# Opioid-Sparing pain management for Chronic Low Back Pain patients using TMC-CP01 - A VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) based program

> **NIH NIH R44** · TAMADE, LLC · 2022 · $989,571

## Abstract

An estimated 100 million Americans suffer from chronic pain and low back pain is the leading
type of chronic pain. In fact, low back pain (LBP) is the number one cause of disability in the
world and in the U.S. this chronic disease accounts for 264 million lost work days in one year.
While 31 million Americans suffer from chronic low back pain (CLBP), today the most commonly
prescribed drug for low back pain remains opioids. However, opioids have been found to be
ineffective for CLBP. Rather, opioids provide modest short-term pain relief that render them
inadequate for patients living day to day with CLBP. Furthermore, Opioids users are subject to
drug tolerance and decreasing pain management efficacy over time.
A significant portion of CLBP patients are on a 50mg or more-morphine milligram equivalent
(MME) daily opioid dosage. Even more than a significant increase in risk of inadvertent
prescription opioid overdose, individuals on 50mg or more MME a day are more likely to
experience fatality.
CLBP patients need an effective, safe, and accessible form of pain management that addresses
both physical symptoms of pain as well as psychological symptoms such as depression and
anxiety.
We will seek to provide a pain management alternative for CLBP patients who are on a greater
than 50mg morphine milligram equivalent (MME) daily opioid dosage to reduce medication
usage, increase pain management, and increase overall functionality. To address these issues,
we will develop, utilize, and augment one novel science-enabling technology combined with
validated pain management treatments: 1) virtual reality to stimulate patients’ visual, auditory,
and haptic fields in effort to simultaneously distract and actively engage patients in 2)
biofeedback therapy, which will allow patients to consciously self-regulate their nervous system
by paring down their sympathetic tone through exercises in controlling respiration and HRV. We
leverage novel technology and validated therapy for the overarching aim of this proposal: to
provide CLBP patients on a 50mg or more MME daily opioid dosage with an opioid-sparing pain
management tool aiming to increase pain management efficacy and decrease risk of health
complications.
Across both Phase I and Phase II, we will sample from a population of CLBP patients on a
50mg or more MME daily opioid dosage. In Phase I a group receiving our intervention with
opioids will be compared to a group receiving just opioids. Both groups will receive the same
opioid tapering guidelines and we expect the intervention group to have greater success
reducing opioid usage. Our Phase II trial will test the two previous groups in addition to a third
group receiving opioids and a sham virtual reality experience, similar to current distraction-
based VR used for acute pain management. All three groups will receive identical opioid
tapering instructions. We hypothesize patients in the intervention group will observe lower pain
scores, less opioid usage, gre...

## Key facts

- **NIH application ID:** 10512769
- **Project number:** 4R44DA049630-02
- **Recipient organization:** TAMADE, LLC
- **Principal Investigator:** Gale Lucas
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $989,571
- **Award type:** 4N
- **Project period:** 2019-09-30 → 2024-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10512769

## Citation

> US National Institutes of Health, RePORTER application 10512769, Opioid-Sparing pain management for Chronic Low Back Pain patients using TMC-CP01 - A VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) based program (4R44DA049630-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10512769. Licensed CC0.

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