Large Clinical Study Finds Home-based Virtual Reality Treatment of Chronic Low Back Pain Clinically Effective Across Key Socio-demographics Factors

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Jun 06, 2024, 08:00 ET

Analysis of a randomized, placebo-controlled study of 1,000+ participants indicates socio-demographics are not a factor impacting clinically meaningful reductions in pain intensity and pain interference for patients using AppliedVR's RelieVRx device.

LOS ANGELES, June 6, 2024 /PRNewswire/ -- AppliedVR, an immersive therapeutics (ITx) pioneer advancing a novel, virtual reality-based approach to medicine, today announced results from a secondary analysis of a large randomized controlled trial (RCT) that evaluated whether socio-demographic factors affected the clinical effectiveness of receiving a virtual reality (VR) therapy that treats chronic low back pain (cLBP) at home. Researchers sought to determine whether there were differences among key participant cohorts across patient-reported clinical effectiveness, therapeutic program engagement, and patient-reported VR device usability ratings.

The findings, which were published in Journal of Medical Extended Reality, found that AppliedVR's FDA-authorized RelieVRx device produced clinically effective results that were largely invariant across age (over vs. under 65), gender (male vs. female), race/ethnicity (Black vs. White vs. Other) and socioeconomic (education and income) subgroups. Additionally, therapeutic program engagement was largely consistent across all socio-demographic categories and was influenced only by age where, perhaps surprisingly, older adults (65+) showed greater engagement than younger adults. Similarly, RelieVRx's usability ratings were consistently high (A+) and mostly invariant across subgroups except for some slight differences among race/ethnicity.

"Finding clinical effectiveness, therapeutic program engagement and usability to be generally consistent across socio-demographics is extremely notable because it mitigates questions surrounding how underrepresented populations may benefit from the RelieVRx program," said AppliedVR Chief Science Advisor Dr. Beth Darnall. "Pain care is notoriously hard to access, with some areas having no pain specialist available at all to serve patients. This study both underscores the importance of addressing healthcare disparities and should compel the industry to advocate and invest in more scalable and equitable pain care approaches."

Inequities in chronic pain care are well established, making immersive therapeutics like RelieVRx device a powerful solution that could transcend common barriers to care. By providing a clinically proven intervention that is seamlessly self-administered by patients in their own homes – without requiring connectivity or complex setups – providers have a powerful tool that reduces reliance on pharmacological interventions or surgical procedures and can scale to meet the needs of their diverse patient populations.

"The power and potential of every promising intervention must be measured by how well it serves those who need it most. At AppliedVR, we are driven by our commitment to democratize access to immersive therapeutics, and this study represents a pivotal step forward in our

mission to ensure that our innovative solutions reach every corner of society, irrespective of socio-demographic differences," said AppliedVR CEO and Co-founder Matthew Stoudt. "As we continue to advance the frontiers of immersive therapeutics, we will continue to invest in clinical research that underscores the impact immersive therapeutics like RelieVRx can have to revolutionize chronic pain care."

The socio-demographic research follows a previous analysis published in Mayo Clinic Proceedings: Digital Health where researchers found the RelieVRx program produced clinically meaningful reductions in pain intensity and pain interference in clinically severe and diverse adults with cLBP. Specifically, researchers found that participants who completed the RelieVRx program achieved an average reduction in pain intensity of 2.0 points on a pain numerical rating scale, which asks people to rate their pain on a scale from zero to 10. Similarly, participants who completed the RelieVRx program reported reductions in pain interference of 2.3 points, on average. Both studies were based on data from the largest RCT of its kind with a demographically diverse sample, including data from more than 1,000 participants.

As AppliedVR's flagship device, RelieVRx has seen significant traction and adoption over the past year:

It previously received a unique code and final pricing determination from the Centers for Medicare and Medicaid Services (CMS);
It was recently added to the Department of Veterans Affairs' Federal Supply Schedule (FSS), Defense Logistics Agency's Electronic Catalogue for Medical Supply Chain (ECAT), and the Department of Defense's Distribution and Pricing Agreement (DAPA), allowing government customers to make streamlined purchases.
AppliedVR also recently received an expanded contract from the U.S. Department of Veterans Affairs, extending access to the RelieVRx program as a covered treatment to more veterans across the VA.

Chronic pain costs the U.S. an estimated $635 billion each year and is a major contributing factor driving America's opioid crisis. Research suggests that more than 72 million Americans suffer from chronic low back pain, with the condition being a leading cause of disability.

About AppliedVR

AppliedVR is creating a new reality in healthcare. We are pioneering immersive therapeutics (ITx), a new category of medicine, to treat intractable health conditions that affect millions of people worldwide. Today, AppliedVR's treatments represent a robust approach to chronic lower back pain (CLBP) that empowers patients with an intuitive device they can self-manage at home. AppliedVR's RelieVRx® program is the first VR-based, prescription therapeutic to receive Breakthrough Device Designation and De Novo authorization by the FDA for CLBP. AppliedVR's wellness programs have been trusted by more than 200 leading health systems and thousands of healthcare professionals globally, used on more than 60,000 patients. For more information, visit www.appliedvr.io.

Contacts
Sam Moore
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SOURCE AppliedVR