pain: A Scoping Review.","authors":"Peter D Vu, Steven Mach, Saba Javed","doi":"10.1016/j.neurom.2024.10.006","DOIUrl":"10.1016/j.neurom.2024.10.006","url":null,"abstract":"<p><strong>Objectives: </strong>Cancer pain is among the most prevalent and challenging symptoms in cancer care, with up to 95% of patients with late-stage cancer experiencing moderate-to-severe pain. Conventional pharmacologic treatments, including opioids, carry risks, and patients' conditions may be refractory to medical management or have contraindications. Neurostimulation techniques, such as spinal cord stimulation (SCS), dorsal root ganglion stimulation (DRGS), and peripheral nerve stimulation (PNS), have shown promise in treating treatment-induced cancer pain. However, a comprehensive review focusing on these techniques for cancer-induced pain alone is necessary.</p><p><strong>Materials and methods: </strong>A comprehensive literature review was conducted using Medline, Embase, and Cochrane Library data bases, focusing on studies from 2000 onward. Inclusion criteria included interventional and observational studies reporting on SCS, DRGS, and PNS in cancer-induced pain. Studies addressing treatment-induced pain, systematic reviews, meta-analyses, and non-English studies were excluded. Data were extracted and evaluated using the Grades of Recommendation, Assessment, Development, and Evaluation system.</p><p><strong>Results: </strong>The search yielded 831 references, with 24 studies meeting the inclusion criteria. Sixteen studies focused on SCS, seven on PNS, and two cases on DRGS. SCS showed significant pain reduction, with an average decrease in numeric rating scale (NRS) scores from 8.0 to 2.2 over an average 8.4-month follow-up period. PNS also indicated substantial pain relief, with NRS scores decreasing from 8.29 to 3.04 over an average 5.2-month follow-up period. DRGS, although less studied, showed a reduction in NRS scores from 6.0 to 1.0 over an average 6.0-month follow-up period. SCS was associated with a significant reduction in opioid use, with average reported morphine equivalent daily dose (MEDD) change from 1152.2 mg to 739.7 mg over an average 5.0-month period, whereas PNS and DRGS had limited impact on opioid consumption, with no reported MEDD change.</p><p><strong>Conclusions: </strong>Our scoping review synthesizes evidence on neurostimulation interventions for treating cancer-induced pain. Current evidence suggests that interventions such as SCS, DRGS, and PNS may provide clinically meaningful pain relief in patients with cancer-induced pain. Several studies also reported improvements in functionality and quality of life. However, the level of evidence is limited owing to the lack of prospective comparative studies, clinical and methodologic heterogeneity, and small sample sizes.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":"191-203"},"PeriodicalIF":3.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142731117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NeuromodulationPub Date : 2025-02-01Epub Date: 2023-04-29DOI: 10.1016/j.neurom.2023.03.015
Jianan Jian, Jicheng Wang, Bing Shen, Zhijun Shen, Khari Goosby, Joseph Scolieri, Jonathan Beckel, William C de Groat, Changfeng Tai
{"title":"Pudendal Nerve Block by Adaptively Stepwise Increasing the Intensity of High-Frequency (10 kHz) Biphasic Stimulation.","authors":"Jianan Jian, Jicheng Wang, Bing Shen, Zhijun Shen, Khari Goosby, Joseph Scolieri, Jonathan Beckel, William C de Groat, Changfeng Tai","doi":"10.1016/j.neurom.2023.03.015","DOIUrl":"10.1016/j.neurom.2023.03.015","url":null,"abstract":"<p><strong>Objective: </strong>The purpose of this study is to determine whether adaptively stepwise increasing the intensity of a high-frequency (10 kHz) biphasic stimulation (HFBS) can produce nerve conduction block without generating a large initial response.</p><p><strong>Materials and methods: </strong>In anesthetized cats, three cuff electrodes were implanted on the left pudendal nerve for stimulation or block. The urethral pressure increase induced by pudendal nerve stimulation was used to measure the pudendal nerve block induced by HFBS.</p><p><strong>Results: </strong>HFBS applied suddenly with a large step increase in intensity induced a large (86 ± 16 cmH<sub>2</sub>O) urethral pressure increase before it blocked pudendal nerve conduction. However, HFBS applied by adaptively stepwise increasing the intensity every 10 to 60 seconds over a long period (33-301 minutes; average 108 ± 35 minutes) with many small intensity increases (0.005-0.1 mA) induced no response or low-amplitude high-frequency urethral pressure changes before it blocked pudendal nerve conduction. The minimal HFBS intensities required by the two different methods to block pudendal nerve conduction are similar.</p><p><strong>Conclusion: </strong>This study is important for better understanding the possible mechanisms underlying the HFBS-induced nerve block and provides the possibility of developing a new nerve block method for clinical applications in which an initial large response is a concern.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":"249-255"},"PeriodicalIF":3.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10613126/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9416336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NeuromodulationPub Date : 2025-02-01Epub Date: 2024-12-10DOI: 10.1016/j.neurom.2024.10.011
Ian R Whittle, Derek Yull, Allen Huang, Sally Fish, Dani Chene, Michael Selby, Kyle Craig, Eleanor Clausen, Yun-Hom Yau
{"title":"Restorative Neurostimulation of the Multifidus for Chronic Low Back Pain After Prior Lumbar Spinal Surgery: A Single-Center, Consecutive Case Series.","authors":"Ian R Whittle, Derek Yull, Allen Huang, Sally Fish, Dani Chene, Michael Selby, Kyle Craig, Eleanor Clausen, Yun-Hom Yau","doi":"10.1016/j.neurom.2024.10.011","DOIUrl":"10.1016/j.neurom.2024.10.011","url":null,"abstract":"<p><strong>Objectives: </strong>Restorative neurostimulation of the lumbar multifidus muscle is a novel therapy for chronic nonspecific low back pain (CLBP). Previous studies have excluded patients with prior lumbar surgery. In this study, we describe outcomes in patients with CLBP after prior lumbar surgery.</p><p><strong>Materials and methods: </strong>This was a single-center, consecutive case series. The primary outcome measure was the change from baseline numeric rating score (NRS) for low back pain (LBP) and Oswestry Disability Index (ODI) in the first 12 months after treatment. Secondary outcomes were number of patients having minimal clinically important difference (MCID) in NRS and ODI scores, Short Assessment of Patient Satisfaction with their management, relationships between type of prior surgery and outcome, and incidence of adverse events.</p><p><strong>Results: </strong>The cohort comprised 26 patients (12 men; 14 women; mean age 56 years) who had their lumbar surgery a mean 6.9 years previously; 16 were followed up for 12 months and nine for >six months. One patient (3.6%) had a postoperative infection and required device removal. Both mean ODI and LBP NRS and their 95% CIs decreased serially from baseline 41.8 (36.5-46.5) to 29.3 (22.1-36.6) at six months and 28.1 (21.8-34.4) at 12 months (ODI), and from 6.4 (5.5-7.0), 3.8 (3.1-4.6) and 3.6 (2.5-4.7), respectively, for NRS. Patient levels of satisfaction with treatment were very high. MCIDs were observed in ten patients (40%) who experienced improvement in both their ODI (by >10) and NRS (by >2), and in ten patients who experienced improvement in one of these variables but not the other. The type of prior lumbar surgery did not influence outcomes. There were no device-related complications.</p><p><strong>Conclusions: </strong>The early outcome profiles after restorative neurostimulation after lumbar spinal surgery are similar to those reported in patients without prior surgery. Further prospective clinical studies are required to establish the validity of these findings.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":"297-305"},"PeriodicalIF":3.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NeuromodulationPub Date : 2025-02-01Epub Date: 2024-10-11DOI: 10.1016/j.neurom.2024.08.011
Jay Karri, Eellan Sivanesan, Amitabh Gulati, Vinita Singh, Soun Sheen, Bhavana Yalamuru, Eric J Wang, Saba Javed, Matthew Chung, Rohan Sohini, Nasir Hussain, Ryan S D'Souza
{"title":"Peripheral Nerve Stimulation for Pain Management: A Survey of Clinical Practice Patterns.","authors":"Jay Karri, Eellan Sivanesan, Amitabh Gulati, Vinita Singh, Soun Sheen, Bhavana Yalamuru, Eric J Wang, Saba Javed, Matthew Chung, Rohan Sohini, Nasir Hussain, Ryan S D'Souza","doi":"10.1016/j.neurom.2024.08.011","DOIUrl":"10.1016/j.neurom.2024.08.011","url":null,"abstract":"<p><strong>Background: </strong>Clinical interest in and utilization of peripheral nerve stimulation (PNS) for treating chronic pain has significantly increased in recent years owing to its potential for providing analgesia and improved function and quality of life in comparison with pharmacologic treatments. However, the relative infancy of PNS-specific systems and limited clinical practice guidance likely contribute to significant variation in PNS utilization patterns.</p><p><strong>Objectives: </strong>We sought to conduct a survey study to characterize PNS-specific clinical practices and propose the next steps in standardizing key practices for PNS utilization.</p><p><strong>Materials and methods: </strong>A 19-question survey exploring PNS-relevant clinical parameters was disseminated online to pain physicians in practice. Descriptive statistics were used to summarize results.</p><p><strong>Results: </strong>A total of 94 responses were collected. Regarding patient selection, most practitioners would apply PNS to treat nociceptive pain from major joint osteoarthritis (77.7%) and chronic low back pain (64.9%), but not for axial neck pain (50.0%). In contrast, most would apply PNS to treat neuropathic pain from peripheral neuralgia (94.7%), pericranial neuralgia (77.7%), and cancer-related neuropathic pain (64.9%). In treating complex regional pain syndrome, most practitioners would apply PNS before all other forms of neuraxial neuromodulation (>50% for each form). Similarly, for treating nonsurgical low back pain, most would apply PNS before neuraxial neuromodulation (>50% for each form) but not before radiofrequency ablation (19.2%). Most routinely performed nerve blocks before PNS, mainly to confirm anatomical coverage (84.0%), and regarded a 50% to 75% interquartile range as the minimum analgesic benefit required before proceeding with PNS. Regarding nerve target selection for treating complex regional pain syndrome of the wrist/hand or ankle/foot, or knee osteoarthritis, we observed a very wide variance of PNS target locations and discrete nerves. Regarding \"minor\" adverse events, most reported not changing PNS utilization on encountering skin/soft tissue reactions (85.1%), minor infections (76.6%), or lead migration/loss of efficacy (50.0%). In comparison, most reported reducing PNS utilization on encountering skin erosion (58.5%), major infections (58.5%), or lead fractures (41.5%).</p><p><strong>Conclusions: </strong>There is significant practice variation regarding the utilization of PNS across numerous key clinical considerations. Future research that explores the reasons driving these differences might help optimize patient selection, target selection, periprocedural management, and ultimately outcomes.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":"348-361"},"PeriodicalIF":3.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142470840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}