Pub Date : 2024-10-01Epub Date: 2024-07-17DOI: 10.1007/s40122-024-00638-x
Xia Xu, Ying-Xin Xie, Meng Zhang, Jian-Hui Du, Jin-Xian He, Li-Hong Hu
{"title":"A Response to: Letter to the Editor Regarding \"Comparison of Thoracoscopy-Guided Thoracic Paravertebral Block and Ultrasound-Guided Thoracic Paravertebral Block in Postoperative Analgesia of Thoracoscopic Lung Cancer Radical Surgery: A Randomized Controlled Trial\".","authors":"Xia Xu, Ying-Xin Xie, Meng Zhang, Jian-Hui Du, Jin-Xian He, Li-Hong Hu","doi":"10.1007/s40122-024-00638-x","DOIUrl":"10.1007/s40122-024-00638-x","url":null,"abstract":"","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1319-1321"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393362/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141627318","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Neck pain constitutes a prevalent and burdensome health issue, substantially impairing patients' quality of life and functional capabilities. Kinesio taping (KT), a commonly employed intervention within physical therapy, holds promise for mitigating such symptoms; however, a comprehensive evaluation of its efficacy and evidence base is lacking. Therefore, this study endeavors to systematically investigate the therapeutic effects of KT on both subjective neck pain intensity and objective measures of physical activity limitations through a rigorous meta-analytic approach. By synthesizing existing literature and scrutinizing methodological nuances, we aim to furnish healthcare practitioners with evidence-informed insights, facilitating more judicious clinical decision-making and optimizing patient outcomes.
Methods: According to the PRISMA guidelines, we conducted searches on PubMed, Cochrane Library, Embase, and Web of Science for randomized controlled trials (RCTs) investigating the efficacy of KT in treating neck pain. Screening was performed based on predefined inclusion and exclusion criteria. Characteristics of the included RCTs were extracted. Trial heterogeneity was assessed using the I2 statistic. Meta-analysis was conducted using Stata 17 software. Risk of bias and methodological quality were evaluated using the Cochrane Risk of Bias 2 tool and the PEDro scale, respectively.
Results: In our analysis of 10 RCTs involving 620 patients meeting our inclusion criteria, KT demonstrated significant beneficial effects on neck pain, notably surpassing conventional treatment (weighted mean difference = -0.897, 95% CI -1.30 to -0.49, P < 0.001). Subgroup analysis further revealed that KT exhibited particularly pronounced efficacy in the treatment of nonspecific neck pain and mechanical neck pain, with a more substantial effect observed after 4 weeks of KT intervention compared to 1 week. Moreover, KT demonstrated superior efficacy in alleviating pain symptoms compared to both conventional treatment and sham interventions.
Conclusion: KT has demonstrated efficacy in reducing neck pain and improving cervical dysfunction among patients. Prolonged KT treatment or its combination with other therapeutic modalities may potentially enhance therapeutic outcomes.
引言颈部疼痛是一个普遍存在且负担沉重的健康问题,严重影响了患者的生活质量和功能。Kinesio taping(KT)是物理治疗中常用的一种干预方法,有望缓解此类症状;然而,目前还缺乏对其疗效和证据基础的全面评估。因此,本研究试图通过严格的荟萃分析方法,系统地研究 KT 对主观颈部疼痛强度和客观体力活动限制的治疗效果。通过综合现有文献并仔细研究方法上的细微差别,我们旨在为医疗从业人员提供以证据为依据的见解,从而促进更明智的临床决策并优化患者预后:根据 PRISMA 指南,我们在 PubMed、Cochrane 图书馆、Embase 和 Web of Science 上检索了研究 KT 治疗颈痛疗效的随机对照试验 (RCT)。根据预先确定的纳入和排除标准进行筛选。提取了纳入的 RCT 的特征。使用 I2 统计量评估试验的异质性。使用 Stata 17 软件进行 Meta 分析。偏倚风险和方法学质量分别采用 Cochrane Risk of Bias 2 工具和 PEDro 量表进行评估:结果:在我们对符合纳入标准的 10 项 RCT(涉及 620 名患者)进行的分析中,KT 对颈部疼痛有显著的疗效,明显优于常规治疗(加权平均差 = -0.897,95% CI -1.30 至 -0.49,P 结论:KT 对颈部疼痛有显著的疗效,明显优于常规治疗(加权平均差 = -0.897,95% CI -1.30 至 -0.49,P 结论):KT 在减轻患者颈部疼痛和改善颈椎功能障碍方面具有明显疗效。延长 KT 治疗时间或将其与其他治疗方法结合使用可能会提高治疗效果:系统综述注册:PREMCORD42024524685。
{"title":"Effects of Kinesio Taping on Neck Pain: A Meta-Analysis and Systematic Review of Randomized Controlled Trials.","authors":"Qian Hu, Ying Liu, Shao Yin, Hui Zou, Houyin Shi, Fengya Zhu","doi":"10.1007/s40122-024-00635-0","DOIUrl":"10.1007/s40122-024-00635-0","url":null,"abstract":"<p><strong>Introduction: </strong>Neck pain constitutes a prevalent and burdensome health issue, substantially impairing patients' quality of life and functional capabilities. Kinesio taping (KT), a commonly employed intervention within physical therapy, holds promise for mitigating such symptoms; however, a comprehensive evaluation of its efficacy and evidence base is lacking. Therefore, this study endeavors to systematically investigate the therapeutic effects of KT on both subjective neck pain intensity and objective measures of physical activity limitations through a rigorous meta-analytic approach. By synthesizing existing literature and scrutinizing methodological nuances, we aim to furnish healthcare practitioners with evidence-informed insights, facilitating more judicious clinical decision-making and optimizing patient outcomes.</p><p><strong>Methods: </strong>According to the PRISMA guidelines, we conducted searches on PubMed, Cochrane Library, Embase, and Web of Science for randomized controlled trials (RCTs) investigating the efficacy of KT in treating neck pain. Screening was performed based on predefined inclusion and exclusion criteria. Characteristics of the included RCTs were extracted. Trial heterogeneity was assessed using the I<sup>2</sup> statistic. Meta-analysis was conducted using Stata 17 software. Risk of bias and methodological quality were evaluated using the Cochrane Risk of Bias 2 tool and the PEDro scale, respectively.</p><p><strong>Results: </strong>In our analysis of 10 RCTs involving 620 patients meeting our inclusion criteria, KT demonstrated significant beneficial effects on neck pain, notably surpassing conventional treatment (weighted mean difference = -0.897, 95% CI -1.30 to -0.49, P < 0.001). Subgroup analysis further revealed that KT exhibited particularly pronounced efficacy in the treatment of nonspecific neck pain and mechanical neck pain, with a more substantial effect observed after 4 weeks of KT intervention compared to 1 week. Moreover, KT demonstrated superior efficacy in alleviating pain symptoms compared to both conventional treatment and sham interventions.</p><p><strong>Conclusion: </strong>KT has demonstrated efficacy in reducing neck pain and improving cervical dysfunction among patients. Prolonged KT treatment or its combination with other therapeutic modalities may potentially enhance therapeutic outcomes.</p><p><strong>Systematic review registration: </strong>PROSPERO CRD42024524685.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1031-1046"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393280/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141748854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-08-10DOI: 10.1007/s40122-024-00640-3
Yunze Li, Jiali Jin, Xianhui Kang, Zhiying Feng
Postherpetic neuralgia (PHN) manifests as persistent chronic pain that emerges after a herpes zoster outbreak and greatly diminishes quality of life. Unfortunately, its treatment efficacy has remained elusive, with many therapeutic efforts yielding less than satisfactory results. The research to discern risk factors predicting the onset, trajectory, and prognosis of PHN has been extensive. However, these risk factors often present as nonspecific and diverse, indicating the need for more reliable, measurable, and objective detection methods. The exploration of potential biological markers, including hematological indices, pathological insights, and supportive tests, is increasing. This review highlights potential biomarkers that are instrumental for the diagnosis, management, and prognosis of PHN while also delving deeper into its genesis. Drawing from prior research, aspects such as immune responsiveness, neuronal injury, genetic makeup, cellular metabolism, and pain signal modulation have emerged as prospective biomarkers. The immune spectrum spans various cell subtypes, with an emphasis on T cells, interferons, interleukins, and other related cytokines. Studies on nerve injury are directed toward pain-related proteins and the density and health of epidermal nerve fibers. On the genetic and metabolic fronts, the focus lies in the detection of predisposition genes, atypical protein manifestations, and energy-processing dynamics, with a keen interest in vitamin metabolism. Tools such as functional magnetic resonance imaging, electromyography, and infrared imaging have come to the forefront in the pain signaling domain. This review compiles the evidence, potential clinical implications, and challenges associated with these promising biomarkers, paving the way for innovative strategies for predicting, diagnosing, and addressing PHN.
{"title":"Identifying and Evaluating Biological Markers of Postherpetic Neuralgia: A Comprehensive Review.","authors":"Yunze Li, Jiali Jin, Xianhui Kang, Zhiying Feng","doi":"10.1007/s40122-024-00640-3","DOIUrl":"10.1007/s40122-024-00640-3","url":null,"abstract":"<p><p>Postherpetic neuralgia (PHN) manifests as persistent chronic pain that emerges after a herpes zoster outbreak and greatly diminishes quality of life. Unfortunately, its treatment efficacy has remained elusive, with many therapeutic efforts yielding less than satisfactory results. The research to discern risk factors predicting the onset, trajectory, and prognosis of PHN has been extensive. However, these risk factors often present as nonspecific and diverse, indicating the need for more reliable, measurable, and objective detection methods. The exploration of potential biological markers, including hematological indices, pathological insights, and supportive tests, is increasing. This review highlights potential biomarkers that are instrumental for the diagnosis, management, and prognosis of PHN while also delving deeper into its genesis. Drawing from prior research, aspects such as immune responsiveness, neuronal injury, genetic makeup, cellular metabolism, and pain signal modulation have emerged as prospective biomarkers. The immune spectrum spans various cell subtypes, with an emphasis on T cells, interferons, interleukins, and other related cytokines. Studies on nerve injury are directed toward pain-related proteins and the density and health of epidermal nerve fibers. On the genetic and metabolic fronts, the focus lies in the detection of predisposition genes, atypical protein manifestations, and energy-processing dynamics, with a keen interest in vitamin metabolism. Tools such as functional magnetic resonance imaging, electromyography, and infrared imaging have come to the forefront in the pain signaling domain. This review compiles the evidence, potential clinical implications, and challenges associated with these promising biomarkers, paving the way for innovative strategies for predicting, diagnosing, and addressing PHN.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1095-1117"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393369/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141913662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-07-03DOI: 10.1007/s40122-024-00629-y
Yinfeng Zheng, Tianyi Wang, Lei Zang, Peng Du, Xiaochuan Kong, Gang Hong, Le Zhang, Jian Li
Introduction: The best treatment yielding clinical benefits was still equivocal and controversial for the treatment of recalcitrant plantar fasciitis (PF). This study aimed to propose a novel combination strategy of ultrasound-guided percutaneous radiofrequency ablation (RFA) and corticosteroid injection (CI) for recalcitrant PF, and to compare its therapeutic effects with CI alone and continued conservative management.
Methods: We retrospectively reviewed consecutive patients with recalcitrant PF who underwent combined strategy (RFA + CI), CI alone, and continue conservative treatment at our institution between October 2021 and February 2023. The technical pearls were described elaborately. A comparison of demographic data and clinical outcomes, including visual analog scale (VAS), Ankle-Hindfoot Scale (AOFAS-AHS), and plantar fascia thickness, were conducted among the three groups.
Results: Seventy-one eligible patients were enrolled in this study, with 17 in the combined strategy group, 25 in the CI group, and 29 in the continued conservative treatment group. Both the combined strategy group and the CI group showed significant improvements in VAS scores, AOFAS-AHS scores, and significant reductions in plantar fascia thickness during the 12-month follow-up period compared to those preoperatively (P < 0.05). The combined strategy group achieved comparable immediate pain relief to the CI group after the intervention ([25.7 ± 15.7] vs. [20.6 ± 17.6], P = 0.850). However, the combined strategy group demonstrated superior improvement in symptom and function compared to the CI group at the 3-month (VAS: [21.9 ± 13.5] vs. [39.6 ± 20.4]; AOFAS-AHS: [77.9 ± 12.4] vs. [60.5 ± 17.4], P < 0.05) and 12-month follow-up (VAS: [15.7 ± 12.0] vs. [56.8 ± 17.5]; AOFAS-AHS: [84.5 ± 10.7] vs. [53.8 ± 12.4], P < 0.05). Obvious adverse effects or complications were not identified in either group, while two cases (11.8%) in the combined strategy group and five cases (20.0%) in the CI group experienced unsatisfactory symptom remission.
Conclusions: We introduced and detailed a novel combination strategy involving ultrasound-guided percutaneous RFA and CI for treating recalcitrant PF. The strategy is both effective and safe in alleviating pain and enhancing function throughout the entire treatment course.
导言:在治疗顽固性足底筋膜炎(PF)方面,能产生临床疗效的最佳治疗方法仍不明确且存在争议。本研究旨在提出一种治疗顽固性足底筋膜炎的新型组合策略,即超声引导下经皮射频消融(RFA)和皮质类固醇注射(CI),并比较其与单纯 CI 和持续保守治疗的疗效:我们回顾性研究了 2021 年 10 月至 2023 年 2 月期间在我院接受联合策略(RFA + CI)、单纯 CI 和继续保守治疗的顽固性 PF 患者。对技术要点进行了详细描述。对三组患者的人口统计学数据和临床结果(包括视觉模拟量表(VAS)、踝-后足量表(AOFAS-AHS)和足底筋膜厚度)进行了比较:71名符合条件的患者参加了此次研究,其中17人属于联合策略组,25人属于CI组,29人属于继续保守治疗组。与术前相比,联合策略组和 CI 组的 VAS 评分、AOFAS-AHS 评分均有显著改善,足底筋膜厚度在 12 个月的随访期间也有显著减少(P 结论:联合策略组和 CI 组的 VAS 评分、AOFAS-AHS 评分均有显著改善,足底筋膜厚度在 12 个月的随访期间也有显著减少:我们介绍并详细说明了一种新颖的联合策略,即在超声引导下经皮 RFA 和 CI 治疗顽固性足底筋膜炎。在整个治疗过程中,该策略在缓解疼痛和增强功能方面既有效又安全。
{"title":"A Novel Combination Strategy of Ultrasound-Guided Percutaneous Radiofrequency Ablation and Corticosteroid Injection for Treating Recalcitrant Plantar Fasciitis: A Retrospective Comparison Study.","authors":"Yinfeng Zheng, Tianyi Wang, Lei Zang, Peng Du, Xiaochuan Kong, Gang Hong, Le Zhang, Jian Li","doi":"10.1007/s40122-024-00629-y","DOIUrl":"10.1007/s40122-024-00629-y","url":null,"abstract":"<p><strong>Introduction: </strong>The best treatment yielding clinical benefits was still equivocal and controversial for the treatment of recalcitrant plantar fasciitis (PF). This study aimed to propose a novel combination strategy of ultrasound-guided percutaneous radiofrequency ablation (RFA) and corticosteroid injection (CI) for recalcitrant PF, and to compare its therapeutic effects with CI alone and continued conservative management.</p><p><strong>Methods: </strong>We retrospectively reviewed consecutive patients with recalcitrant PF who underwent combined strategy (RFA + CI), CI alone, and continue conservative treatment at our institution between October 2021 and February 2023. The technical pearls were described elaborately. A comparison of demographic data and clinical outcomes, including visual analog scale (VAS), Ankle-Hindfoot Scale (AOFAS-AHS), and plantar fascia thickness, were conducted among the three groups.</p><p><strong>Results: </strong>Seventy-one eligible patients were enrolled in this study, with 17 in the combined strategy group, 25 in the CI group, and 29 in the continued conservative treatment group. Both the combined strategy group and the CI group showed significant improvements in VAS scores, AOFAS-AHS scores, and significant reductions in plantar fascia thickness during the 12-month follow-up period compared to those preoperatively (P < 0.05). The combined strategy group achieved comparable immediate pain relief to the CI group after the intervention ([25.7 ± 15.7] vs. [20.6 ± 17.6], P = 0.850). However, the combined strategy group demonstrated superior improvement in symptom and function compared to the CI group at the 3-month (VAS: [21.9 ± 13.5] vs. [39.6 ± 20.4]; AOFAS-AHS: [77.9 ± 12.4] vs. [60.5 ± 17.4], P < 0.05) and 12-month follow-up (VAS: [15.7 ± 12.0] vs. [56.8 ± 17.5]; AOFAS-AHS: [84.5 ± 10.7] vs. [53.8 ± 12.4], P < 0.05). Obvious adverse effects or complications were not identified in either group, while two cases (11.8%) in the combined strategy group and five cases (20.0%) in the CI group experienced unsatisfactory symptom remission.</p><p><strong>Conclusions: </strong>We introduced and detailed a novel combination strategy involving ultrasound-guided percutaneous RFA and CI for treating recalcitrant PF. The strategy is both effective and safe in alleviating pain and enhancing function throughout the entire treatment course.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1137-1149"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141498678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-08-05DOI: 10.1007/s40122-024-00642-1
Kordula Lang-Illievich, Christoph Klivinyi, Julia Ranftl, Ala Elhelali, Sascha Hammer, Istvan S Szilagyi, Helmar Bornemann-Cimenti
Introduction: Chronic pain is a public health issue, leading to substantial healthcare costs and diminished quality of life for sufferers. While the role of anxiety in pain modulation has been extensively studied, the effects of other emotional states on the body's pain control mechanisms remain less understood. This study sought to explore how different emotions (happiness, anger, sadness, and interest) affect conditioned pain modulation (CPM) and the wind-up phenomenon in healthy adults.
Methods: This randomized controlled, cross-over trial involved 28 healthy participants aged 18-60. Participants watched video clips designed to induce specific emotions: happiness, anger, sadness, and interest. Emotional states were assessed using a 7-point Likert scale. Pain modulation was measured using CPM and the wind-up phenomenon. CPM was assessed with a hot water bath as the conditioning stimulus and pressure pain tolerance as the test stimulus. Wind-up was measured using pinprick needle stimulators and a visual analog scale. Data were analyzed using paired t tests to compare pre- and post-emotion induction values.
Results: Significant changes in emotional self-assessment values were observed for all emotions. Happiness increased CPM (4.6 ± 11.4, p = 0.04277), while sadness - 9.9 ± 23.1, p = 0.03211) and anger - 9.1 ± 23.3, p = 0.04804) decreased it. Interest did not significantly alter CPM (- 5.1 ± 25.8, p = 0.31042). No significant effects were found for the wind-up phenomenon across any emotional states.
Conclusion: This study shows that emotional states significantly affect the body's ability to modulate pain. Positive emotions like happiness enhance pain inhibition, while negative emotions such as sadness and anger impair it. These findings suggest that emotional modulation techniques could be integrated into pain management strategies to improve patient outcomes. Further research should explore a broader range of emotions and include objective measures to validate these results.
{"title":"Change in Endogenous Pain Modulation Depending on Emotional States in Healthy Subjects: A Randomized Controlled Trial.","authors":"Kordula Lang-Illievich, Christoph Klivinyi, Julia Ranftl, Ala Elhelali, Sascha Hammer, Istvan S Szilagyi, Helmar Bornemann-Cimenti","doi":"10.1007/s40122-024-00642-1","DOIUrl":"10.1007/s40122-024-00642-1","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic pain is a public health issue, leading to substantial healthcare costs and diminished quality of life for sufferers. While the role of anxiety in pain modulation has been extensively studied, the effects of other emotional states on the body's pain control mechanisms remain less understood. This study sought to explore how different emotions (happiness, anger, sadness, and interest) affect conditioned pain modulation (CPM) and the wind-up phenomenon in healthy adults.</p><p><strong>Methods: </strong>This randomized controlled, cross-over trial involved 28 healthy participants aged 18-60. Participants watched video clips designed to induce specific emotions: happiness, anger, sadness, and interest. Emotional states were assessed using a 7-point Likert scale. Pain modulation was measured using CPM and the wind-up phenomenon. CPM was assessed with a hot water bath as the conditioning stimulus and pressure pain tolerance as the test stimulus. Wind-up was measured using pinprick needle stimulators and a visual analog scale. Data were analyzed using paired t tests to compare pre- and post-emotion induction values.</p><p><strong>Results: </strong>Significant changes in emotional self-assessment values were observed for all emotions. Happiness increased CPM (4.6 ± 11.4, p = 0.04277), while sadness - 9.9 ± 23.1, p = 0.03211) and anger - 9.1 ± 23.3, p = 0.04804) decreased it. Interest did not significantly alter CPM (- 5.1 ± 25.8, p = 0.31042). No significant effects were found for the wind-up phenomenon across any emotional states.</p><p><strong>Conclusion: </strong>This study shows that emotional states significantly affect the body's ability to modulate pain. Positive emotions like happiness enhance pain inhibition, while negative emotions such as sadness and anger impair it. These findings suggest that emotional modulation techniques could be integrated into pain management strategies to improve patient outcomes. Further research should explore a broader range of emotions and include objective measures to validate these results.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1287-1298"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393222/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141889903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-07-09DOI: 10.1007/s40122-024-00631-4
Jason E Pope, Ajay Antony, Erika A Petersen, Steven M Rosen, Dawood Sayed, Corey W Hunter, Johnathan H Goree, Chau M Vu, Harjot S Bhandal, Philip M Shumsky, Todd A Bromberg, G Lawson Smith, Christopher M Lam, Hemant Kalia, Jennifer M Lee, Abeer Khurram, Ian Gould, Dean M Karantonis, Timothy R Deer
Introduction: Drawbacks of fixed-output spinal cord stimulation (SCS) screening trials may lead to compromised trial outcomes and poor predictability of long-term success. Evoked compound action potential (ECAP) dose-controlled closed-loop (CL) SCS allows objective confirmation of therapeutic neural activation and pulse-to-pulse stimulation adjustment. We report on the immediate patient-reported and neurophysiologic treatment response post-physiologic CL-SCS and feasibility of early SCS trial responder prediction.
Methods: Patient-reported pain relief, functional improvement, and willingness to proceed to permanent implant were compared between the day of the trial procedure (Day 0) and end of trial (EOT) for 132 participants in the ECAP Study undergoing a trial stimulation period. ECAP-based neurophysiologic measurements from Day 0 and EOT were compared between responder groups.
Results: A high positive predictive value (PPV) was achieved with 98.4% (60/61) of patients successful on the Day 0 evaluation also responding at EOT. The false-positive rate (FPR) was 5.6% (1/18). ECAP-based neurophysiologic measures were not different between patients who passed all Day 0 success criteria ("Day 0 successes") and those who did not ("needed longer to evaluate the therapy"). However, at EOT, responders had higher therapeutic usage and dose levels compared to non-responders.
Conclusions: The high PPV and low FPR of the Day 0 evaluation provide confidence in predicting trial outcomes as early as the day of the procedure. Day 0 trials may be beneficial for reducing patient burden and complication rates associated with extended trials. ECAP dose-controlled CL-SCS therapy may provide objective data and rapid-onset pain relief to improve prognostic ability of SCS trials in predicting outcomes.
Trial registration: The ECAP Study is registered with ClinicalTrials.gov (NCT04319887).
{"title":"Identifying SCS Trial Responders Immediately After Postoperative Programming with ECAP Dose-Controlled Closed-Loop Therapy.","authors":"Jason E Pope, Ajay Antony, Erika A Petersen, Steven M Rosen, Dawood Sayed, Corey W Hunter, Johnathan H Goree, Chau M Vu, Harjot S Bhandal, Philip M Shumsky, Todd A Bromberg, G Lawson Smith, Christopher M Lam, Hemant Kalia, Jennifer M Lee, Abeer Khurram, Ian Gould, Dean M Karantonis, Timothy R Deer","doi":"10.1007/s40122-024-00631-4","DOIUrl":"10.1007/s40122-024-00631-4","url":null,"abstract":"<p><strong>Introduction: </strong>Drawbacks of fixed-output spinal cord stimulation (SCS) screening trials may lead to compromised trial outcomes and poor predictability of long-term success. Evoked compound action potential (ECAP) dose-controlled closed-loop (CL) SCS allows objective confirmation of therapeutic neural activation and pulse-to-pulse stimulation adjustment. We report on the immediate patient-reported and neurophysiologic treatment response post-physiologic CL-SCS and feasibility of early SCS trial responder prediction.</p><p><strong>Methods: </strong>Patient-reported pain relief, functional improvement, and willingness to proceed to permanent implant were compared between the day of the trial procedure (Day 0) and end of trial (EOT) for 132 participants in the ECAP Study undergoing a trial stimulation period. ECAP-based neurophysiologic measurements from Day 0 and EOT were compared between responder groups.</p><p><strong>Results: </strong>A high positive predictive value (PPV) was achieved with 98.4% (60/61) of patients successful on the Day 0 evaluation also responding at EOT. The false-positive rate (FPR) was 5.6% (1/18). ECAP-based neurophysiologic measures were not different between patients who passed all Day 0 success criteria (\"Day 0 successes\") and those who did not (\"needed longer to evaluate the therapy\"). However, at EOT, responders had higher therapeutic usage and dose levels compared to non-responders.</p><p><strong>Conclusions: </strong>The high PPV and low FPR of the Day 0 evaluation provide confidence in predicting trial outcomes as early as the day of the procedure. Day 0 trials may be beneficial for reducing patient burden and complication rates associated with extended trials. ECAP dose-controlled CL-SCS therapy may provide objective data and rapid-onset pain relief to improve prognostic ability of SCS trials in predicting outcomes.</p><p><strong>Trial registration: </strong>The ECAP Study is registered with ClinicalTrials.gov (NCT04319887).</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1173-1185"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393271/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141559463","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-07-10DOI: 10.1007/s40122-024-00626-1
David True, Kathleen Mullin, Robert Croop
Introduction: Cardiovascular (CV) risk factors can limit treatment options for migraine. Rimegepant is an orally administered small-molecule calcitonin gene-related peptide receptor antagonist that does not induce vasoconstriction. The aim of these post hoc subgroup analyses was to assess the safety of rimegepant according to CV risk.
Methods: In a multicenter, long-term, open-label, phase II/III safety study, participants with a history of 2-14 migraine attacks per month of moderate or severe pain intensity self-administered rimegepant 75 mg, orally, to treat migraine up to once daily for up to 52 weeks. Uncontrolled, unstable, or recently diagnosed CV disease was part of the exclusion criteria. Safety was assessed across subgroups according to number of CV risk factors (0, 1, or ≥ 2) and Framingham Risk Score (< 10% or ≥ 10%).
Results: Of 1800 treated participants, 28.8% had one CV risk factor and 12.1% had ≥ 2 CV risk factors; 7.0% had Framingham Risk Score ≥ 10%. Across the subgroups with 0, 1, and ≥ 2 CV risk factors and Framingham Risk Score < 10% and ≥ 10%, respectively, proportions of participants reporting adverse events (AEs; 59.6%, 61.4%, 62.2%, 59.9%, 67.5%) and serious AEs (2.7%, 2.5%, 2.3%, 2.6%, 2.4%) were consistent, and AEs leading to study drug discontinuation were low (1.9%, 3.1%, 5.5%, 2.5%, 4.8%).
Conclusions: Rimegepant showed favorable safety and tolerability in adults with migraine and CV risk factors, including those with moderate to high CV risk.
{"title":"Safety of Rimegepant in Adults with Migraine and Cardiovascular Risk Factors: Analysis of a Multicenter, Long-Term, Open-Label Study.","authors":"David True, Kathleen Mullin, Robert Croop","doi":"10.1007/s40122-024-00626-1","DOIUrl":"10.1007/s40122-024-00626-1","url":null,"abstract":"<p><strong>Introduction: </strong>Cardiovascular (CV) risk factors can limit treatment options for migraine. Rimegepant is an orally administered small-molecule calcitonin gene-related peptide receptor antagonist that does not induce vasoconstriction. The aim of these post hoc subgroup analyses was to assess the safety of rimegepant according to CV risk.</p><p><strong>Methods: </strong>In a multicenter, long-term, open-label, phase II/III safety study, participants with a history of 2-14 migraine attacks per month of moderate or severe pain intensity self-administered rimegepant 75 mg, orally, to treat migraine up to once daily for up to 52 weeks. Uncontrolled, unstable, or recently diagnosed CV disease was part of the exclusion criteria. Safety was assessed across subgroups according to number of CV risk factors (0, 1, or ≥ 2) and Framingham Risk Score (< 10% or ≥ 10%).</p><p><strong>Results: </strong>Of 1800 treated participants, 28.8% had one CV risk factor and 12.1% had ≥ 2 CV risk factors; 7.0% had Framingham Risk Score ≥ 10%. Across the subgroups with 0, 1, and ≥ 2 CV risk factors and Framingham Risk Score < 10% and ≥ 10%, respectively, proportions of participants reporting adverse events (AEs; 59.6%, 61.4%, 62.2%, 59.9%, 67.5%) and serious AEs (2.7%, 2.5%, 2.3%, 2.6%, 2.4%) were consistent, and AEs leading to study drug discontinuation were low (1.9%, 3.1%, 5.5%, 2.5%, 4.8%).</p><p><strong>Conclusions: </strong>Rimegepant showed favorable safety and tolerability in adults with migraine and CV risk factors, including those with moderate to high CV risk.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03266588.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1203-1218"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393218/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141564035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Fibromyalgia (FM) is a complex and common syndrome characterized by chronic widespread pain, fatigue, sleep disturbances, and various functional symptoms without clear structural or pathological causes. Affecting approximately 1-5% of the global population, with a higher prevalence in women, FM significantly impacts patients' quality of life, often leading to considerable healthcare costs and loss of productivity. Despite its prevalence, the etiology of FM remains elusive, with genetic, environmental, and psychological factors, including nutrition, being implicated. Currently, no universally accepted treatment guidelines exist, and management strategies are often symptomatic. This narrative review explores the potential of a neuronutritional approach to FM management. It synthesizes existing research on the relationship between FM and nutrition, suggesting that dietary interventions could be a promising complementary treatment strategy. Various nutritional interventions, including vitamin D, magnesium, iron, and probiotics supplementation, have shown potential in reducing FM symptoms, such as chronic pain, anxiety, depression, cognitive dysfunction, sleep disturbances, and gastrointestinal issues. Additionally, weight loss has been associated with reduced inflammation and improved quality of life in FM patients. The review highlights the anti-inflammatory benefits of plant-based diets and the low-FODMAPs diet, which have shown promise in managing FM symptoms and related gastrointestinal disorders. Supplements such as vitamin D, magnesium, vitamin B12, coenzyme Q10, probiotics, omega-3 fatty acids, melatonin, S-adenosylmethionine, and acetyl-L-carnitine are discussed for their potential benefits in FM management through various mechanisms, including anti-inflammatory effects, modulation of neurotransmitters, and improvement of mitochondrial function. In conclusion, this review underscores the importance of considering neuronutrition as a holistic approach to FM treatment, advocating for further research and clinical trials to establish comprehensive dietary guidelines and to optimize management strategies for FM patients.
纤维肌痛(FM)是一种复杂而常见的综合征,以慢性广泛性疼痛、疲劳、睡眠障碍和各种功能性症状为特征,没有明确的结构或病理原因。纤维肌痛约占全球总人口的 1%-5%,女性发病率较高,严重影响患者的生活质量,往往导致大量医疗费用和生产力损失。尽管 FM 很普遍,但其病因仍然难以捉摸,遗传、环境和心理因素(包括营养)都与之有关。目前,还没有普遍接受的治疗指南,管理策略通常是对症治疗。这篇叙述性综述探讨了神经营养学方法治疗 FM 的潜力。它综合了现有关于 FM 与营养之间关系的研究,指出饮食干预可能是一种很有前景的辅助治疗策略。各种营养干预措施,包括维生素 D、镁、铁和益生菌补充剂,都显示出减少 FM 症状的潜力,如慢性疼痛、焦虑、抑郁、认知功能障碍、睡眠障碍和肠胃问题。此外,减轻体重也与减轻炎症和改善 FM 患者的生活质量有关。综述强调了植物性膳食和低 FODMAPs 膳食的抗炎益处,这两种膳食在控制 FM 症状和相关胃肠道疾病方面显示出良好的前景。本综述还讨论了维生素 D、镁、维生素 B12、辅酶 Q10、益生菌、ω-3 脂肪酸、褪黑素、S-腺苷蛋氨酸和乙酰基-L-肉碱等补充剂,这些补充剂通过各种机制(包括抗炎作用、神经递质调节和线粒体功能改善)对 FM 的治疗具有潜在益处。总之,这篇综述强调了将神经营养作为治疗 FM 的整体方法的重要性,提倡进一步开展研究和临床试验,以制定全面的饮食指南,优化 FM 患者的管理策略。
{"title":"Neuronutritional Approach to Fibromyalgia Management: A Narrative Review.","authors":"Anastasiia Badaeva, Alexey Danilov, Anastasiia Kosareva, Mariia Lepshina, Viacheslav Novikov, Yulia Vorobyeva, Andrey Danilov","doi":"10.1007/s40122-024-00641-2","DOIUrl":"10.1007/s40122-024-00641-2","url":null,"abstract":"<p><p>Fibromyalgia (FM) is a complex and common syndrome characterized by chronic widespread pain, fatigue, sleep disturbances, and various functional symptoms without clear structural or pathological causes. Affecting approximately 1-5% of the global population, with a higher prevalence in women, FM significantly impacts patients' quality of life, often leading to considerable healthcare costs and loss of productivity. Despite its prevalence, the etiology of FM remains elusive, with genetic, environmental, and psychological factors, including nutrition, being implicated. Currently, no universally accepted treatment guidelines exist, and management strategies are often symptomatic. This narrative review explores the potential of a neuronutritional approach to FM management. It synthesizes existing research on the relationship between FM and nutrition, suggesting that dietary interventions could be a promising complementary treatment strategy. Various nutritional interventions, including vitamin D, magnesium, iron, and probiotics supplementation, have shown potential in reducing FM symptoms, such as chronic pain, anxiety, depression, cognitive dysfunction, sleep disturbances, and gastrointestinal issues. Additionally, weight loss has been associated with reduced inflammation and improved quality of life in FM patients. The review highlights the anti-inflammatory benefits of plant-based diets and the low-FODMAPs diet, which have shown promise in managing FM symptoms and related gastrointestinal disorders. Supplements such as vitamin D, magnesium, vitamin B12, coenzyme Q10, probiotics, omega-3 fatty acids, melatonin, S-adenosylmethionine, and acetyl-L-carnitine are discussed for their potential benefits in FM management through various mechanisms, including anti-inflammatory effects, modulation of neurotransmitters, and improvement of mitochondrial function. In conclusion, this review underscores the importance of considering neuronutrition as a holistic approach to FM treatment, advocating for further research and clinical trials to establish comprehensive dietary guidelines and to optimize management strategies for FM patients.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1047-1061"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393252/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141748855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-07-02DOI: 10.1007/s40122-024-00628-z
Harold Nijhuis, Jan-Willem Kallewaard, Johan van de Minkelis, Willem-Jan Hofsté, Lars Elzinga, Philippa Armstrong, Ismaïl Gültuna, Emre Almac, Ganesan Baranidharan, Serge Nikolic, Ashish Gulve, Jan Vesper, Birte E Dietz, Dave Mugan, Frank J P M Huygen
<p><strong>Introduction: </strong>Closed-loop spinal cord stimulation (CL-SCS) is a recently introduced system that records evoked compound action potentials (ECAPs) from the spinal cord elicited by each stimulation pulse and uses this information to automatically adjust the stimulation strength in real time, known as ECAP-controlled SCS. This innovative system compensates for fluctuations in the distance between the epidural leads and the spinal cord by maintaining the neural response (ECAP) at a predetermined target level. This data collection study was designed to assess the performance of the first CL-SCS system in a real-world setting under normal conditions of use in multiple European centers. The study analyzes and presents clinical outcomes and electrophysiological and device data and compares these findings with those reported in earlier pre-market studies of the same system.</p><p><strong>Methods: </strong>This prospective, multicenter, observational study was conducted in 13 European centers and aimed to gather electrophysiological and device data. The study focused on the real-world application of this system in treating chronic pain affecting the trunk and/or limbs, adhering to standard conditions of use. In addition to collecting and analyzing basic demographic information, the study presents data from the inaugural patient cohort permanently implanted at multiple European centers.</p><p><strong>Results: </strong>A significant decrease in pain intensity was observed for overall back or leg pain scores (verbal numerical rating score [VNRS]) between baseline (mean ± standard error of the mean [SEM]; n = 135; 8.2 ± 0.1), 3 months (n = 93; 2.3 ± 0.2), 6 months (n = 82; 2.5 ± 0.3), and 12 months (n = 76; 2.5 ± 0.3). Comparison of overall pain relief (%) to the AVALON and EVOKE studies showed no significant differences at 3 and 12 months between the real-world data release (RWE; 71.3%; 69.6%) and the AVALON (71.2%; 73.6%) and EVOKE (78.1%; 76.7%) studies. Further investigation was undertaken to objectively characterize the physiological parameters of SCS therapy in this cohort using the metrics of percent time above ECAP threshold (%), dose ratio, and dose accuracy (µV), according to previously described methods. Results showed that a median of 90% (40.7-99.2) of stimuli were above the ECAP threshold, with a dose ratio of 1.3 (1.1-1.4) and dose accuracy of 4.4 µV (0.0-7.1), based on data from 236, 230, and 254 patients, respectively. Thus, across all three metrics, the majority of patients had objective therapy metrics corresponding to the highest levels of pain relief in previously reported studies (usage over threshold > 80%, dose ratio > 1.2, and error < 10 µV).</p><p><strong>Conclusions: </strong>In conclusion, this study provides valuable insights into the real-world application of the ECAP-controlled CL-SCS system, highlighting its potential for maintaining effective pain relief and objective neurophysiological therapy metrics at le
{"title":"Durability of Evoked Compound Action Potential (ECAP)-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) in a Real-World European Chronic Pain Population.","authors":"Harold Nijhuis, Jan-Willem Kallewaard, Johan van de Minkelis, Willem-Jan Hofsté, Lars Elzinga, Philippa Armstrong, Ismaïl Gültuna, Emre Almac, Ganesan Baranidharan, Serge Nikolic, Ashish Gulve, Jan Vesper, Birte E Dietz, Dave Mugan, Frank J P M Huygen","doi":"10.1007/s40122-024-00628-z","DOIUrl":"10.1007/s40122-024-00628-z","url":null,"abstract":"<p><strong>Introduction: </strong>Closed-loop spinal cord stimulation (CL-SCS) is a recently introduced system that records evoked compound action potentials (ECAPs) from the spinal cord elicited by each stimulation pulse and uses this information to automatically adjust the stimulation strength in real time, known as ECAP-controlled SCS. This innovative system compensates for fluctuations in the distance between the epidural leads and the spinal cord by maintaining the neural response (ECAP) at a predetermined target level. This data collection study was designed to assess the performance of the first CL-SCS system in a real-world setting under normal conditions of use in multiple European centers. The study analyzes and presents clinical outcomes and electrophysiological and device data and compares these findings with those reported in earlier pre-market studies of the same system.</p><p><strong>Methods: </strong>This prospective, multicenter, observational study was conducted in 13 European centers and aimed to gather electrophysiological and device data. The study focused on the real-world application of this system in treating chronic pain affecting the trunk and/or limbs, adhering to standard conditions of use. In addition to collecting and analyzing basic demographic information, the study presents data from the inaugural patient cohort permanently implanted at multiple European centers.</p><p><strong>Results: </strong>A significant decrease in pain intensity was observed for overall back or leg pain scores (verbal numerical rating score [VNRS]) between baseline (mean ± standard error of the mean [SEM]; n = 135; 8.2 ± 0.1), 3 months (n = 93; 2.3 ± 0.2), 6 months (n = 82; 2.5 ± 0.3), and 12 months (n = 76; 2.5 ± 0.3). Comparison of overall pain relief (%) to the AVALON and EVOKE studies showed no significant differences at 3 and 12 months between the real-world data release (RWE; 71.3%; 69.6%) and the AVALON (71.2%; 73.6%) and EVOKE (78.1%; 76.7%) studies. Further investigation was undertaken to objectively characterize the physiological parameters of SCS therapy in this cohort using the metrics of percent time above ECAP threshold (%), dose ratio, and dose accuracy (µV), according to previously described methods. Results showed that a median of 90% (40.7-99.2) of stimuli were above the ECAP threshold, with a dose ratio of 1.3 (1.1-1.4) and dose accuracy of 4.4 µV (0.0-7.1), based on data from 236, 230, and 254 patients, respectively. Thus, across all three metrics, the majority of patients had objective therapy metrics corresponding to the highest levels of pain relief in previously reported studies (usage over threshold > 80%, dose ratio > 1.2, and error < 10 µV).</p><p><strong>Conclusions: </strong>In conclusion, this study provides valuable insights into the real-world application of the ECAP-controlled CL-SCS system, highlighting its potential for maintaining effective pain relief and objective neurophysiological therapy metrics at le","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1119-1136"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393244/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141492952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Central post-stroke pain (CPSP) is a common type of central neuropathic pain (CNeP) that can occur following the onset of stroke. The oral gabapentinoid mirogabalin besylate (mirogabalin) is a selective α2δ ligand that is effective for the treatment of CNeP, including CPSP. However, it is unknown whether the analgesic effect of mirogabalin on CPSP varies in patients with different background factors.
Methods: This was a post hoc subgroup analysis of a multinational, open-label, long-term phase 3 study of mirogabalin for the treatment of CNeP conducted between March 2019 and December 2020. Data from patients with CPSP were stratified by type of stroke (ischemic or hemorrhagic), stroke location (thalamus, putamen, brainstem, or other), presence/absence of motor weakness, median time since stroke (≥ 59 or < 59 months), and median duration of CPSP (≥ 55.5 or < 55.5 months). Efficacy was assessed with the short-form McGill Pain Questionnaire (SF-MPQ), and treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs) were recorded.
Results: This subanalysis included all 94 patients with CPSP from the phase 3 study; all were Japanese, and the mean age was 65.3 years. The least squares mean change [95% confidence interval] in SF-MPQ visual analog scale (VAS) score from baseline at week 52 (last observation carried forward) was - 17.0 [- 22.1, - 11.9] mm. Among the subgroups, least squares mean changes in SF-MPQ VAS scores were not different. Most TEAEs were mild or moderate; severe TEAEs occurred in six patients (6.4%). Somnolence (25.5%), peripheral edema (13.8%), dizziness (11.7%), and weight gain (6.4%) were the most common ADRs, and the types and frequencies of ADRs were similar among subgroups.
Conclusion: Mirogabalin was generally effective and well tolerated in patients with CPSP, regardless of background factors such as stroke type or location, presence/absence of motor weakness, time since stroke, and duration of CPSP.
Trial registration: Trial registration number NCT03901352.
{"title":"Usefulness of Mirogabalin in Central Neuropathic Pain After Stroke: Post Hoc Analysis of a Phase 3 Study by Stroke Type and Location.","authors":"Koichi Hosomi, Yoichi Katayama, Hiroshi Sakoda, Kunika Kikumori, Masanori Kuroha, Takahiro Ushida","doi":"10.1007/s40122-024-00616-3","DOIUrl":"10.1007/s40122-024-00616-3","url":null,"abstract":"<p><strong>Introduction: </strong>Central post-stroke pain (CPSP) is a common type of central neuropathic pain (CNeP) that can occur following the onset of stroke. The oral gabapentinoid mirogabalin besylate (mirogabalin) is a selective α<sub>2</sub>δ ligand that is effective for the treatment of CNeP, including CPSP. However, it is unknown whether the analgesic effect of mirogabalin on CPSP varies in patients with different background factors.</p><p><strong>Methods: </strong>This was a post hoc subgroup analysis of a multinational, open-label, long-term phase 3 study of mirogabalin for the treatment of CNeP conducted between March 2019 and December 2020. Data from patients with CPSP were stratified by type of stroke (ischemic or hemorrhagic), stroke location (thalamus, putamen, brainstem, or other), presence/absence of motor weakness, median time since stroke (≥ 59 or < 59 months), and median duration of CPSP (≥ 55.5 or < 55.5 months). Efficacy was assessed with the short-form McGill Pain Questionnaire (SF-MPQ), and treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs) were recorded.</p><p><strong>Results: </strong>This subanalysis included all 94 patients with CPSP from the phase 3 study; all were Japanese, and the mean age was 65.3 years. The least squares mean change [95% confidence interval] in SF-MPQ visual analog scale (VAS) score from baseline at week 52 (last observation carried forward) was - 17.0 [- 22.1, - 11.9] mm. Among the subgroups, least squares mean changes in SF-MPQ VAS scores were not different. Most TEAEs were mild or moderate; severe TEAEs occurred in six patients (6.4%). Somnolence (25.5%), peripheral edema (13.8%), dizziness (11.7%), and weight gain (6.4%) were the most common ADRs, and the types and frequencies of ADRs were similar among subgroups.</p><p><strong>Conclusion: </strong>Mirogabalin was generally effective and well tolerated in patients with CPSP, regardless of background factors such as stroke type or location, presence/absence of motor weakness, time since stroke, and duration of CPSP.</p><p><strong>Trial registration: </strong>Trial registration number NCT03901352.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1151-1171"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393279/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141498679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}