Self-Applied Wearable Ultrasound Therapy for Osteoarthritis Management in Underserved Populations



 DESCRIPTION (provided by applicant): Osteoarthritis (OA) is a degenerative disease of the joints which affects 27 million Americans, causing chronic pain, limited mobility and overall reduction in the quality of life. Americans with OA currently manage their symptoms through lifestyle changes (weight loss, exercise, etc.), physiotherapy, and medications to reduce pain and inflammation. Although OA affects individuals from all races and backgrounds, minorities and individuals lacking access to quality healthcare experience more negative outcomes and worse disease progressions, including severe pain and working limitations. Therapeutic ultrasound has shown promise as a non-pharmaceutical treatment for OA, but limitations on the accessibility, cost and length of treatment have prevented therapeutic ultrasound from becoming widespread. The investigative team proposes to develop a portable, wearable, self-applied ultrasound device to deliver multi-hour Sustained Acoustic Medicine for OsteoArthritis (SAMOA). The teams Phase I proposal demonstrated that the SAMOA device could be engineered for daily therapeutic self-application by the participants at home, and that SAMOA significantly reduced the pain of knee OA over the placebo device. This Phase II project further develops SAMOA and moves towards commercialization of the technology for the symptomatic management of OA. First, the SAMOA device will be engineered for improved ergonomic function in the arthritic community, ensuring that all user-interface elements are streamlined for those who may have reduced manual strength or dexterity. Second, the device will be evaluated in a larger clinical trial, providing a statistical demonstration of the treatment's benefit across minority groups which will be essential for regulatory approval and acceptance in the medical community. Third, the SAMOA device will be tested in the field for a real-world evaluation of how physicians prescribe, and patients adopt and interact with the device, providing a critical final test of the system. The SAMOA medical device will have a cost under $100 to purchase and under $20 per month to operate, making it broadly accessible and less costly to operate for 1 year than 3 months of many prescription medications. After the successful completion of Phase II, SAMOA technology will have the potential to be adopted as a pharmaceutical-free alternative to traditional OA care. Furthermore, the ease of use and low cost of this device will make it accessible to minorities and underserved communities, reducing disparities in healthcare across America.