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.

项目摘要： 在服务不足的少数族裔和美国退伍军人的疼痛管理中使用麻醉品 在正在进行的绿木危机中发挥了重要作用。根据NIH的说法，退伍军人更容易受到opioid的影响 成瘾，与非退伍军人相比，患有严重的慢性关节疼痛的可能性高40％。在下一个 十年来，少数民族退伍军人的百分比将从23％增加到34％，预计将上升。这种转变 种族和少数民族直接与少数现役士兵的人口统计数据直接相关 弥补了我们国家40％以上的军事力量。联邦政府认为1820万退伍军人和 健康差异的4200万非少数民族美国人将成为“潜在脆弱的患者人群” 特别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，并在服务中发生了更高的19倍事件和流行率 - 残疾退伍军人人口。尽管这种疾病本身似乎在少数群体中似乎不太频繁，但 它的影响和进展更为严重。在关节炎的少数民族中尤其如此 黑人患者和35.5％的西班牙裔患者报告了严重的关节疼痛，而非西班牙裔则只有23.0％ 白人。 OA的退伍军人的经济燃烧估计每年应接近或超过600亿美元 延长预期寿命。关节炎在整个美国也是一个重要的经济和健康伯恩。 到2030年，估计的医疗保健费用将超过3940亿美元。我们的I阶段SBIR NIH/NIMHD治愈 项目旨在彻底改变服务不足的家庭设定中慢性疼痛的治疗。 Zetroz 系统微型超声技术可以将目标的透皮药物递送到组织中2-20 时间可以缓解有效的疼痛。此外，超声药物输送技术已显示出临床 将慢性关节疼痛降低50-70％的潜力。在该项目的第一阶段，我们将首先（1）优化超声波 剂量（频率，强度和治疗算法）用于增加药物的递送，并整合了 技术进入易于应用，易于使用的无线系统，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， 通过在一项为期8周的双盲安慰剂控制临床试验中评估该技术的慢性关节疼痛。这 Heal Initiative响应团队包括Zetroz Systems的生物医学科学家和工程师（全球 可穿戴超声技术的领导者）以及詹姆斯·A·海莉（James A. Haley）的临床研究人员和从业者 佛罗里达州坦帕的退伍军人医院（慢性疼痛管理卓越中心）。在一起，我们会的 开发可用于少数民族和服务不足的创新超声药物输送技术 减少美国医疗保健系统中分布和阿片类药物使用的社区。