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

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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.