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 "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.
