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，持续性疼痛是患者进入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、焦虑和睡眠障碍等继发性疾病有关。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，很少有非药物治疗制度存在，以帮助管理疼痛。多年来，超声波已安全有效地用于缓解疼痛。此外，超声波中的机械和热作用机制已被证明有助于伤口和骨折愈合，促进局部软膏渗透到皮肤中，并发现可增强各种医疗保健应用。尽管超声治疗的潜力，大小，价格和交付模式已禁止其广泛的翻译。我们开发了一种新的超声设备，为不同的社会经济弱势社区的一线医学超声提供了独特的平台解决方案。该系统依赖于积极的微型化和集成的超声换能器，电子器件和电源，以产生一个iPod大小的低强度超声系统，可以提供便携式，方便，有效的治疗长时间。对于本项目，将对iPod大小的超声器械进行改进，并对膝关节骨关节炎受试者进行临床评价。要求受试者在研究期间每天佩戴该装置6小时，并监测疼痛减轻、活动性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对OA引起的肌肉骨骼疼痛和活动性的有效性的科学理解，并为疼痛控制提供第一个非侵入性、便携式、变革性的解决方案。

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.