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

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 慢性腰痛患者的有效治疗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， 目前谁必须完全依靠回顾性自我报告措施（例如调查问卷）来了解这一点 信息。这些评估通常仅在患者每次返回诊所时完成，因此 过度依赖患者的记忆，可能会错过症状或症状的关键拐点 功能轨迹。潜在的偏见和不可靠的报告相结合，使得这种方法 评估远非最佳。 我们最近完成了 NIH I-Corps 计划，该计划显示疼痛专家迫切需要 有关患者功能的客观数据可指导治疗决策。我们采访的医生表示 活动水平的定量评估或体动记录仪可以提供解决方案，因为它是经过验证的 用于评估与疼痛相关的残疾/功能和治疗反应的临床研究工具。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（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，我们建议将一种新型临床级可穿戴活动监测器商业化，称为 Vera Band 专为集成到医疗保健工作流程而设计。维拉乐队将提供 低调、耐用、超低成本的可穿戴设备和支持服务，不会给用户带来任何技术负担 患者或临床医生，可以收集准确的日常活动数据。该快速通道申请的第一阶段将 包括目标 1 和目标 2，各持续 1 年。我们首先会进行迭代的技术设计和 实验室验证过程，以及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 FDA 批准的临床研究中使用的领先体动记录仪在技术上等效（目标 2）。经过 目标 2 的结论是，我们建议获得 FDA 510(k) 许可。在第二阶段，我们将进行多方 中心临床研究，跨越四个三级疼痛诊所，为期三年，以确定医生 对设备可用性的满意度以及临床采用的可能性（目标 3）。