Development of Innovative Medical Device Technology for Quantifying Forces during Soft Tissue Manipulation Assessment and Intervention

项目总结 临床上缺乏量化软组织手法(STM)运动和剂量的方法是一种 这种非侵入性和非药理学的重复性和治疗潜力中的关键问题 情态。STM是一种手动疗法，用于评估和治疗肌肉骨骼疼痛、炎症和 功能障碍。不同的软组织力量具有不同的生物效应和结果。有证据表明STM 可以作为锻炼的替代品或补充，这对康复有重要的意义。像锻炼一样， STM的最佳剂量需要客观参数。然而，初步研究表明，高水平的 STM强制应用的不一致性，无论是在治疗师内部还是在治疗师之间，而定量反馈显著 提高了它的准确性和一致性。不幸的是，目前的STM实践主要依赖于主观治疗 软组织质量和疼痛的变量和模糊描述。在评估和治疗方面的不正当更改 可能会损害结果，并降低实践的价值。迫切需要一种能够 生成STM指标以通过提供公共语言来优化STM检查并改进实践 干预，使剂量处方，促进培训，研究其效果，并评估结果。 我们的团队开发了一种新的医疗器械系统--可量化软组织操纵(QSTM™) 作为一种解决手动治疗中这一空白的解决方案。QSTM™包括用于该应用的设备(Q1)和 感应较小区域的局部力(例如手指或肘部)和另一种用于分散力的设备(Q2) 在较大区域(例如背部或大腿)，连同用于记录和分析治疗数据的定制软件， 包括STM力的大小、角度、速率和方向。这项建议的主要目的是 论证了QSTM™临床应用的可行性。中心假设是QSTM™将改善 STM检测和干预的重复性。项目目标旨在优化设备的设计 系统；定量表征基本STM行程运动模式；测试STM施力的可靠性 使用QSTM™数据输出；并确定其在疼痛评估中的可用性。有很大的市场可供使用 QSTM™在多个健康学科、体育、教育、研究和兽医领域。人和付款人 寻求精确的、以患者为中心的护理最终将推动市场。QSTM™代表着一项重大改进 对传统手工方法的竞争，无论有没有硬性仪器或模拟装置。QSTM™ 提供了对其他方法的替代或补充。我们已经就我们的商业模式咨询了专家 以及营销和销售战略。该项目与国家互补和综合中心保持一致 健康优先事项。NIH的支持将加快商业化进程。QSTM™对于手动治疗的意义就像Fitbit对于手工治疗的意义一样 锻炼身体。QSTM™通过客观措施和目标设定，更好地实现个性化康复， 记录、监控和重现性。这项进步的技术将把患者反馈和临床医生整合在一起 与量化指标的感知，创造了一个积极的转变到数字时代的软组织手动治疗实践。

PROJECT SUMMARY The lack of a means to quantify soft tissue manipulation (STM) motion and dose as delivered in the clinic is a critical problem in the reproducibility and therapeutic potential of this non-invasive and non-pharmacological modality. STM is a form of manual therapy used to evaluate and treat musculoskeletal pain, inflammation, and dysfunction. Different soft tissue forces have differing biological effects and outcomes. Evidence suggests STM may serve as a surrogate or augment to exercise, which has important implications in rehabilitation. Like exercise, objective parameters are needed for optimal STM dosing. However, initial research indicates a high level of inconsistency in STM force application, both within and between therapists, while quantitative feedback significantly improves its accuracy and consistency. Unfortunately, current STM practice relies mostly on subjective treatment variables and vague descriptors of soft tissue quality and pain. Unwarranted variation in assessment and treatment can compromise outcomes and diminish the value of the practice. There is a strong need for technology that can generate STM metrics to improve practice by providing a common language to optimize STM examination and intervention, enable dose prescriptions, facilitate training, study its effects, and evaluate outcomes. Our team has developed a novel medical device system, Quantifiable Soft Tissue Manipulation (QSTM™) as a solution to address this void in manual therapy. QSTM™ includes a device (Q1) for the application and sensing of localized forces in smaller regions (e.g., finger or elbow) and another device (Q2) for dispersive forces in larger regions (e.g., back or thigh), along with custom software for recording and analysis of treatment data, including STM force magnitude, angle, rate, and direction. The primary purpose of this proposal is to demonstrate the feasibility of QSTM™ for clinical use. The central hypothesis is that QSTM™ will improve the reproducibility of STM examination and intervention. Project objectives aim to optimize the design of the device system; quantitatively characterize basic STM stroke motion patterns; test the reliability of STM force application using QSTM™ data output; and determine its usability for pain assessment. A large market exists for use of QSTM™ in multiple health disciplines, sports, education, research, and veterinary medicine. People and payers seeking precise, patient-centric care will eventually drive the market. QSTM™ represents a significant improvement over its competition of traditional manual methods, with or without rigid instruments, or mimetic devices. QSTM™ offers an alternative or complement to other approaches. We have consulted with experts on our business model and marketing and sales strategies. This project aligns with the National Center of Complementary and Integrative Health priorities. NIH support will accelerate commercialization. QSTM™ is to manual therapy what the Fitbit is to exercise. QSTM™ better enables individualized rehabilitation through objective measures and goal setting, recording, monitoring, and reproducibility. This progressive technology will integrate patient feedback and clinician perception with quantitative metrics, creating a positive shift to the digital era of soft tissue manual therapy practice.