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Does sleep quality mediate the association of depressive symptoms with pain and disability in older adults with low back pain? A longitudinal population-based study. 睡眠质量是否介导老年腰痛患者抑郁症状与疼痛和残疾的关联?一项基于人群的纵向研究。
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-20 DOI: 10.1093/pm/pnag011
Priscila Kalil Morelhão, Allan Saj Porcacchia, Cynthia Gobbi, Márcia Rodrigues Franco, Viviane Akemi Kakazu, Sergio Tufik, Monica Levy Andersen, Rafael Zambelli Pinto

Introduction: Chronic low back pain (LBP) is common in older adults and can cause functional disability. It is often linked with depressive symptoms and poor sleep quality, which are factors related to each other that have bidirectional relationships with pain, forming a complex interdependent triad.

Objective: We examined whether sleep quality plays a mediating role in the association between depressive symptoms, pain, and disability in older adults with LBP.

Design: This study is an observational cohort.

Methods: A total of 171 participants aged ≥60 years were interviewed. Data on depressive symptoms (Center for Epidemiologic Studies Depression Scale), sleep quality (Pittsburgh Sleep Quality Index), pain intensity (Numeric Pain Scale), and functional disability (Roland-Morris Disability Questionnaire) were collected at different time-points (baseline, 6 months, and 12 months). Mediation analysis was used to assess whether sleep quality was a mediating factor in the relationship between pain and depressive symptoms.

Results: The results indicated that sleep quality at 6 months significantly mediated the association between baseline depressive symptoms with both pain intensity and functional disability at 12 months. The influence of baseline insomnia symptoms on outcomes at 12 months depended on sleep quality at 6 months. The indirect mediation explained 43.4% of the relationship with pain intensity and 47.9% with functional disability.

Conclusion: Sleep quality was found to mediate the relationship between depressive symptoms and pain/disability. These findings highlight the importance of assessing/improving sleep quality in older adults with LBP and depressive symptoms.

慢性腰痛(LBP)在老年人中很常见,可导致功能障碍。它通常与抑郁症状和睡眠质量差有关,这是相互关联的因素,与疼痛有双向关系,形成一个复杂的相互依存的三位一体。目的:我们研究睡眠质量是否在老年腰痛患者的抑郁症状、疼痛和残疾之间起中介作用。设计:本研究为观察性队列研究。方法:对171名年龄≥60岁的参与者进行访谈。在不同时间点(基线、6个月和12个月)收集抑郁症状(流行病学研究中心抑郁量表)、睡眠质量(匹兹堡睡眠质量指数)、疼痛强度(数值疼痛量表)和功能障碍(Roland-Morris残疾问卷)的数据。采用中介分析来评估睡眠质量是否是疼痛与抑郁症状之间关系的中介因素。结果:6个月时的睡眠质量显著调节基线抑郁症状与12个月时疼痛强度和功能障碍之间的关联。基线失眠症状对12个月预后的影响取决于6个月时的睡眠质量。间接中介解释了43.4%与疼痛强度的关系,47.9%与功能障碍的关系。结论:睡眠质量在抑郁症状与疼痛/残疾之间起中介作用。这些发现强调了评估/改善有腰痛和抑郁症状的老年人睡眠质量的重要性。
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引用次数: 0
Intra-Nasal Ketamine Compared to Intravenous Morphine for Acute Pain in the Emergency Department: A Prospective, Triple Blind, Controlled Study. 在急诊科,鼻内氯胺酮与静脉注射吗啡治疗急性疼痛:一项前瞻性、三盲、对照研究。
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-20 DOI: 10.1093/pm/pnag012
Noaa Shopen, Neta Cohen, Michal Mizrahi, Reut Aviv Mordechai, Omri Ritter, Julieta Werthein, Lauren Achiam Cohen, David Zeltser, Pinchas Halpern

Objective: Evidence on intranasal (IN) ketamine as an alternative to opioids for acute pain is limited. We compared the efficacy and safety of IN ketamine to intravenous (IV) morphine in emergency department (ED) patients.

Methods: This triple-blinded, placebo-controlled, randomized trial included consenting adult patients with moderate-to-severe pain (≥70 mm on a visual analog scale[VAS]) who were given either 0.1 mg/kg IV morphine and IN placebo or 1 mg/kg IN ketamine and IV placebo and were monitored for vital signs, pain levels, and adverse events for 120 minutes. The primary outcome was the efficacy of intranasal ketamine compared with intravenous morphine in reducing pain, defined as achieving a ≥ 15-mm decrease in the VAS pain score. The secondary outcomes were adverse events (AEs) and overall patient's satisfaction.

Results: Sixty-eight participants (mean age 43.5 ± 12.2 years, 48 male) were randomized equally. Groups were similar at baseline in mean age, sex, and pre-treatment median pain levels. There were no significant differences between IV morphine and IN- ketamine groups in the median [Intra quartile range (IQR)] values of time to onset of significant pain reduction (10.0 [5.0-20.0] vs. 10.0 [5.0-15.0) minutes, P =0.92), maximal pain reduction (30.0 [10.0- 57.0] vs. 20.5 [4.2- 39.5] mm VAS, P =0.18) and time to maximal pain reduction (105.0 [63.7-120.0] vs. 90.0 [45.0-120.0] minutes, P = 0.35). There were no significant differences in frequency of adverse effects at 0, 60, and 120 minutes.

Conclusions: This study did not demonstrate a statistically significant difference in efficacy or safety between IN ketamine and IV morphine for the management of acute pain in the emergency department (ED). Moreover, the findings indicate that IN ketamine may be a viable, and potentially superior, alternative to IV morphine.

目的:鼻内氯胺酮替代阿片类药物治疗急性疼痛的证据有限。我们比较了IN氯胺酮与静脉注射吗啡在急诊科(ED)患者中的疗效和安全性。方法:这项三盲、安慰剂对照、随机试验纳入了中度至重度疼痛(视觉模拟量表[VAS]≥70 mm)的成年患者,他们被给予0.1 mg/kg IV吗啡和IN安慰剂或1 mg/kg IN氯胺酮和IV安慰剂,并监测120分钟的生命体征、疼痛水平和不良事件。主要结局是与静脉注射吗啡相比,鼻内氯胺酮减轻疼痛的疗效,定义为VAS疼痛评分降低≥15mm。次要结局是不良事件(ae)和患者总体满意度。结果:68例参与者(平均年龄43.5±12.2岁,男性48例)平均随机分组。各组在基线时的平均年龄、性别和治疗前的中位疼痛水平相似。IV吗啡组和IN-氯胺酮组疼痛显著缓解时间(10.0 [5.0-20.0]vs. 10.0 [5.0-15.0] min, P =0.92)、最大疼痛缓解时间(30.0 [10.0- 57.0]vs. 20.5 [4.2- 39.5] mm VAS, P =0.18)和最大疼痛缓解时间(105.0 [63.7-120.0]vs. 90.0 [45.0-120.0] min, P = 0.35)的中位数[四分位数内范围(IQR)]值无显著差异。在0、60和120分钟时,不良反应的频率没有显著差异。结论:本研究未证明在急诊治疗急性疼痛时,静脉注射吗啡和注射氯胺酮在疗效和安全性上有统计学上的显著差异。此外,研究结果表明,氯胺酮可能是静脉注射吗啡的一种可行的、潜在的更好的替代品。
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引用次数: 0
Pain outcomes in persons with multiple sclerosis receiving S1PR modulators: A cross-sectional study. 接受S1PR调节剂治疗的多发性硬化症患者的疼痛结局:一项横断面研究
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-20 DOI: 10.1093/pm/pnag008
Salvador Sierra, Anna L Kratz, Tiffany J Braley

Background: The impact of disease-modifying therapies (DMT) on chronic pain in multiple sclerosis (MS) is poorly understood. Preclinical research suggests that modulation of sphingosine-1-phosphate pathways involved in inflammation and central sensitization could exert analgesic effects alongside MS relapse prevention, but more clinical data is needed.

Objective: To compare pain phenotypes, severity, and treatment regimens in persons living with MS (PwMS) using S1PR modulators versus other DMTs.

Methods: We conducted a secondary analysis of cross-sectional data from a nationwide MS survey. Univariate analyses were used to (t- and chi-square tests) examine associations between DMT class, demographics, disability severity, MS duration, pain outcomes, including pain phenotype (painDETECT Questionnaire for neuropathic pain and American College of Rheumatology Fibromyalgia survey for nociplastic pain), intensity and interference (PROMIS scales), analgesics and comorbidities (PROMIS measures).

Results: Among 731 participants, 82 used S1PR modulators. S1PR users were younger (48.02 vs. 52.51), but other characteristics were similar. After adjusting for age, pain types were similar in both groups. Among those with nociplastic pain, S1PR patients reported lower pain intensity than those on other DMTs (p = 0.02).

Conclusions: Compared to other DMTs, S1PR modulators are associated with lower pain intensity in MS patients with nociplastic pain.

背景:疾病改善疗法(DMT)对多发性硬化症(MS)慢性疼痛的影响尚不清楚。临床前研究表明,参与炎症和中枢致敏的鞘氨醇-1-磷酸通路的调节可以在预防MS复发的同时发挥镇痛作用,但需要更多的临床数据。目的:比较MS患者(PwMS)使用S1PR调节剂和其他dmt的疼痛表型、严重程度和治疗方案。方法:我们对全国多发性硬化症调查的横断面数据进行了二次分析。采用单变量分析(t-和卡方检验)检验DMT类别、人口统计学、残疾严重程度、MS持续时间、疼痛结局(包括疼痛表型(神经性疼痛的painDETECT问卷调查和美国风湿病学会纤维肌痛调查的伤害性疼痛)、强度和干扰(PROMIS量表)、镇痛药和合并症(PROMIS测量)之间的关联。结果:731名参与者中,82名使用S1PR调节剂。S1PR用户更年轻(48.02 vs 52.51),但其他特征相似。在调整年龄后,两组的疼痛类型相似。在有伤害性疼痛的患者中,S1PR患者报告的疼痛强度低于其他dmt患者(p = 0.02)。结论:与其他DMTs相比,S1PR调节剂与MS致伤性疼痛患者疼痛强度降低相关。
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引用次数: 0
Post-Sacral Lateral Branch Radiofrequency Ablation Neuritis: The More We Know, the Less We Understand. 骶骨后外侧支射频消融性神经炎:我们知道的越多,我们了解的越少。
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-14 DOI: 10.1093/pm/pnag003
Steven P Cohen, Zachary L McCormick, Robert W Hurley
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引用次数: 0
Sacroiliac joint complex pain post-procedural physical examination. 骶髂关节术后复合体疼痛。
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-14 DOI: 10.1093/pm/pnag002
Victor M Silva-Ortiz
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引用次数: 0
The Role of Peptides in Pain Management. 多肽在疼痛管理中的作用。
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-10 DOI: 10.1093/pm/pnag001
William Schultze, Joshua B Lewis, Sandeep Yerra, Maria R Eibel, Jillian Dean, Trent Emerick
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引用次数: 0
Dissection Study of the Innervation of the Anterior Elbow Joint: Laying the Anatomical Foundation for Minimally Invasive Pain Relief Procedures to Treat Elbow Joint Pain. 肘关节前神经支配的解剖研究:为肘关节疼痛的微创镇痛手术奠定解剖学基础。
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-07 DOI: 10.1093/pm/pnaf172
Denise M J Arnold, Emily S Ho, Sharon Switzer-McIntyre, Catherine E Amara, Anne M R Agur

Background: Minimally invasive pain relief treatments targeting articular nerves have emerged as treatment options for chronic joint pain, bridging the gap between conservative management and surgical intervention. These procedures have not been developed for the elbow joint due to insufficient anatomical knowledge of the articular branches innervating the elbow joint.

Objective: To determine origin, course, frequency, landmarks and capsular distribution of the articular branches supplying the anterior elbow joint.

Design: Anatomical dissection study.

Methods: 6 upper extremity specimens were meticulously dissected. Articular branches were traced from their origin on the brachial plexus to their termination. Origin, course, termination, and landmarks of each branch were documented and photographed in high-resolution. A frequency map was generated to visualize the capsular areas supplied by each articular branch.

Results: The musculocutaneous and/or median nerve gave rise to an extramuscular branch supplying the capsule deep to brachialis (83%). The median nerve supplied the medial capsule via a direct articular branch (17%), branches to flexor digitorum superficialis (100%), and a branch to pronator teres (67%). The anterior interosseus nerve supplied the capsule over the proximal radioulnar joint (67%). The radial nerve provided articular innervation to the lateral capsule via a radial branch to brachialis (83%), branches to extensor carpi radialis longus (100%), and branches to supinator (100%).

Conclusions: Detailed anatomical knowledge of the articular branches supplying the anterior elbow joint is essential for identifying potential targets for therapeutic intervention and exploring selective blockade of articular nerves to alleviate pain originating from specific capsular areas.

背景:针对关节神经的微创疼痛缓解治疗已成为慢性关节疼痛的治疗选择,弥合了保守治疗和手术干预之间的差距。由于对支配肘关节的关节分支的解剖学知识不足,这些手术尚未发展到肘关节。目的:了解肘关节前支的起源、运动轨迹、频率、标志和关节囊分布。设计:解剖解剖研究。方法:对6例上肢标本进行解剖。关节分支从它们在臂丛上的起源一直追踪到它们的终结。每个分支的起源、路线、终点和地标都被记录下来并以高分辨率拍摄下来。生成频率图以显示每个关节分支提供的囊膜区域。结果:肌皮神经和(或)正中神经产生肌外分支,供应深至肱肌的囊(83%)。正中神经通过直接关节分支(17%)、指浅屈肌分支(100%)和旋前圆肌分支(67%)供给内侧囊。前骨间神经支配尺桡关节近端关节囊(67%)。桡神经通过桡支到肱肌(83%)、分支到桡侧腕长伸肌(100%)和分支到旋后肌(100%)提供关节神经支配外侧包膜。结论:肘关节前分支的详细解剖学知识对于确定治疗干预的潜在目标和探索选择性阻断关节神经以减轻源自特定关节囊区域的疼痛至关重要。
{"title":"Dissection Study of the Innervation of the Anterior Elbow Joint: Laying the Anatomical Foundation for Minimally Invasive Pain Relief Procedures to Treat Elbow Joint Pain.","authors":"Denise M J Arnold, Emily S Ho, Sharon Switzer-McIntyre, Catherine E Amara, Anne M R Agur","doi":"10.1093/pm/pnaf172","DOIUrl":"https://doi.org/10.1093/pm/pnaf172","url":null,"abstract":"<p><strong>Background: </strong>Minimally invasive pain relief treatments targeting articular nerves have emerged as treatment options for chronic joint pain, bridging the gap between conservative management and surgical intervention. These procedures have not been developed for the elbow joint due to insufficient anatomical knowledge of the articular branches innervating the elbow joint.</p><p><strong>Objective: </strong>To determine origin, course, frequency, landmarks and capsular distribution of the articular branches supplying the anterior elbow joint.</p><p><strong>Design: </strong>Anatomical dissection study.</p><p><strong>Methods: </strong>6 upper extremity specimens were meticulously dissected. Articular branches were traced from their origin on the brachial plexus to their termination. Origin, course, termination, and landmarks of each branch were documented and photographed in high-resolution. A frequency map was generated to visualize the capsular areas supplied by each articular branch.</p><p><strong>Results: </strong>The musculocutaneous and/or median nerve gave rise to an extramuscular branch supplying the capsule deep to brachialis (83%). The median nerve supplied the medial capsule via a direct articular branch (17%), branches to flexor digitorum superficialis (100%), and a branch to pronator teres (67%). The anterior interosseus nerve supplied the capsule over the proximal radioulnar joint (67%). The radial nerve provided articular innervation to the lateral capsule via a radial branch to brachialis (83%), branches to extensor carpi radialis longus (100%), and branches to supinator (100%).</p><p><strong>Conclusions: </strong>Detailed anatomical knowledge of the articular branches supplying the anterior elbow joint is essential for identifying potential targets for therapeutic intervention and exploring selective blockade of articular nerves to alleviate pain originating from specific capsular areas.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145918156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Intraoperative computed tomography-guided neuronavigation for radiofrequency rhizotomy in trigeminal neuralgia: optimizing cannulation trajectories for individual anatomy. 术中ct引导神经导航射频神经根切断术治疗三叉神经痛:优化个体化解剖插管轨迹。
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-01 DOI: 10.1093/pm/pnaf060
Junhyung Kim, Jung Woo Yu, Jinu Rim, Won Seok Chang, Hyun Ho Jung

Objective: Fluoroscopy-guided radiofrequency rhizotomy for trigeminal neuralgia relies on biplanar fluoroscopic imaging and surface landmarks. However, anatomical variations and imaging limitations often necessitate multiple attempts, leading to patient discomfort and increased procedural risks. This study evaluated the procedural outcomes of radiofrequency rhizotomy using preplanned trajectories and intraoperative computed tomography with neuronavigation.

Design: Retrospective study.

Setting: Single-center study conducted in a neurosurgical department.

Participants: Forty-six patients with trigeminal neuralgia who underwent radiofrequency rhizotomy between September 2019 and December 2024 were recruited in this study.

Intervention: Cannulation of the foramen ovale was performed using navigation-guided trajectories, with intraoperative computed tomography used to adjust the trajectory if initial attempts failed. Success rates and the distances between the landmark-based and neuronavigation-guided entry points were measured.

Results: Among the 46 procedures, the entry points were adjusted from the landmark-based entry points in 22 patients (47.8%) to achieve successful foramen ovale cannulation. Adjustments involved inferolateral displacement in 17 cases and inferomedial displacement in 5 cases. The mean lateral displacement was 3.75 ± 5.40 mm, and the mean inferior displacement was 14.65 ± 6.91 mm. Foramen ovale cannulation was successfully achieved in all the patients without complications.

Conclusions: Intraoperative computed tomography and navigation-guided radiofrequency rhizotomy are safe and effective techniques for treating trigeminal neuralgia. The conventional entry point designated by surface landmarks was not optimal in 47.8% cases, who required an inferior shift to accommodate anatomical variations.

目的:透视引导下射频神经根切断术治疗三叉神经痛依赖于双平面透视成像和表面标志。然而,解剖变异和成像限制往往需要多次尝试,导致患者不适和手术风险增加。本研究使用预先计划的轨迹和术中神经导航计算机断层扫描评估射频根切断术的手术结果。设计:回顾性研究。背景:在神经外科进行的单中心研究。研究对象:本研究招募了46名在2019年9月至2024年12月期间接受射频神经根切断术的三叉神经痛患者。方法:使用导航引导的轨迹进行插管,如果最初的尝试失败,术中使用计算机断层扫描来调整轨迹。测量了成功率和基于地标和神经导航的入口点之间的距离。结果:在46例手术中,22例(47.8%)患者的入路点从标记入路点调整,成功实现卵圆孔插管。调整包括17例内外侧移位和5例内内侧移位。平均侧移位3.75±5.40 mm,平均下移位14.65±6.91 mm。所有患者均成功完成卵圆孔插管,无并发症。结论:术中计算机断层扫描和导航引导下射频神经根切断术是治疗三叉神经痛安全有效的技术。在47.8%的病例中,由表面标志指定的传统进入点不是最佳的,他们需要较低的移位来适应解剖变化。
{"title":"Intraoperative computed tomography-guided neuronavigation for radiofrequency rhizotomy in trigeminal neuralgia: optimizing cannulation trajectories for individual anatomy.","authors":"Junhyung Kim, Jung Woo Yu, Jinu Rim, Won Seok Chang, Hyun Ho Jung","doi":"10.1093/pm/pnaf060","DOIUrl":"10.1093/pm/pnaf060","url":null,"abstract":"<p><strong>Objective: </strong>Fluoroscopy-guided radiofrequency rhizotomy for trigeminal neuralgia relies on biplanar fluoroscopic imaging and surface landmarks. However, anatomical variations and imaging limitations often necessitate multiple attempts, leading to patient discomfort and increased procedural risks. This study evaluated the procedural outcomes of radiofrequency rhizotomy using preplanned trajectories and intraoperative computed tomography with neuronavigation.</p><p><strong>Design: </strong>Retrospective study.</p><p><strong>Setting: </strong>Single-center study conducted in a neurosurgical department.</p><p><strong>Participants: </strong>Forty-six patients with trigeminal neuralgia who underwent radiofrequency rhizotomy between September 2019 and December 2024 were recruited in this study.</p><p><strong>Intervention: </strong>Cannulation of the foramen ovale was performed using navigation-guided trajectories, with intraoperative computed tomography used to adjust the trajectory if initial attempts failed. Success rates and the distances between the landmark-based and neuronavigation-guided entry points were measured.</p><p><strong>Results: </strong>Among the 46 procedures, the entry points were adjusted from the landmark-based entry points in 22 patients (47.8%) to achieve successful foramen ovale cannulation. Adjustments involved inferolateral displacement in 17 cases and inferomedial displacement in 5 cases. The mean lateral displacement was 3.75 ± 5.40 mm, and the mean inferior displacement was 14.65 ± 6.91 mm. Foramen ovale cannulation was successfully achieved in all the patients without complications.</p><p><strong>Conclusions: </strong>Intraoperative computed tomography and navigation-guided radiofrequency rhizotomy are safe and effective techniques for treating trigeminal neuralgia. The conventional entry point designated by surface landmarks was not optimal in 47.8% cases, who required an inferior shift to accommodate anatomical variations.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":"62-67"},"PeriodicalIF":3.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12773734/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144079224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine. 针对非恢复性睡眠的纤维肌痛疼痛缓解:睡前舌下环苯扎林的3期随机试验。
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-01 DOI: 10.1093/pm/pnaf089
Seth Lederman, Lesley M Arnold, Ben Vaughn, Jean M Engels, Mary Kelley, Gregory M Sullivan

Objective: Fibromyalgia is the prototypic nociplastic chronic pain syndrome, characterized by widespread pain, nonrestorative sleep, and fatigue. We evaluated efficacy and safety of bedtime TNX-102 SL (sublingual cyclobenzaprine) 5.6 mg for treatment of fibromyalgia.

Methods: This phase 3, double-blind, multicenter, placebo-controlled trial randomized patients 1:1 to once-nightly TNX-102 SL 2.8 mg for 2 weeks, followed by 5.6 mg for 12 weeks, or to matching placebo (NCT05273749). The primary endpoint was change from baseline at week 14 in weekly average of daily diary pain intensity scores. Secondary endpoints included Patient Global Impression of Change, Fibromyalgia Impact Questionnaire (Revised) Symptoms and Function domains, Patient-Reported Outcomes Measurement Information System instruments for Sleep Disturbance and Fatigue, and daily diary sleep quality scores.

Results: Overall, 81.0% (n = 187/231) and 79.6% (n = 179/225) of patients receiving TNX-102 SL and placebo completed the trial, respectively. Treatment with TNX-102 SL vs placebo was associated with significantly greater reductions in the primary pain endpoint (P < .001; mean [SE], -1.8 [0.12] vs -1.2 [0.12]) and in each of the 6 secondary endpoints (P ≤ .001; all). The most common systemic treatment-emergent adverse events (TEAEs) with TNX-102 SL and placebo were COVID-19 (4.3% vs 3.1%, respectively), headache (3.0% vs 1.8%), and somnolence (3.0% vs 1.3%); the most common TEAEs overall were local administration-site reactions including oral hypoesthesia (23.4% vs 0.4%), product taste abnormal (11.3% vs 0.9%), and oral paresthesia (6.9% vs 0.9%), which were transient and self-limited.

Conclusion: Bedtime TNX-102 SL treatment was associated with significant improvements in fibromyalgia symptoms and function and was well tolerated.

Clinical trial registration: ClinicalTrials.gov/study/NCT05273749, first patient screened March 21, 2022.

目的:纤维肌痛是一种典型的致伤性慢性疼痛综合征,其特征是广泛的疼痛、非恢复性睡眠和疲劳。我们评估了睡前使用TNX-102 SL(舌下环苯扎林)5.6 mg治疗纤维肌痛的疗效和安全性。方法:这项3期、双盲、多中心、安慰剂对照试验将患者1:1随机分配到每晚一次的TNX-102 SL 2.8 mg,持续2周,随后使用5.6 mg,持续12周,或匹配安慰剂(NCT05273749)。主要终点是第14周时每日日记疼痛强度评分的周平均值与基线的变化。次要终点包括患者总体印象变化,纤维肌痛影响问卷(修订)症状和功能域,患者报告的睡眠障碍和疲劳的结果测量信息系统工具,以及每日日记睡眠质量评分。结果:总体而言,接受TNX-102 SL和安慰剂治疗的患者分别有81.0% (n = 187/231)和79.6% (n = 179/225)完成了试验。与安慰剂相比,TNX-102 SL治疗与原发性疼痛终点的显著降低相关(P结论:睡前TNX-102 SL治疗与纤维肌痛症状和功能的显着改善相关,并且耐受性良好。
{"title":"Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine.","authors":"Seth Lederman, Lesley M Arnold, Ben Vaughn, Jean M Engels, Mary Kelley, Gregory M Sullivan","doi":"10.1093/pm/pnaf089","DOIUrl":"10.1093/pm/pnaf089","url":null,"abstract":"<p><strong>Objective: </strong>Fibromyalgia is the prototypic nociplastic chronic pain syndrome, characterized by widespread pain, nonrestorative sleep, and fatigue. We evaluated efficacy and safety of bedtime TNX-102 SL (sublingual cyclobenzaprine) 5.6 mg for treatment of fibromyalgia.</p><p><strong>Methods: </strong>This phase 3, double-blind, multicenter, placebo-controlled trial randomized patients 1:1 to once-nightly TNX-102 SL 2.8 mg for 2 weeks, followed by 5.6 mg for 12 weeks, or to matching placebo (NCT05273749). The primary endpoint was change from baseline at week 14 in weekly average of daily diary pain intensity scores. Secondary endpoints included Patient Global Impression of Change, Fibromyalgia Impact Questionnaire (Revised) Symptoms and Function domains, Patient-Reported Outcomes Measurement Information System instruments for Sleep Disturbance and Fatigue, and daily diary sleep quality scores.</p><p><strong>Results: </strong>Overall, 81.0% (n = 187/231) and 79.6% (n = 179/225) of patients receiving TNX-102 SL and placebo completed the trial, respectively. Treatment with TNX-102 SL vs placebo was associated with significantly greater reductions in the primary pain endpoint (P < .001; mean [SE], -1.8 [0.12] vs -1.2 [0.12]) and in each of the 6 secondary endpoints (P ≤ .001; all). The most common systemic treatment-emergent adverse events (TEAEs) with TNX-102 SL and placebo were COVID-19 (4.3% vs 3.1%, respectively), headache (3.0% vs 1.8%), and somnolence (3.0% vs 1.3%); the most common TEAEs overall were local administration-site reactions including oral hypoesthesia (23.4% vs 0.4%), product taste abnormal (11.3% vs 0.9%), and oral paresthesia (6.9% vs 0.9%), which were transient and self-limited.</p><p><strong>Conclusion: </strong>Bedtime TNX-102 SL treatment was associated with significant improvements in fibromyalgia symptoms and function and was well tolerated.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov/study/NCT05273749, first patient screened March 21, 2022.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":"86-94"},"PeriodicalIF":3.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12773742/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144584493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Mindful meditation for epidural catheter placement during labor: a single-center randomized controlled trial. 正念冥想对分娩时硬膜外置管的作用:一项单中心随机对照试验。
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-01 DOI: 10.1093/pm/pnaf075
Mario I Lumbreras-Marquez, Asimina Lazaridou, Diego Villela-Franyutti, Kara G Fields, Michaela K Farber, Ehren R Nelson, Kristin L Schreiber, Dominique Y Arce

Importance: Labor epidural placement can cause significant procedural anxiety for patients. Behavioral interventions, such as mindful meditation, can effectively reduce anxiety, including during pregnancy.

Objective: This study aimed to assess the impact of a 10-minute mindful meditation session on anxiety and pain during labor epidural placement.

Design, setting, participants, intervention, and outcome measures: Pregnant women were recruited and randomized into 2 groups: A 10-minute guided mindful meditation, or a neutral content recording, both delivered via headphones before the epidural procedure as a recording. After the procedure, participants reported their levels of anxiety, pain, and satisfaction. Linear regression analyses were used to evaluate the main effects of the intervention on anxiety, pain, and satisfaction. Additionally, an exploratory post hoc moderation analysis assessed the role of baseline pain catastrophizing and its interaction with the intervention.

Results: A total of 100 participants were included (50 per group). There were no overall main effect of mindful meditation on primary outcomes of anxiety and pain, or secondary outcome of procedural satisfaction, compared to the neutral content recording (P's > .05). Exploratory post hoc analysis indicated a moderation of treatment effect, such that participants with higher baseline pain catastrophizing experienced greater benefits from mindful meditation compared to neutral content on anxiety (b = -0.18, P = .01) and pain (b = -0.14, P = .03).

Conclusions and relevance: While no overall group-level effects of mindful meditation were found, exploratory analysis suggested that the intervention may be more beneficial for participants with high baseline pain catastrophizing. Future studies enrolling a larger sample, or enriching for patients with these characteristics are needed to confirm these results.

Clinical trial number and registry url: ClinicalTrials.gov Identifier: NCT04687085 (https://clinicaltrials.gov/ct2/show/NCT04687085).

背景:硬膜外分娩可引起患者明显的手术焦虑。行为干预,如正念冥想,可以有效地减少焦虑,包括在怀孕期间。这项研究旨在评估10分钟正念冥想对分娩时的焦虑和疼痛的影响。方法:招募孕妇并随机分为两组:一组是10分钟的引导正念冥想,另一组是中性内容录音,两组都是在硬膜外手术前通过耳机进行录音。手术后,参与者报告了他们的焦虑、疼痛和满意度。采用线性回归分析评估干预对焦虑、疼痛和满意度的主要影响。此外,一项探索性事后调节分析评估了基线疼痛灾难化的作用及其与干预的相互作用。结果:共纳入受试者100人(每组50人)。与中性内容记录相比,正念冥想对焦虑和疼痛的主要结局或程序满意度的次要结局没有总体主要影响(p < 0.05)。探索性事后分析表明,与中性内容相比,基线疼痛灾难化程度较高的参与者在焦虑((b=-0.18, p = 0.01)和疼痛(b=-0.14, p = 0.03)方面从正念冥想中获得的益处更大。结论:虽然没有发现正念冥想对整体群体水平的影响,但探索性分析表明,干预可能对基线疼痛灾难化高的参与者更有益。未来的研究需要纳入更大的样本,或丰富具有这些特征的患者,以证实这些结果。
{"title":"Mindful meditation for epidural catheter placement during labor: a single-center randomized controlled trial.","authors":"Mario I Lumbreras-Marquez, Asimina Lazaridou, Diego Villela-Franyutti, Kara G Fields, Michaela K Farber, Ehren R Nelson, Kristin L Schreiber, Dominique Y Arce","doi":"10.1093/pm/pnaf075","DOIUrl":"10.1093/pm/pnaf075","url":null,"abstract":"<p><strong>Importance: </strong>Labor epidural placement can cause significant procedural anxiety for patients. Behavioral interventions, such as mindful meditation, can effectively reduce anxiety, including during pregnancy.</p><p><strong>Objective: </strong>This study aimed to assess the impact of a 10-minute mindful meditation session on anxiety and pain during labor epidural placement.</p><p><strong>Design, setting, participants, intervention, and outcome measures: </strong>Pregnant women were recruited and randomized into 2 groups: A 10-minute guided mindful meditation, or a neutral content recording, both delivered via headphones before the epidural procedure as a recording. After the procedure, participants reported their levels of anxiety, pain, and satisfaction. Linear regression analyses were used to evaluate the main effects of the intervention on anxiety, pain, and satisfaction. Additionally, an exploratory post hoc moderation analysis assessed the role of baseline pain catastrophizing and its interaction with the intervention.</p><p><strong>Results: </strong>A total of 100 participants were included (50 per group). There were no overall main effect of mindful meditation on primary outcomes of anxiety and pain, or secondary outcome of procedural satisfaction, compared to the neutral content recording (P's > .05). Exploratory post hoc analysis indicated a moderation of treatment effect, such that participants with higher baseline pain catastrophizing experienced greater benefits from mindful meditation compared to neutral content on anxiety (b = -0.18, P = .01) and pain (b = -0.14, P = .03).</p><p><strong>Conclusions and relevance: </strong>While no overall group-level effects of mindful meditation were found, exploratory analysis suggested that the intervention may be more beneficial for participants with high baseline pain catastrophizing. Future studies enrolling a larger sample, or enriching for patients with these characteristics are needed to confirm these results.</p><p><strong>Clinical trial number and registry url: </strong>ClinicalTrials.gov Identifier: NCT04687085 (https://clinicaltrials.gov/ct2/show/NCT04687085).</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":"26-32"},"PeriodicalIF":3.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144507325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Pain Medicine
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