Clinical Optimization of Ultrasonic Drug Delivery Technologies for Underserved Minority US Veterans in Chronic Pain

针对服务不足的美国少数族裔退伍军人慢性疼痛的超声药物输送技术的临床优化

• 批准号: 10263383
• 负责人: George Kenneth Lewis
• 金额: $ 23.36万
• 依托单位: ZETROZ SYSTEMS, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-14 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10263383
• 关键词: Adverse effects; Affect; Age-Years; Algorithms; American; Americas; Arthralgia; Arthritis; Biomedical Engineering; Cadaver; Cardiovascular system; Caring; Chronic; Client satisfaction; Clinical; Clinical Research; Clinical Trials; Controlled Clinical Trials; Coupled; Coupling; Data; Degenerative polyarthritis; Devices; Diclofenac; Disabled Persons; Disease; Dose; Double-Blind Method; Drug Delivery Systems; Drug Utilization; Economic Burden; Economics; Effectiveness; Exercise; Family suidae; Federal Government; Florida; Foundations; Frequencies; Gel; Health; Health Care Costs; Healthcare Systems; Helping to End Addiction Long-term; Hispanics; Home; Hour; Human; Incidence; Joints; Kidney; Knee Osteoarthritis; Legal patent; Life Expectancy; Measures; Medical; Medical Device; Military Personnel; Minority; Minority Groups; Multi-Institutional Clinical Trial; Narcotics; Non-Steroidal Anti-Inflammatory Agents; Not Hispanic or Latino; Opiate Addiction; Oral; Outcome Measure; Outcome Study; Output; Pain; Pain management; Participant; Patients; Penetration; Pharmacologic Substance; Phase; Pilot Projects; Placebos; Play; Polypropylenes; Population; Prevalence; Process; Quality of life; Randomized; Regulation; Reporting; Research Personnel; Role; Services; Small Business Innovation Research Grant; Soldier; System; Technology; Temperature; Testing; Time; Tissue Model; Tissues; Transdermal substance administration; Ultrasonics; Ultrasonography; United States; United States National Institutes of Health; Veterans; Veterans Hospitals; Walking; Water; Western Ontario and McMaster Universities Arthritis Index; Wireless Technology; active duty; active method; arm; arthropathies; biomedical scientist; black patient; celecoxib; chronic pain; chronic pain management; clinical efficacy; commercialization; demographics; design; disability; disparity reduction; dosimetry; drug development; efficacy study; ethnic minority population; experience; gastrointestinal; healing; health disparity; improved; indexing; innovation; military veteran; miniaturize; minority communities; novel; opioid epidemic; opioid use; osteoarthritis pain; pain reduction; pain relief; pain scale; pain score; patient population; placebo group; primary outcome; racial minority; research clinical testing; response; side effect; tissue phantom; treatment group; underserved community; underserved minority; usability

Project Summary: Narcotic use in pain management of underserved minority populations and minority United States veterans has played a major role in the ongoing opioid crisis. According to the NIH, veterans are more susceptible to opioid addiction and are 40% more likely to suffer from severe chronic joint pain then non-veterans. Over the next decade, the percentage of minority veterans will increase from 23% to 34% and is expected to rise. This shift of racial and ethnic minorities directly correlates to the growing demographics of minority active duty soldiers that make up over 40% of our nation’s military forces. The federal government considers the 18.2 million veteran and 42 million non-veteran minority Americans to be "potentially vulnerable patient populations” with health disparities particularly related to joint diseases care. Osteoarthritis (OA) is one of the most common of these joint diseases affecting the entire US population, and of considerably higher 19-fold incidence and prevalence in the service- disabled veteran population. Although the disease itself does not appear to occur more frequently in minorities, its effects and progression are more severe. This is especially true among minorities with arthritis, 36.7% of Black patients and 35.5% of Hispanic patients reported severe joint pain compared to only 23.0% of non-Hispanic Whites. The economic burden of veterans with OA is estimated to approach or exceed $60 billion annually due to longer life expectancies. Arthritis is also a significant economic and health burden in the United States at large which is estimated to exceed $394 billion in healthcare costs by 2030. Our Phase I SBIR NIH/NIMHD HEAL project is aimed at revolutionizing the treatment of chronic pain in the home-setting for the underserved. ZetrOZ Systems miniature ultrasound technology can increase targeted transdermal drug delivery into tissue by 2-20 times providing effective pain relief. Additionally, the ultrasonic drug delivery technology has shown clinical potential in reducing chronic joint pain by 50-70%. In Phase I of this project we will first (1) optimize ultrasonic dosimetry (frequency, intensity, and treatment algorithm) for increased drug delivery, and integrate the technologies into easy-to-apply and easy-to-use wireless systems for clinical evaluation. Secondly (2), we will determine the clinical potential of the innovative drug delivery systems in treating minority veteran chronic pain, by evaluating the technology in an 8-week double blind placebo controlled clinical trial on chronic joint pain. The HEAL INITIATIVE response team includes biomedical scientists and engineers from ZetrOZ Systems (global leader in wearable ultrasound technologies), and clinician researchers and practitioners from the James A. Haley Veterans' Hospital Tampa, Florida (a center of excellence for chronic pain management). Together, we will develop an innovative ultrasonic drug delivery technology accessible for minorities and underserved communities to reduce disparities and opioid use in the healthcare system of America.

项目概要： 在服务不足的少数群体和少数美国退伍军人的疼痛管理中使用麻醉剂已 在当前的阿片类药物危机中发挥了重要作用。据美国国立卫生研究院称，退伍军人更容易受到阿片类药物的影响 与非退伍军人相比，他们患有严重慢性关节疼痛的可能性高出 40%。在接下来的 十年内，少数族裔退伍军人的比例将从23%增加到34%，并且预计还会上升。这种转变 种族和族裔少数群体与少数族裔现役士兵人口统计数据的不断增长直接相关， 占我国军事力量的40%以上。联邦政府认为 1820 万退伍军人和 4200万非退伍军人少数族裔美国人将成为“潜在的弱势患者群体”，健康状况存在差异 特别是与关节疾病护理有关。骨关节炎（OA）是这些关节疾病中最常见的一种 影响整个美国人口，并且服务中的发病率和流行率高出 19 倍 残疾退伍军人人口。尽管这种疾病本身在少数族裔中的发生率似乎并不高， 其影响和进展更为严重。对于少数患有关节炎的人来说尤其如此，36.7% 黑人患者和 35.5% 的西班牙裔患者报告严重关节疼痛，而非西班牙裔患者只有 23.0% 报告严重关节疼痛 白人。据估计，患有 OA 的退伍军人每年的经济负担接近或超过 600 亿美元 延长预期寿命。关节炎对整个美国来说也是一个重大的经济和健康负担 预计到 2030 年，医疗保健费用将超过 3940 亿美元。我们的第一阶段 SBIR NIH/NIMHD HEAL 该项目旨在彻底改变服务不足的家庭中慢性疼痛的治疗方法。泽特奥兹 系统微型超声技术可将靶向透皮药物输送到组织中的速度提高 2-20 次提供有效的疼痛缓解。此外，超声给药技术已在临床上显示出 可以减少 50-70% 的慢性关节疼痛。在该项目的第一阶段，我们将首先 (1) 优化超声波 剂量测定（频率、强度和治疗算法）以增加药物输送，并整合 将技术融入易于应用和易于使用的无线系统中以进行临床评估。其次（2），我们将 确定创新药物输送系统在治疗少数退伍军人慢性疼痛方面的临床潜力， 通过在为期 8 周的针对慢性关节疼痛的双盲安慰剂对照临床试验中评估该技术。这 HEAL INITIATIVE 响应团队包括来自 ZetrOZ Systems（全球 可穿戴超声技术的领导者）以及来自 James A. Haley 的临床研究人员和从业者 佛罗里达州坦帕退伍军人医院（慢性疼痛管理卓越中心）。我们将一起 开发一种可供少数族裔和服务不足的群体使用的创新超声波药物输送技术 社区减少美国医疗保健系统中的差异和阿片类药物的使用。