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Response to "BiFeS Block: Distinction or Redundancy?" 对“bes块:区别还是冗余?”的回应
IF 2.9 3区 医学
Pain Medicine Pub Date : 2025-07-26 DOI: 10.1093/pm/pnaf097
Ali Ahiskalioglu, Serkan Tulgar, Alper Kilicaslan
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引用次数: 0
Phenotypes of patients with symptomatic lumbar spinal stenosis presenting for non-operative care: Baseline data from The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) Study. 非手术治疗的症状性腰椎管狭窄患者的表型:腰椎管狭窄个性化护理和治疗预后亚组(前景)研究的基线数据。
IF 2.9 3区 医学
Pain Medicine Pub Date : 2025-07-25 DOI: 10.1093/pm/pnaf099
Sean D Rundell, Eric N Meier, Jeffrey G Jarvik, Janna L Friedly, Maggie E Horn, Pradeep Suri, Amy M Cizik, Patrick J Heagerty, Sandra K Johnston, Rebecca Fillipo, Colleen Burke, Stephanie T Danyluk, Kelley Seebeck, Adam P Goode
{"title":"Phenotypes of patients with symptomatic lumbar spinal stenosis presenting for non-operative care: Baseline data from The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) Study.","authors":"Sean D Rundell, Eric N Meier, Jeffrey G Jarvik, Janna L Friedly, Maggie E Horn, Pradeep Suri, Amy M Cizik, Patrick J Heagerty, Sandra K Johnston, Rebecca Fillipo, Colleen Burke, Stephanie T Danyluk, Kelley Seebeck, Adam P Goode","doi":"10.1093/pm/pnaf099","DOIUrl":"https://doi.org/10.1093/pm/pnaf099","url":null,"abstract":"<p><strong>Objective: </strong>This study describes the enrollment and baseline characteristics of participants in the PROSPECTS cohort and explores subgroups of patients presenting for non-operative care.</p><p><strong>Design: </strong>Cross-sectional study.</p><p><strong>Setting and subjects: </strong>We enrolled adults ≥50 years initiating non-operative care for symptomatic lumbar spinal stenosis. We excluded those with serious spinal pathology, conditions limiting ambulation, and prior or planned lumbar surgery.</p><p><strong>Methods: </strong>We collected demographics, the PROMIS-29, pain intensity, Oswestry Disability Index, Swiss Spinals Stenosis Questionnaire, chronicity of symptoms, pain sites, comorbidities, falls, and opioid use. We used descriptive statistics to characterize the sample and Latent Class Analysis (LCA) to derive subgroups with distinct phenotypes. The best model was selected based on model fit statistics, class separation, and clinical interpretability.</p><p><strong>Results: </strong>We enrolled 598 participants. The mean age was 67 (SD = 9), and 61% were female. Back and leg pain were present for ≥1 year for 65% of participants. Multiple pain sites were common, mean of 4.3 sites (SD = 2.2), and a majority of patients had multiple comorbidities (54%). We selected a four-class solution as the best model from the LCA. These phenotypes were described as 1) \"high pain impact, low psychosocial features\" n = 233 (39%), 2) \"mild pain impact, low psychosocial features\" n = 218 (36%), 3) \"high pain impact, complex health needs\" n = 95 (16%), and 4) \"acute, intermittent, moderate-severe leg pain with high pain impact\" n = 52 (9%).</p><p><strong>Conclusions: </strong>These phenotypes reflect distinct profiles which may inform health needs and patient-centered care. Future studies should examine longitudinal outcomes to establish their clinical utility and prognostic value.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144715172","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
Biobehavioral Phenotypes of Chronic Low Back Pain: Psychosocial Subgroup Identification Using Latent Profile Analysis. 慢性腰痛的生物行为表型:使用潜在剖面分析的社会心理亚群识别。
IF 2.9 3区 医学
Pain Medicine Pub Date : 2025-07-25 DOI: 10.1093/pm/pnaf095
Fatemeh Gholi Zadeh Kharrat, Prakruthi Amar Kumar, Wolf Mehling, Irina Strigo, Jeffrey Lotz, Thomas A Peterson
{"title":"Biobehavioral Phenotypes of Chronic Low Back Pain: Psychosocial Subgroup Identification Using Latent Profile Analysis.","authors":"Fatemeh Gholi Zadeh Kharrat, Prakruthi Amar Kumar, Wolf Mehling, Irina Strigo, Jeffrey Lotz, Thomas A Peterson","doi":"10.1093/pm/pnaf095","DOIUrl":"https://doi.org/10.1093/pm/pnaf095","url":null,"abstract":"<p><strong>Objective: </strong>This study identifies distinct biobehavioral phenotypes among patients with chronic low back pain (cLBP) using Latent Profile Analysis (LPA).</p><p><strong>Methods: </strong>These phenotypes were derived from baseline data from two cohorts within the NIH HEAL BACPAC consortium: BACKHOME, a large nationwide e-cohort (N = 3,025) utilized for model training, and COMEBACK as external test set, a deep phenotyping cohort (N = 450) utilized for generalization. The analysis incorporated variables including pain characteristics, psychosocial factors, lifestyle habits, and social determinants of health. Model fit was optimized via 10-fold cross-validation with 100 bootstraps and evaluated using Akaike Information Criterion (AIC), Bayesian Information Criterion (BIC), and Entropy(uncertainty).</p><p><strong>Results: </strong>Four classes were identified: Class 1 (\"High Distress and Maladaptive Behaviors\") displayed high levels of anxiety, depression, and fear avoidance. Class 2 (\"Resilient and Adaptive Coping\") exhibited low maladaptive behaviors and high pain self-efficacy. Class 3 (\"Intermediate Maladaptive Patterns\") represented moderate levels of psychological and behavioral challenges, while Class 4 (\"Emotionally Regulated with High Pain Burden\") demonstrated strong emotional regulation despite significant pain burden. Class sizes were 701, 413, 893, and 947 for the train set, and 127, 108, 95, and 68 for the test set, respectively. Fit metrics supported the model's performance and generalizability (BACKHOME (train set): AIC = 77,792, BIC = 78,338, Entropy = 0.82; COMEBACK(test set): AIC = 72,437, BIC = 73,880, Entropy = 0.81). Statistical analysis revealed significant differences between classes (p < 0.05) in key variables such as pain self-efficacy, fear avoidance, and emotional awareness, and changes in pain severity and health-related quality of life over time (p ≤ 0.001), indicating clinical utility.</p><p><strong>Conclusions: </strong>Our findings highlight the heterogeneity of cLBP and suggest that tailored treatments targeting these distinct subgroups could improve clinical outcomes. This work advances our understanding of cLBP by providing a robust framework for identifying patient subgroups based on biobehavioral characteristics. Results underscore the value of LPA in uncovering clinically meaningful patterns in complex conditions like cLBP, paving the way for more personalized treatment approaches.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144715171","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
Editorial: Are they being difficult or just having a difficult time? 社论:他们是很难相处,还是只是遇到了困难?
IF 2.9 3区 医学
Pain Medicine Pub Date : 2025-07-24 DOI: 10.1093/pm/pnaf098
Samantha M Meints, Jolin Yamin
{"title":"Editorial: Are they being difficult or just having a difficult time?","authors":"Samantha M Meints, Jolin Yamin","doi":"10.1093/pm/pnaf098","DOIUrl":"https://doi.org/10.1093/pm/pnaf098","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144699215","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
Cognitive Behavioral Therapy as a Psychological Optimization Strategy in Spine Surgery: A Scoping Review. 认知行为疗法作为脊柱外科心理优化策略:范围综述。
IF 2.9 3区 医学
Pain Medicine Pub Date : 2025-07-22 DOI: 10.1093/pm/pnaf093
Rafael Garcia Andujar, Kari Odland, Cale Hendricks, Nathan Hendrickson
{"title":"Cognitive Behavioral Therapy as a Psychological Optimization Strategy in Spine Surgery: A Scoping Review.","authors":"Rafael Garcia Andujar, Kari Odland, Cale Hendricks, Nathan Hendrickson","doi":"10.1093/pm/pnaf093","DOIUrl":"https://doi.org/10.1093/pm/pnaf093","url":null,"abstract":"<p><strong>Background: </strong>Psychosocial factors such as pain catastrophizing, fear-avoidance behaviors, and depression are associated with poor outcomes after spine surgery. Cognitive Behavioral Therapy (CBT) is a structured psychological intervention shown to improve coping, reduce disability, and mitigate pain in musculoskeletal conditions. However, its role and implementation in surgical spine populations remain variable.</p><p><strong>Objective: </strong>This scoping review aims to evaluate how CBT has been applied in spine surgery settings and synthesize findings related to patient-reported outcomes, opioid use, and rehabilitation trajectories.</p><p><strong>Methods: </strong>A comprehensive search was conducted across Ovid Medline, PubMed, and Scopus. Inclusion criteria were: (1) adult spine surgery population, (2) CBT-based intervention (pre- or postoperatively), and (3) reporting on functional, psychological, or opioid-related outcomes. Seven eligible studies were included.</p><p><strong>Results: </strong>CBT was delivered preoperatively in 3 studies and postoperatively in 4 studies. Commonly measured outcomes included ODI, PCS, FABQ, and VAS. Across studies, CBT was associated with reduced disability, improved pain coping behaviors, and accelerated early recovery. Telehealth delivery was feasible and effective in some contexts. However, session frequency, provider type, and mode of delivery varied substantially. Long-term benefit beyond 6-12 months was inconsistent.</p><p><strong>Conclusion: </strong>CBT appears to be a valuable adjunct to spine surgery recovery, particularly for high-risk patients. Yet, heterogeneity in implementation highlights the need for standardized protocols and longer-term outcome evaluation.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682840","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
Pain-Related Evoked Potentials in Older Adults with Chronic Pain: A Cross-Sectional study. 老年人慢性疼痛的疼痛相关诱发电位:一项横断面研究。
IF 2.9 3区 医学
Pain Medicine Pub Date : 2025-07-22 DOI: 10.1093/pm/pnaf092
Alejandro Dorado, Juan Lorenzo Terrasa, Pedro Montoya, Marian van der Meulen, Ana María González-Roldán
{"title":"Pain-Related Evoked Potentials in Older Adults with Chronic Pain: A Cross-Sectional study.","authors":"Alejandro Dorado, Juan Lorenzo Terrasa, Pedro Montoya, Marian van der Meulen, Ana María González-Roldán","doi":"10.1093/pm/pnaf092","DOIUrl":"https://doi.org/10.1093/pm/pnaf092","url":null,"abstract":"<p><strong>Background: </strong>Chronic pain and aging trigger different plastic changes in pain processing, however, their combined effects on electroencephalographic correlates remain unexplored. This study aimed to examine these neural processing alterations in older adults with chronic pain, comparing them with pain-free older and younger adults.</p><p><strong>Methods: </strong>We compared pain-related evoked potentials (Pain ERPs) of 26 older adults with chronic pain (69,15 ± 4.63 years; 11 males), 26 pain-free older participants (69,65 ± 4.08 years; 12 males) and 27 pain-free younger adults (21,37 ± 1.92 years; 14 males). Participants received 30 painful and 30 non-painful electrical stimuli to the dorsum of the non-dominant hand individually calibrated using intra-epidermal electrical stimulation (IES) delivered via a concentric needle WASP electrode. EEG data were analysed using cluster-based permutation test.</p><p><strong>Results: </strong>Older participants with chronic pain showed enhanced pain ERPs from 150 to 500 ms in comparison to healthy older adults. Younger adults showed higher amplitudes than both older participants' groups except in late potentials (350-500 ms). No differences between younger and older adults with chronic pain were found.</p><p><strong>Conclusions: </strong>: We found a similar amplitude reduction in early (linked to sensory processing), but increased amplitude in late (linked to evaluative and attentional mechanisms) evoked potentials to pain in older adults with chronic pain in contrast to pain-free older adults. This pattern may reflect an age-related sensory coding decline combined with chronic pain-related enhancement of affective-attentional processing. Altogether suggest that plastic changes driven by suffering from long-lasting pain outweigh those resulting from the normal aging process when both coexist.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144691179","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
Clinical Perspectives: Navigating Buprenorphine Formulations for Pain Treatment and Opioid Use Disorder - A Case-Based Approach. 临床观点:导航丁丙诺啡配方疼痛治疗和阿片类药物使用障碍-基于病例的方法。
IF 2.9 3区 医学
Pain Medicine Pub Date : 2025-07-21 DOI: 10.1093/pm/pnaf094
Steven T Abriola, Jennifer B Oliver, Robert W Hurley
{"title":"Clinical Perspectives: Navigating Buprenorphine Formulations for Pain Treatment and Opioid Use Disorder - A Case-Based Approach.","authors":"Steven T Abriola, Jennifer B Oliver, Robert W Hurley","doi":"10.1093/pm/pnaf094","DOIUrl":"https://doi.org/10.1093/pm/pnaf094","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682839","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
Understanding Pain as Threat or Challenge: Predictive Roles of Resilience, Attachment, and Sensory Sensitivity. 理解疼痛是威胁还是挑战:弹性、依恋和感觉敏感性的预测作用。
IF 2.9 3区 医学
Pain Medicine Pub Date : 2025-07-15 DOI: 10.1093/pm/pnaf091
Aurianna M Lajaunie, Dennis Smythe, Guohao Zhu, John A Sturgeon, Jennifer Pierce
{"title":"Understanding Pain as Threat or Challenge: Predictive Roles of Resilience, Attachment, and Sensory Sensitivity.","authors":"Aurianna M Lajaunie, Dennis Smythe, Guohao Zhu, John A Sturgeon, Jennifer Pierce","doi":"10.1093/pm/pnaf091","DOIUrl":"https://doi.org/10.1093/pm/pnaf091","url":null,"abstract":"<p><strong>Introduction: </strong>Appraisals of pain as threatening or as a challenge are important for chronic pain patients' quality of life. The aim of this study was to examine the role of psychosocial factors (attachment, resilience, and self-esteem), as well as pain characteristics (pain intensity and generalized sensory sensitivity) in shaping pain appraisals among individuals with chronic pain from a single medical center in the Midwestern United States.</p><p><strong>Methods: </strong>A cross-sectional survey study was conducted with 278 participants from Michigan Medicine who reported chronic pain. Participants completed measures assessing psychosocial factors (attachment orientation, resilience, self-esteem), pain characteristics (pain intensity, generalized sensory sensitivity), and pain appraisals (threat and challenge). Gamma regression models were used to analyze the predictors of threat and challenge appraisals.</p><p><strong>Results: </strong>Higher pain intensity (β  =  1.11, p < 0.001), generalized sensory sensitivity (β  =  1.03, p = 0.005), anxious attachment (β  =  1.04, p = 0.002), and lower resilience (β  =  0.99, p < 0.001) were significantly associated with higher threat appraisals. Challenge appraisals were seldom endorsed and were significantly associated with higher resilience (β  =  1.02, p = 0.001) and pain intensity (β  =  1.05, p = 0.003).</p><p><strong>Discussion: </strong>Pain characteristics, anxious attachment, and resilience were associated with pain appraisals. Identifying the potential antecedents of pain appraisals will provide a more comprehensive view of this important cognitive process linked to quality of life among individuals with chronic pain. Additionally, it may guide clinicians in identifying and applying appropriate pain interventions that best fit clients' needs.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144637712","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
Physiotherapy for endometriosis-associated pelvic pain: A systematic review and meta-analysis. 物理治疗子宫内膜异位症相关盆腔疼痛:系统回顾和荟萃分析。
IF 2.9 3区 医学
Pain Medicine Pub Date : 2025-07-10 DOI: 10.1093/pm/pnaf083
Gökçe Can, Isabel Pinto Amorim das Virgens, Boglárka Fehér, Enikő Pálma Orbán, Péter Fehérvári, Ferenc Bánhidy, Péter Hegyi, Ágnes Andrea Mayer, Nándor Ács
{"title":"Physiotherapy for endometriosis-associated pelvic pain: A systematic review and meta-analysis.","authors":"Gökçe Can, Isabel Pinto Amorim das Virgens, Boglárka Fehér, Enikő Pálma Orbán, Péter Fehérvári, Ferenc Bánhidy, Péter Hegyi, Ágnes Andrea Mayer, Nándor Ács","doi":"10.1093/pm/pnaf083","DOIUrl":"https://doi.org/10.1093/pm/pnaf083","url":null,"abstract":"<p><strong>Background: </strong>Endometriosis is a disease often associated with chronic pelvic pain (CPP). It affects around 190 million females of reproductive age globally.</p><p><strong>Objectives: </strong>To investigate the effect of physiotherapy techniques (PTs) in relieving endometriosis-associated pain.</p><p><strong>Methods: </strong>This systematic review and meta-analysis followed the PRISMA 2020 and Cochrane Handbook guidelines. The study protocol was followed and registered on PROSPERO (CRD42023474231).</p><p><strong>Search strategy: </strong>A systematic search was conducted in three databases: PubMed, Embase, and Cochrane.</p><p><strong>Selection criteria: </strong>We used the following PICO strategy: Population, women with endometriosis-associated pelvic pain (EAPP); intervention, physiotherapy techniques; comparator, non-physiotherapy techniques; outcome, pelvic pain changes. The article selection was conducted by two independent reviewers.</p><p><strong>Data collection and analysis: </strong>Two authors extracted data independently from the eligible articles. For continuous outcomes, the mean difference (MD) in change scores between intervention and control groups was used as an effect size with a 95% confidence interval (CI). Within-group correlation of before- and after-treatment was assumed to be equal across groups and studies.</p><p><strong>Results: </strong>Out of eight eligible studies identified in our selection, seven were included in the quantitative analysis. PTs were effective in reducing pain compared to non-PTs (MD -1.97, CI -2.99 to -0.95), and physiotherapy modalities (electrotherapy and laser devices) had the greatest reduction in pain levels (MD -2.03, CI -3.9 to -0.14) among all studies. Additionally, locally applied techniques resulted in greater pain reduction than the generally applied techniques.</p><p><strong>Conclusion: </strong>Physiotherapy techniques are effective in reducing pain in women with endometriosis, especially when applied locally.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144699216","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
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 2.9 3区 医学
Pain Medicine Pub Date : 2025-07-08 DOI: 10.1093/pm/pnaf089
Seth Lederman, Lesley M Arnold, Ben Vaughn, Jean M Engels, Mary Kelley, Gregory M Sullivan
{"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":"https://doi.org/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 < 0.001; mean [SE], -1.8 [0.12] vs -1.2 [0.12]) and in each of the 6 secondary endpoints (P ≤ 0.001; 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>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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