Randomized, placebo-controlled study of more than 1,000 participants indicates AppliedVR's RelieVRx program can have clinically meaningful impact on reducing pain intensity and interference
LOS ANGELES, Nov. 7, 2023 /PRNewswire/ -- AppliedVR, an immersive therapeutics (ITx) pioneer advancing a novel, virtual reality-based approach to medicine, today announced results from a large randomized controlled trial (RCT), evaluating virtual reality (VR) therapy for treating chronic low back pain (CLBP) at home. The study, which was published in Mayo Clinic Proceedings: Digital Health, found that AppliedVR's RelieVRx program produced clinically meaningful improvements in clinically severe and diverse adults with CLBP.
Researchers concluded that the RelieVRx program was superior to a strong, active VR sham at Day 56 (completion of RelieVRx program) for reducing pain intensity and pain interference in a large real-world sample. Specifically, researchers found that study participants who completed the RelieVRx program achieved a reduction in pain intensity by an average of 2.0 points on a pain numerical rating scale, which asks people to rate their pain on a scale of zero to 10. Similarly, participants who completed the RelieVRx program reported reductions in pain interference by 2.3 points, on average.
The clinical study was the largest of its kind with a demographically diverse sample, including data from more than 1,000 participants (n=1,067) where approximately half were treated by the RelieVRx program over an eight-week period. The results represent the clinical results from AppliedVR's larger health economics and outcomes research (HEOR study).
"Pain is a complex condition that requires a multidisciplinary treatment approach. However, traditional clinical guidelines have over-relied on medications or surgical procedures, which can be costly and ineffective over the long term," said Dr. Beth Darnall, AppliedVR chief science advisor, who co-authored the study. "This landmark study builds on our previous research at a much larger scale and demonstrates that RelieVRx can be a powerful tool in providers' tool belts for treating people experiencing chronic low back pain."
The RelieVRx program is a self-administered behavioral skills VR program for use in the home that was authorized by the FDA to treat CLBP. It provides a fully immersive VR experience that incorporates principles of cognitive behavioral therapy, diaphragmatic breathing, biofeedback, cognition and emotion regulation, mindfulness, and pain education, helping patients learn skills that modulate the brain.
Each chapter of interactive VR therapy builds upon the last to induce neuroplasticity, regulating neural regions associated with pain for long-lasting change. In previous clinical research, the RelieVRx program was shown to deliver durable effects up to 24 months after treatment completion.
This research builds on recent momentum for AppliedVR's flagship product, which recently was granted a unique code and final pricing determination from the Centers for Medicare and Medicaid Services (CMS), representing a huge achievement that puts AppliedVR in the final stages of securing broadscale reimbursement through CMS. Additionally, the RelieVRx program 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), which allows government customers to make streamlined purchases.
AppliedVR recently received a contract award from the U.S. Department of Veterans Affairs, expanding access to RelieVRx as a covered treatment to more veterans at multiple VA sites.
"We are committed to expanding access to high-quality immersive therapeutics that can deliver exceptional clinical outcomes, and this clinical research demonstrates that RelieVRx holds that potential at scale," said Matthew Stoudt, AppliedVR co-founder and CEO. "Combined with our growing relationship with the VA and after receiving our pricing determination from CMS, this study represents yet another huge milestone for us in what has already been a banner year."
Chronic pain costs the U.S. an estimated $635 billion each year and is a major contributing factor driving America's opioid crisis. Research has suggested 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.
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