Self-Applied Wearable Ultrasound Therapy for Osteoarthritis Management in Rural C

描述（由申请人提供）：根据美国国立卫生研究院的数据，持续疼痛是患者访问医疗保健系统的首要原因。疼痛严重影响患者的生活质量，并与抑郁、焦虑、睡眠障碍等继发性并发症相关。药物通常是缓解疼痛的一线治疗方法，但它们并非没有严重的副作用。特别是对于农村居民和社会经济弱势群体，很少有非药物治疗方案可以帮助控制疼痛。多年来，超声波一直被安全有效地用于缓解疼痛。此外，超声作用的机械和热机制已被证明可以促进伤口和骨折愈合，促进局部软膏渗透到皮肤中，并被发现可以增强各种医疗保健应用。尽管超声治疗的潜力，大小，价格和交付方式限制了其广泛的翻译。我们开发了一种新的超声设备，为不同和社会经济弱势社区的一线医学提供了独特的超声平台解决方案。该系统依靠积极的小型化和集成超声换能器、电子设备和电源来生产一个iPod大小的低强度超声系统，可以提供便携式、方便和有效的长时间治疗。本项目将对ipod大小的超声设备进行改进，并对膝关节骨关节炎患者进行临床评估。在研究期间，受试者将被要求每天佩戴该设备6小时，并将监测疼痛的减轻、活动能力的增加以及疼痛控制药物的使用情况。该研究的成功完成将增加对低强度连续超声治疗骨骼肌疼痛和骨性关节炎的有效性的科学理解，并提供第一个非侵入性、便携式、变革性的疼痛控制解决方案。

DESCRIPTION (provided by applicant): Persistent pain is the number one reason that patients access the healthcare system according to the National institutes of Health. Pain seriously affects patients' quality of life and is associated with secondary morbidities such as depression, anxiety, and sleep disturbance. Medications are often the first-line treatment for pain relief, but they are not without serious side effects. Particularly for rural citizens and socioeconomic disadvantaged individuals very few non-pharmacotherapy regimes exist to help manage pain. Ultrasound has been used safely and effectively for years to provide pain relief. Additionally, the mechanical and thermal mechanisms of action in ultrasound have been shown to facilitate wound and bone fracture healing, to promote the penetration of topical ointments into the skin and found to enhance a variety healthcare applications. Despite the potential of ultrasound therapy, the size, price, and mode of delivery has prohibited its broad translation. We have developed a new ultrasound device that provides a unique platform solution for ultrasound in frontline medicine in disparate and socioeconomic disadvantaged communities. The system relies on aggressive miniaturization and integration of the ultrasound transducer, electronics, and power supply to produce an iPod- sized low-intensity ultrasound system that can deliver portable, convenient, and effective therapy for long durations. For this project, the iPod-sized ultrasound devices will be refined and clinically evaluated on subjects with osteoarthritis of the knee. Subjects will be asked to wear the device for 6 hours a day over the duration of the study, and will be monitored for reductions in pain, increased mobility and their use of pharmaceuticals for pain control. Successful completion of the study will increase scientific understanding of the efficacy of low- intensity continuous ultrasound treatment on musculoskeletal pain and mobility from OA, and provide the first non-invasive, portable, transformative solution to pain control.