Actigraphy Enhanced Clinical Chronic Lower Back Pain Management

摘要 慢性腰痛患者的有效管理需要准确可靠的方法， 测量治疗对疼痛和功能的影响。然而，这给临床医生带来了一个严重的困境， 目前必须完全依赖于回顾性自我报告测量（例如，调查问卷）来捕捉这一点 信息.这些评估通常仅在患者每次返回诊所时完成， 过度依赖患者的记忆，可能会错过症状的关键转折点， 功能轨迹潜在的偏见和不可靠的报告相结合，使这种方法， 评估远不是最佳的。 我们最近完成了NIH I-Corps计划，该计划显示疼痛专家迫切需要 患者功能的客观数据，以指导治疗决策。我们采访的医生表示， 活动水平的定量评估，或活动记录，可以提供一个解决方案，因为它是一个有效的 用于评估疼痛相关残疾/功能和治疗反应的临床研究工具。的障碍 然而，现有的商业和研究设备所面临的问题，阻碍了 由于患者和临床医生的技术负担，装置 充电，蓝牙/Wi-Fi配对，所需的应用程序，同步，分析软件），成本，以及缺乏 设备质量和数据输出标准化。 因此，我们建议将一类新的临床级可穿戴活动监测器商业化，称为 Vera Band，专为整合到医疗保健工作流程中而设计。维拉乐队将提供一个 低调、耐用、超低成本的可穿戴和支持服务， 患者或临床医生，并可以收集准确的日常活动数据。此快速通道申请的第一阶段将 由目标1和目标2组成，各为期一年。我们将首先进行迭代的技术设计， 实验室验证过程，沿着建立所需的技术和监管基础设施， 提供建议的服务（目标1）。然后，我们将评估其可用性和工作流程集成，并验证其 与临床研究中使用的领先FDA批准的体动记录仪的技术等同性（目标2）。通过 根据目标2的结论，我们建议获得FDA 510（k）许可。在第二阶段，我们将进行一个多- 中心临床研究，在四个三级疼痛诊所，为期3年，以确定医生 器械可用性满意度和临床采用可能性（目标3）。

ABSTRACT Effective management of patients with chronic low back pain requires accurate and reliable methods to measure the effects of treatment on both pain and function. Yet this presents a serious dilemma to clinicians, who must currently rely exclusively on retrospective self-report measures (e.g., questionnaires) to capture this information. These assessments are usually only completed each time the patient returns to the clinic, thus placing an over-reliance on patients' memories and potentially missing critical inflection points in symptom or functional trajectories. The combination of potentially biased and unreliable reporting makes this method of assessment far from optimal. We recently completed the NIH I-Corps program that revealed pain specialists are in urgent need of objective data on patient functioning to guide treatment decisions. The physicians we interviewed indicated that quantitative assessment of activity levels, or actigraphy, may provide a solution because it is a validated clinical research tool for assessing pain-related disability/function and response to treatment. The hurdles faced by existing commercial and research devices, however, have prevented the implementation of actigraphy for routine clinical care due to the technological burden for patients and clinicians (e.g., device charging, Bluetooth/Wi-Fi pairing, required apps, syncing, analysis software), cost, and the lack of standardization in device quality and data output. Therefore, we propose to commercialize a new class of clinical-grade wearable activity monitor, called the Vera Band, designed specially to be integrated into healthcare workflows. The Vera Band will provide a low-profile, durable, ultra-low-cost wearable and supporting service that presents no technical burden to patients or clinicians and can collect accurate daily activity data. Phase I of this Fast-Track application will consist of both Aims 1 and 2, each 1-year in duration. We will first conduct an iterative technical design and laboratory verification process, along with establishing the required technical and regulatory infrastructure to provide the proposed service (Aim 1). We will then assess its usability and workflow integration and verify its technical equivalence against a leading FDA-approved actigraphy monitor used in clinical research (Aim 2). By the conclusion of Aim 2, we propose to obtain FDA 510(k) clearance. During Phase II, we will conduct a multi- center clinical study, across four tertiary pain clinics, over a period of 3-years to determine physician satisfaction with device usability, and likelihood of clinical adoption (Aim 3).