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

自行佩戴式超声治疗在农村地区治疗骨关节炎

• 批准号: 8471562
• 负责人: George Kenneth Lewis
• 金额: $ 19.66万
• 依托单位: ZETROZ, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-24 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8471562
• 关键词: Acoustics; Adherence; Adverse effects; Affect; Age-Years; American; Analgesics; Animals; Anxiety; Area; Bandage; Cartilage; Charge; Clinic; Clinical Research; Communities; Coupling; Data; Data Analyses; Degenerative polyarthritis; Development; Devices; Disadvantaged; Doctor of Philosophy; Double-Blind Method; Effectiveness; Electronics; Engineering; Enrollment; Evaluation; Fracture; Fracture Healing; Frequencies; Funding; Gel; Goals; Healthcare; Healthcare Systems; Hip region structure; Home environment; Hour; Human; Human body; Individual; Inflammation; Insurance Coverage; Joints; Knee; Knee Osteoarthritis; Mechanics; Mediating; Medicine; Mental Depression; Miniaturization; Monitor; Morbidity - disease rate; Musculoskeletal Pain; Ointments; Opioid; Outcome Study; Outpatients; Pain; Pain management; Patients; Penetration; Persistent pain; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Physiology; Placebos; Population; Power Sources; Price; Public Health; Quality of life; Radiology Specialty; Randomized; Recording of previous events; Reporting; Research; Rural; Rural Population; Secure; Skin; Sleep disturbances; Solutions; Sports; System; Target Populations; Technology; Testing; Therapeutic; Training; Transducers; Translational Research; Translations; Treatment Effectiveness; Ultrasonic Therapy; Ultrasonic Transducer; Ultrasonography; United States; United States National Institutes of Health; Visual; Work; addiction; analog; arthritis therapy; chronic pain; commercialization; cost; design; dosimetry; effective therapy; engineering design; ergonomics; experience; improved; improved mobility; innovation; placebo controlled study; primary outcome; public health relevance; research clinical testing; socioeconomics; usability; user-friendly; wound

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.

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来说，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，超声波的机械和热作用机制已被证明可以促进伤口和骨折愈合，促进局部药膏渗透到皮肤中，并发现可以增强各种医疗保健应用。尽管超声治疗具有潜力，但其尺寸、价格和治疗方式阻碍了其广泛推广。我们开发了一种新型超声设备，为不同的社会经济弱势社区的前线医学超声提供独特的平台解决方案。该系统依靠超声换能器、电子器件和电源的积极小型化和集成来生产 iPod 大小的低强度超声系统，可以提供便携式、方便且有效的长期治疗。在这个项目中，iPod 大小的超声设备将得到改进，并针对患有膝骨关节炎的受试者进行临床评估。在研究期间，受试者将被要求每天佩戴该设备 6 小时，并将监测其疼痛减轻情况、活动能力增加情况以及控制疼痛药物的使用情况。该研究的成功完成将增进对低强度连续超声治疗对骨关节炎肌肉骨骼疼痛和活动能力功效的科学认识，并为疼痛控制提供第一个非侵入性、便携式、革命性的解决方案。