Actigraphy Enhanced Clinical Chronic Lower Back Pain Management

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).