Neuromodulation最新文献

{"title":"Assessing the Efficacy of Spinal Cord Stimulation in Managing Painful Diabetic Neuropathy: A Systematic Review and Meta-Analysis.","authors":"Abdallah Abbas, Moaz Abouelmagd, Mohamed El-Moslemani, Ahmed Diaa, Ahmed Samir, Mohamed Hatem Ellabban, Ali Bakr, Amira M Taha, Mahmoud Tarek Hefnawy, Mostafa Hossam El Din Moawad, Dina Essam Abo-Elnour, Amna Hussein, Hoda Awad, Alaa Rashad, Ahmed Negida, Ahmed M Raslan","doi":"10.1016/j.neurom.2025.01.016","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.01.016","url":null,"abstract":"<p><strong>Background: </strong>Diabetes mellitus affects more than half a billion people globally, often leading to painful diabetic neuropathy (PDN). Spinal cord stimulation (SCS) has emerged as a promising treatment for PDN.</p><p><strong>Objective: </strong>This meta-analysis evaluated the efficacy of SCS compared with the best medical therapy (BMT) for PDN.</p><p><strong>Materials and methods: </strong>Following the Preferred Reporting Items of Systematic reviews and Meta-Analyses guidelines, a systematic search of the PubMed, Scopus, Web of Science, Embase, and Cochrane CENTRAL data bases was conducted up to December 1, 2023 and updated on January 2, 2025. Data extraction was performed using Microsoft Excel, and quality assessment was conducted using Cochrane's Risk of Bias 2.0 and ROBINS-1 tools. Statistical analysis and heterogeneity assessment were performed using Review Manager (RevMan) software (The Cochrane Collaboration, London, UK).</p><p><strong>Results: </strong>Nine clinical trials involving 407 patients were included. The analysis revealed significant pain reduction in the SCS group (mean difference [MD]: -5.46, 95% CI: [-6.09, -4.83], p < 0.00001). Subgroup analysis indicated pain relief benefits in both conventional SCS (MD: -4.176, 95% CI: [-4.865, -3.486], p < 0.001) and 10-kHz SCS (MD: -4.581, 95% CI: [-6.376, -2.785], p < 0.001). SCS also achieved higher treatment success rates (≥50% pain relief) than did BMT (risk difference: 0.59, 95% CI: [0.33, 0.85], p < 0.00001). Moreover, SCS significantly improved the EuroQol-5 Dimension utility index (MD: 0.16, 95% CI: [0.10, 0.23], p < 0.00001) and self-reported health (MD: 15.29, 95% CI: [4.51, 26.07], p = 0.005).</p><p><strong>Conclusion: </strong>This meta-analysis provides robust evidence supporting SCS as an effective intervention for managing chronic pain and enhancing the quality of life in patients with PDN, highlighting its superiority to conventional medical therapy.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143586417","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}

{"title":"A First-In-Human Feasibility Study of a New Implantable Tibial Nerve Stimulator for Overactive Bladder Syndrome.","authors":"Parminder S Sethi, Kenneth M Peters","doi":"10.1016/j.neurom.2025.01.013","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.01.013","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to evaluate the preliminary feasibility and safety of a new implantable tibial nerve stimulator device in patients with overactive bladder (OAB).</p><p><strong>Materials and methods: </strong>Ten patients with OAB in whom conservative treatments had failed participated in the study. All patients received daily stimulation therapy for two weeks and weekly stimulation therapy for 13 weeks, at the lowest electrical output amplitude at which paresthesia or motor response occurred. OAB symptoms (three-day bladder diary), quality-of-life scores (OAB-questionnaire Short Form), and patient global response (GRA) were assessed at each follow-up visit.</p><p><strong>Results: </strong>Among the patients enrolled (mean age 68 years), seven were OAB-wet and three OAB-dry. After 13 weeks of therapy delivery, a reduction in the number of daily voids during waking hours (8.5 ± 2.5 to 6.3 ± 1.9; p = 0.016), incontinence episodes (2.5 ± 1.8 to 0.3 ± 0.5; p < 0.001), and the daily voids associated with urgency (7.6 ± 3.1 to 3.0 ± 3.1; p < 0.001) was reported. Eight of the ten subjects were classified as responders for ≥one OAB component, with one patient reporting worsened symptoms of urgency (+6%). All ten patients reported global improvement in symptoms on the GRA with a median score of 6. Improvements in OAB severity and health-related quality-of-life scores were noted from pre- to posttreatment across participants (p < 0.001). No serious adverse effects were noted.</p><p><strong>Conclusion: </strong>This first-in-human pilot study allowed for capture of preliminary safety and effectiveness information on a new implantable tibial nerve stimulator device in the population of interest to adequately power a larger, pivotal randomized study.</p><p><strong>Clinical trial registration: </strong>The Clinicaltrials.gov registration number for the study is NCT04115228.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143542557","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}

{"title":"Safety and Effectiveness of Multisite Transcutaneous Spinal Cord Stimulation Combined With Activity-Based Therapy When Delivered in a Community Rehabilitation Setting: A Real-World Pilot Study.","authors":"Jenny Suggitt, Jane Symonds, Jessica M D'Amico","doi":"10.1016/j.neurom.2025.01.005","DOIUrl":"10.1016/j.neurom.2025.01.005","url":null,"abstract":"<p><strong>Objective: </strong>Evaluate the preliminary safety and efficacy of multi-site transcutaneous spinal cord stimulation (tSCS) combined with activity-based therapy (ABT) in individuals with chronic spinal cord injury (SCI) when delivered in a community-based neurorehabilitation center.</p><p><strong>Materials and methods: </strong>Ten participants were enrolled in a nonrandomized pilot trial. Participants completed 120 sessions of tSCS + ABT focused on recovery of upper extremity, trunk, and lower extremity function dependent on their neurologic level of injury. NeuroRecovery Scale (NRS), Berg Balance Scale (BBS), pinch and grasp force, and Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) were obtained at baseline and every 20 sessions. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), quality of life, spasticity, and respiratory measures were assessed at baseline and after 40 and 120 sessions. Nonparametric testing with post hoc correction was used to assess improvements in outcomes.</p><p><strong>Results: </strong>Median improvements (median [interquartile range]) in NRS-total (Δ1.5 [1.0, 2.0]), NRS-trunk (Δ2.0 [1.2, 3.1]), and BBS scores (Δ2.0 [0, 4.5]) were significant after 120 sessions of tSCS-ABT (all p < 0.013). In the cervical cohort, median improvements in NRS-upper extremity (Δ2.1 [0.6, 2.5]), GRASSP-Sensibility (Δ1.0 [0.0, 1.5]), Prehension ability (Δ2.0 [1.0, 5.5]), and Prehension performance (Δ10.0 [7.5, 13.5]) were significant (all p < 0.05). Post hoc comparisons revealed continued improvements with an increased number of sessions. There were no significant improvements in the ISNCSCI motor and sensory scores as a group; however, three individuals showed improved American Spinal Injury Association Impairment Scale classifications, with four individuals also indicating changes in the neurologic level of injury. No improvements were noted in other exploratory outcomes.</p><p><strong>Conclusions: </strong>Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating continued improvement. These findings indicate that prolonged training with tSCS-ABT can be an effective neuromodulatory intervention for individuals with SCI.</p><p><strong>Clinical trial registration: </strong>The Clinicaltrials.gov registration number for the study is NCT04132596.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143493066","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}

{"title":"Response to: YouTube as a Source of Medical Information About Peripheral Nerve Stimulation.","authors":"Levent Karataş","doi":"10.1016/j.neurom.2025.01.014","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.01.014","url":null,"abstract":"","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143493062","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}

{"title":"Effects of Auricular Stimulation on Inflammatory Parameters: Results of a Systematic Review and Meta-Analysis of Randomized Controlled Trials.","authors":"Kevin Hua, Mike Cummings, Miriam Bernatik, Benno Brinkhaus, Taras Usichenko, Stefan N Willich, Carmen Scheibenbogen, Joanna Dietzel","doi":"10.1016/j.neurom.2024.12.007","DOIUrl":"10.1016/j.neurom.2024.12.007","url":null,"abstract":"<p><strong>Background: </strong>The number of randomized controlled trials (RCTs) using auricular stimulation (AS) techniques, such as transauricular vagus nerve stimulation, auricular electrostimulation, auricular acupuncture, and acupressure in experimental and clinical settings has increased markedly over the last three decades. This systematic review evaluates the effects of AS on biomarkers of inflammation and stress responses.</p><p><strong>Materials and methods: </strong>The following data bases were searched: MEDLINE (PubMed), EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science, and Scopus Data base. Data collection and analysis were conducted independently by two reviewers. Quality and risk assessments of the included studies were performed, and a meta-analysis of the effects of the most frequently assessed biomarkers was conducted using RevMan statistical software.</p><p><strong>Results: </strong>A total of 1122 patients and healthy volunteers from 27 RCTs were included in this systematic review; 81% of the participants were female, with a median age of 51 years. Pooled data of 18 studies showed a significant effect of AS regarding a reduction of serum C-reactive protein, tumor necrosis factor-α, interleukin (IL)-6, and IL-10. Although IL-4, IL1β, cortisol, substance P and calcitonin gene-related peptide, and adrenocorticotropic hormone did not show any changes, salivary amylase increased under AS.</p><p><strong>Conclusions: </strong>The influence of inflammatory cytokines seems to be mediated by AS. More research is needed to investigate the effects of AS on the immunologic system in addition to its clinical significance in high-quality RCT.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143493047","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}

{"title":"Phase-Amplitude Coupling in Response to Transcutaneous Vagus Nerve Stimulation: Focus on Regions Implicated in Mood and Memory.","authors":"Charlotte Keatch, Elisabeth Lambert, Will Woods, Tatiana Kameneva","doi":"10.1016/j.neurom.2025.01.011","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.01.011","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to investigate whether transcutaneous vagus nerve stimulation (tVNS) at different frequencies affects phase-amplitude coupling among regions of the brain linked to mood and memory disorders using simultaneous magnetoencephalography (MEG) in healthy participants.</p><p><strong>Materials and methods: </strong>Phase-amplitude coupling was measured among brain areas in response to different stimulation frequencies of tVNS using concurrent MEG and tVNS in 17 healthy participants. The 4 protocols were: 24 Hz cymba concha, 1 Hz cymba concha, PFM cymba concha, and 24 Hz ear lobe. A driven autoregressive method was used to estimate the coupling among brain areas in different physiological frequency bands in response to these protocols.</p><p><strong>Results: </strong>Different tVNS stimulation protocols led to alterations in phase-amplitude coupling among multiple brain regions linked to mood and memory, notably the prefrontal cortex, hippocampus, and temporal pole. Stimulation delivered at 24 Hz was observed to decrease delta-gamma coupling within the temporal pole and cingulate cortex when contrasted with 24-Hz sham stimulation. Increased alpha-gamma coupling was observed between the hippocampus and prefrontal cortex when contrasting 24 Hz with pulse-frequency-modulated stimulation. Finally, a comparison of 24-Hz with low-frequency 1-Hz stimulation showed an increase in theta-gamma coupling within the prefrontal cortex.</p><p><strong>Significance: </strong>To our knowledge, this study represents the first attempt to quantify phase-amplitude coupling in response to tVNS and suggests that different stimulation frequencies can modulate coupling between different areas of the brain. Abnormal phase-amplitude coupling has been linked to multiple mood and memory disorders. Further investigations using different stimulation frequencies of tVNS to alter phase-amplitude coupling may lead to the development of tVNS as a therapeutic option for different medical conditions.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143493059","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}

{"title":"Pulsed Shortwave (Radiofrequency) Therapy With a Noninvasive, Wearable, Disposable Device: A Randomized, Participant- and Assessor-Masked, Sham-Controlled Pilot Study.","authors":"Brian M Ilfeld, John J Finneran, Engy T Said, Scott T Ball, Bryan J Sandler, Ryan C Broderick, Francis B Gonzales, Nathan J Lau, Adam Schaar, Baharin Abdullah","doi":"10.1016/j.neurom.2025.01.008","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.01.008","url":null,"abstract":"<p><strong>Objectives: </strong>Pulsed shortwave therapy (PSWT) is a nonpharmacologic/noninvasive modality that may offer analgesic benefits without notable side effects or complications. This pilot study aimed to assess the feasibility of a PSWT protocol and provide an estimate of its treatment effects.</p><p><strong>Materials and methods: </strong>The study included adults who underwent cholecystectomy or unilateral total hip or knee arthroplasty. Participants were randomized to eight days of either PSWT with a single functioning device (SofPulse, Endonovo Therapeutics, Woodland Hills, CA) or a sham device placed over the surgical bandages in a participant- and assessor-masked fashion. The primary end point was the sum of the average and worst (maximum) daily pain intensity as measured with the numeric rating scale collected over the first seven postoperative days.</p><p><strong>Results: </strong>No systemic side effects or significant complications occurred. During the first seven postoperative days, the sum of the daily pain intensity scores in the active group was a mean (SD) of 28 (11) vs 34 (14) in sham: difference -6.5 (95% CI, -12.4 to -0.6), p = 0.032. During the same period, cumulative oxycodone consumption in the active group was a mean (SD) of 4.6 (4.9) mg vs 5.1 (7.3) mg in sham: difference -0.5 (95% CI, -3.4 to 2.5), p = 0.761. Subgroup analysis suggested that the analgesic effect for knee arthroplasty was greater than for the other surgical procedures.</p><p><strong>Conclusions: </strong>PSWT is feasible for inpatients and outpatients, and reduced pain over the first postoperative week. These results are preliminary and should be replicated with a subsequent study before being considered definitive. Although this pilot study was inadequately powered to conclusively identify statistically significant differences between treatments for the secondary end points, if the analgesic improvements are successfully replicated in a definitive trial, they would meet or exceed the benefits identified for oral acetaminophen. Data from this pilot study may be used to help plan future trials.</p><p><strong>Clinical trial registration: </strong>The Clinicaltrials.gov registration number for the study is NCT05796583.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476841","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}

{"title":"Development of an Educational Curriculum for Implanting and Managing Vagus Nerve Stimulators for Epilepsy.","authors":"David Bieber, Kunal Gupta, Rany Abdallah, Alaa Abd-Elsayed, Alyson Engle, Irina Duff, Duvan Hoffman, Hemant Kalia, Joshua Rosenow, Micheal Macken, Ahmed M Raslan, Konstantin Slavin, Amy Tennant, Jeffrey S Raskin","doi":"10.1016/j.neurom.2024.12.008","DOIUrl":"https://doi.org/10.1016/j.neurom.2024.12.008","url":null,"abstract":"<p><strong>Background: </strong>Vagus nerve stimulation (VNS) devices are commonly used for extracranial neuromodulation of drug-resistant epilepsy. These devices are implanted by multiple surgical subspecialties and managed by practitioners with varying levels of epilepsy-specific expertise. The North American Neuromodulation Society (NANS) education committee presents a curriculum defining level-dependent recommendations within the six-core competency rubric for the implantation and management of VNS devices.</p><p><strong>Material and methods: </strong>A multidisciplinary (anesthesiology, neurology, neurosurgery, and physiatrists) and diverse (advanced practice providers, physicians, and surgeons) subcommittee of the NANS education committee met virtually over a year to develop a curriculum following the Accreditation Council for Graduate Medical Education (ACGME) core competencies. The subcommittee used a consensus approach, evidence-based development strategy; once completed, the VNS curriculum was approved by the NANS board.</p><p><strong>Results: </strong>The subcommittee developed a VNS curriculum as a standard to be used for implanting surgeons, managing physicians, and advanced practice providers. The vertical orientation of the curriculum uses the ACGME educational core competencies framework; within this paradigm is a horizontal progression of skills with distinct competency groups for implanting surgeons and/or managing physicians. The horizontal progression defines the expected competence for early learner, advanced learner, and independent practitioner.</p><p><strong>Conclusion: </strong>A NANS education subcommittee iteratively developed a VNS curriculum for defining progressive competence of myriad care providers, including clinicians and advanced practice providers, within the ACGME six core competencies.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449684","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}

{"title":"Incidence of Lead Tip Fracture and Retention After Percutaneous Lead Implantation for Peripheral Nerve Stimulation With an External Pulse Generator: A Multicenter Comparative Analysis of 456 Lead Implants Across Two Lead Hardware Generations.","authors":"Chelsey Hoffmann, Kalli J Fautsch, Ryan S D'Souza","doi":"10.1016/j.neurom.2025.01.009","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.01.009","url":null,"abstract":"<p><strong>Objectives: </strong>Lead fracture and retention are potential adverse events that can occur after peripheral nerve stimulator (PNS) lead implantation, although recent technologic advancements in PNS hardware have been implemented to avert this risk. We aim to quantify the current incidence of temporary PNS lead fracture/retention and compare this with rates before changes in lead hardware design of temporary PNS.</p><p><strong>Materials and methods: </strong>A multicenter, retrospective observational study was conducted for patients implanted with a temporary PNS system (SPR© Therapeutics, Cleveland, OH) between June 1, 2018 and August 1, 2024. Patients were included if they underwent a temporary percutaneous PNS system implantation with planned lead removal at 60 days. Patients were excluded if there was ambiguity regarding the status of the lead tip at time of removal (intact vs fractured) or if there was inadvertent lead removal by the patient during the 60-day treatment. The primary objectives of this study were 1) to quantify the incidence of lead retention with removal of temporary percutaneous PNS and 2) to compare the rates of lead retention in the original lead design (version 1.0) and the revised lead design (version 2.0). Secondary objectives included analysis of lead retention rates based on the following covariates: body mass index (BMI), patient age, location of lead placement, or duration of lead implant.</p><p><strong>Results: </strong>Within the studied timeframe, 337 patients were implanted with a total of 456 leads. Of 337 patients, 40.4% (n = 136) were implanted with lead version 1.0, and 59.6% (n = 201) were implanted with lead version 2.0. Overall, 7.5% of implanted leads (34/456) were retained, affecting 10.1% of patients. Of 194 implanted version 1.0 leads, 13.4% of leads (n = 26) were retained, whereas of 262 version 2.0 leads, 3.1% (n = 8) were retained (p < 0.001). These results showed a reduction in retained leads per patient from 19.1% with lead version 1.0 to 4.0% with revised lead version 2.0. Covariates including BMI, patient age, location of lead placement, or duration of lead implant did not predict lead retention rates.</p><p><strong>Conclusions: </strong>Retention and fracture of temporary PNS leads remain prevalent, affecting 7.5% of all implanted leads, although we also observed a significant decrease in rates (3.1% vs 13.4%) with implementation of the revised lead version 2.0 hardware design.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425675","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}

{"title":"Is There a Correlation Between Objective Measurement Tools and Self-Reporting Questionnaires To Evaluate Physical Activity and Health Status in Patients With Persistent Spinal Pain Syndrome Type 2 Before and After Spinal Cord Stimulation? Outcomes of a Feasibility Study.","authors":"Tanja E Hamm-Faber, Kris C P Vissers, Ewald Bronkhorst, Inge Arnts, Ismail Gültuna, Frank G A M van Haren, Carin A G L Wensing, Yvonne Engels, Dylan J H A Henssen","doi":"10.1016/j.neurom.2025.01.007","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.01.007","url":null,"abstract":"<p><strong>Introduction: </strong>The effect of spinal cord stimulation (SCS) on physical activity in patients with persistent spinal pain syndrome (PSPS) type 2 is commonly evaluated with standardized, validated self-reporting questionnaires. However, questionnaires are susceptible to subjective bias and may not align with objective data.</p><p><strong>Objective: </strong>We investigated the correlation among objective measurement devices, the Oswestry Disability Index (ODI), and patient's health status regarding physical activity in patients with PSPS type 2 receiving SCS.</p><p><strong>Materials and methods: </strong>Alongside the ODI, we used an activity tracker to objectively measure physical activity and a neurostimulator device to objectively measure body positions at baseline and three-month follow-up. In addition, health status was measured using the positive model of health.</p><p><strong>Results: </strong>We included 20 patients, of whom 17 completed the three-month follow-up period. At three months follow-up, we found a significant correlation between the activity tracker's steps (r = -0.636, p = 0.006) and distance per day (r = -0.649, p = 0.005) with the ODI and a significant correlation of the neurostimulator's mobile position with the ODI (r = -0.497, p = 0.043). Furthermore, the activity tracker showed a significant increase in strenuous physical activity at three-month follow-up (p = 0.039). We also observed a substantial improvement across the domains of bodily function, social and societal participation, and daily functioning of the positive model of health.</p><p><strong>Conclusions: </strong>This study showed significant correlations among objective measurement devices, the ODI, and health status, which could contribute to a more holistic approach to evaluating the effect of SCS. Prospective powered studies with a control group are needed to better understand this area.</p><p><strong>Clinical trial registration: </strong>The protocol was registered in the Dutch Trial Register (NTR) on March 13, 2021 under registration number NL 9301 (number NL-OMON21829).</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425681","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}