Pain and Therapy最新文献

{"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":"https://doi.org/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":""},"PeriodicalIF":3.3,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"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":"https://doi.org/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":""},"PeriodicalIF":3.3,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transauricular Vagus Nerve Stimulation for Postoperative Analgesia following Arthroscopic Shoulder Surgery: A Double-Blind, Randomized, Placebo-Controlled Trial.","authors":"Jia-Yi Xia, Xiao-Min Hou, Ke Liu, Min Kong, Ying Ma, Dania Saif, Hua-Dong Ni, Qi-Hong Shen","doi":"10.1007/s40122-025-00785-9","DOIUrl":"https://doi.org/10.1007/s40122-025-00785-9","url":null,"abstract":"<p><strong>Introduction: </strong>Despite growing interest in non-pharmacological analgesia, clinical evidence supporting transauricular vagus nerve stimulation (taVNS) for postoperative pain management following arthroscopic shoulder surgery remains limited. This study aimed to evaluate the efficacy and safety of taVNS in postoperative analgesia after shoulder arthroscopy.</p><p><strong>Methods: </strong>Seventy patients scheduled for arthroscopic shoulder surgery were randomly assigned to two groups on the basis fo computer-generated concealed allocation sequences. The intervention group received taVNS once on the day of surgery and once daily for the following two consecutive days, with each session lasting 2 h. The control group received sham stimulation following an identical schedule. The primary outcome was total sufentanil consumption within 24 h postoperatively.</p><p><strong>Results: </strong>Postoperative sufentanil consumption at 24 and 48 h, resting Numeric Rating Scale (NRS) scores at 4, 6, 12, 24, and 48 h, and the requirement for rescue analgesia were all significantly lower in the taVNS group compared with the sham stimulation group (all P < 0.05). In addition, quality of recovery-15 (QoR-15) scores at 24, 48, and 72 h post surgery were significantly higher in the taVNS group (all P < 0.05). No significant intergroup differences were observed in hemodynamic parameters (all P > 0.05). The incidences of nausea, vomiting, constipation, and gastrointestinal dysmotility were lower in the taVNS group, while other adverse events did not differ significantly between groups.</p><p><strong>Conclusions: </strong>TaVNS demonstrates both safety and efficacy in the management of postoperative pain following shoulder arthroscopy. Its application is associated with a reduction in analgesic requirements and contributes to an improved quality of recovery during the early postoperative period.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier no. ChiCTR2400094087.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145286637","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}

{"title":"Self-Management Strategies for Treating Pediatric and Adolescent Headaches and Migraines with Over-the-Counter Molecules: Expert Opinion and Literature Review.","authors":"Christopher Oakley, Preeti Kachroo, Ashoke Mitra, John Bell","doi":"10.1007/s40122-025-00783-x","DOIUrl":"https://doi.org/10.1007/s40122-025-00783-x","url":null,"abstract":"<p><strong>Introduction: </strong>Acute pain associated with headaches and migraines in children and adolescents may be managed with over-the-counter (OTC) treatments (e.g., paracetamol and ibuprofen); however, there are few studies on their safety and effectiveness in these patients. This narrative review evaluates the use of OTC treatments in children and adolescents with headaches and migraines.</p><p><strong>Methods: </strong>A literature search of Embase, MEDLINE, ToxFile, and Derwent Drug File was performed for reviews of clinical studies and meta-analyses (January 2010-October 2023) related to the acute treatment of headaches and migraines in children (1 month-11 years) and adolescents (12-18 years) with OTC analgesics (paracetamol, ibuprofen, aspirin, and naproxen). The results of the literature search were interpreted alongside expert recommendations per real-world clinical experience.</p><p><strong>Results: </strong>Twenty-eight articles were identified, of which half included recommendations that either paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs; typically, ibuprofen) were appropriate first-line OTC treatments for headache and/or migraine in children and adolescents. The remaining studies recommended ibuprofen and/or other NSAIDs (particularly naproxen) exclusively or preferentially over paracetamol. Four studies noted that aspirin was appropriate for adolescent patients > 16 years of age. An overall lack of clinical evidence on children and adolescents was noted, particularly regarding combinations of paracetamol and NSAIDs, and adjuvants such as caffeine.</p><p><strong>Conclusion: </strong>Paracetamol appears to be effective for treating headaches and migraines in children and adolescents; however, evidence is inconclusive regarding the equivalence or superiority of NSAIDs for the same indication. Clinical judgment and patient or caregiver preferences should guide medication selection.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275456","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}

{"title":"First Objective Evidence Characterizing Differences in Cervical and Thoracic Spinal Cord Neurophysiology Using ECAP-Controlled Closed-Loop Technology.","authors":"Johnathan H Goree, Harold Nijhuis, Gregory L Smith, Erika A Petersen, Jason E Pope, Ajay B Antony, Chau M Vu, Dawood Sayed, Christopher M Lam, Usman Latif, Shrif J Costandi, Paul Verrills, Lalit Venkatesan, Weirong Ge, Ian Gould, Jan Willem Kallewaard","doi":"10.1007/s40122-025-00782-y","DOIUrl":"https://doi.org/10.1007/s40122-025-00782-y","url":null,"abstract":"<p><strong>Introduction: </strong>Spinal cord stimulation (SCS) is a widely accepted therapy in patients with chronic intractable neuropathic pain in the trunk and limbs. However, open-loop (OL) SCS systems, which rely on fixed stimulation parameters and subjective feedback, face limitations in delivering consistent neural activation and durable pain relief. Anatomical and physiological characteristics of the cervical spinal cord, such as decreased cerebrospinal fluid thickness and increased mobility, exacerbate these challenges. Limited evidence exists on differences in cervical and thoracic neurophysiology, and the corresponding impact on neural activation in SCS. This post hoc analysis characterizes neurophysiological differences between the cervical and thoracic regions using evoked compound action potential (ECAP)-controlled closed-loop (CL) technology to assess implications for SCS dosing and therapy optimization.</p><p><strong>Methods: </strong>Global study and real-world chronic pain patients implanted with ECAP-controlled CL-SCS systems were included. To identify differences between cervical (n = 187) and thoracic (n = 1899) neurophysiology, the relationship between stimulation current and neural activation was analyzed. Additionally, neural activation stability was evaluated in both in-clinic and out-of-clinic settings.</p><p><strong>Results: </strong>The cervical spinal cord demonstrated significantly lower ECAP thresholds (p < 0.001) and > 100% higher spinal cord sensitivity compared to the thoracic region (p < 0.001). Cervical therapeutic dosing range was ≥ 48% narrower (p < 0.001), increasing the risk of overstimulation with OL-SCS. CL-SCS significantly improved dose accuracy in both regions (p < 0.001) during postural changes simulating activities of daily living. These findings highlight the superior precision and consistency in neural dosing with ECAP-controlled CL systems.</p><p><strong>Conclusions: </strong>This is the first study to objectively characterize differences in cervical and thoracic spinal neurophysiology using SCS. ECAP-controlled CL-SCS maintains consistent neural activation in both cervical and thoracic regions. Given the heightened sensitivity and narrow dosing range in the cervical region, ECAP-controlled CL-SCS may enhance therapeutic outcomes through more precise and consistent neural dosing compared to OL systems.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145252155","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}

{"title":"Reducing Pain and Improving Mobility Using Haptic Patch Technology: Results of the RESTORE Study.","authors":"Janet Fason, Peter Hurwitz, Jeffrey Gudin","doi":"10.1007/s40122-025-00780-0","DOIUrl":"https://doi.org/10.1007/s40122-025-00780-0","url":null,"abstract":"<p><strong>Introduction: </strong>Acute and chronic pain affects patients' overall health status and well-being, and the assessment and treatment of these patients can be challenging. Unfortunately, many patients fail to respond to the available multimodal treatment options, with some even failing advanced interventions including surgery. Therefore, alternative approaches to pain treatment represent an unmet medical need. Haptic vibrotactile trigger technology (VTT) is designed to target nociceptive pathways and is theorized to disrupt the neuromatrix of pain. The aim of this study was to evaluate the analgesic effects of a wearable VTT haptic patch in adults diagnosed with mild-to-moderate acute or chronic pain.</p><p><strong>Methods: </strong>This was a prospective, randomized, controlled, double-blind study. A total of 118 research participants (58 male, 60 female) met the inclusion criteria and were enrolled in the study. Participants were randomly assigned to either a treatment group receiving the active patch (N = 64) or a control group which used a similar-appearing vehicle/placebo patch (N = 54). Assessments were performed at baseline (day 0), day 7, and day 14. Reduction in pain severity and interference was assessed using the validated Brief Pain Inventory (BPI), and range of motion/flexibility assessment was performed using the Schober (only for low back pain), goniometer, and bubble inclinometer tests. Data for the active patch user group and the control group were aggregated and compared over the 14-day time frame of the study.</p><p><strong>Results: </strong>The active patch user group had significantly greater improvement in pain severity and reduction in pain interference; in addition, the active patch group showed greater objective improvement in range of motion (ROM)/flexibility than the control group at day 7 and day 14.</p><p><strong>Conclusion: </strong>These findings suggest that this non-pharmacological, noninvasive, topical VTT haptic patch (FREEDOM Super Patch with VTT) can reduce pain severity and increase ROM/flexibility. Considering the multitude of serious adverse effects associated with standard pharmacological pain treatments, clinicians should consider this readily available, over-the-counter VTT patch as a potential first-line or adjunct therapy to treat pain.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT06505005.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145244845","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}

{"title":"Patterns of Pain in Middle-Aged and Older Adults in China: A Latent Class Analysis.","authors":"Changsen Zhu, Yiyi Xu, Zhenping Lin, Weibang Xu, Zhuoming Chen","doi":"10.1007/s40122-025-00775-x","DOIUrl":"https://doi.org/10.1007/s40122-025-00775-x","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic pain is a leading global cause of disability in aging populations, yet pain distribution patterns among middle-aged and older adults in China remain uncharacterized. Using latent class analysis (LCA), this study identified distinct pain location patterns and their associations with cognitive impairment, depressive symptoms, and functional limitations.</p><p><strong>Methods: </strong>A cross-sectional analysis of 9544 participants from the CHARLS 2020 database was conducted. LCA categorized pain patterns, and multivariate logistic regression examined influencing factors and associations with cognitive impairment, depressive symptoms, and activities of daily living (ADL) impairment. Model fit was optimized via AIC/BIC and entropy/posterior probabilities (> 0.8).</p><p><strong>Results: </strong>Four distinct categories were identified: the broad pain group (n = 935, 9.8%), the shoulder-low back pain group (n = 2426, 25.4%), the lower limb pain group (n = 2568, 26.9%), and the head-neck-stomach pain group (n = 3615, 37.9%). The analysis revealed significant associations between pain location patterns and variables such as sex, income, and the presence of multiple comorbidities, including dyslipidemia, stomach disease, cancer, asthma, chronic lung disease, stroke, kidney disease, arthritis, mood disorders, Parkinson's disease, and memory-related diseases. In addition, the broad pain group showed stronger associations with cognitive impairment, depressive symptoms, and ADL difficulties (including BADL difficulties and IADL difficulties), and the lower limb pain group was associated with a significantly higher likelihood of ADL impairment than the head-neck-stomach pain group.</p><p><strong>Conclusions: </strong>Pain patterns in Chinese adults ≥ 45 years reflect distinct phenotypes with differential health risks. The broad pain group warrants comprehensive intervention targeting pain, cognition, mood, and function. Lower limb pain requires prioritized mobility preservation strategies. Findings support phenotype-specific pain management to reduce disability burden.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145252157","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}

{"title":"Buprenorphine Substitution as a Tapering Strategy for Opioid Discontinuation in Patients with Chronic Pain: A Nonrandomized and Proof of Concept Study.","authors":"Célian Bertin, Nicolas Kerckhove, Florent Ferrer, Bruno Pereira, Christian Duale, Damien Richard, Nicolas Authier, Noémie Delage","doi":"10.1007/s40122-025-00781-z","DOIUrl":"https://doi.org/10.1007/s40122-025-00781-z","url":null,"abstract":"<p><strong>Introduction: </strong>Long-term use (≥ 3 months) of opioids for chronic noncancer pain (CNCP) shows limited benefit and often leads to dependence, especially when tapered too quickly. Standard opioid discontinuation typically involves gradual dose reduction, yet many patients fail to complete it. Meta-analyses show buprenorphine reduces withdrawal severity, increases treatment retention and completion rates, and facilitates analgesia and smoother transitions in patients with chronic pain, with low adverse effects and high initiation success.</p><p><strong>Methods: </strong>This single-center, prospective, nonrandomized proof-of-concept study assessed the efficacy of an outpatient buprenorphine-based discontinuation strategy in patients with CNCP and opioid dependence who had failed standard tapering. Participants first attempted gradual tapering; those unsuccessful transitioned to buprenorphine: 4-8 mg/day for 1 month, followed by tapering over up to 9 months. Success was defined as complete opioid cessation at 9 months, confirmed by urine analysis (including buprenorphine). The primary outcome was the success rate of the buprenorphine strategy, with ≥ 60% considered effective. A secondary outcome compared success rates between strategies.</p><p><strong>Results: </strong>Of 20 patients, six (30.0%) successfully withdrew using standard tapering. Fourteen failed; 11 of them transitioned to buprenorphine. Of these, seven (63.6%) achieved full discontinuation. While not statistically significant, the buprenorphine group showed a higher success rate than standard tapering (p = 0.076; OR = 4.08 [0.90-21.23]).</p><p><strong>Conclusions: </strong>Buprenorphine substitution appears at least as effective as conventional tapering and may benefit patients unable to succeed with tapering alone. These preliminary results support further investigation in larger trials.</p><p><strong>Trial registration: </strong>ClinicalTrials. gov identifier, NCT03156907.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145213414","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}

{"title":"A Randomized Placebo-Controlled Trial of the Efficacy and Tolerability of Etofenamate 70 mg Medicated Plaster for the Treatment of Pain in Acute Sprains, Strains or Bruises of the Soft Tissues Following Blunt Trauma.","authors":"Hans-Georg Predel, Andrew C Leary, Roger Imboden, Ralph-Steven Wedemeyer, Bruno M Giannetti","doi":"10.1007/s40122-025-00764-0","DOIUrl":"10.1007/s40122-025-00764-0","url":null,"abstract":"<p><strong>Introduction: </strong>Topical nonsteroidal anti-inflammatory drug (NSAID) formulations provide significant pain relief with excellent tolerability in the local treatment of soft tissue injuries. This study aimed to assess the efficacy and safety of a novel etofenamate 70 mg medicated plaster for treatment of pain in patients with acute sprains, strains and contusions (bruises).</p><p><strong>Methods: </strong>In this randomized, placebo-controlled trial patients with acute injuries of recent onset received etofenamate or placebo plasters (2:1) applied once daily for 7 days. Regular clinical assessments were made with focus on pain on movement (POM) in millimetres on a 100-mm visual analogue scale (VAS).</p><p><strong>Results: </strong>A total of 180 adult patients (mean age 34.5 ± 13.5 years; 49.4% female) were enrolled. Mean VAS values for POM were 70.0 ± 6.3 mm at baseline; at 72 h POM had reduced by 59.0 mm and 33.3 mm in the etofenamate and placebo groups, respectively. Least squares mean treatment difference was 25.0 mm (p value for analysis of covariance < 0.0001). Results were consistent across type of injury (sprain/strain or contusion). Clinically meaningful superiority of etofenamate versus placebo was also seen for POM at the 24-, 48-, 96- and 120-h visits (p < 0.0001). Time to reach meaningful (30%), optimal (50%) and complete (100%) reduction of POM was significantly shorter with etofenamate. A significantly greater proportion of patients using etofenamate rated their progress and/or treatment as 'good' or 'very good'. The responder rate (proportion of patients with at least 50% pain reduction at 72 h) was 98.3% for etofenamate and 38.3% for placebo, resulting in a number needed to treat of 1.7, a value consistent with high effectiveness. The plasters adhered well over the 24-h dosing period and were very well tolerated.</p><p><strong>Conclusion: </strong>In the setting of acute sprains, strains and contusions (bruises) the etofenamate plaster has therapeutic efficacy that is comparable to that for the best available topical NSAID formulations.</p><p><strong>Registration: </strong>2021-003778-30 (EudraCT number).</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1461-1472"},"PeriodicalIF":3.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484470/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144659810","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}

{"title":"Cross-Cultural Adaptation and Psychometric Evaluation of the Chinese Version of the Functional Disability Inventory.","authors":"Hang Guo, Lisa Duan, Shina Gu, Jingjing Zhang, Jinqiao Huang, Xin Wang, Ruizhong Ran, Zhangya Lin, Fuqiang Mao, Jiangnan Sun","doi":"10.1007/s40122-025-00765-z","DOIUrl":"10.1007/s40122-025-00765-z","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic pain is a major public health issue affecting approximately one-fifth of children and adolescents worldwide, and it is also a common complaint among Chinese adolescents. Despite its impact on daily functioning in this population, culturally adapted tools for assessing pain-related disability are lacking. The Functional Disability Inventory (FDI) is a widely used measure for evaluating functional impairment, but its simplified Chinese version has yet to be validated. This study aimed to translate and culturally adapt the FDI into simplified Chinese to assess its reliability and validity in measuring pain-related functional disability among Chinese adolescents.</p><p><strong>Methods: </strong>First, the FDI was translated into simplified Chinese according to international guidelines. Subsequently, 1569 adolescents (aged 10-18) completed six scales: FDI, the Pain Catastrophizing Scale (PCS), the Depression Anxiety Stress Scales (DASS-21), the Tampa Scale for Kinesiophobia (TSK), the Children's Somatization Inventory (CSI), and the Wong-Baker Faces Pain Scale (WBS). After that, psychometric properties were evaluated, including internal consistency reliability (Cronbach's α and McDonald's ω), test-retest reliability (intraclass correlation coefficient and Pearson correlation coefficient), convergent validity (correlations with the other scales). In addition, the sample of 224 pediatric patients with functional abdominal pain (aged 8-18) was drawn to analyze the clinical validity by performing receiver operating characteristic (ROC) analysis.</p><p><strong>Results: </strong>The Chinese FDI demonstrated strong internal consistency (α = 0.86; ω = 0.86) and acceptable test-retest reliability (ICC = 0.63; Pearson correlation coefficient was 0.64). Convergent validity was supported by significantly moderate correlations with all the other scales, coefficients ranging from r = 0.30 to r = 0.50 (p < 0.01). ROC analysis revealed excellent clinical validity, with an optimal cutoff score of ≥ 15 [area under the curve (AUC) = 0.90, sensitivity = 0.78, specificity = 0.92] for distinguishing adolescents with chronic pain from healthy peers.</p><p><strong>Conclusions: </strong>The simplified Chinese FDI is a reliable and valid tool for assessing pain-related functional disability in Chinese adolescents. Its psychometric properties align with global versions while accounting for cultural differences, making it suitable for clinical and research use.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1499-1511"},"PeriodicalIF":3.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484487/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144744105","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}