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： 麻醉品在服务不足的少数民族人口和少数民族美国退伍军人的疼痛管理中的使用， 在持续的阿片类药物危机中发挥了重要作用。根据NIH的数据，退伍军人更容易受到阿片类药物的影响。 成瘾和40%更有可能遭受严重的慢性关节疼痛，然后非退伍军人。在未来 十年来，少数族裔退伍军人的比例将从23%增加到34%，预计还会上升。这种转变 种族和少数民族直接关系到少数民族现役士兵的人口增长， 占我国军队的40%以上联邦政府认为这位1820万退伍军人和 4200万非退伍军人少数族裔美国人将成为健康差异的“潜在脆弱患者群体” 特别是与关节疾病护理相关的。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，并且在服务中的发病率和患病率高出19倍- 残疾退伍军人虽然这种疾病本身似乎在少数民族中并不常见， 其影响和进展更为严重。这在患有关节炎的少数民族中尤其如此，36.7%的 黑人患者和35.5%的西班牙裔患者报告严重关节疼痛，而非西班牙裔患者仅为23.0%。 白人据估计，患有OA的退伍军人的经济负担每年接近或超过600亿美元， 到更长的预期寿命关节炎也是一个重大的经济和健康负担，在美国的大部分 预计到2030年，医疗费用将超过3940亿美元。我们的第一阶段SBIR NIH/NIMHD HEAL 该项目的目的是彻底改变对得不到充分服务的人的家庭慢性疼痛的治疗。ZetrOZ 系统的微型超声技术可以将靶向经皮药物输送到组织中增加2-20 时间提供有效的疼痛缓解。此外，超声给药技术已显示出临床应用前景。 减少慢性关节疼痛50- 70%的潜力。在本项目的第一阶段，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 技术转化为易于应用和易于使用的无线系统进行临床评估。（2）我们将 确定创新药物递送系统在治疗少数退伍军人慢性疼痛中的临床潜力， 通过在为期8周的双盲安慰剂对照慢性关节疼痛临床试验中评估该技术。的 HEAL INITIATIVE响应团队包括来自ZetrOZ Systems（全球）的生物医学科学家和工程师 可穿戴超声技术的领导者），以及来自James A. Haley 退伍军人医院坦帕，佛罗里达（慢性疼痛管理卓越中心）。我们将共同 开发创新的超声波药物输送技术，使少数民族和服务不足的人能够使用 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。