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

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 andquot;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 Veteransandapos; 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.Project Narrative: This project proposes to clinically optimize localized ultrasonic drug delivery technologies for underserved minority United States Veterans in chronic pain. Wireless ultrasonic patches to enhance the transfer and effectiveness of topical diclofenac pain relief gel will be evaluated in the home-setting by minority veterans for clinical efficacy.