Pub Date : 2024-08-01Epub Date: 2024-06-13DOI: 10.1007/s40122-024-00620-7
Salah N El-Tallawy, Joseph V Pergolizzi, Ingrid Vasiliu-Feltes, Rania S Ahmed, JoAnn K LeQuang, Tariq Alzahrani, Giustino Varrassi, Fouad I Awaleh, Abdullah T Alsubaie, Mohamed S Nagiub
Since the COVID-19 pandemic, healthcare systems are facing extraordinary challenges. Our approaches to medicine have changed and created a whole new generation of people who have chronic pain. Various medical services were postponed. The pandemic significantly impacted the bio-psychosocial model of pain and the management of chronic pain. These new challenges affected millions of patients worldwide, with more burden on patients with chronic pain. Telemedicine and digital health rather than traditional office visits have become essential tools for communications, resulting in an unmatched surge in telehealth adoption. This new approach facilitated the remote treatment and follow-up of patients who have difficulty to access the healthcare services, particularly patients with chronic pain and those who were receiving regular controlled medications. An extensive computer search was conducted, during the period (from January 2014 to March 2024), and included literature from PubMed, Scopus, MEDLINE, and Google scholar. According to preset inclusion and exclusion criteria, a total of 38 articles have been included in this review article. This literature review focuses on the innovation of telemedicine and digital health in pain management, especially in the context of the challenges posed by the COVID-19 pandemic. The manuscript provides a comprehensive overview of telemedicine and digital communications, their evolution, and their significance in healthcare. It also emphasizes the benefits, challenges, limitations, and the ethical concerns of telemedicine in pain management after the COVID-19 pandemic. Furthermore, the document explores the different modes of the telecommunications and discusses the future directions of the digital health technology.
{"title":"Innovative Applications of Telemedicine and Other Digital Health Solutions in Pain Management: A Literature Review.","authors":"Salah N El-Tallawy, Joseph V Pergolizzi, Ingrid Vasiliu-Feltes, Rania S Ahmed, JoAnn K LeQuang, Tariq Alzahrani, Giustino Varrassi, Fouad I Awaleh, Abdullah T Alsubaie, Mohamed S Nagiub","doi":"10.1007/s40122-024-00620-7","DOIUrl":"10.1007/s40122-024-00620-7","url":null,"abstract":"<p><p>Since the COVID-19 pandemic, healthcare systems are facing extraordinary challenges. Our approaches to medicine have changed and created a whole new generation of people who have chronic pain. Various medical services were postponed. The pandemic significantly impacted the bio-psychosocial model of pain and the management of chronic pain. These new challenges affected millions of patients worldwide, with more burden on patients with chronic pain. Telemedicine and digital health rather than traditional office visits have become essential tools for communications, resulting in an unmatched surge in telehealth adoption. This new approach facilitated the remote treatment and follow-up of patients who have difficulty to access the healthcare services, particularly patients with chronic pain and those who were receiving regular controlled medications. An extensive computer search was conducted, during the period (from January 2014 to March 2024), and included literature from PubMed, Scopus, MEDLINE, and Google scholar. According to preset inclusion and exclusion criteria, a total of 38 articles have been included in this review article. This literature review focuses on the innovation of telemedicine and digital health in pain management, especially in the context of the challenges posed by the COVID-19 pandemic. The manuscript provides a comprehensive overview of telemedicine and digital communications, their evolution, and their significance in healthcare. It also emphasizes the benefits, challenges, limitations, and the ethical concerns of telemedicine in pain management after the COVID-19 pandemic. Furthermore, the document explores the different modes of the telecommunications and discusses the future directions of the digital health technology.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"791-812"},"PeriodicalIF":4.1,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11255158/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141311383","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}
Pub Date : 2024-08-01Epub Date: 2024-05-24DOI: 10.1007/s40122-024-00601-w
Yuwei He, Jialin Wang, Peng Zhao, Ruirui Wang, Meng Li
Introduction: Chronic neck pain (CNP) is a global public health problem, with high prevalence and absenteeism rates. Central sensitization (CS) as a basis for chronic pain may play an essential role in its development and progression. It is often comorbid with low conditioned pain modulation (CPM) effects, cognitions, and psychological problems.
Objectives: The purposes of this study were to (1) explore the relationship between pain-related cognitions and psychological factors, CPM effects, and the central sensitization inventory (CSI) scores; and (2) determine whether cognitions and psychological factors can predict CSI scores and CPM effects in individuals with CNP.
Methods: Fifty-four individuals with CNP were recruited for this cross-sectional study. The following outcome measures were evaluated: The CSI (screening tool) was compared with the cold pressor test (CPT), which was the psychophysical test used to assess the CPM; neck pain intensity using the visual analogue scale (VAS), as well as pain-related cognitions (including kinesiophobia and pain catastrophization) and psychological states (including anxiety and depression) using self-report questionnaires.
Results: CSI score was not associated with the CPM effect (r = 0.257, p > 0.05), and no cognitions or psychological factors were associated with CPM (p > 0.05), but CSI score was moderately positively correlated with kinesiophobia (r = 0.554, p < 0.01), lowly positively correlated with pain catastrophization (r = 0.332, p = 0.017) and anxiety (r = 0.492, p < 0.01), but not depression (r = 0.207, p = 0.132). Multiple linear regression analysis showed that kinesiophobia (B = 1.308, p < 0.01) and anxiety (B = 1.806, p = 0.02) were significant positive predictors of CSI score.
Conclusions: The findings confirm some of our hypotheses. Accordingly, the findings inferred that the CSI does not seem to respond to CPM effect in patients with CNP effectively. In addition, CSI score was associated with cognitions and psychological factors, of which kinesiophobia and anxiety were effective predictors. In clinical practice, pain-related cognitions and psychological factors should be fully considered to manage neck pain efficiently.
{"title":"Correlations of The Central Sensitization Inventory, conditioned pain modulation, cognitions and psychological factors in individuals with chronic neck pain: A cross-sectional study.","authors":"Yuwei He, Jialin Wang, Peng Zhao, Ruirui Wang, Meng Li","doi":"10.1007/s40122-024-00601-w","DOIUrl":"10.1007/s40122-024-00601-w","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic neck pain (CNP) is a global public health problem, with high prevalence and absenteeism rates. Central sensitization (CS) as a basis for chronic pain may play an essential role in its development and progression. It is often comorbid with low conditioned pain modulation (CPM) effects, cognitions, and psychological problems.</p><p><strong>Objectives: </strong>The purposes of this study were to (1) explore the relationship between pain-related cognitions and psychological factors, CPM effects, and the central sensitization inventory (CSI) scores; and (2) determine whether cognitions and psychological factors can predict CSI scores and CPM effects in individuals with CNP.</p><p><strong>Methods: </strong>Fifty-four individuals with CNP were recruited for this cross-sectional study. The following outcome measures were evaluated: The CSI (screening tool) was compared with the cold pressor test (CPT), which was the psychophysical test used to assess the CPM; neck pain intensity using the visual analogue scale (VAS), as well as pain-related cognitions (including kinesiophobia and pain catastrophization) and psychological states (including anxiety and depression) using self-report questionnaires.</p><p><strong>Results: </strong>CSI score was not associated with the CPM effect (r = 0.257, p > 0.05), and no cognitions or psychological factors were associated with CPM (p > 0.05), but CSI score was moderately positively correlated with kinesiophobia (r = 0.554, p < 0.01), lowly positively correlated with pain catastrophization (r = 0.332, p = 0.017) and anxiety (r = 0.492, p < 0.01), but not depression (r = 0.207, p = 0.132). Multiple linear regression analysis showed that kinesiophobia (B = 1.308, p < 0.01) and anxiety (B = 1.806, p = 0.02) were significant positive predictors of CSI score.</p><p><strong>Conclusions: </strong>The findings confirm some of our hypotheses. Accordingly, the findings inferred that the CSI does not seem to respond to CPM effect in patients with CNP effectively. In addition, CSI score was associated with cognitions and psychological factors, of which kinesiophobia and anxiety were effective predictors. In clinical practice, pain-related cognitions and psychological factors should be fully considered to manage neck pain efficiently.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"843-856"},"PeriodicalIF":4.1,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11254877/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141093663","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}
Pub Date : 2024-08-01Epub Date: 2024-06-26DOI: 10.1007/s40122-024-00623-4
Giustino Varrassi, Magdi Hanna, Stefano Coaccioli, Paolo Fabrizzi, Simone Baldini, Ivan Kruljac, Carles Brotons, Serge Perrot
Introduction: Dexketoprofen/tramadol 25/75 mg (DKP/TRAM) is a fixed-dose combination of a cyclooxygenase inhibitor and opioid receptor agonist. To better understand the efficacy and safety of DKP/TRAM in the treatment of moderate to severe acute lower back pain (LBP) with or without radiculopathy, we carried out a large explorative phase IV international, multicenter, prospective, randomized, double-blind, parallel group, placebo-controlled study (DANTE).
Methods: A total of 538 patients with or without a history of LBP and experiencing acute LPB of moderate to severe intensity [Numerical Rating Scale-Pain Intensity (NRS-PI) score > 5] were randomized 4:4:1:1 to DKP/TRAM 25/75 mg every 8 h (n = 211), tramadol (TRAM) 100 mg (n = 207), placebo-matched DKP/TRAM (n = 59), or placebo-matched TRAM (n = 61).
Results: The proportion of patients achieving the primary endpoint, defined as the time to first achieve NRS-PI score < 4 or pain intensity reduction ≥ 30% from drug intake up to 8 h after the first dose, was higher in the DKP/TRAM arm than in the placebo group, but the difference was not statistically significant (46.1% vs. 42.6%, respectively; hazard ratio 1.11; 95% confidence interval 0.775, 1.595; p = 0.566). DKP/TRAM achieved superiority over TRAM in total pain relief at 4, 6, and 8 h (p < 0.05). Conversely, in relation to the secondary endpoints, a significantly greater reduction in NRS-PI score was seen with DKP/TRAM versus placebo starting from 1 h, and this reduction remained numerically lower throughout 8 h. Summed pain intensity difference values were also significantly lower at 4, 6, and 8 h with DKP/TRAM compared to TRAM (p < 0.05). Overall, DKP/TRAM was well tolerated.
Conclusion: Although the primary endpoint was not met, secondary efficacy analyses suggest the superiority of DKP/TRAM over placebo and TRAM alone in terms of total pain relief. DKP/TRAM can be considered to be an effective and safe option for the treatment of moderate to severe acute LBP.
Dante study registration: EudraCT number: 2019-003656-37; ClinicalTrials.gov Identifier: NCT05170841.
{"title":"Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain: A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE).","authors":"Giustino Varrassi, Magdi Hanna, Stefano Coaccioli, Paolo Fabrizzi, Simone Baldini, Ivan Kruljac, Carles Brotons, Serge Perrot","doi":"10.1007/s40122-024-00623-4","DOIUrl":"10.1007/s40122-024-00623-4","url":null,"abstract":"<p><strong>Introduction: </strong>Dexketoprofen/tramadol 25/75 mg (DKP/TRAM) is a fixed-dose combination of a cyclooxygenase inhibitor and opioid receptor agonist. To better understand the efficacy and safety of DKP/TRAM in the treatment of moderate to severe acute lower back pain (LBP) with or without radiculopathy, we carried out a large explorative phase IV international, multicenter, prospective, randomized, double-blind, parallel group, placebo-controlled study (DANTE).</p><p><strong>Methods: </strong>A total of 538 patients with or without a history of LBP and experiencing acute LPB of moderate to severe intensity [Numerical Rating Scale-Pain Intensity (NRS-PI) score > 5] were randomized 4:4:1:1 to DKP/TRAM 25/75 mg every 8 h (n = 211), tramadol (TRAM) 100 mg (n = 207), placebo-matched DKP/TRAM (n = 59), or placebo-matched TRAM (n = 61).</p><p><strong>Results: </strong>The proportion of patients achieving the primary endpoint, defined as the time to first achieve NRS-PI score < 4 or pain intensity reduction ≥ 30% from drug intake up to 8 h after the first dose, was higher in the DKP/TRAM arm than in the placebo group, but the difference was not statistically significant (46.1% vs. 42.6%, respectively; hazard ratio 1.11; 95% confidence interval 0.775, 1.595; p = 0.566). DKP/TRAM achieved superiority over TRAM in total pain relief at 4, 6, and 8 h (p < 0.05). Conversely, in relation to the secondary endpoints, a significantly greater reduction in NRS-PI score was seen with DKP/TRAM versus placebo starting from 1 h, and this reduction remained numerically lower throughout 8 h. Summed pain intensity difference values were also significantly lower at 4, 6, and 8 h with DKP/TRAM compared to TRAM (p < 0.05). Overall, DKP/TRAM was well tolerated.</p><p><strong>Conclusion: </strong>Although the primary endpoint was not met, secondary efficacy analyses suggest the superiority of DKP/TRAM over placebo and TRAM alone in terms of total pain relief. DKP/TRAM can be considered to be an effective and safe option for the treatment of moderate to severe acute LBP.</p><p><strong>Dante study registration: </strong>EudraCT number: 2019-003656-37; ClinicalTrials.gov Identifier: NCT05170841.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1007-1022"},"PeriodicalIF":4.1,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11255173/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141451137","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}
Pub Date : 2024-08-01Epub Date: 2024-05-28DOI: 10.1007/s40122-024-00611-8
Hang Sun, Yiwei Zhong, Min Wang, Shujie Niu, Rusong Yang, Yali Tian, Bingbing Li
Introduction: Patients frequently suffer from debilitating chronic postsurgical pain (CPSP) subsequent to thoracoscopic surgery. The impact of postoperative dexmedetomidine infusion on CPSP remains elusive. This study aimed to scrutinize the effect of dexmedetomidine on both 1-year incidence of CPSP and the quality of recovery after thoracoscopic pulmonary nodule surgery.
Methods: This retrospective analysis encompassed clinical and follow-up data from 1148 patients undergoing thoracoscopic pulmonary nodule surgery at our institution between September 2021 and August 2022. Depending on whether dexmedetomidine was infused intravenously or not on the first night after surgery, patients were stratified into the dexmedetomidine group or the control group, with propensity score matching applied to harmonize baseline characteristics. Comparative analysis sought to delineate distinctions of CPSP and recovery quality 1 year after surgery.
Results: Following propensity score matching, a cohort of 258 patients in each group underwent analysis. Comparisons after matching revealed no statistically significant disparities in 1-year CPSP incidence [76/258 (29.5%) versus 78/258 (30.2%), P = 0.847], moderate-to-severe pain occurrence [17/76 (22.4%) versus 22/78 (28.2%), P = 0.405], neuropathic pain occurrence [11/76 (14.5%) versus 11/78 (14.1%), P = 0.948], and postoperative recovery quality assessed by 12-Item Short Form Health Survey (SF-12) score (113.1 [107.2, 116.0] versus 113.0 [107.4, 116.0], P = 0.328). Multivariate logistic regression analysis encompassing the entire cohort identified being female [odds ratio (OR) 2.10, 95% confidence interval (CI) 1.59-2.79, P < 0.001) and postoperative rescue analgesia (OR 1.47, 95% CI 1.09-1.96, P = 0.010) as risk factors for CPSP, while intraoperative fentanyl dosage (OR 0.92, 95% CI 0.87-0.98, P = 0.006) emerged as a protective factor.
Conclusion: The prolonged administration of dexmedetomidine did not yield discernible amelioration in either 1-year CPSP or the recovery quality after thoracoscopic surgery. Noteworthy risk factors for CPSP encompassed female sex, postoperative rescue analgesia, and diminished fentanyl dosage intraoperatively.
{"title":"Postoperative Dexmedetomidine Infusion and Chronic Postsurgical Pain in Thoracoscopic Pulmonary Nodule Surgery: A Retrospective Study with Propensity-Score-Matched Analysis.","authors":"Hang Sun, Yiwei Zhong, Min Wang, Shujie Niu, Rusong Yang, Yali Tian, Bingbing Li","doi":"10.1007/s40122-024-00611-8","DOIUrl":"10.1007/s40122-024-00611-8","url":null,"abstract":"<p><strong>Introduction: </strong>Patients frequently suffer from debilitating chronic postsurgical pain (CPSP) subsequent to thoracoscopic surgery. The impact of postoperative dexmedetomidine infusion on CPSP remains elusive. This study aimed to scrutinize the effect of dexmedetomidine on both 1-year incidence of CPSP and the quality of recovery after thoracoscopic pulmonary nodule surgery.</p><p><strong>Methods: </strong>This retrospective analysis encompassed clinical and follow-up data from 1148 patients undergoing thoracoscopic pulmonary nodule surgery at our institution between September 2021 and August 2022. Depending on whether dexmedetomidine was infused intravenously or not on the first night after surgery, patients were stratified into the dexmedetomidine group or the control group, with propensity score matching applied to harmonize baseline characteristics. Comparative analysis sought to delineate distinctions of CPSP and recovery quality 1 year after surgery.</p><p><strong>Results: </strong>Following propensity score matching, a cohort of 258 patients in each group underwent analysis. Comparisons after matching revealed no statistically significant disparities in 1-year CPSP incidence [76/258 (29.5%) versus 78/258 (30.2%), P = 0.847], moderate-to-severe pain occurrence [17/76 (22.4%) versus 22/78 (28.2%), P = 0.405], neuropathic pain occurrence [11/76 (14.5%) versus 11/78 (14.1%), P = 0.948], and postoperative recovery quality assessed by 12-Item Short Form Health Survey (SF-12) score (113.1 [107.2, 116.0] versus 113.0 [107.4, 116.0], P = 0.328). Multivariate logistic regression analysis encompassing the entire cohort identified being female [odds ratio (OR) 2.10, 95% confidence interval (CI) 1.59-2.79, P < 0.001) and postoperative rescue analgesia (OR 1.47, 95% CI 1.09-1.96, P = 0.010) as risk factors for CPSP, while intraoperative fentanyl dosage (OR 0.92, 95% CI 0.87-0.98, P = 0.006) emerged as a protective factor.</p><p><strong>Conclusion: </strong>The prolonged administration of dexmedetomidine did not yield discernible amelioration in either 1-year CPSP or the recovery quality after thoracoscopic surgery. Noteworthy risk factors for CPSP encompassed female sex, postoperative rescue analgesia, and diminished fentanyl dosage intraoperatively.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"865-881"},"PeriodicalIF":4.1,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11254894/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141158578","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}
Pub Date : 2024-08-01Epub Date: 2024-06-24DOI: 10.1007/s40122-024-00624-3
Solomon Tesfaye, Ponnusamy Saravanan, Edvard Ehler, Karel Zinek, Ilona Palka-Kisielowska, Marcin Nastaj, Pierre Serusclat, Paola Lipone, Andrea Vergallo, Elisa Quarchioni, Fabrizio Calisti, Alessandro Comandini, Agnese Cattaneo
<p><strong>Introduction: </strong>Up to 50% of diabetic patients with neuropathy suffer from chronic pain, namely painful diabetic neuropathy (PDN), an unmet medical need with significant impact on quality of life. Gabapentin is widely used for PDN, albeit with frequent dose-limiting effects. Trazodone, an antidepressant with multi-modal action, has shown promising results when given at low doses as an add-on to gabapentin. Upon previous clinical trials and experimental evidence, a fixed-dose combination (FDC) of both compounds, at low doses, was developed for neuropathic pain.</p><p><strong>Methods: </strong>This was a phase II, randomized, double-blind, placebo and reference controlled, dose-finding, multicenter, international, prospective study. Male and female diabetic patients aged 18-75 years and affected by PDN were eligible for enrolment. Patients were randomized (1:1:1:1:2 ratio) to trazodone and gabapentin (Trazo/Gaba) 2.5/25 mg t.i.d. for 8 weeks, Trazo/Gaba 5/50 mg t.i.d. for 8 weeks, Trazo/Gaba 10/100 mg t.i.d. for 8 weeks, gabapentin (Gaba), or placebo (PLB). The aim of the study was to collect preliminary information on the effect of the 3 different FDCs of Trazo/Gaba on pain intensity based on the 11-point numeric rating score (NRS) after 8 weeks of treatment. The secondary objectives were the evaluation of the percentage of responders, neuropathic pain symptoms, anxiety, sleep, quality of life, safety, and tolerability. The primary efficacy endpoint was evaluated with last observation carried out forward (LOCF), using an analysis of covariance (ANCOVA), including treatment and centers as factors and baseline as covariate and applying linear contrast test, excluding the active treatment. Only if the linear contrast test was significant (p < 0.05), the step-down Dunnett test would be used to determine the minimum effective dose significantly different from PLB. If linearity was not verified, an adjusted ANCOVA model and comparisons with Dunnett test were performed. Before the application of the ANCOVA model, the non-significance of interaction treatment per baseline was verified.</p><p><strong>Results: </strong>A total of 240 patients were included in the modified intention-to-treat (m-ITT) population: 39 in Trazo/Gaba 2.5/25 mg, 38 in Trazo/Gaba 5/50 mg, 37 in Trazo/Gaba 10/100 mg, 83 in PLB, and 43 in Gaba. After 8 weeks of treatment, changes of the average daily pain score based on the 11-point NRS from baseline were - 2.52 ± 2.31 in Trazo/Gaba 2.5/25 mg group, - 2.24 ± 1.96 in Trazo/Gaba 5/50 mg group, - 2.46 ± 2.12 in Trazo/Gaba 10/100 mg group, - 1.92 ± 2.21 in Gaba group, and - 2.02 ± 1.95 in the PLB group. The linear contrast test did not result in significant differences (p > 0.05) among treatment groups. Consequently, the minimum effective dose against PLB was not determined. The multiple comparison with Dunnett adjustment did not show any statistically significant differences vs. PLB after 8 weeks of treatment: Trazo/Gab
{"title":"Efficacy and Safety of Trazodone and Gabapentin Fixed-Dose Combination in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Dose-Finding Study.","authors":"Solomon Tesfaye, Ponnusamy Saravanan, Edvard Ehler, Karel Zinek, Ilona Palka-Kisielowska, Marcin Nastaj, Pierre Serusclat, Paola Lipone, Andrea Vergallo, Elisa Quarchioni, Fabrizio Calisti, Alessandro Comandini, Agnese Cattaneo","doi":"10.1007/s40122-024-00624-3","DOIUrl":"10.1007/s40122-024-00624-3","url":null,"abstract":"<p><strong>Introduction: </strong>Up to 50% of diabetic patients with neuropathy suffer from chronic pain, namely painful diabetic neuropathy (PDN), an unmet medical need with significant impact on quality of life. Gabapentin is widely used for PDN, albeit with frequent dose-limiting effects. Trazodone, an antidepressant with multi-modal action, has shown promising results when given at low doses as an add-on to gabapentin. Upon previous clinical trials and experimental evidence, a fixed-dose combination (FDC) of both compounds, at low doses, was developed for neuropathic pain.</p><p><strong>Methods: </strong>This was a phase II, randomized, double-blind, placebo and reference controlled, dose-finding, multicenter, international, prospective study. Male and female diabetic patients aged 18-75 years and affected by PDN were eligible for enrolment. Patients were randomized (1:1:1:1:2 ratio) to trazodone and gabapentin (Trazo/Gaba) 2.5/25 mg t.i.d. for 8 weeks, Trazo/Gaba 5/50 mg t.i.d. for 8 weeks, Trazo/Gaba 10/100 mg t.i.d. for 8 weeks, gabapentin (Gaba), or placebo (PLB). The aim of the study was to collect preliminary information on the effect of the 3 different FDCs of Trazo/Gaba on pain intensity based on the 11-point numeric rating score (NRS) after 8 weeks of treatment. The secondary objectives were the evaluation of the percentage of responders, neuropathic pain symptoms, anxiety, sleep, quality of life, safety, and tolerability. The primary efficacy endpoint was evaluated with last observation carried out forward (LOCF), using an analysis of covariance (ANCOVA), including treatment and centers as factors and baseline as covariate and applying linear contrast test, excluding the active treatment. Only if the linear contrast test was significant (p < 0.05), the step-down Dunnett test would be used to determine the minimum effective dose significantly different from PLB. If linearity was not verified, an adjusted ANCOVA model and comparisons with Dunnett test were performed. Before the application of the ANCOVA model, the non-significance of interaction treatment per baseline was verified.</p><p><strong>Results: </strong>A total of 240 patients were included in the modified intention-to-treat (m-ITT) population: 39 in Trazo/Gaba 2.5/25 mg, 38 in Trazo/Gaba 5/50 mg, 37 in Trazo/Gaba 10/100 mg, 83 in PLB, and 43 in Gaba. After 8 weeks of treatment, changes of the average daily pain score based on the 11-point NRS from baseline were - 2.52 ± 2.31 in Trazo/Gaba 2.5/25 mg group, - 2.24 ± 1.96 in Trazo/Gaba 5/50 mg group, - 2.46 ± 2.12 in Trazo/Gaba 10/100 mg group, - 1.92 ± 2.21 in Gaba group, and - 2.02 ± 1.95 in the PLB group. The linear contrast test did not result in significant differences (p > 0.05) among treatment groups. Consequently, the minimum effective dose against PLB was not determined. The multiple comparison with Dunnett adjustment did not show any statistically significant differences vs. PLB after 8 weeks of treatment: Trazo/Gab","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"987-1006"},"PeriodicalIF":4.1,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11255147/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141446753","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}
Pub Date : 2024-08-01Epub Date: 2024-05-11DOI: 10.1007/s40122-024-00609-2
Ashim Gupta, David Han, Stephen M Norwood
Introduction: Chronic neck pain (cNP) is one of the leading causes of disability worldwide, often being refractory to conventional forms of treatment. Various forms of electrical stimulation have been proposed to decrease pain and improve function. Patient-reported outcome measures (PROMs) for treatment of cNP have rarely been published.
Methods: An independent retrospective statistical analysis of PROMs data for users of H-Wave® device stimulation (HWDS), prospectively collected by the device manufacturer over a 4-year period, was conducted. Final surveys for 34,192 pain management patients were filtered for pain chronicity limited to 3-24 months and device use of 22-365 days, resulting in 11,503 patients with "all diagnoses"; this number was further reduced to 1482 patients with cNP, sprain, or strain.
Results: Neck pain was reduced by 3.13 points (0-10 pain scale), with significant (≥ 20%) relief in 86.6%. Function/activities of daily living (ADL) improved in 96.19%, while improved work performance was reported in 84.76%. Medication use decreased or stopped in 65.42% and sleep improved in 60.39%. Over 95% reported having expectations met or exceeded, service satisfaction, and confidence in device use, while no adverse events were reported. Subgroup analyses found positive benefit associations with longer duration of device use.
Conclusion: Near-equivalent outcomes were self-reported by cNP HWDS patients as for (previously published) chronic low back pain (cLBP) patients. HWDS provided effective and safe cNP relief, improvements in function and ADL, along with additional benefits including decreased medication use, better sleep, and improved work performance.
{"title":"H-Wave<sup>®</sup> Device Stimulation for Chronic Neck Pain: A Patient-Reported Outcome Measures (PROMs) Study.","authors":"Ashim Gupta, David Han, Stephen M Norwood","doi":"10.1007/s40122-024-00609-2","DOIUrl":"10.1007/s40122-024-00609-2","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic neck pain (cNP) is one of the leading causes of disability worldwide, often being refractory to conventional forms of treatment. Various forms of electrical stimulation have been proposed to decrease pain and improve function. Patient-reported outcome measures (PROMs) for treatment of cNP have rarely been published.</p><p><strong>Methods: </strong>An independent retrospective statistical analysis of PROMs data for users of H-Wave<sup>®</sup> device stimulation (HWDS), prospectively collected by the device manufacturer over a 4-year period, was conducted. Final surveys for 34,192 pain management patients were filtered for pain chronicity limited to 3-24 months and device use of 22-365 days, resulting in 11,503 patients with \"all diagnoses\"; this number was further reduced to 1482 patients with cNP, sprain, or strain.</p><p><strong>Results: </strong>Neck pain was reduced by 3.13 points (0-10 pain scale), with significant (≥ 20%) relief in 86.6%. Function/activities of daily living (ADL) improved in 96.19%, while improved work performance was reported in 84.76%. Medication use decreased or stopped in 65.42% and sleep improved in 60.39%. Over 95% reported having expectations met or exceeded, service satisfaction, and confidence in device use, while no adverse events were reported. Subgroup analyses found positive benefit associations with longer duration of device use.</p><p><strong>Conclusion: </strong>Near-equivalent outcomes were self-reported by cNP HWDS patients as for (previously published) chronic low back pain (cLBP) patients. HWDS provided effective and safe cNP relief, improvements in function and ADL, along with additional benefits including decreased medication use, better sleep, and improved work performance.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"829-841"},"PeriodicalIF":4.1,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11255171/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140909069","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}
Pub Date : 2024-08-01Epub Date: 2024-05-25DOI: 10.1007/s40122-024-00595-5
Francesco Coletta, Rossella Pirolli, Raffaele Annunziata, Manuela Nugnes, Antonio Tommasello, Romolo Villani, Luca Gregorio Giaccari, Maria Beatrice Passavanti, Maria Caterina Pace, Pasquale Sansone
Introduction: The management of pain following a burn is extremely complex because of the multifactorial nature of burn pain (nociceptive and neuropathic). In the pre-hospital setting and emergency department (ED), the main goal of acute pain management is to reduce the patient's pain, allowing them to maintain function and to prevent the chronification of pain. Opioids are used as first-line treatment in management of burn pain. The aim of our study was to evaluate the efficacy and adverse effects of intravenous (IV) morphine for burn pain management in the ED and to evaluate pain management in the pre-hospital setting.
Methods: In this single-center observational study, patients presenting with second- and third-degree burns were enrolled in our ED. Numerical Rating Scale (NRS) and Burn Specific Pain Anxiety Scale (BSPAS) were performed at ED admission and after 1 h. Pain medications administered before arrival in the ED were reported by the rescue team. All patients received IV acetaminophen every 8 h and IV morphine according NRS.
Results: Thirty patients were included in this study. At the time of arrival to the ED, > 90% of the patients reported severe pain; 95.8% of them received IV morphine to achieve pain relief. After 1 h, > 65% of patients had NRS < 3. The total amount of IV morphine was 18.12 ± 4.26 mg in the first hour. No adverse events were recorded. The BSPAS on admission to the ED was 34.8 ± 5.6, indicating severe anxiety. After 1 h, BSPAS was 12.8 ± 4.8, indicating mild anxiety.
Conclusion: IV morphine used for burn pain management in the emergency setting significantly improves patient outcomes in terms of pain. IV morphine also reduced anxiety scores at 1 h.
{"title":"Efficacy and Adverse Effects of IV Morphine for Burn Pain Management in the Emergency Department: An Observational Study.","authors":"Francesco Coletta, Rossella Pirolli, Raffaele Annunziata, Manuela Nugnes, Antonio Tommasello, Romolo Villani, Luca Gregorio Giaccari, Maria Beatrice Passavanti, Maria Caterina Pace, Pasquale Sansone","doi":"10.1007/s40122-024-00595-5","DOIUrl":"10.1007/s40122-024-00595-5","url":null,"abstract":"<p><strong>Introduction: </strong>The management of pain following a burn is extremely complex because of the multifactorial nature of burn pain (nociceptive and neuropathic). In the pre-hospital setting and emergency department (ED), the main goal of acute pain management is to reduce the patient's pain, allowing them to maintain function and to prevent the chronification of pain. Opioids are used as first-line treatment in management of burn pain. The aim of our study was to evaluate the efficacy and adverse effects of intravenous (IV) morphine for burn pain management in the ED and to evaluate pain management in the pre-hospital setting.</p><p><strong>Methods: </strong>In this single-center observational study, patients presenting with second- and third-degree burns were enrolled in our ED. Numerical Rating Scale (NRS) and Burn Specific Pain Anxiety Scale (BSPAS) were performed at ED admission and after 1 h. Pain medications administered before arrival in the ED were reported by the rescue team. All patients received IV acetaminophen every 8 h and IV morphine according NRS.</p><p><strong>Results: </strong>Thirty patients were included in this study. At the time of arrival to the ED, > 90% of the patients reported severe pain; 95.8% of them received IV morphine to achieve pain relief. After 1 h, > 65% of patients had NRS < 3. The total amount of IV morphine was 18.12 ± 4.26 mg in the first hour. No adverse events were recorded. The BSPAS on admission to the ED was 34.8 ± 5.6, indicating severe anxiety. After 1 h, BSPAS was 12.8 ± 4.8, indicating mild anxiety.</p><p><strong>Conclusion: </strong>IV morphine used for burn pain management in the emergency setting significantly improves patient outcomes in terms of pain. IV morphine also reduced anxiety scores at 1 h.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"857-864"},"PeriodicalIF":4.1,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11254875/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141096979","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}
Pub Date : 2024-08-01Epub Date: 2024-06-18DOI: 10.1007/s40122-024-00618-1
Jian-Han Xu, Hai-Ling Tan, Li-Na Zhang, Zan-Gong Zhou, Li Yuan, Ling-Xin Kong, Ming-Quan Song, Li-Jie Qi, Xiang-Yu Ji
Introduction: Further clinical validation is required to determine whether transcutaneous electrical acupoint stimulation (TEAS) can replace opioids and be used in combination with remimazolam for sedation during gastrointestinal endoscopy.
Methods: A total of 108 outpatients who underwent diagnostic gastrointestinal endoscopy were randomly divided into three groups: fentanyl plus remimazolam group (group C), TEAS plus remimazolam group (group E), and placebo-TEAS plus remimazolam group (group P). The assessments of patient satisfaction, physician satisfaction, and pain scale score during the examination constituted the primary endpoints of the study. The secondary endpoints were the time of recovery, recovery of normal behavioral function and discharge, incidence of adverse reactions, and dose of remimazolam.
Results: Compared with group C, group E had a greater median score for patient satisfaction at follow-up and a slightly lower median score for physician satisfaction. The pain score of group E was slightly greater than that of group C, but the difference was not significant. However, in group C, the incidence of hypoxemia, the rate of nausea and the severity of vertigo were greater, and the number of patients discharged and resuming normal behavioral function was greater than those in the other two groups. The dose of remimazolam in group C and group E was less than that in group P.
Conclusions: TEAS combined with moderate sedation of remimazolam can provide an ideal sedative effect, which preferably suppresses discomfort caused by gastrointestinal endoscopy and has fewer sedation-related complications.
Trial registration: ID: NCT05485064; First registration (29/07/2022); Last registration (02/11/2022) (Clinical Trials.gov).
简介:经皮穴位电刺激(TEAS)能否取代阿片类药物,并与瑞马唑仑联合使用,用于胃肠道内窥镜检查期间的镇静,还需要进一步的临床验证:共有108名门诊患者接受了诊断性消化内镜检查,他们被随机分为三组:芬太尼加瑞马唑仑组(C组)、TEAS加瑞马唑仑组(E组)和安慰剂-TEAS加瑞马唑仑组(P组)。患者满意度、医生满意度和检查过程中的疼痛量表评分构成研究的主要终点。次要终点是康复时间、正常行为功能恢复和出院时间、不良反应发生率和雷马唑仑剂量:与 C 组相比,E 组患者随访满意度的中位数得分更高,而医生满意度的中位数得分略低。E 组的疼痛评分略高于 C 组,但差异不显著。然而,C 组患者的低氧血症发生率、恶心发生率和眩晕严重程度均高于其他两组,出院并恢复正常行为功能的患者人数也多于其他两组。C组和E组的雷马唑仑剂量小于P组:结论:TEAS联合适度镇静的瑞马唑仑可提供理想的镇静效果,能较好地抑制消化道内镜检查引起的不适,且镇静相关并发症较少:试验注册:ID:NCT05485064;首次注册(2022 年 7 月 29 日);最后注册(2022 年 11 月 2 日)(Clinical Trials.gov)。
{"title":"Transcutaneous Electrical Acupoint Stimulation Combined with Moderate Sedation of Remimazolam Tosilate in Gastrointestinal Endoscopy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","authors":"Jian-Han Xu, Hai-Ling Tan, Li-Na Zhang, Zan-Gong Zhou, Li Yuan, Ling-Xin Kong, Ming-Quan Song, Li-Jie Qi, Xiang-Yu Ji","doi":"10.1007/s40122-024-00618-1","DOIUrl":"10.1007/s40122-024-00618-1","url":null,"abstract":"<p><strong>Introduction: </strong>Further clinical validation is required to determine whether transcutaneous electrical acupoint stimulation (TEAS) can replace opioids and be used in combination with remimazolam for sedation during gastrointestinal endoscopy.</p><p><strong>Methods: </strong>A total of 108 outpatients who underwent diagnostic gastrointestinal endoscopy were randomly divided into three groups: fentanyl plus remimazolam group (group C), TEAS plus remimazolam group (group E), and placebo-TEAS plus remimazolam group (group P). The assessments of patient satisfaction, physician satisfaction, and pain scale score during the examination constituted the primary endpoints of the study. The secondary endpoints were the time of recovery, recovery of normal behavioral function and discharge, incidence of adverse reactions, and dose of remimazolam.</p><p><strong>Results: </strong>Compared with group C, group E had a greater median score for patient satisfaction at follow-up and a slightly lower median score for physician satisfaction. The pain score of group E was slightly greater than that of group C, but the difference was not significant. However, in group C, the incidence of hypoxemia, the rate of nausea and the severity of vertigo were greater, and the number of patients discharged and resuming normal behavioral function was greater than those in the other two groups. The dose of remimazolam in group C and group E was less than that in group P.</p><p><strong>Conclusions: </strong>TEAS combined with moderate sedation of remimazolam can provide an ideal sedative effect, which preferably suppresses discomfort caused by gastrointestinal endoscopy and has fewer sedation-related complications.</p><p><strong>Trial registration: </strong>ID: NCT05485064; First registration (29/07/2022); Last registration (02/11/2022) (Clinical Trials.gov).</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"919-936"},"PeriodicalIF":4.1,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11254895/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141420348","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}
Pub Date : 2024-08-01Epub Date: 2024-06-04DOI: 10.1007/s40122-024-00612-7
Zheng Lin, Lu-Yan Yu, Si-Yi Pan, Yi Cao, Ping Lin
Introduction: Postherpetic neuralgia (PHN), a complication of herpes zoster, significantly impacts the quality of life of affected patients. Research indicates that early intervention for pain can reduce the occurrence or severity of PHN. This study aims to develop a predictive model and scoring table to identify patients at risk of developing PHN following acute herpetic neuralgia, facilitating informed clinical decision-making.
Methods: We conducted a retrospective review of 524 hospitalized patients with herpes zoster at The First Affiliated Hospital of Zhejiang Chinese Medical University from December 2020 to December 2023 and classified them according to whether they had PHN, collecting a comprehensive set of 30 patient characteristics and disease-related indicators, 5 comorbidity indicators, 2 disease score values, and 10 serological indicators. Relevant features associated with PHN were identified using the least absolute shrinkage and selection operator (LASSO). Then, the patients were divided into a training set and a test set in a 4:1 ratio, with comparability tested using univariate analysis. Six models were established in the training set using machine learning methods: support vector machines, logistic regression, random forest, k-nearest neighbor, gradient boosting, and neural network. The performance of these models was evaluated in the test set, and a nomogram based on logistic regression was used to create a PHN prediction score table.
Results: Eight non-zero characteristic variables selected from the LASSO regression results were included in the model, including age [area under the curve (AUC) = 0.812, p < 0.001], Numerical Rating Scale (NRS) (AUC = 0.792, p < 0.001), receiving treatment time (AUC = 0.612, p < 0.001), rash recovery time (AUC = 0.680, p < 0.001), history of malignant tumor (AUC = 0.539, p < 0.001), history of diabetes (AUC = 0.638, p < 0.001), varicella-zoster virus immunoglobulin M (AUC = 0.620, p < 0.001), and serum nerve-specific enolase (AUC = 0.659, p < 0,001). The gradient boosting model outperformed other classifier models on the test set with an AUC of 0.931, 95% confidence interval (CI) (0.882-0.980), accuracy of 0.886 (95% CI 0.809-0.940). In the test set, our predictive scoring table achieved an AUC of 0.820 (95% CI 0.869-0.970) with accuracy of 0.790 (95% CI 0.700-0.864).
Conclusion: This study presents a methodology for predicting the development of postherpetic neuralgia in shingles patients by analyzing historical case data, employing various machine learning techniques, and selecting the optimal model through comparative analysis. In addition, a logistic regression model has been used to create a scoring table for predicting the postherpetic neuralgia.
{"title":"Development of a Prediction Model and Corresponding Scoring Table for Postherpetic Neuralgia Using Six Machine Learning Algorithms: A Retrospective Study.","authors":"Zheng Lin, Lu-Yan Yu, Si-Yi Pan, Yi Cao, Ping Lin","doi":"10.1007/s40122-024-00612-7","DOIUrl":"10.1007/s40122-024-00612-7","url":null,"abstract":"<p><strong>Introduction: </strong>Postherpetic neuralgia (PHN), a complication of herpes zoster, significantly impacts the quality of life of affected patients. Research indicates that early intervention for pain can reduce the occurrence or severity of PHN. This study aims to develop a predictive model and scoring table to identify patients at risk of developing PHN following acute herpetic neuralgia, facilitating informed clinical decision-making.</p><p><strong>Methods: </strong>We conducted a retrospective review of 524 hospitalized patients with herpes zoster at The First Affiliated Hospital of Zhejiang Chinese Medical University from December 2020 to December 2023 and classified them according to whether they had PHN, collecting a comprehensive set of 30 patient characteristics and disease-related indicators, 5 comorbidity indicators, 2 disease score values, and 10 serological indicators. Relevant features associated with PHN were identified using the least absolute shrinkage and selection operator (LASSO). Then, the patients were divided into a training set and a test set in a 4:1 ratio, with comparability tested using univariate analysis. Six models were established in the training set using machine learning methods: support vector machines, logistic regression, random forest, k-nearest neighbor, gradient boosting, and neural network. The performance of these models was evaluated in the test set, and a nomogram based on logistic regression was used to create a PHN prediction score table.</p><p><strong>Results: </strong>Eight non-zero characteristic variables selected from the LASSO regression results were included in the model, including age [area under the curve (AUC) = 0.812, p < 0.001], Numerical Rating Scale (NRS) (AUC = 0.792, p < 0.001), receiving treatment time (AUC = 0.612, p < 0.001), rash recovery time (AUC = 0.680, p < 0.001), history of malignant tumor (AUC = 0.539, p < 0.001), history of diabetes (AUC = 0.638, p < 0.001), varicella-zoster virus immunoglobulin M (AUC = 0.620, p < 0.001), and serum nerve-specific enolase (AUC = 0.659, p < 0,001). The gradient boosting model outperformed other classifier models on the test set with an AUC of 0.931, 95% confidence interval (CI) (0.882-0.980), accuracy of 0.886 (95% CI 0.809-0.940). In the test set, our predictive scoring table achieved an AUC of 0.820 (95% CI 0.869-0.970) with accuracy of 0.790 (95% CI 0.700-0.864).</p><p><strong>Conclusion: </strong>This study presents a methodology for predicting the development of postherpetic neuralgia in shingles patients by analyzing historical case data, employing various machine learning techniques, and selecting the optimal model through comparative analysis. In addition, a logistic regression model has been used to create a scoring table for predicting the postherpetic neuralgia.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"883-907"},"PeriodicalIF":4.1,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11254897/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141248373","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}
Pub Date : 2024-08-01Epub Date: 2024-06-12DOI: 10.1007/s40122-024-00622-5
Rudolf Likar, Ruth Poglitsch, Štěpán Bejvančický, Ludwig Carl, Miroslav Ferencik, Alfred Klein-Watrycz, Monika Rieger, Keveen Salirrosas Flores, Astrid Schumich, Zoe Vlamaki, Marc Werner
Introduction: Pain is the most common reason for seeking medical treatment. Despite extensive research efforts and effective analgesics modulating pain, there is still a major therapeutic gap in addressing the root causes of pain. Pain is associated with tissue damage induced by oxidative stress and induction of inflammatory mediators following high consumption of antioxidants. The role of antioxidants in general, and the administration of L-ascorbate in particular, is still controversially discussed and underestimated in the daily clinical practice.
Methods: The current literature on the therapeutic effect of L-ascorbate, ascorbic acid, and vitamin C on various pain conditions was evaluated against the background of evidence-based medicine. Those articles, obtained from systematic search in PubMed, were critically assessed and rated in terms of evidence level and methodological quality by two independent experts. The primary purpose of this work was to establish specific pain therapy guidance for intravenous L-ascorbate.
Results: A PubMed search revealed 14 suitable articles comprising controlled clinical trials and meta-analyses. An additional ten publications could be identified via secondary literature. There is supporting evidence for the efficacy of ascorbate treatment in inflammatory pain conditions, in the complex regional pain syndrome, in post zoster neuralgia, in neuropathic pain, in post-operative pain conditions, and in tumor-related pain. However, the considered studies differ in the type of administration, in dosage, in duration of treatment, as well as in quality of research. Despite all study heterogeneity, it became evident that research of high scientific quality is in support of the efficacy of L-ascorbate in pain treatment.
Discussion: Oxidative stress is present in almost all pain conditions. Because oral administration of most magistral formulas of vitamin C does not provide biological availability, parenteral administration should be preferred and can be supported by an oral dose with high bioavailability on days without intravenous treatment. L-ascorbate should be preferred for parenteral high dosage, rather than ascorbic acid, as it does not release acid valences under physiological conditions.
Conclusions: L-ascorbate is an effective, safe, and economically favorable integrative treatment option for various pain conditions, addressing the root cause of tissue damage and inflammatory mediator burst.
导言疼痛是最常见的就医原因。尽管开展了广泛的研究工作并使用了有效的镇痛药来调节疼痛,但在解决疼痛根源方面仍存在重大治疗差距。疼痛与氧化应激引起的组织损伤以及大量摄入抗氧化剂后诱发的炎症介质有关。抗氧化剂的作用,尤其是左旋抗坏血酸的作用,在日常临床实践中仍存在争议和低估:方法:在循证医学的背景下,对目前关于左旋抗坏血酸、抗坏血酸和维生素 C 对各种疼痛症状的治疗效果的文献进行了评估。两位独立专家对从 PubMed 上系统搜索到的这些文章进行了严格评估,并从证据水平和方法质量方面进行了评分。这项工作的主要目的是为静脉注射左旋抗坏血酸制定具体的疼痛治疗指南:在 PubMed 上搜索发现了 14 篇合适的文章,包括对照临床试验和荟萃分析。通过二手文献还可以找到另外 10 篇文献。有支持性证据表明,抗坏血酸治疗对炎症性疼痛、复杂性区域疼痛综合征、带状疱疹后神经痛、神经性疼痛、术后疼痛和肿瘤相关疼痛具有疗效。然而,所考虑的研究在给药类型、剂量、治疗时间以及研究质量方面都存在差异。尽管所有研究都不尽相同,但高科学质量的研究显然支持左旋抗坏血酸在疼痛治疗中的疗效:讨论:氧化应激几乎存在于所有疼痛病症中。由于大多数维生素 C 的口服配方不能提供生物利用率,因此应首选肠外给药,在没有静脉治疗的日子里,可通过口服高生物利用率的剂量来支持肠外给药。肠外大剂量给药应首选左旋抗坏血酸,而不是抗坏血酸,因为左旋抗坏血酸在生理条件下不会释放酸价:结论:L-抗坏血酸是一种有效、安全、经济的综合治疗方案,可治疗各种疼痛病症,从根本上解决组织损伤和炎症介质爆发问题。
{"title":"The Use of High-Dose Intravenous L-Ascorbate in Pain Therapy: Current Evidence from the Literature.","authors":"Rudolf Likar, Ruth Poglitsch, Štěpán Bejvančický, Ludwig Carl, Miroslav Ferencik, Alfred Klein-Watrycz, Monika Rieger, Keveen Salirrosas Flores, Astrid Schumich, Zoe Vlamaki, Marc Werner","doi":"10.1007/s40122-024-00622-5","DOIUrl":"10.1007/s40122-024-00622-5","url":null,"abstract":"<p><strong>Introduction: </strong>Pain is the most common reason for seeking medical treatment. Despite extensive research efforts and effective analgesics modulating pain, there is still a major therapeutic gap in addressing the root causes of pain. Pain is associated with tissue damage induced by oxidative stress and induction of inflammatory mediators following high consumption of antioxidants. The role of antioxidants in general, and the administration of L-ascorbate in particular, is still controversially discussed and underestimated in the daily clinical practice.</p><p><strong>Methods: </strong>The current literature on the therapeutic effect of L-ascorbate, ascorbic acid, and vitamin C on various pain conditions was evaluated against the background of evidence-based medicine. Those articles, obtained from systematic search in PubMed, were critically assessed and rated in terms of evidence level and methodological quality by two independent experts. The primary purpose of this work was to establish specific pain therapy guidance for intravenous L-ascorbate.</p><p><strong>Results: </strong>A PubMed search revealed 14 suitable articles comprising controlled clinical trials and meta-analyses. An additional ten publications could be identified via secondary literature. There is supporting evidence for the efficacy of ascorbate treatment in inflammatory pain conditions, in the complex regional pain syndrome, in post zoster neuralgia, in neuropathic pain, in post-operative pain conditions, and in tumor-related pain. However, the considered studies differ in the type of administration, in dosage, in duration of treatment, as well as in quality of research. Despite all study heterogeneity, it became evident that research of high scientific quality is in support of the efficacy of L-ascorbate in pain treatment.</p><p><strong>Discussion: </strong>Oxidative stress is present in almost all pain conditions. Because oral administration of most magistral formulas of vitamin C does not provide biological availability, parenteral administration should be preferred and can be supported by an oral dose with high bioavailability on days without intravenous treatment. L-ascorbate should be preferred for parenteral high dosage, rather than ascorbic acid, as it does not release acid valences under physiological conditions.</p><p><strong>Conclusions: </strong>L-ascorbate is an effective, safe, and economically favorable integrative treatment option for various pain conditions, addressing the root cause of tissue damage and inflammatory mediator burst.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"767-790"},"PeriodicalIF":4.1,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11255149/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141306512","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}