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The effects of EXOPULSE Mollii suit in patients with fibromyalgia: A double-blind randomized sham controlled trial (EXOFIB2). EXOPULSE Mollii套装对纤维肌痛患者的影响:一项双盲随机假对照试验(EXOFIB2)。
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-22 DOI: 10.1093/pm/pnag010
Naji Riachi, Ahmed Shatila, Sehriban Diab, Hasan Jaber, Mais Jawhari, Joseph G Mattar, Jean-Pascal Lefaucheur, Moussa A Chalah, Samar S Ayache

Background: Neuromodulation via transcutaneous electrical stimulation shows promise in fibromyalgia, but conventional devices have limited coverage. The EXOPULSE Mollii Suit is a full-body garment with 58 electrodes, potentially addressing widespread pain. This study evaluated repeated Mollii Suit sessions on disease impact, pain, and fibromyalgia-related symptoms.

Methods: In this double-blind, randomized, sham-controlled crossover trial (phase 1), adults with fibromyalgia received two weeks of daily active or sham stimulation (1 hour/day), followed by a ≥ 2-week washout and crossover. Participants were offered a four-week open-label extension (phase 2). The primary outcome was the Fibromyalgia Impact Questionnaire (FIQtotal). Secondary outcomes included pain, anxiety, depression, and quality of life.

Results: Twenty-two patients completed phase 1 and 20 completed phase 2. In phase 1, FIQtotal scores significantly decreased following the active intervention (66.06 ± 13.46 to 50.81 ± 23.22, Friedman's p < 0.01, Bonferroni-adjusted Dunn's p < 0.05), whereas no significant effects were observed following the sham intervention. Improvements were also observed in several secondary measures (pain catastrophizing and some quality of life domains). Phase 2 also revealed significant benefits in FIQtotal as well as several secondary outcomes. No severe adverse events occurred at any time.

Conclusions: EXOPULSE Mollii Suit led to clinically meaningful improvements in fibromyalgia impact and related outcomes. The results of this work are in line with those of previous trials and support its potential as a home-based neuromodulation therapy for fibromyalgia. Future large-scale studies would help further understand the effects of this medical device.

背景:经皮电刺激的神经调节在纤维肌痛中显示出前景,但传统设备的覆盖范围有限。EXOPULSE Mollii套装是一件全身服装,有58个电极,可能会解决广泛的疼痛。这项研究评估了反复的Mollii Suit治疗对疾病的影响、疼痛和纤维肌痛相关症状。方法:在这项双盲、随机、假对照交叉试验(一期)中,患有纤维肌痛的成年人接受两周的每日活动或假刺激(1小时/天),随后进行≥2周的洗脱期和交叉试验。参与者接受为期四周的开放标签延长治疗(第二阶段)。主要结果是纤维肌痛影响问卷(FIQtotal)。次要结局包括疼痛、焦虑、抑郁和生活质量。结果:22例患者完成了一期临床试验,20例患者完成了二期临床试验。在第一阶段,fiq总分在积极干预后显著下降(66.06±13.46至50.81±23.22)。Friedman’s p结论:EXOPULSE Mollii Suit对纤维肌痛的影响和相关结局有临床意义的改善。这项工作的结果与先前的试验结果一致,并支持其作为纤维肌痛的家庭神经调节疗法的潜力。未来的大规模研究将有助于进一步了解这种医疗设备的影响。
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引用次数: 0
Comments on Early outcomes with a flexible ECAP based closed loop using multiplexed spinal cord stimulation waveforms-single-arm study with in-clinic randomized crossover testing. 基于多路脊髓刺激波形的柔性ECAP闭合环路的早期结果-单臂临床随机交叉试验研究
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-21 DOI: 10.1093/pm/pnag007
Peng-Bo Zhou, Hong-Tao Sun
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引用次数: 0
Author response. 作者的回应。
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-21 DOI: 10.1093/pm/pnag006
Vahid Mohabbati, Richard Sullivan, James Yu, Peter Georgius, Charles D Brooker, Malgorzata Siorek, Nancy L McClelland, Filippo Coletti, Xiaoxi Sun, Abi Franke, Marc A Russo
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引用次数: 0
REACH-BMAS (Body-Map Auto-Segmentation): Screening Body-Map Drawings for Chronic Widespread Pain. 身体图谱自动分割:慢性广泛性疼痛的身体图谱筛选。
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-21 DOI: 10.1093/pm/pnag005
Elisabetta de Rinaldis, Trisha F Hue, Jennifer Cummings, Thomas A Peterson, Jeannie F Bailey, Jeffrey C Lotz, Andrew Bishara
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引用次数: 0
Influence of Anxiety/Depressive Levels, Sleep Quality and Pain Catastrophizing on Conditioned Pain Modulation: A Case-Control Study of Women with Chronic/Episodic Migraine and Pain-Free Women. 焦虑/抑郁水平、睡眠质量和疼痛灾变对条件性疼痛调节的影响:慢性/发作性偏头痛女性和无痛女性的病例对照研究
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-20 DOI: 10.1093/pm/pnag009
Margarita Cigarán-Méndez, Juan C Pacho-Hernández, Angela Tejera-Alonso, Francisco G Fernández-Palacios, Cristina Gómez, César Fernández-de-Las-Peñas, Silvia Ambite-Quesada, Beatriz Alvarez-Mariño, Carlos Ordás, Ana I de-la-Llave-Rincón

Objective: To investigate the influence of anxiety/depression, sleep quality and pain catastrophizing in conditioned pain modulation (CPM) in women with episodic/chronic migraine and pain-free women.

Design: A cross-sectional case-control study.

Setting: Laboratory experimental study.

Subjects: Seventy women with chronic migraine, 70 women with episodic migraine and 70 pain-free women.

Methods: Migraine features and psychological/emotional (e.g., anxiety, depression, sleep, pain catastrophizing) aspects were evaluated. Pressure pain thresholds (PPT) were assessed at the temporalis, lateral epicondyle, and tibialis anterior muscle. Heat (HPT) and cold (CPT) pain thresholds were assessed at the frontalis muscle. Thus, CPM was evaluated immediately after one minute cold-pressor test paradigm on changes in mechanical/thermal stimuli after the conditioned stimulus.

Result: Significant group*time interactions without significant effect of anxiety/depressive levels, sleep quality, or pain catastrophizing for PPTs at the temporalis muscle (Wilk's λ = 0.646, F[2,201]=55.108, p < 0.001, n2p = 0.354, 1-β=0.999), epicondyle (Wilk's λ = 0.736, F[2,201]=36.024, p < 0.001, n2p = 0.264, 1-β=0.999), and tibialis anterior (Wilk's λ = 0.798, F[2,201]=25.148, p < 0.001, n2p = 0.202, 1-β=0.999) were found: PPTs were higher in all points after the conditioned stimulus in pain-free women (increases from 10.7-16.2%) whereas PPTs in all points were lower after conditioned stimulus in women with migraine (decrease from -7.6% to -0.3%) as compared to PPT at baseline. Changes in HPT and CPT were small (<1%).

Conclusion: Women with migraine showed CPM deficits against mechanical, not thermal, stimuli compared to women without migraine. Deficits in CPM were similar between women with episodic/chronic migraine. Anxiety/depressive levels, sleep quality and pain catastrophizing did not influence CPM in women with migraine.

目的:探讨焦虑/抑郁、睡眠质量和疼痛灾难化对发作性/慢性偏头痛和无痛女性条件疼痛调节(CPM)的影响。设计:横断面病例对照研究。设置:实验室实验研究。研究对象:70名患有慢性偏头痛的女性,70名患有间歇性偏头痛的女性和70名无痛女性。方法:对偏头痛的特征和心理/情绪(如焦虑、抑郁、睡眠、疼痛灾难化)方面进行评估。在颞肌、外上髁和胫前肌处评估压痛阈值(PPT)。在额肌处评估热(HPT)和冷(CPT)疼痛阈值。因此,CPM在条件刺激后的一分钟冷压试验范式后立即评估机械/热刺激的变化。结果:组*时间交互作用对颞肌PPTs的焦虑/抑郁水平、睡眠质量或疼痛突变无显著影响(Wilk λ = 0.646, F[2201]=55.108, p)。结论:与没有偏头痛的女性相比,偏头痛女性对机械刺激表现出CPM缺陷,而不是热刺激。发作性/慢性偏头痛患者的CPM缺陷相似。焦虑/抑郁水平、睡眠质量和疼痛灾难化对女性偏头痛患者的CPM没有影响。
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引用次数: 0
Caregiver Pain in a Pediatric Pain Setting: The Role of Socioeconomic Disadvantage and Caregiver Psychological Variables. 儿童疼痛环境中的照顾者疼痛:社会经济劣势和照顾者心理变量的作用。
IF 3 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2026-01-20 DOI: 10.1093/pm/pnag004
Brynn LiaBraaten, Keri R Hainsworth, Jian Zhang, Ke Yan, Steven J Weisman, Theresa L Kapke
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引用次数: 0
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。
{"title":"Pain outcomes in persons with multiple sclerosis receiving S1PR modulators: A cross-sectional study.","authors":"Salvador Sierra, Anna L Kratz, Tiffany J Braley","doi":"10.1093/pm/pnag008","DOIUrl":"https://doi.org/10.1093/pm/pnag008","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>To compare pain phenotypes, severity, and treatment regimens in persons living with MS (PwMS) using S1PR modulators versus other DMTs.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>Compared to other DMTs, S1PR modulators are associated with lower pain intensity in MS patients with nociplastic pain.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146011494","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
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
{"title":"Post-Sacral Lateral Branch Radiofrequency Ablation Neuritis: The More We Know, the Less We Understand.","authors":"Steven P Cohen, Zachary L McCormick, Robert W Hurley","doi":"10.1093/pm/pnag003","DOIUrl":"https://doi.org/10.1093/pm/pnag003","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145970895","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
期刊
Pain Medicine
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