Pain and Therapy最新文献

{"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}

{"title":"The Impact of Opioid-Sparing Analgesia on Postoperative Pain and Recovery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.","authors":"Zhen Zhang, Jing-Jing Wang, Zhi-Guang Ping, Xiao-Gao Jin, Jian-Jun Yang, Yan Wang, Qin-Jun Chu","doi":"10.1007/s40122-025-00762-2","DOIUrl":"10.1007/s40122-025-00762-2","url":null,"abstract":"<p><strong>Introduction: </strong>Opioids are commonly used for postoperative pain management but are associated with adverse effects and risk of dependence, potentially hindering recovery. This systematic review evaluates the impact of opioid-sparing analgesic strategies on postoperative pain and functional recovery to provide evidence-based guidance for clinical practice and future research.</p><p><strong>Methods: </strong>A comprehensive systematic review and meta-analysis was conducted by searching PubMed, Embase, Web of Science, and the Cochrane Library for randomized controlled trials on adult surgical patients from the inception of each database to July 10, 2024. The primary outcome was the total morphine consumption within 24 h postoperatively. Secondary outcomes included postoperative pain scores at 24 h, patient satisfaction, length of stay, quality of recovery, and opioid-related adverse effects, such as postoperative nausea and vomiting (PONV), sedation, dizziness, drowsiness, pruritus, urinary retention, and hypotension.</p><p><strong>Results: </strong>A total of 58 studies (5614 patients) were included. The total morphine consumption was reduced, with a mean difference (MD) of -9.47, 95% confidence interval (95% CI) [-13, -5.95]. The postoperative pain score at 24 h was lower than in the control group, with an MD of -0.72 (95% CI [-0.97, -0.47]). Patient satisfaction was higher than in the control group, with an MD of 0.88 (95% CI [0.36, 1.40]). There were no significant differences in length of stay or recovery quality compared to the control group (P = 0.7, P = 0.48). The incidence of PONV was lower than the control group, with an odds ratio (OR) of 0.73 (95% CI [0.59, 0.90]), and the incidence of pruritus was also lower than in the control group, with an OR of 0.64 (95% CI [0.41, 0.98]). There were no differences in other adverse reactions compared to the control group.</p><p><strong>Conclusion: </strong>The results of this meta-analysis indicate that, compared to opioid-based analgesia, opioid-sparing analgesia is associated with reduced morphine consumption within 24 h postoperatively, lower pain scores, and a decreased incidence of PONV and pruritus. Patient satisfaction was also improved. The findings will help clinicians make evidence-based decisions for postoperative pain management.</p><p><strong>Trial registration: </strong>The protocol for this meta-analysis: PROSPERO CRD42024579882.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1473-1497"},"PeriodicalIF":3.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484494/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144708359","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":"Adherence to CONSORT-PRO Extension Guidelines for Patient-Reported Outcomes in Randomized Controlled Trials Focused on Peripheral Nerve Blocks: A Meta-epidemiological Study.","authors":"Adam Khan, Tiffany Nguyen, Bryan Dunford, Taimoor Khan, Mahnoor Khalid, Cody Hillman, Samuel Shepard, Micah Kee, Will Roberts, Ashlyn Terrell, Landon Stallings, Ryan Ottwell, Micah Hartwell, Matt Vassar","doi":"10.1007/s40122-025-00766-y","DOIUrl":"10.1007/s40122-025-00766-y","url":null,"abstract":"<p><strong>Introduction: </strong>Patient-reported outcomes (PROs), such as peri- and postoperative pain scores, capture patient perspectives in regional anesthesia trials. However, whether these outcomes are reported according to established guidelines remains unclear. The CONSORT statement and its PRO extension (CONSORT-PRO) aim to enhance transparency in reporting PROs, yet no study has investigated adherence in peripheral nerve block (PNB) trials. Our meta-epidemiological investigation evaluated how well PNB randomized controlled trials (RCTs) adhere with CONSORT-PRO and explored whether trial characteristics affect reporting quality.</p><p><strong>Methods: </strong>We performed a cross-sectional, meta-epidemiological study to determine adherence to CONSORT-PRO reporting guidelines in RCTs. We searched Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and MEDLINE for RCT publications investigating PNBs between 2006 and 2020. RCTs investigating PNBs that incorporated PROs as a primary or secondary outcome were included. All other studies, reviews, or publications without a PRO were excluded.</p><p><strong>Results: </strong>In total, 65 RCTs met the inclusion criteria. Mean CONSORT-PRO adherence was 46.80 ± 17.36%, and trials that designated a PRO as the primary endpoint were more adherent than those in which the PRO was secondary (49.27 ± 16.58% versus 38.57 ± 17.92%; P = 0.035). Trials with ≥ 6-month follow-up were 16.24% more adherent than those with ≤ 3-month follow-up (P = 0.006). Studies that used a visual analog scale (VAS) or numeric rating scale (NRS) in combination with other PRO instruments were significantly more adherent than trials using VAS alone (P = 0.028).</p><p><strong>Conclusions: </strong>Our meta-epidemiological review reveals substantial nonadherence to CONSORT-PRO guidelines in PNB trials. Although PROs are crucial for capturing patient-centered outcomes, they remain under-reported, especially when treated as secondary endpoints. Using diverse, validated measures beyond VAS/NRS and consistently applying CONSORT-PRO can enhance the quality, transparency, and clinical relevance of future trials. Targeted education for authors, editors, and clinicians-and expanded research on neuraxial techniques-will further strengthen reporting standards and the interpretability of anesthesia evidence.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1531-1546"},"PeriodicalIF":3.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484481/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144795047","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":"Cervical Tenderness (Parametropathy) is a Diagnostic Tool for the Chronic Pelvic Pain Syndrome.","authors":"Stefan Weinschenk, Thomas Strowitzki, Nura Fitnat Topbas Selcuki, Oliver Zivanovic, Axel Gerhardt, Manuel Feisst","doi":"10.1007/s40122-025-00760-4","DOIUrl":"10.1007/s40122-025-00760-4","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic pelvic pain syndrome (CPPS) is a diagnosis of exclusion in the absence of pathological findings. We aimed to test the hypothesis that cervical motion tenderness (or parametropathy) may serve as a diagnostic tool for CPPS.</p><p><strong>Methods: </strong>We examined the prevalence of parametropathy in patients with and without chronic pelvic pain by analyzing consecutive vaginal examinations in 155 women ≥ 18 years. Patients with malignant pelvic tumors, acute inflammatory disease, abnormal bleeding, genital atrophy, or pregnancy were excluded. Results from repeat examinations were also excluded. Parametropathy was defined as tenderness at three different points (left, middle, and right vaginal fornix) on bimanual examination, expressed by the patient on a three-digit scale: Pain index 0, absent; 1, slight tenderness; 2, remarkable tenderness. A pain index (PI) of 2 at one or more sites was considered positive.</p><p><strong>Results: </strong>We included 155 first examinations, 125 for preventive screening (control group), and 30 examinations from patients with lower abdominal pain for ≥ 6 months. Parametropathy with a PI ≥ 2 in ≥ 1 site was found in 96.7% of the pain group, and in 7.2% of the control group (p < 0.001). The diagnostic value of parametropathy for chronic pelvic pain was 96.7% sensitivity and 92.8% specificity. Vaginal ultrasound probe pressure revealed a similar tenderness rate (agreement kappa 0.94-1.00), but with a lower sensitivity of 86.7% and specificity of 92.0%. The prevalence of parametropathy in both groups was higher on the left side (p = 0.03).</p><p><strong>Conclusions: </strong>Parametropathy, defined as cervical motion tenderness, is a positive sign of chronic pelvic pain syndrome. The cervical motion test to detect parametropathy can be used both as a screening tool and to confirm suspected chronic pelvic pain syndrome. We suggest including this easy-to-perform clinical test in every gynecological examination. By doing so, chronic pelvic pain syndrome will no longer be a diagnosis of exclusion.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1443-1459"},"PeriodicalIF":3.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144609024","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":"Effect of Repetitive Transcranial Magnetic Stimulation on the Symptoms and Brain Imaging in Patients with Fibromyalgia Syndrome: A Randomized Controlled Pilot Trial.","authors":"Laura Ackermann, Daniel Zeller, Thorsten Odorfer, György A Homola, Thomas Kampf, Mirko Pham, Hans-Christoph Aster, Claudia Sommer","doi":"10.1007/s40122-025-00770-2","DOIUrl":"10.1007/s40122-025-00770-2","url":null,"abstract":"<p><strong>Introduction: </strong>Repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (DLPFC) has been shown to reduce the symptoms of patients with fibromyalgia syndrome (FMS). We tested whether rTMS of the left DLPFC can reduce the main symptoms in FMS and whether TMS induces changes in brain functional and structural connectivity, cortical gray matter volume, and the metabolites/neurotransmitters GABA and combined glutamate/glutamine (Glx).</p><p><strong>Methods: </strong>Twenty-seven women diagnosed with FMS according to the 2010 ACR criteria were included in a randomized controlled trial. They received either ten sessions of active or sham 10-Hz stimulation over 2 weeks embedded in a longitudinal neuroimaging setup, including one pre-treatment (T1), one post-treatment (T2), and one follow-up (T3) 3 T MRI scan. Pain and pain catastrophizing, depression, daily life/quality of life, and anxiety were assessed using standard questionnaires.</p><p><strong>Results: </strong>Linear mixed-model analysis of clinical data showed a significant main effect of the main factor time but did not reveal group differences or group-time interactions, indicating a large placebo effect with symptom reduction in both groups. Fractional anisotropy (FA) values of the pontine crossing tract, the sagittal stratum, and the right cingulum in the active rTMS group increased between pre-TMS and the follow-up time points. Subgroup analysis of responders of the treatment group revealed higher functional connectivity between the left DLPFC and the right cerebellum. We did not find evidence for changes in the treatment group in the gray matter of the left DLPFC and for the concentrations of GABA and Glx, but a trend towards decreasing Glx levels for the factor time in all patients could be detected.</p><p><strong>Conclusions: </strong>While these results may be due to small sample size and short treatment duration, the findings of increased FA after active rTMS and higher functional connectivity between DLPFC and cerebellum in responders should be further explored.</p><p><strong>Trial registration: </strong>Auswirkungen der nicht-invasiven Neuromodulation auf das Gehirn bei Fibromyalgiepatienten.</p><p><strong>Drks-id: </strong>DRKS00019051.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1547-1572"},"PeriodicalIF":3.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484483/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144964516","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":"Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China: A Retrospective, Database, Multicenter Study (ReTARdant) Protocol.","authors":"Qi Pan, Xiaoyu Zhai, Haining Wang, Jianling Du, Yanxia Shi, Xuefeng Yu, Sunjie Yan, Xiaohong Wu, Hui-Hui Li, Tao Sun, Lixin Guo, Jun Zhao, Bifa Fan","doi":"10.1007/s40122-025-00767-x","DOIUrl":"10.1007/s40122-025-00767-x","url":null,"abstract":"<p><strong>Introduction: </strong>Neuropathic pain (NP), including diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) as common subtypes, imposes a significant clinical burden on patients, severely affecting their quality of life. The real-world evidence on demographic characteristics, treatment patterns, and adherence data of DPNP and CIPN is still limited.</p><p><strong>Methods: </strong>A multicenter, retrospective, observational study using electronic medical record (EMR) systems involving approximately 600 patients with DPNP and 400 with CIPN from nine hospitals was planned. The study period extended from January 1, 2017 to December 31, 2022, which includes the enrollment period, pre-enrollment period, and observation period. Included patients will be adult (aged ≥ 18 years) diagnosed with DPNP or CIPN and receiving at least one index regimen, with index date defined as the initiation date of index regimen. At least one medical record within 12 months after index date will also be required for inclusion. The observation period is defined as the period from the index date to the end of the study data collection for at least 12 months.</p><p><strong>Planned outcomes: </strong>The primary objective is to describe the demographics, clinical characteristics, and treatment patterns, including types and proportion of treatment regimens, treatment discontinuation/switching/add-on, restarting after discontinuation, duration of index regimen, and time to treatment add-on. The secondary and exploratory measures include the dosing pattern and real-world adherence of regimens.</p><p><strong>Trial registration: </strong>NCT06546202 (ClinicalTrials.gov).</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1611-1627"},"PeriodicalIF":3.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484476/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144817326","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":"Cost-Effectiveness of a High-Concentration (179 mg) Capsaicin Patch for the Treatment of Patients with Peripheral Neuropathic Pain in Scotland.","authors":"Rita Freitas, Marjolijn van Keep, Prashanth Kandaswamy, Anja Prüfert, Miranda Ager, Marielle Eerdekens","doi":"10.1007/s40122-025-00769-9","DOIUrl":"10.1007/s40122-025-00769-9","url":null,"abstract":"<p><strong>Introduction: </strong>Peripheral neuropathic pain (PNP) is a chronic condition often inadequately controlled by oral pharmacologic treatments. High-concentration capsaicin patch (HCCP) is a topical neurolytic treatment for PNP. This study assessed the cost-effectiveness of HCCP as an add-on to standard of care (SoC) in patients with PNP in Scotland.</p><p><strong>Methods: </strong>A cost-utility analysis was conducted using a Markov model with 3-month cycles and a lifetime horizon to determine the cost-effectiveness of HCCP added-on to SoC compared to SoC alone, in adult patients with PNP. The model included five health states (no pain, mild, moderate, severe pain, and death) and was developed according to Scottish Medicines Consortium (SMC) guidance from a National Health Service (NHS) Scotland perspective. Clinical inputs were derived from HCCP trials (e.g., PACE), and health-related quality of life was based on EQ-5D values from HCCP trials. Analyses were conducted for an adult PNP population, and diabetic and non-diabetic etiologies. Costs included drug acquisition, administration, drug and disease monitoring, adverse events, and-in a scenario analysis-societal costs.</p><p><strong>Results: </strong>For the adult PNP population, HCCP + SoC resulted in an incremental gain of 1.00 quality-adjusted life-years (QALYs) at an additional cost of £13,479, yielding an incremental cost-effectiveness ratio (ICER) of £13,516 per QALY. ICERs for specific etiologies were £11,383 for non-diabetic and £16,442 for diabetic PNP populations. Deterministic and probabilistic sensitivity analyses (PSA) confirmed robustness of the model, with 89% of PSA iterations falling below a £20,000/QALY threshold. Scenario analysis using a societal perspective further improved cost-effectiveness (ICER: £7475).</p><p><strong>Conclusions: </strong>HCCP is a cost-effective add-on therapy for the treatment of adults with PNP in Scotland, with consistent findings across diabetic and non-diabetic populations. These results support the benefits of integrating HCCP in healthcare systems and clinical practice, both in terms of patient outcomes and economic benefits for the system.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1573-1595"},"PeriodicalIF":3.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484434/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144964262","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":"Efficacy of Rebox Electrotherapy in Pain Management: A Randomized Double-Blind Sham-Controlled Crossover Trial.","authors":"Igor Martuliak, Ľuboš Chvála, Miroslav Ferenčík, Vratislav Fabián, Matěj Slovák","doi":"10.1007/s40122-025-00768-w","DOIUrl":"10.1007/s40122-025-00768-w","url":null,"abstract":"<p><strong>Introduction: </strong>Rebox therapy is a form of noninvasive transcutaneous electrotherapy, which delivers microcurrent kilohertz-frequency pulses in multiple points over the target area. Despite decades of use in pain management, clinical evidence supporting Rebox remains inconclusive, with a lack of rigorous sham-controlled trials. This study aimed to evaluate its analgesic effect in a single-center, randomized, double-blind, sham-controlled crossover trial.</p><p><strong>Methods: </strong>The study included consecutive patients with non-cancer nociceptive pain with average pain intensity ≥ 4 on a numerical rating scale (NRS), and pain duration of 2-12 weeks (de novo or acutely exacerbated chronic pain). Patients were randomized (1:1) into two arms based on the sequence of stimulation periods. Each period consisted of eight sessions of either Rebox or sham treatment, administered every other working day, with a 1-week washout period. The primary outcome was the difference in the reduction of pain intensity (average and worst pain in the last 24 h) following active versus sham stimulation.</p><p><strong>Results: </strong>Seventy-one patients completed the study, with musculoskeletal back pain being the most common indication (n = 60). Compared to the sham, Rebox significantly reduced both average pain (NRS difference: 2.2, 95% CI 0.8-3.6, Cohen's d = 0.75, p = 0.002) and worst pain (NRS difference: 2.3, 95% CI 1.2-3.5, Cohen's d = 0.91, p < 0.001). A significant placebo analgesic effect was observed only in the sham-first arm. The treatment was well tolerated, with only minor and transient side effects.</p><p><strong>Conclusion: </strong>Rebox demonstrated a significant analgesic effect compared to the sham. The treatment was safe and well tolerated. These findings support integrating Rebox into clinical pain management, warranting further investigation in larger trials.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1597-1610"},"PeriodicalIF":3.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484431/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144964483","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}