Actigraphy Enhanced Clinical Chronic Lower Back Pain Management

体动记录仪增强临床慢性腰痛管理

• 批准号: 10211966
• 负责人: Grant H Kruger
• 金额: $ 99.71万
• 依托单位: ARBOR MEDICAL INNOVATIONS, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10211966
• 关键词: Absenteeism; Accelerometer; Address; Adopted; Adoption; Adult; Agreement; Algorithmic Analysis; Area; Back; Bluetooth; California; Charge; Chronic low back pain; Clinic; Clinical; Clinical Research; Computer software; Consensus; Current Procedural Terminology Codes; Data; Data Analyses; Decision Making; Development; Devices; Ensure; Exhibits; FDA approved; Focus Groups; Future; Generations; Healthcare; Individual; Infrastructure; Innovation Corps; Intervention; Interview; Kansas; Laboratories; Lead; Low Back Pain; Measures; Medical; Medical center; Memory; Methods; Michigan; Monitor; Multi-site clinical study; Notification; Output; Pain; Pain Clinics; Pain management; Patient Monitoring; Patient Self-Report; Patients; Phase; Physical Function; Physical activity; Physicians; Process; Production; Provider; Publishing; Quality of life; Questionnaires; Recovery; Regulation; Reporting; Research; Sampling; Self-Examination; Services; Specialist; Standardization; Symptoms; System; Technology; Time; Treatment Cost; United States National Institutes of Health; Universities; Validation; Work; actigraphy; chronic pain; chronic painful condition; clinical care; clinical decision support; clinical decision-making; clinical practice; clinical research site; cost; daily functioning; design; disability; experience; functional disability; innovation; pain patient; post-market; prevent; programs; prototype; recruit; response; satisfaction; success; tool; treatment effect; treatment response; usability; wireless fidelity; Absenteeism; Accelerometer; Address; Adopted; Adoption; Adult; Agreement; Algorithmic Analysis; Area; Back; Bluetooth; California; Charge; Chronic low back pain; Clinic; Clinical; Clinical Research; Computer software; Consensus; Current Procedural Terminology Codes; Data; Data Analyses; Decision Making; Development; Devices; Ensure; Exhibits; FDA approved; Focus Groups; Future; Generations; Healthcare; Individual; Infrastructure; Innovation Corps; Intervention; Interview; Kansas; Laboratories; Lead; Low Back Pain; Measures; Medical; Medical center; Memory; Methods; Michigan; Monitor; Multi-site clinical study; Notification; Output; Pain; Pain Clinics; Pain management; Patient Monitoring; Patient Self-Report; Patients; Phase; Physical Function; Physical activity; Physicians; Process; Production; Provider; Publishing; Quality of life; Questionnaires; Recovery; Regulation; Reporting; Research; Sampling; Self-Examination; Services; Specialist; Standardization; Symptoms; System; Technology; Time; Treatment Cost; United States National Institutes of Health; Universities; Validation; Work; actigraphy; chronic pain; chronic painful condition; clinical care; clinical decision support; clinical decision-making; clinical practice; clinical research site; cost; daily functioning; design; disability; experience; functional disability; innovation; pain patient; post-market; prevent; programs; prototype; recruit; response; satisfaction; success; tool; treatment effect; treatment response; usability; wireless fidelity

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).

抽象的 有效管理患有慢性腰痛的患者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严重的困境， 谁必须仅依靠回顾性自我报告措施（例如问卷）来捕获这一点 信息。通常，每次患者返回诊所时，这些评估通常只完成 过度依赖患者的记忆，并可能缺少症状或 功能轨迹。潜在的偏见和不可靠的报告的结合使得这种方法 评估远非最佳。 我们最近完成了NIH I-Corps计划，该计划揭示疼痛专家迫切需要 有关患者功能以指导治疗决策的客观数据。我们采访的医生表明 对活动水平或行为的定量评估可能会提供解决方案，因为它是经过验证的 用于评估疼痛相关的残疾/功能和对治疗的反应的临床研究工具。障碍 但是，由现有的商业和研究设备面对 由于患者和临床医生的技术负担，用于常规临床护理的行为（例如，设备 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的标准化。 因此，我们建议将一类新的临床级可穿戴活动监视器商业化，称为 Vera乐队专门设计为融合到医疗保健工作流程中。 Vera乐队将提供 低调，耐用，超低成本可穿戴和支持服务，没有任何技术负担 患者或临床医生可以收集准确的日常活动数据。此快速轨道应用程序的第一阶段将 每个目标1和2组成，每1年的持续时间为1年。我们将首先进行迭代技术设计，并 实验室验证过程，以及建立所需的技术和法规基础设施 提供拟议的服务（AIM 1）。然后，我们将评估其可用性和工作流集成并验证其 针对临床研究中使用的领先FDA批准的Actraphy监测仪的技术等效性（AIM 2）。经过 AIM 2的结论，我们建议获得FDA 510（k）清除。在第二阶段，我们将进行多个 在四个三级疼痛诊所中的中心临床研究，在3年的时间内确定医生 对设备可用性的满意度和临床采用的可能性（AIM 3）。