Introduction: Headaches are among the most prevalent and disabling sources of pain, affecting nearly half of adults worldwide. Many patients experience debilitating headaches refractory to conservative treatments, including pharmacotherapy, steroid injections, or other interventional therapies. Radiofrequency ablation (RFA) is a minimally invasive technique that uses controlled thermal energy to create targeted tissue necrosis, disrupting the nociceptive signaling within targeted sensory nerves, and is a promising therapy for patients with chronic headaches refractory to conservative treatments. The objective of this study is to evaluate the clinical efficacy of thermal RFA for chronic headache management by examining changes in pain scores and the duration and degree of symptom relief.
Methods: This retrospective chart review of this study investigates patients who received thermal RFA of the occipital, supraorbital, supratrochlear, infraorbital, infratrochlear, and/or anterior ethmoid nerves between 2015 and 2025. Preoperative and postoperative pain scores were assessed using the Visual Analogue Scale (VAS). Additionally, the duration of relief and any adverse events associated with the procedures were recorded. Paired t-tests were performed between preoperative and postoperative VAS pain scores to determine statistical significance, with a p-value of ≤ 0.05 denoting significance.
Results: In total, 940 procedures were reviewed; 108 were excluded, and 832 procedures from 464 patients were included. The 464 patients comprised 369 female and 95 male patients, with a mean age of 44.83 ± 15.99 years and body mass index (BMI) of 29.65 ± 7.44 kg/m2. Average preoperative and postoperative VAS scores were 5.34 ± 2.01 and 3.04 ± 2.33, respectively, representing a statistically significant reduction (p < 0.001). Quantitative or qualitative improvement was reported in 68.63% of procedures, and 13.10% noted complete remission for a total of 81.73% experiencing pain relief, whereas 18.27% saw no change. Among effective cases, the mean improvement was 60.20 ± 28.54%, lasting an average of 7.47 ± 9.78 months. A total of 12 adverse events were reported.
Conclusions: These findings suggest that thermal RFA of pericranial nerves can offer meaningful, lasting relief for patients with neuralgic headaches that resist traditional treatments. As a minimally invasive option with limited side effects, RFA may reduce the need for ongoing pharmacologic management and improve the quality of life for chronic headache sufferers.
{"title":"Radiofrequency Ablation of Pericranial Nerves for Treating Headaches: 10-Year Follow-Up.","authors":"Alaa Abd-Elsayed, Madelyn J Reilly, Nina Hashimoto, Mohan Xu, Barnabas T Shiferaw, Lukas J Henjum","doi":"10.1007/s40122-025-00792-w","DOIUrl":"10.1007/s40122-025-00792-w","url":null,"abstract":"<p><strong>Introduction: </strong>Headaches are among the most prevalent and disabling sources of pain, affecting nearly half of adults worldwide. Many patients experience debilitating headaches refractory to conservative treatments, including pharmacotherapy, steroid injections, or other interventional therapies. Radiofrequency ablation (RFA) is a minimally invasive technique that uses controlled thermal energy to create targeted tissue necrosis, disrupting the nociceptive signaling within targeted sensory nerves, and is a promising therapy for patients with chronic headaches refractory to conservative treatments. The objective of this study is to evaluate the clinical efficacy of thermal RFA for chronic headache management by examining changes in pain scores and the duration and degree of symptom relief.</p><p><strong>Methods: </strong>This retrospective chart review of this study investigates patients who received thermal RFA of the occipital, supraorbital, supratrochlear, infraorbital, infratrochlear, and/or anterior ethmoid nerves between 2015 and 2025. Preoperative and postoperative pain scores were assessed using the Visual Analogue Scale (VAS). Additionally, the duration of relief and any adverse events associated with the procedures were recorded. Paired t-tests were performed between preoperative and postoperative VAS pain scores to determine statistical significance, with a p-value of ≤ 0.05 denoting significance.</p><p><strong>Results: </strong>In total, 940 procedures were reviewed; 108 were excluded, and 832 procedures from 464 patients were included. The 464 patients comprised 369 female and 95 male patients, with a mean age of 44.83 ± 15.99 years and body mass index (BMI) of 29.65 ± 7.44 kg/m<sup>2</sup>. Average preoperative and postoperative VAS scores were 5.34 ± 2.01 and 3.04 ± 2.33, respectively, representing a statistically significant reduction (p < 0.001). Quantitative or qualitative improvement was reported in 68.63% of procedures, and 13.10% noted complete remission for a total of 81.73% experiencing pain relief, whereas 18.27% saw no change. Among effective cases, the mean improvement was 60.20 ± 28.54%, lasting an average of 7.47 ± 9.78 months. A total of 12 adverse events were reported.</p><p><strong>Conclusions: </strong>These findings suggest that thermal RFA of pericranial nerves can offer meaningful, lasting relief for patients with neuralgic headaches that resist traditional treatments. As a minimally invasive option with limited side effects, RFA may reduce the need for ongoing pharmacologic management and improve the quality of life for chronic headache sufferers.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"161-173"},"PeriodicalIF":3.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12804506/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145422393","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 : 2026-02-01Epub Date: 2025-11-22DOI: 10.1007/s40122-025-00797-5
Yufeng Zhang, Songchao Xu, Haoning Lan, Danxu Ma, Yun Wang
Anatomical variations in nerves are common and can significantly impact ultrasound-guided regional anesthesia. They directly influence needle trajectory, local anesthetic spread, and block efficacy, contributing to procedural failure or complications. However, the literature specifically addressing the clinical implications of neural variations for regional anesthesia remains limited. This narrative review synthesizes evidence on three key aspects: (1) variations of common peripheral nerves and their clinical significance in regional anesthesia (including the terminal branches of the trigeminal nerve, suprascapular nerve, phrenic nerve, lumbar plexus, saphenous nerve, obturator nerve, and sciatic nerve); (2) variations of major vessels relevant to regional anesthesia and their clinical significance in regional anesthesia (including the Adamkiewicz artery and vertebral artery); (3) variations of the spine and spinal nerve roots and their clinical significance in regional anesthesia. This review systematically synthesizes current evidence on these anatomical variations and introduces practical resources, including regional ultrasound guidance and tables correlating specific variants with technical modifications, to enhance ultrasound recognition and clinical decision-making, thereby serving as a valuable reference for clinicians.
{"title":"Clinical Implications of Anatomical Variations in Nerves and Adjacent Structures for Regional Anesthesia: A Narrative Review.","authors":"Yufeng Zhang, Songchao Xu, Haoning Lan, Danxu Ma, Yun Wang","doi":"10.1007/s40122-025-00797-5","DOIUrl":"10.1007/s40122-025-00797-5","url":null,"abstract":"<p><p>Anatomical variations in nerves are common and can significantly impact ultrasound-guided regional anesthesia. They directly influence needle trajectory, local anesthetic spread, and block efficacy, contributing to procedural failure or complications. However, the literature specifically addressing the clinical implications of neural variations for regional anesthesia remains limited. This narrative review synthesizes evidence on three key aspects: (1) variations of common peripheral nerves and their clinical significance in regional anesthesia (including the terminal branches of the trigeminal nerve, suprascapular nerve, phrenic nerve, lumbar plexus, saphenous nerve, obturator nerve, and sciatic nerve); (2) variations of major vessels relevant to regional anesthesia and their clinical significance in regional anesthesia (including the Adamkiewicz artery and vertebral artery); (3) variations of the spine and spinal nerve roots and their clinical significance in regional anesthesia. This review systematically synthesizes current evidence on these anatomical variations and introduces practical resources, including regional ultrasound guidance and tables correlating specific variants with technical modifications, to enhance ultrasound recognition and clinical decision-making, thereby serving as a valuable reference for clinicians.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"41-69"},"PeriodicalIF":3.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12804495/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145582437","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: Lumbar facet joint pain is a treatable condition often overlooked or misclassified as nonspecific low back pain. Although facet joint blocks are useful for diagnosis, they are unsuitable for early-stage screening. This study aimed to develop practical diagnostic criteria for lumbar facet joint pain that are easily applicable by general practitioners without invasive procedures to facilitate early identification and referral for appropriate treatment.
Methods: PubMed was searched for articles on facet joint pain. All diagnostic items described in the identified articles were comprehensively collected. A questionnaire survey was administered to orthopedic spine surgeons, who rated each item based on its diagnostic value; only those considered important were extracted. Next, using factor analysis, the items were grouped into a small number of factors. Diagnostic criteria were then established through multiple Delphi rounds.
Results: The query identified 2682 articles published between 2000 and 2023; eight articles were used to extract 77 diagnostic items. A survey collected responses from 39 orthopedic spine surgeons. The 25 most important items were selected from the survey results, and factor analysis was applied. Through multiple Delphi rounds, four diagnostic criteria were established: physical findings suggesting facet joint pain, neurological symptoms, imaging findings suggesting non-facet causes, and signs of discogenic low back pain. Diagnosis is confirmed if the first criterion is met and no more than one of the others is present.
Conclusion: Consensus-based diagnostic criteria for lumbar facet joint pain were developed, which offer a noninvasive, clinically practical approach to diagnosis, promoting early recognition and appropriate referral by general practitioners.
{"title":"Expert Consensus-Based Criteria for Identifying Lumbar Facet Joint Pain in Primary Care: Development Using Factor Analysis and a Modified Delphi Method.","authors":"Hiroaki Abe, So Kato, Hirokazu Takami, Satoshi Kodama, Masashi Hamada, Yuki Taniguchi, Masahiko Sumitani, Yasushi Oshima","doi":"10.1007/s40122-025-00788-6","DOIUrl":"10.1007/s40122-025-00788-6","url":null,"abstract":"<p><strong>Introduction: </strong>Lumbar facet joint pain is a treatable condition often overlooked or misclassified as nonspecific low back pain. Although facet joint blocks are useful for diagnosis, they are unsuitable for early-stage screening. This study aimed to develop practical diagnostic criteria for lumbar facet joint pain that are easily applicable by general practitioners without invasive procedures to facilitate early identification and referral for appropriate treatment.</p><p><strong>Methods: </strong>PubMed was searched for articles on facet joint pain. All diagnostic items described in the identified articles were comprehensively collected. A questionnaire survey was administered to orthopedic spine surgeons, who rated each item based on its diagnostic value; only those considered important were extracted. Next, using factor analysis, the items were grouped into a small number of factors. Diagnostic criteria were then established through multiple Delphi rounds.</p><p><strong>Results: </strong>The query identified 2682 articles published between 2000 and 2023; eight articles were used to extract 77 diagnostic items. A survey collected responses from 39 orthopedic spine surgeons. The 25 most important items were selected from the survey results, and factor analysis was applied. Through multiple Delphi rounds, four diagnostic criteria were established: physical findings suggesting facet joint pain, neurological symptoms, imaging findings suggesting non-facet causes, and signs of discogenic low back pain. Diagnosis is confirmed if the first criterion is met and no more than one of the others is present.</p><p><strong>Conclusion: </strong>Consensus-based diagnostic criteria for lumbar facet joint pain were developed, which offer a noninvasive, clinically practical approach to diagnosis, promoting early recognition and appropriate referral by general practitioners.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"235-249"},"PeriodicalIF":3.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12804469/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145513486","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: Given the limitations of single-modality analgesia for rib fractures, this study aimed to determine whether combining systemic flurbiprofen axetil with a regional intercostal nerve block (ICNB) yields more effective and sustained preoperative pain relief than either technique used alone.
Methods: In this single-center, randomized, double-blind, controlled trial, 150 patients scheduled for surgery were allocated to one of three groups: Group F (flurbiprofen axetil + saline ICNB), Group FB (flurbiprofen axetil + ropivacaine ICNB), and Group B (saline + ropivacaine ICNB). The primary outcome was the Visual Analog Scale (VAS) score at quiet breathing 30 min post-intervention. Secondary outcomes included VAS scores at 6, 12, 18, and 24 h, rescue analgesia requirements, diaphragmatic excursion, arterial blood gas parameters, adverse events, and patient satisfaction.
Results: The FB group demonstrated significantly lower VAS scores at 30 min than the other groups (p < 0.001), along with significantly reduced rescue analgesia requirements across most time intervals (p < 0.05). No patients in the FB group required rescue thoracic paravertebral block versus eight in Group F (p < 0.001). The FB group also showed a significantly higher sum of pain intensity difference over 0-24 h (SPID0-24h), improved diaphragmatic excursion, higher oxygenation index, and greater patient satisfaction (all p < 0.001). The overall incidence of adverse events was low, with no serious complications reported.
Conclusion: The combination of flurbiprofen axetil and ultrasound-guided ICNB provided superior preoperative analgesia than either agent alone, reduced rescue medication needs, improved respiratory function, and enhanced patient satisfaction, with a favorable safety profile in patients with traumatic multiple rib fractures.
Trial registration: The study protocol was registered at the Chinese Clinical Trial Registry with registration no. ChiCTR2500105786 ( https://www.chictr.org.cn ).
{"title":"Flurbiprofen Axetil Combined with Ultrasound-Guided Intercostal Nerve Block for Preoperative Analgesia in Patients with Traumatic Multiple Rib Fractures: A Randomized Controlled Trial.","authors":"Ziwen Chen, Yuyuan You, Yonghua Rao, Huahao Li, Chengxiang Huang, Xiayu Zou, Wenying Liang, Zhixin Wu, Zhongqi Zhang","doi":"10.1007/s40122-025-00811-w","DOIUrl":"10.1007/s40122-025-00811-w","url":null,"abstract":"<p><strong>Introduction: </strong>Given the limitations of single-modality analgesia for rib fractures, this study aimed to determine whether combining systemic flurbiprofen axetil with a regional intercostal nerve block (ICNB) yields more effective and sustained preoperative pain relief than either technique used alone.</p><p><strong>Methods: </strong>In this single-center, randomized, double-blind, controlled trial, 150 patients scheduled for surgery were allocated to one of three groups: Group F (flurbiprofen axetil + saline ICNB), Group FB (flurbiprofen axetil + ropivacaine ICNB), and Group B (saline + ropivacaine ICNB). The primary outcome was the Visual Analog Scale (VAS) score at quiet breathing 30 min post-intervention. Secondary outcomes included VAS scores at 6, 12, 18, and 24 h, rescue analgesia requirements, diaphragmatic excursion, arterial blood gas parameters, adverse events, and patient satisfaction.</p><p><strong>Results: </strong>The FB group demonstrated significantly lower VAS scores at 30 min than the other groups (p < 0.001), along with significantly reduced rescue analgesia requirements across most time intervals (p < 0.05). No patients in the FB group required rescue thoracic paravertebral block versus eight in Group F (p < 0.001). The FB group also showed a significantly higher sum of pain intensity difference over 0-24 h (SPID<sub>0-24h</sub>), improved diaphragmatic excursion, higher oxygenation index, and greater patient satisfaction (all p < 0.001). The overall incidence of adverse events was low, with no serious complications reported.</p><p><strong>Conclusion: </strong>The combination of flurbiprofen axetil and ultrasound-guided ICNB provided superior preoperative analgesia than either agent alone, reduced rescue medication needs, improved respiratory function, and enhanced patient satisfaction, with a favorable safety profile in patients with traumatic multiple rib fractures.</p><p><strong>Trial registration: </strong>The study protocol was registered at the Chinese Clinical Trial Registry with registration no. ChiCTR2500105786 ( https://www.chictr.org.cn ).</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"417-431"},"PeriodicalIF":3.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12804474/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145892859","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: Postoperative pain management poses unique challenges in older adult patients undergoing laparoscopic abdominal tumor surgery. While morphine remains a standard analgesic option, its use in this population is frequently complicated by adverse effects. Tegileridine represents a potential alternative with distinct pharmacological properties that warrant clinical evaluation.
Methods: This will be a single-center, randomized, assessor-blinded, active-controlled trial. A total of 66 older adult patients undergoing laparoscopic abdominal tumor surgery will be randomized in a 1:1 ratio to receive either tegileridine (0.1 mg bolus) or morphine (1 mg bolus) via patient-controlled intravenous analgesia.
Planned outcomes: The primary endpoint is the incidence of moderate-to-severe movement-related pain (NRS ≥ 4) at 24 h postoperatively. Secondary assessments include pain at rest, requirement for rescue analgesia, safety outcomes, and recovery parameters.
Trial registration: Registered at the Chinese Clinical Trial Registry on October 14, 2025.
{"title":"The Analgesic Effect of Tegileridine in Older Adult Patients After Laparoscopic Abdominal Tumor Surgery: Study Protocol for a Randomized Controlled Trial.","authors":"Yu Feng, Guanyu Yang, Pin Zhang, Liumei Li, Jiayao Tian, Yan Wang, Qinjun Chu","doi":"10.1007/s40122-025-00798-4","DOIUrl":"10.1007/s40122-025-00798-4","url":null,"abstract":"<p><strong>Introduction: </strong>Postoperative pain management poses unique challenges in older adult patients undergoing laparoscopic abdominal tumor surgery. While morphine remains a standard analgesic option, its use in this population is frequently complicated by adverse effects. Tegileridine represents a potential alternative with distinct pharmacological properties that warrant clinical evaluation.</p><p><strong>Methods: </strong>This will be a single-center, randomized, assessor-blinded, active-controlled trial. A total of 66 older adult patients undergoing laparoscopic abdominal tumor surgery will be randomized in a 1:1 ratio to receive either tegileridine (0.1 mg bolus) or morphine (1 mg bolus) via patient-controlled intravenous analgesia.</p><p><strong>Planned outcomes: </strong>The primary endpoint is the incidence of moderate-to-severe movement-related pain (NRS ≥ 4) at 24 h postoperatively. Secondary assessments include pain at rest, requirement for rescue analgesia, safety outcomes, and recovery parameters.</p><p><strong>Trial registration: </strong>Registered at the Chinese Clinical Trial Registry on October 14, 2025.</p><p><strong>Trial registration number: </strong>ChiCTR2500110485.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"433-441"},"PeriodicalIF":3.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12804478/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145564748","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: Epidural analgesia has shown high maternal-fetal safety and satisfactory analgesia. Sufentanil is associated with a high risk of pruritus, nausea, and vomiting for epidural labor analgesia. Alfentanil is characterized by a rapid onset and is also used for labor analgesia. The study aimed to compare the analgesic efficacy and adverse effects of epidural ropivacaine combined with equipotent doses of alfentanil or sufentanil for labor analgesia, and to provide evidence for optimizing obstetric analgesic regimens.
Methods: In this multicenter, randomized, controlled, single-blind trial conducted at four tertiary hospitals in China between June 2023 and June 2024, 442 nulliparous women with singleton, term pregnancies were enrolled. Participants were randomly assigned (1:1) to receive epidural 0.075% ropivacaine combined with either 4 μg/ml alfentanil (group A) or 0.2 μg/ml sufentanil (group S). Analgesia was delivered via a programmed intermittent epidural bolus (PIEB) plus patient-controlled epidural analgesia (PCEA) regimen (10 ml bolus, 50-min interval, 3 ml/h background infusion, 8-ml patient-controlled bolus, 20-min lockout). The onset of analgesia, defined as the median time from drug administration to the first recording of a visual analogue scale (VAS) score ≤ 3 within 30 min was the primary outcome. Hemodynamic parameters, labor characteristics, analgesic consumption, maternal satisfaction, neonatal outcomes, and adverse events were recorded as secondary outcomes.
Results: The median onset time of analgesia was significantly shorter in the alfentanil group compared with the sufentanil group (8.0 min vs. 10.0 min, P < 0.001). No significant differences were observed between groups in blood pressure, heart rate, SpO₂, fetal heart rate, Bromage scores, VAS scores at subsequent time points, uterine pressure, sensory block level, body temperature, duration of analgesia, labor duration, mode of delivery, oxytocin use, total drug consumption, maternal satisfaction, or neonatal Apgar scores (all P > 0.05). Adverse events such as pruritus, nausea, vomiting, urinary retention, and lower limb numbness were infrequent and comparable between groups.
Conclusions: Both alfentanil and sufentanil, when combined with 0.075% ropivacaine, provide effective and safe epidural labor analgesia. However, alfentanil offers the advantage of a faster onset of analgesia, making it a valuable alternative to sufentanil in clinical practice.
Trial registration: Chinese Clinical Trial Registry, ChiCTR2300072104, Date of registration: June 2, 2023.
硬膜外镇痛具有较高的母胎安全性和满意的镇痛效果。舒芬太尼与硬膜外分娩镇痛时瘙痒、恶心和呕吐的高风险相关。阿芬太尼的特点是起效快,也用于分娩镇痛。本研究旨在比较硬膜外罗哌卡因联合等剂量阿芬太尼或舒芬太尼用于分娩镇痛的镇痛效果和不良反应,为优化产科镇痛方案提供依据。方法:这项多中心、随机、对照、单盲试验于2023年6月至2024年6月在中国四家三级医院进行,纳入了442名单胎足月未生育妇女。参与者被随机分配(1:1)接受0.075%罗哌卡因硬膜外注射,同时给予4 μg/ml阿芬太尼(A组)或0.2 μg/ml舒芬太尼(S组)。镇痛通过计划性间歇硬膜外输注(PIEB)加患者自控硬膜外镇痛(PCEA)方案(10ml输注,间隔50分钟,背景输注3ml /h, 8ml患者自控输注,闭锁20分钟)进行。镇痛的开始,定义为从给药到30分钟内首次记录视觉模拟评分(VAS)评分≤3的中位时间是主要终点。血流动力学参数、分娩特征、镇痛药消耗、产妇满意度、新生儿结局和不良事件被记录为次要结局。结果:阿芬太尼组镇痛的中位起效时间明显短于舒芬太尼组(8.0 min vs. 10.0 min, P < 0.05)。瘙痒、恶心、呕吐、尿潴留和下肢麻木等不良事件不常见,组间具有可比性。结论:阿芬太尼和舒芬太尼联合0.075%罗哌卡因均能有效、安全地用于硬膜外分娩镇痛。然而,阿芬太尼具有更快起效止痛的优点,使其在临床实践中成为舒芬太尼的有价值的替代品。试验注册:中国临床试验注册中心,ChiCTR2300072104,注册日期:2023年6月2日。
{"title":"Analgesic Efficacy and Adverse Effects of Epidural Ropivacaine Combined with Equipotent Alfentanil or Sufentanil for Labor Analgesia: A Multicenter Randomized Controlled Single-Blind Trial.","authors":"Xiao Jiang, Yufang Xiu, Chang Jia, Bo Han, Jianyu Zu, Shanni Zhang, Nana Han, Lingling Pan, Huixuan Sun, Jing Li, Yingjian Wang, Kean Wang, Yufei Man, Wenchao Liu, Zhenzhou Guan, Fang Yao, Ning Jin, Zhiqiang Xue, Wenhua Yuan, Peng Li, Yuyue Gong, Qi Wang, Sijin Lu, Huijun Wang, Yingjie Sun, Yugang Diao, Huijuan Cao","doi":"10.1007/s40122-025-00812-9","DOIUrl":"https://doi.org/10.1007/s40122-025-00812-9","url":null,"abstract":"<p><strong>Introduction: </strong>Epidural analgesia has shown high maternal-fetal safety and satisfactory analgesia. Sufentanil is associated with a high risk of pruritus, nausea, and vomiting for epidural labor analgesia. Alfentanil is characterized by a rapid onset and is also used for labor analgesia. The study aimed to compare the analgesic efficacy and adverse effects of epidural ropivacaine combined with equipotent doses of alfentanil or sufentanil for labor analgesia, and to provide evidence for optimizing obstetric analgesic regimens.</p><p><strong>Methods: </strong>In this multicenter, randomized, controlled, single-blind trial conducted at four tertiary hospitals in China between June 2023 and June 2024, 442 nulliparous women with singleton, term pregnancies were enrolled. Participants were randomly assigned (1:1) to receive epidural 0.075% ropivacaine combined with either 4 μg/ml alfentanil (group A) or 0.2 μg/ml sufentanil (group S). Analgesia was delivered via a programmed intermittent epidural bolus (PIEB) plus patient-controlled epidural analgesia (PCEA) regimen (10 ml bolus, 50-min interval, 3 ml/h background infusion, 8-ml patient-controlled bolus, 20-min lockout). The onset of analgesia, defined as the median time from drug administration to the first recording of a visual analogue scale (VAS) score ≤ 3 within 30 min was the primary outcome. Hemodynamic parameters, labor characteristics, analgesic consumption, maternal satisfaction, neonatal outcomes, and adverse events were recorded as secondary outcomes.</p><p><strong>Results: </strong>The median onset time of analgesia was significantly shorter in the alfentanil group compared with the sufentanil group (8.0 min vs. 10.0 min, P < 0.001). No significant differences were observed between groups in blood pressure, heart rate, SpO₂, fetal heart rate, Bromage scores, VAS scores at subsequent time points, uterine pressure, sensory block level, body temperature, duration of analgesia, labor duration, mode of delivery, oxytocin use, total drug consumption, maternal satisfaction, or neonatal Apgar scores (all P > 0.05). Adverse events such as pruritus, nausea, vomiting, urinary retention, and lower limb numbness were infrequent and comparable between groups.</p><p><strong>Conclusions: </strong>Both alfentanil and sufentanil, when combined with 0.075% ropivacaine, provide effective and safe epidural labor analgesia. However, alfentanil offers the advantage of a faster onset of analgesia, making it a valuable alternative to sufentanil in clinical practice.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry, ChiCTR2300072104, Date of registration: June 2, 2023.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146086616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-08DOI: 10.1007/s40122-025-00808-5
Daniel J Parker, Ajay B Antony, Gregory L Smith, Johnathan H Goree, Marc A Russo, Erika A Petersen, Chau M Vu, Paul Verrills, Christopher Gilmore, Leonardo Kapural, Darayus Nanavati, Dean M Karantonis, Jason E Pope
Introduction: Evoked compound action potentials (ECAPs) are neurophysiological biomarkers of neural activation during spinal cord stimulation (SCS). Clear distinction between ECAPs and nonphysiological signals is critical to the application of contemporary, ECAP-based closed-loop (CL) SCS therapies. Herein, we evaluated the performance and user acceptability of a novel programming software that automates generation of ECAP-based CL-SCS programs-the Assisted Programming Module (APM).
Methods: We report results from two prospective, multicenter, single-arm, feasibility studies: Freshwater (NCT04662905) and Rosella (NCT06057480). APM performance was compared with the previous generation programming software and other published methods. Performance was assessed by comparing signal-to-noise ratios, artifact rejection, and other objective parameters. User acceptability was assessed using questionnaires administered to SCS users.
Results: The APM successfully generated a CL program in 96% of initial programming sessions (n = 81/84; Freshwater, 31/34; Rosella, 50/50). In the Rosella study, median time to generate an automated CL program (n = 68) was 11.9 min [interquartile range (IQR) 9.9-14.0]. Median dose ratio was 1.31 (IQR 1.20-1.46) at end of trial (n = 24), 1.34 (IQR 1.13-1.51) at 1 month post implant (n = 16), and 1.32 (IQR 1.21-1.48) at 3 months post implant (n = 15). At least 90% of patients [trial, 90% (27/30); implant, 94% (17/18)] were satisfied with their programming experience, and ≥ 90% of patients [trial, 90% (26/29); implant, 94% (16/17)] felt in control of their therapy. The APM achieved a mean signal-to-noise ratio of 4.6 ± 1.2, a 35% improvement over the previous generation ECAP dose-controlled CL-SCS system. Detectable artifact leakage rates decreased by 75% when compared with other published methods without compromise to signal-to-noise performance.
Conclusions: Next-generation ECAP dose-controlled CL technology demonstrated strong feasibility, high patient satisfaction and therapy control, and superior ECAP signal fidelity compared with existing methods. By standardizing CL-SCS programming and enhancing signal fidelity, the APM may improve workflow efficiency and long-term therapy outcomes in chronic pain management.
{"title":"Next-Generation SCS Programming Platform: Enhancing ECAP Fidelity and Objectivity to Improve Patient Experience.","authors":"Daniel J Parker, Ajay B Antony, Gregory L Smith, Johnathan H Goree, Marc A Russo, Erika A Petersen, Chau M Vu, Paul Verrills, Christopher Gilmore, Leonardo Kapural, Darayus Nanavati, Dean M Karantonis, Jason E Pope","doi":"10.1007/s40122-025-00808-5","DOIUrl":"https://doi.org/10.1007/s40122-025-00808-5","url":null,"abstract":"<p><strong>Introduction: </strong>Evoked compound action potentials (ECAPs) are neurophysiological biomarkers of neural activation during spinal cord stimulation (SCS). Clear distinction between ECAPs and nonphysiological signals is critical to the application of contemporary, ECAP-based closed-loop (CL) SCS therapies. Herein, we evaluated the performance and user acceptability of a novel programming software that automates generation of ECAP-based CL-SCS programs-the Assisted Programming Module (APM).</p><p><strong>Methods: </strong>We report results from two prospective, multicenter, single-arm, feasibility studies: Freshwater (NCT04662905) and Rosella (NCT06057480). APM performance was compared with the previous generation programming software and other published methods. Performance was assessed by comparing signal-to-noise ratios, artifact rejection, and other objective parameters. User acceptability was assessed using questionnaires administered to SCS users.</p><p><strong>Results: </strong>The APM successfully generated a CL program in 96% of initial programming sessions (n = 81/84; Freshwater, 31/34; Rosella, 50/50). In the Rosella study, median time to generate an automated CL program (n = 68) was 11.9 min [interquartile range (IQR) 9.9-14.0]. Median dose ratio was 1.31 (IQR 1.20-1.46) at end of trial (n = 24), 1.34 (IQR 1.13-1.51) at 1 month post implant (n = 16), and 1.32 (IQR 1.21-1.48) at 3 months post implant (n = 15). At least 90% of patients [trial, 90% (27/30); implant, 94% (17/18)] were satisfied with their programming experience, and ≥ 90% of patients [trial, 90% (26/29); implant, 94% (16/17)] felt in control of their therapy. The APM achieved a mean signal-to-noise ratio of 4.6 ± 1.2, a 35% improvement over the previous generation ECAP dose-controlled CL-SCS system. Detectable artifact leakage rates decreased by 75% when compared with other published methods without compromise to signal-to-noise performance.</p><p><strong>Conclusions: </strong>Next-generation ECAP dose-controlled CL technology demonstrated strong feasibility, high patient satisfaction and therapy control, and superior ECAP signal fidelity compared with existing methods. By standardizing CL-SCS programming and enhancing signal fidelity, the APM may improve workflow efficiency and long-term therapy outcomes in chronic pain management.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifiers: NCT04662905, NCT06057480.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145934686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-09-30DOI: 10.1007/s40122-025-00773-z
Winfried Meissner, Charles Argoff, Sabine Sator, Volker Schoder, Matthias Karst
Introduction: Chronic low back pain (CLBP) affects over half a billion people worldwide. Current pharmacologic treatments, comprising mainly non-steroidal anti-inflammatory drugs and opioids, offer limited efficacy and pose significant risks, warranting the development of tolerable, safe and effective alternatives.
Methods: This randomized controlled trial on adults with CLBP was designed to confirm the superior efficacy and gastrointestinal tolerability of VER-01, a novel, standardized full-spectrum extract from Cannabis sativa DKJ127 L., over opioids. Subjects were randomized (1:1) to receive VER-01 or a range of commercially available opioids. After a 3-week titration, subjects underwent 24 weeks of treatment, followed by 2 weeks of wash-out. The primary endpoint was the relative risk of constipation occurrence after 27 weeks treatment. Secondary endpoints included changes in pain and sleep scores, determined using an 11-point numeric rating scale (NRS), with key secondary endpoints defined for week 27.
Results: A total of 384 individuals were randomized to receive VER-01 (n = 192) or opioids (n = 192). Subjects receiving VER-01 were fourfold less likely to develop constipation than those receiving opioids (relative risk [RR] VER-01/opioids 0.25; 95% confidence interval [CI] 0.09-0.69; p = 0.007) and threefold less likely to use laxatives (RR 0.34; 95% CI 0.18-0.65; p < 0.001). Longitudinal analysis revealed that VER-01 was superior to opioids in terms of pain reduction over 6 months of treatment, although differences in secondary endpoints limited to week 27 alone were not significant. Throughout the 6 months of treatment, mean pain reduction was 2.50 NRS points with VER-01 versus 2.16 with opioids (mean difference [MD] 0.34; 95% CI 0.00-0.67; p = 0.048), and sleep improved by 2.52 points with VER-01 versus 2.07 with opioids (MD 0.45; 95% CI 0.11-0.79; p = 0.009). These benefits were particularly pronounced in participants with severe pain, with greater pain reduction (MD 0.58; 95% CI 0.01-1.15) and sleep improvement (MD 0.66, 95% CI 0.05-1.27) compared to opioids.
Conclusions: VER-01 demonstrated superiority over opioids in treating CLBP, both in terms of efficacy and gastrointestinal tolerability.
慢性腰痛(CLBP)影响着全球超过5亿人。目前的药物治疗主要包括非甾体类抗炎药和阿片类药物,其疗效有限且存在重大风险,因此需要开发可耐受、安全和有效的替代品。方法:这项针对CLBP成人患者的随机对照试验旨在证实VER-01优于阿片类药物的疗效和胃肠道耐受性。VER-01是一种新型、标准化的大麻全谱提取物DKJ127 L.。受试者被随机(1:1)接受VER-01或一系列市售阿片类药物。3周滴定后,受试者接受24周治疗,随后进行2周洗脱。主要终点是治疗27周后便秘发生的相对风险。次要终点包括疼痛和睡眠评分的变化,使用11分数字评定量表(NRS)确定,关键次要终点为第27周。结果:384例患者随机接受VER-01治疗(n = 192)或阿片类药物治疗(n = 192)。接受VER-01治疗的受试者发生便秘的可能性比接受阿片类药物治疗的受试者低4倍(相对危险度[RR] VER-01/阿片类药物0.25;95%可信区间[CI] 0.09-0.69; p = 0.007),使用泻药的可能性低3倍(RR 0.34; 95% CI 0.18-0.65; p结论:VER-01在治疗CLBP方面的疗效和胃肠道耐受性均优于阿片类药物。试验注册:ClinicalTrials.gov ID: NCT05610813;草案编号:2022-001358-41。
{"title":"VER-01 Shows Enhanced Gastrointestinal Tolerability, Superior Pain Relief, and Improved Sleep Quality Compared to Opioids in Treating Chronic Low Back Pain: A Randomized Phase 3 Clinical Trial.","authors":"Winfried Meissner, Charles Argoff, Sabine Sator, Volker Schoder, Matthias Karst","doi":"10.1007/s40122-025-00773-z","DOIUrl":"10.1007/s40122-025-00773-z","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic low back pain (CLBP) affects over half a billion people worldwide. Current pharmacologic treatments, comprising mainly non-steroidal anti-inflammatory drugs and opioids, offer limited efficacy and pose significant risks, warranting the development of tolerable, safe and effective alternatives.</p><p><strong>Methods: </strong>This randomized controlled trial on adults with CLBP was designed to confirm the superior efficacy and gastrointestinal tolerability of VER-01, a novel, standardized full-spectrum extract from Cannabis sativa DKJ127 L., over opioids. Subjects were randomized (1:1) to receive VER-01 or a range of commercially available opioids. After a 3-week titration, subjects underwent 24 weeks of treatment, followed by 2 weeks of wash-out. The primary endpoint was the relative risk of constipation occurrence after 27 weeks treatment. Secondary endpoints included changes in pain and sleep scores, determined using an 11-point numeric rating scale (NRS), with key secondary endpoints defined for week 27.</p><p><strong>Results: </strong>A total of 384 individuals were randomized to receive VER-01 (n = 192) or opioids (n = 192). Subjects receiving VER-01 were fourfold less likely to develop constipation than those receiving opioids (relative risk [RR] VER-01/opioids 0.25; 95% confidence interval [CI] 0.09-0.69; p = 0.007) and threefold less likely to use laxatives (RR 0.34; 95% CI 0.18-0.65; p < 0.001). Longitudinal analysis revealed that VER-01 was superior to opioids in terms of pain reduction over 6 months of treatment, although differences in secondary endpoints limited to week 27 alone were not significant. Throughout the 6 months of treatment, mean pain reduction was 2.50 NRS points with VER-01 versus 2.16 with opioids (mean difference [MD] 0.34; 95% CI 0.00-0.67; p = 0.048), and sleep improved by 2.52 points with VER-01 versus 2.07 with opioids (MD 0.45; 95% CI 0.11-0.79; p = 0.009). These benefits were particularly pronounced in participants with severe pain, with greater pain reduction (MD 0.58; 95% CI 0.01-1.15) and sleep improvement (MD 0.66, 95% CI 0.05-1.27) compared to opioids.</p><p><strong>Conclusions: </strong>VER-01 demonstrated superiority over opioids in treating CLBP, both in terms of efficacy and gastrointestinal tolerability.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID: NCT05610813; EudraCT ID: 2022-001358-41.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1765-1782"},"PeriodicalIF":3.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12634985/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145200751","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: Lumbar disc herniation (LDH) is characterized by the displacement of intervertebral disc material with compression of adjacent nerve roots, leading to nociceptive and neuropathic pain in the lower limbs and lower back. The Miro-Hers study explored the efficacy and safety of mirogabalin add-on treatment in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) compared with NSAIDs alone. We hypothesized that mirogabalin added on to NSAID therapy may reduce neuropathic pain due to LDH more than NSAIDs alone.
Methods: This was a multicenter, 8-week, randomized (1:1), open-label, parallel-group study conducted in Japan between March 2023 and September 2024. The study included participants with LDH diagnosed by magnetic resonance imaging who had inadequately controlled lower limb pain [numerical rating scale (NRS) score ≥ 4] despite NSAID treatment. The primary endpoint was the change in the NRS score for lower limb pain from baseline to Week 8. The secondary endpoints included quality of life, as assessed by the EuroQol 5 dimensions 5-level score (EQ-5D-5L), and NRS score for sleep disturbance. Safety endpoints included treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs).
Results: Of the 182 participants screened and randomized, 90 in the mirogabalin add-on group and 89 in the NSAIDs alone group were included in the efficacy analysis. The reduction in NRS score for lower limb pain from baseline to Week 8 was significantly greater in the mirogabalin add-on group than in the NSAIDs alone group, with least squares mean changes of - 3.8 [95% confidence interval (CI): - 4.4, - 3.3] and - 2.2 (- 2.8, - 1.7), respectively [intergroup difference - 1.6 (- 2.4, - 0.8); P < 0.001]. EQ-5D-5L and NRS score for sleep disturbance both significantly improved over the study period with mirogabalin add-on treatment compared with NSAIDs alone [intergroup difference: 0.0653 (95% CI 0.0235, 0.1071); P = 0.002 and - 1.3 (- 1.9, - 0.7); P < 0.001, respectively]. No severe or serious TEAEs were observed. In the mirogabalin add-on group, ADRs were observed in 48.9% of participants, with somnolence (31.1%) and dizziness (18.9%) being the most common.
Conclusion: The addition of mirogabalin to NSAIDs treatment significantly improved pain, quality of life, and sleep disturbance in patients with LDH, with no previously undocumented safety concerns identified.
Trial registration: Japan Registry of Clinical Trials (jRCTs061220102, registered 27/February/2023, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs061220102 ).
{"title":"Efficacy and Safety of Mirogabalin as an Add-on to Nonsteroidal Anti-inflammatory Drugs for Neuropathic Pain Caused by Lumbar Disc Herniation: A Randomized Controlled Study (Miro-Hers).","authors":"Hidenori Suzuki, Takashi Kaito, Hiroaki Nakashima, Hiroshi Takahashi, Shuhei Yamamoto, Shunsuke Tabata, Hiromitsu Toyoda","doi":"10.1007/s40122-025-00776-w","DOIUrl":"10.1007/s40122-025-00776-w","url":null,"abstract":"<p><strong>Introduction: </strong>Lumbar disc herniation (LDH) is characterized by the displacement of intervertebral disc material with compression of adjacent nerve roots, leading to nociceptive and neuropathic pain in the lower limbs and lower back. The Miro-Hers study explored the efficacy and safety of mirogabalin add-on treatment in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) compared with NSAIDs alone. We hypothesized that mirogabalin added on to NSAID therapy may reduce neuropathic pain due to LDH more than NSAIDs alone.</p><p><strong>Methods: </strong>This was a multicenter, 8-week, randomized (1:1), open-label, parallel-group study conducted in Japan between March 2023 and September 2024. The study included participants with LDH diagnosed by magnetic resonance imaging who had inadequately controlled lower limb pain [numerical rating scale (NRS) score ≥ 4] despite NSAID treatment. The primary endpoint was the change in the NRS score for lower limb pain from baseline to Week 8. The secondary endpoints included quality of life, as assessed by the EuroQol 5 dimensions 5-level score (EQ-5D-5L), and NRS score for sleep disturbance. Safety endpoints included treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs).</p><p><strong>Results: </strong>Of the 182 participants screened and randomized, 90 in the mirogabalin add-on group and 89 in the NSAIDs alone group were included in the efficacy analysis. The reduction in NRS score for lower limb pain from baseline to Week 8 was significantly greater in the mirogabalin add-on group than in the NSAIDs alone group, with least squares mean changes of - 3.8 [95% confidence interval (CI): - 4.4, - 3.3] and - 2.2 (- 2.8, - 1.7), respectively [intergroup difference - 1.6 (- 2.4, - 0.8); P < 0.001]. EQ-5D-5L and NRS score for sleep disturbance both significantly improved over the study period with mirogabalin add-on treatment compared with NSAIDs alone [intergroup difference: 0.0653 (95% CI 0.0235, 0.1071); P = 0.002 and - 1.3 (- 1.9, - 0.7); P < 0.001, respectively]. No severe or serious TEAEs were observed. In the mirogabalin add-on group, ADRs were observed in 48.9% of participants, with somnolence (31.1%) and dizziness (18.9%) being the most common.</p><p><strong>Conclusion: </strong>The addition of mirogabalin to NSAIDs treatment significantly improved pain, quality of life, and sleep disturbance in patients with LDH, with no previously undocumented safety concerns identified.</p><p><strong>Trial registration: </strong>Japan Registry of Clinical Trials (jRCTs061220102, registered 27/February/2023, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs061220102 ).</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1879-1898"},"PeriodicalIF":3.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12634911/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145308748","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 : 2025-12-01Epub Date: 2025-10-17DOI: 10.1007/s40122-025-00779-7
John R Ingram, Hideki Fujita, Alice B Gottlieb, Hadar Lev-Tov, Errol Prens, Christopher J Sayed, Vivian Y Shi, Jacek C Szepietowski, Kenzo Takahashi, John W Frew, Jérémy Lambert, Leah Davis, Tae Oh, Robert Rolleri, Marie-Hélène Saintmard, Lauren A V Orenstein
Introduction: Pain is a debilitating symptom of hidradenitis suppurativa (HS). Bimekizumab, a humanized IgG1 monoclonal antibody, selectively inhibits IL-17A and IL-17F. The impact of bimekizumab on pain outcomes in moderate to severe HS was assessed using pooled 48-week data from BE HEARD I&II (observed case and multiple imputation).
Methods: Patients were randomized 2:2:2:1 to receive one of bimekizumab 320 mg every 2 weeks (Q2W); bimekizumab Q2W to Week 16, then every 4 weeks (Q4W) to Week 48; bimekizumab Q4W; or placebo to Week 16, then bimekizumab Q2W to Week 48. HS Symptom Daily Diary (HSSDD; baseline-Week 16) and HS Symptom Questionnaire (HSSQ; baseline, Weeks 16-48) assessed patient-reported skin pain. Mean scores, change from baseline (CfB), responder rates, shifts across pain severity categories, and association of HS Clinical Response (HiSCR) with pain outcomes were assessed.
Results: A total of 1014 patients with moderate to severe HS were enrolled. Mean (standard deviation) age was 36.6 (12.2) years and 56.8% were women. Bimekizumab demonstrated rapid reductions in mean HSSDD worst and average skin pain scores after 2 weeks. Greater reductions from baseline in HSSDD worst (mean CfB ± standard error, bimekizumab Q2W: - 1.9 ± 0.1; bimekizumab Q4W: - 1.5 ± 0.2) and average skin pain scores (bimekizumab Q2W: - 1.8 ± 0.1; bimekizumab Q4W: - 1.4 ± 0.2) were observed at Week 16 versus placebo (worst: - 0.7 ± 0.2; average: - 0.8 ± 0.2). Mean HSSQ skin pain showed similar improvements to Week 16; further reductions were seen to Week 48 in those continually receiving bimekizumab. Week 16 placebo switchers saw rapid improvements in HSSQ skin pain scores from Week 16 to Week 18, comparable to those continually receiving bimekizumab. Responses were maintained to Week 48 (bimekizumab Q2W/Q2W: - 2.9 ± 0.2; bimekizumab Q2W/Q4W: - 2.5 ± 0.2; bimekizumab Q4W/Q4W: - 2.8 ± 0.2; placebo/bimekizumab Q2W: - 2.5 ± 0.3). Many patients shifted from severe/very severe to lower severity HSSQ skin pain categories (mild/no pain). Improvements corresponded with higher HiSCR scores at Week 48.
Conclusions: Treatment with bimekizumab leads to rapid, continuous, and clinically meaningful reductions in skin pain.
Trial registration: NCT04242446 ( https://clinicaltrials.gov/study/NCT04242446 ); NCT04242498 ( https://clinicaltrials.gov/study/NCT04242498 ). An Infographic is available for this article. Infographic.
{"title":"Bimekizumab Pain Outcomes in Patients with Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II Phase 3 Randomized Clinical Trials.","authors":"John R Ingram, Hideki Fujita, Alice B Gottlieb, Hadar Lev-Tov, Errol Prens, Christopher J Sayed, Vivian Y Shi, Jacek C Szepietowski, Kenzo Takahashi, John W Frew, Jérémy Lambert, Leah Davis, Tae Oh, Robert Rolleri, Marie-Hélène Saintmard, Lauren A V Orenstein","doi":"10.1007/s40122-025-00779-7","DOIUrl":"10.1007/s40122-025-00779-7","url":null,"abstract":"<p><strong>Introduction: </strong>Pain is a debilitating symptom of hidradenitis suppurativa (HS). Bimekizumab, a humanized IgG1 monoclonal antibody, selectively inhibits IL-17A and IL-17F. The impact of bimekizumab on pain outcomes in moderate to severe HS was assessed using pooled 48-week data from BE HEARD I&II (observed case and multiple imputation).</p><p><strong>Methods: </strong>Patients were randomized 2:2:2:1 to receive one of bimekizumab 320 mg every 2 weeks (Q2W); bimekizumab Q2W to Week 16, then every 4 weeks (Q4W) to Week 48; bimekizumab Q4W; or placebo to Week 16, then bimekizumab Q2W to Week 48. HS Symptom Daily Diary (HSSDD; baseline-Week 16) and HS Symptom Questionnaire (HSSQ; baseline, Weeks 16-48) assessed patient-reported skin pain. Mean scores, change from baseline (CfB), responder rates, shifts across pain severity categories, and association of HS Clinical Response (HiSCR) with pain outcomes were assessed.</p><p><strong>Results: </strong>A total of 1014 patients with moderate to severe HS were enrolled. Mean (standard deviation) age was 36.6 (12.2) years and 56.8% were women. Bimekizumab demonstrated rapid reductions in mean HSSDD worst and average skin pain scores after 2 weeks. Greater reductions from baseline in HSSDD worst (mean CfB ± standard error, bimekizumab Q2W: - 1.9 ± 0.1; bimekizumab Q4W: - 1.5 ± 0.2) and average skin pain scores (bimekizumab Q2W: - 1.8 ± 0.1; bimekizumab Q4W: - 1.4 ± 0.2) were observed at Week 16 versus placebo (worst: - 0.7 ± 0.2; average: - 0.8 ± 0.2). Mean HSSQ skin pain showed similar improvements to Week 16; further reductions were seen to Week 48 in those continually receiving bimekizumab. Week 16 placebo switchers saw rapid improvements in HSSQ skin pain scores from Week 16 to Week 18, comparable to those continually receiving bimekizumab. Responses were maintained to Week 48 (bimekizumab Q2W/Q2W: - 2.9 ± 0.2; bimekizumab Q2W/Q4W: - 2.5 ± 0.2; bimekizumab Q4W/Q4W: - 2.8 ± 0.2; placebo/bimekizumab Q2W: - 2.5 ± 0.3). Many patients shifted from severe/very severe to lower severity HSSQ skin pain categories (mild/no pain). Improvements corresponded with higher HiSCR scores at Week 48.</p><p><strong>Conclusions: </strong>Treatment with bimekizumab leads to rapid, continuous, and clinically meaningful reductions in skin pain.</p><p><strong>Trial registration: </strong>NCT04242446 ( https://clinicaltrials.gov/study/NCT04242446 ); NCT04242498 ( https://clinicaltrials.gov/study/NCT04242498 ). An Infographic is available for this article. Infographic.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1861-1878"},"PeriodicalIF":3.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12634948/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145313484","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}