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

 描述(申请人提供)：骨关节炎(OA)是一种关节退行性疾病，影响2700万美国人，导致慢性疼痛、活动受限和生活质量总体下降。患有骨性关节炎的美国人目前通过改变生活方式(减肥、锻炼等)、物理治疗和药物治疗来减轻疼痛和炎症，从而控制自己的症状。尽管OA影响到所有种族和背景的个人，但少数群体和无法获得高质量医疗保健的个人经历了更多的负面后果和更糟糕的疾病进展，包括剧烈疼痛和工作限制。治疗性超声已显示出作为一种治疗骨性关节炎的非药物治疗的前景，但治疗的可及性、成本和治疗时间的限制阻碍了治疗性超声的普及。研究小组建议开发一种便携式、可穿戴、自我应用的超声波设备，为骨关节炎提供多小时持续声学药物(萨摩亚)。小组的第一阶段提案表明，萨摩亚设备可以设计用于参与者在家中的日常自我治疗，而且萨摩亚大大减少了膝盖骨关节炎相对于安慰剂设备的疼痛。这一第二阶段项目进一步发展了萨摩亚，并逐步实现了无症状性关节炎管理技术的商业化。首先，萨摩亚设备将为改善关节炎社区的人体工学功能而设计，确保所有用户界面元素都得到简化，以满足那些可能降低体力或灵活性的人的需求。其次，该设备将在更大的临床试验中进行评估，提供治疗益处的统计演示 少数群体，这将是监管批准和医学界接受的关键。第三，萨摩亚的设备将在实地进行测试，以对医生如何开处方以及患者如何采用该设备并与其进行交互进行真实世界的评估，从而对该系统进行关键的最终测试。萨摩亚医疗设备的购买成本不到100美元，每月操作成本不到20美元，这使得它可以广泛获得，并且比许多处方药3个月的操作成本更低。在第二阶段成功完成后，萨摩亚技术将有可能被采用为传统的无药替代开放取舍技术。此外，这种设备的易用性和低成本将使少数族裔和服务不足的社区能够获得它，从而缩小美国各地的医疗保健差距。

 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.