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

基本信息

批准号：
9150669
负责人：
George Kenneth Lewis
金额：
$ 40万
依托单位：
ZETROZ SYSTEMS, LLC
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-24 至 2018-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9150669
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 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 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 Underserved Population United States Universities Work arthropathies chronic pain commercialization cost cost effective cytokine design dexterity disparity reduction ergonomics experience follow-up functional improvement health care availability health care disparity health care quality improved innovation insight joint function joint stiffness minority health novel patient population prevent public health relevance socioeconomic disadvantage symptom management symptom treatment treatment duration underserved minority wearable technology

项目摘要

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（由适用提供）：骨关节炎（OA）是影响2700万美国人的关节的退化性疾病，导致慢性疼痛，流动性有限和生活质量的总体降低。目前，有OA的美国人通过改变生活方式（减肥，运动等），物理疗法以及减轻疼痛和炎症的药物来管理症状。尽管OA会影响各种种族和背景的个人，但缺乏获得优质医疗保健的少数民族和个人会经历更多的负面结果和较差的疾病进展，包括严重的疼痛和工作局限性。治疗性超声已经显示出有望作为OA的非药物治疗，但是对治疗的可及性，成本和治疗时间的局限性使治疗性超声无法广泛。调查团队的建议是开发一种便携式，可穿戴，自我应用的超声设备，以提供多小时的骨关节炎（SAMOA）持续声学医学。团队第一阶段提出，萨摩亚设备可以由参与者在家中进行每日治疗自我应用，并且萨摩亚大大减轻了安慰剂设备上膝盖OA的疼痛。该第二阶段项目进一步开发了SAMOA，并朝着该技术的商业化迈向OA的症状管理。首先，将设计SAMOA设备，以改善关节炎社区的人体工程学功能，以确保为那些可能降低手动强度或灵巧性的人精简所有用户界面元素。其次，将在更大的临床试验中评估该设备，从而提供有关治疗益处的统计证明少数群体对于医学界的监管批准和接受至关重要。第三，将在现场测试SAMOA设备，以评估医生的开处方，并与该设备采用和互动，从而对系统进行关键的最终测试。 Samoa医疗设备的购买费用低于100美元，并且每月可运营20美元以下，这使得它可以广泛访问，并且与许多处方药的3个月相比，运营1年的成本较低。成功完成II期后，SAMOA技术有可能被用作传统OA护理的无药替代品。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都可以使用，从而减少了整个美国医疗保健的分布。