Pub Date : 2023-12-09DOI: 10.1101/2023.12.07.23299686
Neetu Bansal, Wael Y. Khawagi, Nan Shang, Li-Chia Chen
Background This systematic review aimed to identify a comprehensive list of prescribing safety indicators for opioids in any setting from published literature.
背景 本系统综述旨在从已发表的文献中找出一份全面的阿片类药物处方安全指标清单。
{"title":"Enhancing Patient Safety in Opioid Prescribing: A Systematic Review of Potential Indicators","authors":"Neetu Bansal, Wael Y. Khawagi, Nan Shang, Li-Chia Chen","doi":"10.1101/2023.12.07.23299686","DOIUrl":"https://doi.org/10.1101/2023.12.07.23299686","url":null,"abstract":"<strong>Background</strong> This systematic review aimed to identify a comprehensive list of prescribing safety indicators for opioids in any setting from published literature.","PeriodicalId":501393,"journal":{"name":"medRxiv - Pain Medicine","volume":"201 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138573079","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-08DOI: 10.1101/2023.12.06.23299610
Vivian Salama, Brandon Godinich, Yimin Geng, Laia Humbert-Vidan, Laura Maule, Kareem A. Wahid, Mohamed A. Naser, Renjie He, Abdallah S. R. Mohamed, Clifton D. Fuller, Amy C. Moreno
Background/objective: Pain is a challenging multifaceted symptom reported by most cancer patients, resulting in a substantial burden on both patients and healthcare systems. This systematic review aims to explore applications of artificial intelligence/machine learning (AI/ML) in predicting pain-related outcomes and supporting decision-making processes in pain management in cancer. Methods: A comprehensive search of Ovid MEDLINE, EMBASE and Web of Science databases was conducted using terms including Cancer, Pain, Pain Management, Analgesics, Opioids, Artificial Intelligence, Machine Learning, Deep Learning, and Neural Networks, published up to September 7, 2023. The screening process was performed using the Covidence screening tool. Only original studies conducted in human cohorts were included. AI/ML models, their validation and performance and adherence to TRIPOD guidelines were summarized from the final included studies. Results: This systematic review included 44 studies from 2006-2023. Most studies were prospective and uni-institutional. There was an increase in the trend of AI/ML studies in cancer pain in the last 4 years. Nineteen studies used AI/ML for classifying cancer patients pain development after cancer therapy, with median AUC 0.80 (range 0.76-0.94). Eighteen studies focused on cancer pain research with median AUC 0.86 (range 0.50-0.99), and 7 focused on applying AI/ML for cancer pain management decisions with median AUC 0.71 (range 0.47-0.89). Multiple ML models were investigated with. median AUC across all models in all studies (0.77). Random forest models demonstrated the highest performance (median AUC 0.81), lasso models had the highest median sensitivity (1), while Support Vector Machine had the highest median specificity (0.74). Overall adherence of included studies to TRIPOD guidelines was 70.7%. Lack of external validation (14%) and clinical application (23%) of most included studies was detected. Reporting of model calibration was also missing in the majority of studies (5%). Conclusion: Implementation of various novel AI/ML tools promises significant advances in the classification, risk stratification, and management decisions for cancer pain. These advanced tools will integrate big health-related data for personalized pain management in cancer patients. Further research focusing on model calibration and rigorous external clinical validation in real healthcare settings is imperative for ensuring its practical and reliable application in clinical practice.
{"title":"Artificial Intelligence and Machine Learning in Cancer Related Pain: A Systematic Review","authors":"Vivian Salama, Brandon Godinich, Yimin Geng, Laia Humbert-Vidan, Laura Maule, Kareem A. Wahid, Mohamed A. Naser, Renjie He, Abdallah S. R. Mohamed, Clifton D. Fuller, Amy C. Moreno","doi":"10.1101/2023.12.06.23299610","DOIUrl":"https://doi.org/10.1101/2023.12.06.23299610","url":null,"abstract":"Background/objective: Pain is a challenging multifaceted symptom reported by most cancer patients, resulting in a substantial burden on both patients and healthcare systems. This systematic review aims to explore applications of artificial intelligence/machine learning (AI/ML) in predicting pain-related outcomes and supporting decision-making processes in pain management in cancer. Methods: A comprehensive search of Ovid MEDLINE, EMBASE and Web of Science databases was conducted using terms including Cancer, Pain, Pain Management, Analgesics, Opioids, Artificial Intelligence, Machine Learning, Deep Learning, and Neural Networks, published up to September 7, 2023. The screening process was performed using the Covidence screening tool. Only original studies conducted in human cohorts were included. AI/ML models, their validation and performance and adherence to TRIPOD guidelines were summarized from the final included studies.\u0000Results: This systematic review included 44 studies from 2006-2023. Most studies were prospective and uni-institutional. There was an increase in the trend of AI/ML studies in cancer pain in the last 4 years. Nineteen studies used AI/ML for classifying cancer patients pain development after cancer therapy, with median AUC 0.80 (range 0.76-0.94). Eighteen studies focused on cancer pain research with median AUC 0.86 (range 0.50-0.99), and 7 focused on applying AI/ML for cancer pain management decisions with median AUC 0.71 (range 0.47-0.89). Multiple ML models were investigated with. median AUC across all models in all studies (0.77). Random forest models demonstrated the highest performance (median AUC 0.81), lasso models had the highest median sensitivity (1), while Support Vector Machine had the highest median specificity (0.74). Overall adherence of included studies to TRIPOD guidelines was 70.7%. Lack of external validation (14%) and clinical application (23%) of most included studies was detected. Reporting of model calibration was also missing in the majority of studies (5%).\u0000Conclusion:\u0000Implementation of various novel AI/ML tools promises significant advances in the classification, risk stratification, and management decisions for cancer pain. These advanced tools will integrate big health-related data for personalized pain management in cancer patients. Further research focusing on model calibration and rigorous external clinical validation in real healthcare settings is imperative for ensuring its practical and reliable application in clinical practice.","PeriodicalId":501393,"journal":{"name":"medRxiv - Pain Medicine","volume":"21 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138562573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-30DOI: 10.1101/2023.11.29.23299209
Peter Bech Hansen, Mikkel Bahnsen, Mikkel Sloth Nørgaard, Jette Frost Jepsen, Michael Skovdal Rathleff, Kristian Damgaard Lyng
Background Implementing new knowledge into clinical practice is a challenge, but nonetheless crucial to improve our healthcare system related to the management of musculoskeletal pain. This systematic review aimed to assess the effectiveness of implementation interventions within musculoskeletal healthcare.
{"title":"Effectiveness of Implementation Interventions in Musculoskeletal Healthcare: A Systematic Review","authors":"Peter Bech Hansen, Mikkel Bahnsen, Mikkel Sloth Nørgaard, Jette Frost Jepsen, Michael Skovdal Rathleff, Kristian Damgaard Lyng","doi":"10.1101/2023.11.29.23299209","DOIUrl":"https://doi.org/10.1101/2023.11.29.23299209","url":null,"abstract":"<strong>Background</strong> Implementing new knowledge into clinical practice is a challenge, but nonetheless crucial to improve our healthcare system related to the management of musculoskeletal pain. This systematic review aimed to assess the effectiveness of implementation interventions within musculoskeletal healthcare.","PeriodicalId":501393,"journal":{"name":"medRxiv - Pain Medicine","volume":"68 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138521981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-28DOI: 10.1101/2023.11.27.23299101
Andrea L. Chadwick, Nadra E. Lisha, Micah E. Lubensky, Zubin Dastur, Mitchell R. Lunn, Juno Obedin-Maliver, Annesa Flentje
Sex-related differences (without taking gender into account) in chronic pain have been widely researched over the past few decades in predominantly cisgender (persons whose gender corresponds to their sex assigned at birth) and heterosexual populations. Historically, chronic pain conditions have a higher incidence and prevalence in cisgender women, including but not limited to fibromyalgia, irritable bowel syndrome, and migraine. The goal of the present study was to identify and characterize the presence and characteristics of chronic pain in SM and GM persons using data from The PRIDE Study, which is the first large-scale, long-term national cohort health study of people who identify as lesbian, gay, bisexual, transgender, queer (LGBTQ+), or as another sexual or gender minority person. A total of 6189 adult participants completed The PRIDE Study’s 2022 Annual Questionnaire at the time of data analysis. A total of 2462 (45.6%) participants reported no chronic pain, leaving 2935 (54.6%) participants who reported experiencing chronic pain. The findings from this study highlight that chronic pain is present to a significant degree in sexual and gender minority (SGM) adults who participated in The PRIDE Study with chronic spine pain (cervical, thoracic, and lumbar) being the most common location/region of pain. Notably, more than one-third of non-binary persons, transgender men, and people who selected another gender experienced chronic widespread pain, defined by having 3 or more total regions of chronic pain. The lowest prevalence of chronic widespread pain was among transgender women and cisgender men. When considering sexual orientation, the highest prevalence of widespread pain was in participants who selected another sexual orientation, followed by queer and asexual/demisexual/gray-ace, with the lowest prevalence of chronic widespread pain being in those who identify as straight/heterosexual, bisexual/pansexual, and gay/lesbian. Future studies are planned to elucidate how a variety of biopsychosocial mechanisms may influence chronic pain in SGM persons.
{"title":"Localized and Widespread Chronic Pain in Sexual and Gender Minority People – An Analysis of The PRIDE Study","authors":"Andrea L. Chadwick, Nadra E. Lisha, Micah E. Lubensky, Zubin Dastur, Mitchell R. Lunn, Juno Obedin-Maliver, Annesa Flentje","doi":"10.1101/2023.11.27.23299101","DOIUrl":"https://doi.org/10.1101/2023.11.27.23299101","url":null,"abstract":"Sex-related differences (without taking gender into account) in chronic pain have been widely researched over the past few decades in predominantly cisgender (persons whose gender corresponds to their sex assigned at birth) and heterosexual populations. Historically, chronic pain conditions have a higher incidence and prevalence in cisgender women, including but not limited to fibromyalgia, irritable bowel syndrome, and migraine. The goal of the present study was to identify and characterize the presence and characteristics of chronic pain in SM and GM persons using data from The PRIDE Study, which is the first large-scale, long-term national cohort health study of people who identify as lesbian, gay, bisexual, transgender, queer (LGBTQ+), or as another sexual or gender minority person. A total of 6189 adult participants completed The PRIDE Study’s 2022 Annual Questionnaire at the time of data analysis. A total of 2462 (45.6%) participants reported no chronic pain, leaving 2935 (54.6%) participants who reported experiencing chronic pain. The findings from this study highlight that chronic pain is present to a significant degree in sexual and gender minority (SGM) adults who participated in The PRIDE Study with chronic spine pain (cervical, thoracic, and lumbar) being the most common location/region of pain. Notably, more than one-third of non-binary persons, transgender men, and people who selected another gender experienced chronic widespread pain, defined by having 3 or more total regions of chronic pain. The lowest prevalence of chronic widespread pain was among transgender women and cisgender men. When considering sexual orientation, the highest prevalence of widespread pain was in participants who selected another sexual orientation, followed by queer and asexual/demisexual/gray-ace, with the lowest prevalence of chronic widespread pain being in those who identify as straight/heterosexual, bisexual/pansexual, and gay/lesbian. Future studies are planned to elucidate how a variety of biopsychosocial mechanisms may influence chronic pain in SGM persons.","PeriodicalId":501393,"journal":{"name":"medRxiv - Pain Medicine","volume":"257 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138521983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-22DOI: 10.1101/2023.11.22.23298877
Lieven A. Schenk, Tahmine Fadai, Christian Büchel
While treatment side effects may adversely impact patients, they could also potentially function as indicators for effective treatment. In this study, we investigated whether and how side effects can trigger positive treatment expectations and enhance treatment outcomes.
{"title":"How side effects can improve treatment efficacy: a randomized trial","authors":"Lieven A. Schenk, Tahmine Fadai, Christian Büchel","doi":"10.1101/2023.11.22.23298877","DOIUrl":"https://doi.org/10.1101/2023.11.22.23298877","url":null,"abstract":"While treatment side effects may adversely impact patients, they could also potentially function as indicators for effective treatment. In this study, we investigated whether and how side effects can trigger positive treatment expectations and enhance treatment outcomes.","PeriodicalId":501393,"journal":{"name":"medRxiv - Pain Medicine","volume":"68 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138521982","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-20DOI: 10.1101/2023.11.20.23298752
Flora Bahrami, Agnes Psikuta, René Michel Rossi, Alex Dommann, Thijs Defraeye
Transdermal drug delivery is suitable for low-molecular-weight drugs with specific lipophilicity, like fentanyl, which is widely used for cancer-induced pain management. However, fentanyl’s transdermal therapy displays high intra-individual variability. Factors like skin characteristics at application sites and ambient temperature contribute to this variation. In this study, we developed a physics-based digital twin of the human body to cope with this variability and propose better adapted setups. This twin includes an in-silico skin model for drug penetration, a pharmacokinetic model, and a pharmacodynamic model. Based on the results of our simulations, applying the patch on the flank (side abdominal area) showed a 15.3% higher maximum fentanyl concentration in the plasma than on the chest. Additionally, the time to reach this maximum concentration when delivered through the flank was 19.8 h, which was 10.3 h earlier than via the upper arm. Finally, this variation led to an 18% lower minimum pain intensity for delivery via the flank than the chest. Moreover, the impact of seasonal changes on ambient temperature and skin temperature by considering the activity level was investigated. Based on our result, the fentanyl uptake flux by capillaries increased by up to 11.8% from an inactive state in winter to an active state in summer. We also evaluated the effect of controlling fentanyl delivery by adjusting the temperature of the patch to alleviate the pain to reach a mild pain intensity (rated three on the VAS scale). By implementing this strategy, the average pain intensity decreased by 1.1 points, and the standard deviation for fentanyl concentration in plasma and average pain intensity reduced by 37.5% and 33.3%, respectively. Therefore, our digital twin demonstrated the efficacy of controlled drug release through temperature regulation, ensuring the therapy toward the intended target outcome and reducing therapy out-come variability. This holds promise as a potentially useful tool for physicians.
{"title":"Exploring the thermally-controlled fentanyl transdermal therapy to provide constant drug delivery by physics-based digital twins","authors":"Flora Bahrami, Agnes Psikuta, René Michel Rossi, Alex Dommann, Thijs Defraeye","doi":"10.1101/2023.11.20.23298752","DOIUrl":"https://doi.org/10.1101/2023.11.20.23298752","url":null,"abstract":"Transdermal drug delivery is suitable for low-molecular-weight drugs with specific lipophilicity, like fentanyl, which is widely used for cancer-induced pain management. However, fentanyl’s transdermal therapy displays high intra-individual variability. Factors like skin characteristics at application sites and ambient temperature contribute to this variation. In this study, we developed a physics-based digital twin of the human body to cope with this variability and propose better adapted setups. This twin includes an <em>in-silico</em> skin model for drug penetration, a pharmacokinetic model, and a pharmacodynamic model. Based on the results of our simulations, applying the patch on the flank (side abdominal area) showed a 15.3% higher maximum fentanyl concentration in the plasma than on the chest. Additionally, the time to reach this maximum concentration when delivered through the flank was 19.8 h, which was 10.3 h earlier than via the upper arm. Finally, this variation led to an 18% lower minimum pain intensity for delivery via the flank than the chest. Moreover, the impact of seasonal changes on ambient temperature and skin temperature by considering the activity level was investigated. Based on our result, the fentanyl uptake flux by capillaries increased by up to 11.8% from an inactive state in winter to an active state in summer. We also evaluated the effect of controlling fentanyl delivery by adjusting the temperature of the patch to alleviate the pain to reach a mild pain intensity (rated three on the VAS scale). By implementing this strategy, the average pain intensity decreased by 1.1 points, and the standard deviation for fentanyl concentration in plasma and average pain intensity reduced by 37.5% and 33.3%, respectively. Therefore, our digital twin demonstrated the efficacy of controlled drug release through temperature regulation, ensuring the therapy toward the intended target outcome and reducing therapy out-come variability. This holds promise as a potentially useful tool for physicians.","PeriodicalId":501393,"journal":{"name":"medRxiv - Pain Medicine","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138542449","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-11-22DOI: 10.1101/2022.11.20.22282558
Hsiangkuo Yuan, Aniket Natekar, Jade Park, Clinton Lauritsen, Eugene Viscusi, Michael Marmura
Subanesthetic ketamine infusion has been used for managing refractory headache in inpatient or outpatient infusion settings. Intranasal (IN) ketamine may be an alternative option for outpatient care. We performed a retrospective study at a single tertiary headache center to assess the clinical effectiveness and tolerability of IN ketamine in patients with refractory chronic migraine (rCM). Candidates who received IN ketamine between January 2019 and February 2020 were screened through an electronic medical record query. Manual chart reviews and structured phone interviews were conducted upon obtaining informed consent. Among 242 subjects screened, 169 (age 44.3 ± 13.8; female 79.9%) were interviewed. They reported 25.0 ± 8.7 monthly headache days and tried 6.9 ± 3.1 preventive medications. Overall, they used roughly 7.8 ± 7.0 sprays (ie., 78 mg) per day and 11.6 ± 8.9 days per month. Intranasal ketamine was reported as "very effective" in 49.1% and quality of life (QOL) was considered "much better" in 35.5%. However, 74.0% reported at least one adverse event (AE). In this retrospective study, IN ketamine can serve as an acute treatment for rCM by reducing headache intensity and improving QOL with relatively tolerable AEs. Most patients found IN ketamine effective and continued to use it despite these AEs. The study is limited by its single-center design and selection/recall biases. Well-designed prospective placebo-controlled trials are necessary to demonstrate the efficacy and safety of IN ketamine in patients with migraine.
{"title":"Real-world study of intranasal ketamine for use in patients with refractory chronic migraine","authors":"Hsiangkuo Yuan, Aniket Natekar, Jade Park, Clinton Lauritsen, Eugene Viscusi, Michael Marmura","doi":"10.1101/2022.11.20.22282558","DOIUrl":"https://doi.org/10.1101/2022.11.20.22282558","url":null,"abstract":"Subanesthetic ketamine infusion has been used for managing refractory headache in inpatient or outpatient infusion settings. Intranasal (IN) ketamine may be an alternative option for outpatient care.\u0000We performed a retrospective study at a single tertiary headache center to assess the clinical effectiveness and tolerability of IN ketamine in patients with refractory chronic migraine (rCM). Candidates who received IN ketamine between January 2019 and February 2020 were screened through an electronic medical record query. Manual chart reviews and structured phone interviews were conducted upon obtaining informed consent. Among 242 subjects screened, 169 (age 44.3 ± 13.8; female 79.9%) were interviewed. They reported 25.0 ± 8.7 monthly headache days and tried 6.9 ± 3.1 preventive medications. Overall, they used roughly 7.8 ± 7.0 sprays (ie., 78 mg) per day and 11.6 ± 8.9 days per month. Intranasal ketamine was reported as \"very effective\" in 49.1% and quality of life (QOL) was considered \"much better\" in 35.5%. However, 74.0% reported at least one adverse event (AE). In this retrospective study, IN ketamine can serve as an acute treatment for rCM by reducing headache intensity and improving QOL with relatively tolerable AEs. Most patients found IN ketamine effective and continued to use it despite these AEs. The study is limited by its single-center design and selection/recall biases. Well-designed prospective placebo-controlled trials are necessary to demonstrate the efficacy and safety of IN ketamine in patients with migraine.","PeriodicalId":501393,"journal":{"name":"medRxiv - Pain Medicine","volume":"28 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138523381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-11-18DOI: 10.1101/2022.11.16.22282417
James C. Eisenach, Regina S. Curry, Timothy T Houle
Objective: To investigate the effect of intrathecal oxytocin compared to placebo on pain and hypersensitivity in individuals with chronic neuropathic pain. Study design: Randomized, controlled, double-blind cross-over study Setting: Outpatient clinical research unit. Subjects: Individuals between ages of 18 and 70 years with neuropathic pain caudal to the umbilicus for at least 6 months. Methods: Individuals received two blinded intrathecal injections of either oxytocin or saline, separated by at least 7 days, and ongoing neuropathic pain (VAS: visual analog scale) and areas of hypersensitivity were measured at intervals for 4 hours. The primary outcome was VAS pain, analyzed by linear mixed effects model. Secondary outcomes were verbal pain intensity scores at intervals for 7 days and areas of hypersensitivity and elicited pain for 4 hr after injections. Results: The study was stopped early after completion of 5 of 40 subjects planned due to slow recruitment and funding limitations. Pain intensity prior to injection was 4.75 +/- 0.99 and modeled pain intensity decreased more after oxytocin than placebo to 1.61 +/- 0.87.and 2.49 +/- 0.87, respectively (p=0.003). Daily pain scores were lower in the week following injection of oxytocin than saline (2.53 +/- 0.89 vs 3.66 +/- 0.89; p=0.001). Hypersensitivity differed between oxytocin and placebo by small amounts in opposite directions depending on modality tested. There were no study drug related adverse effects. Discussion: Although limited by the small number of subjects studied, oxytocin reduced pain more than placebo in all subjects. Further study of spinal oxytocin in this population is warranted.
{"title":"Intrathecal oxytocin for neuropathic pain: A randomized, controlled, cross-over trial","authors":"James C. Eisenach, Regina S. Curry, Timothy T Houle","doi":"10.1101/2022.11.16.22282417","DOIUrl":"https://doi.org/10.1101/2022.11.16.22282417","url":null,"abstract":"Objective: To investigate the effect of intrathecal oxytocin compared to placebo on pain and hypersensitivity in individuals with chronic neuropathic pain.\u0000Study design: Randomized, controlled, double-blind cross-over study\u0000Setting: Outpatient clinical research unit.\u0000Subjects: Individuals between ages of 18 and 70 years with neuropathic pain caudal to the umbilicus for at least 6 months.\u0000Methods: Individuals received two blinded intrathecal injections of either oxytocin or saline, separated by at least 7 days, and ongoing neuropathic pain (VAS: visual analog scale) and areas of hypersensitivity were measured at intervals for 4 hours. The primary outcome was VAS pain, analyzed by linear mixed effects model. Secondary outcomes were verbal pain intensity scores at intervals for 7 days and areas of hypersensitivity and elicited pain for 4 hr after injections.\u0000Results: The study was stopped early after completion of 5 of 40 subjects planned due to slow recruitment and funding limitations. Pain intensity prior to injection was 4.75 +/- 0.99 and modeled pain intensity decreased more after oxytocin than placebo to 1.61 +/- 0.87.and 2.49 +/- 0.87, respectively (p=0.003). Daily pain scores were lower in the week following injection of oxytocin than saline (2.53 +/- 0.89 vs 3.66 +/- 0.89; p=0.001). Hypersensitivity differed between oxytocin and placebo by small amounts in opposite directions depending on modality tested. There were no study drug related adverse effects.\u0000Discussion: Although limited by the small number of subjects studied, oxytocin reduced pain more than placebo in all subjects. Further study of spinal oxytocin in this population is warranted.","PeriodicalId":501393,"journal":{"name":"medRxiv - Pain Medicine","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138523380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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