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

自我应用可穿戴超声治疗治疗服务不足人群的骨关节炎

• 批准号: 9000065
• 负责人: George Kenneth Lewis
• 金额: $ 13.1万
• 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 2016-01-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9000065
• 关键词: Acoustics; Adopted; Adoption; Adrenal Cortex Hormones; Affect; American; Americas; Analgesics; Arthritis; Articular Range of Motion; Bandage; Behavior Therapy; Beryllium; Biological; Biomedical Engineering; Body Weight decreased; Cardiovascular system; Caring; Chronic; Clinic Visits; Clinical; Clinical Research; Clinical Trials; Communities; Community Health; Comorbidity; Connecticut; Couples; Coupling; Degenerative polyarthritis; Device Designs; Devices; Disadvantaged; Disease; Disease Progression; Double-Blind Method; Down-Regulation; Engineering; Enrollment; Ensure; Evaluation; Exercise; Extracellular Matrix; Feedback; Financial compensation; Frequencies; General Population; Goals; Health; Health Benefit; Healthcare; Home environment; Hospitals; Hour; Human; Individual; Inflammation; Inflammatory; Injection of therapeutic agent; Inpatients; Insurance; Insurance Coverage; Intervention; Intestines; Joints; Kinetics; Knee; Knee Osteoarthritis; Length; Life Style; Manuals; Medical; Medical Device; Medicare; Medicine; Minority; Minority Groups; Musculoskeletal; Non-Steroidal Anti-Inflammatory Agents; Ohio; Operative Surgical Procedures; Opioid; Outcome; Outcome Measure; Pain; Pain management; Participant; Patient Monitoring; Patients; Pattern; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Physical Function; Physical therapy; Physicians; Placebos; Population; Protein Biosynthesis; Quality of life; Race; Reporting; Research; Risk; Rural Community; Site; Small Business Innovation Research Grant; Symptoms; System; Technology; Testing; Therapeutic; Tissues; Ultrasonic Therapy; Ultrasonics; Ultrasonography; Underrepresented Minority; Underserved Population; United States; Universities; Work; arthropathies; chronic pain; commercialization; cost; cost effective; cytokine; design; dexterity; ergonomics; experience; follow-up; functional improvement; health care quality; improved; innovation; insight; joint function; joint stiffness; minority health; novel; patient population; prevent; public health relevance; socioeconomics; symptom management; treatment duration

 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.

 描述（由申请人提供）：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OA的美国人目前通过改变生活方式（减肥、锻炼等）来控制他们的症状，物理治疗和药物来减轻疼痛和炎症。虽然OA影响来自所有种族和背景的个人，但少数群体和缺乏优质医疗保健的个人会经历更多的负面结果和更严重的疾病进展，包括严重的疼痛和工作限制。治疗性超声作为OA的非药物治疗已显示出前景，但可及性、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，自我应用的超声设备，以提供多小时的骨关节炎持续声学医学（SAMOA）。该团队的第一阶段提案表明，SAMOA设备可以设计用于参与者在家中的日常治疗自我应用，并且SAMOA与安慰剂设备相比显着减少了膝关节OA的疼痛。该第二阶段项目进一步开发了SAMOA，并朝着OA症状管理技术的商业化迈进。首先，SAMOA设备将被设计为改善关节炎社区的人体工程学功能，确保所有用户界面元素为那些可能减少手动力量或灵活性的人而简化。其次，该设备将在一个更大的临床试验中进行评估，提供治疗益处的统计证明。 少数群体，这将是至关重要的监管批准和接受在医学界。第三，SAMOA设备将在现场进行测试，以真实评估医生如何开处方，患者如何采用设备并与设备互动，为系统提供关键的最终测试。SAMOA医疗设备的购买成本将低于100美元，每月运营成本低于20美元，使其广泛普及，并且运营1年的成本低于许多处方药的3个月。在第二阶段成功完成后，SAMOA技术将有可能被采用作为传统OA护理的无药物替代方案。此外，该设备的易用性和低成本将使少数民族和服务不足的社区能够使用它，减少美国各地医疗保健的差异。