# Actigraphy Enhanced Clinical Chronic Lower Back Pain Management

> **NIH NIH U44** · ARBOR MEDICAL INNOVATIONS, LLC · 2022 · $997,929

## Abstract

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).

## Key facts

- **NIH application ID:** 10485194
- **Project number:** 5U44NS122002-02
- **Recipient organization:** ARBOR MEDICAL INNOVATIONS, LLC
- **Principal Investigator:** Grant H Kruger
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $997,929
- **Award type:** 5
- **Project period:** 2021-09-15 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10485194

## Citation

> US National Institutes of Health, RePORTER application 10485194, Actigraphy Enhanced Clinical Chronic Lower Back Pain Management (5U44NS122002-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10485194. Licensed CC0.

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