Large Clinical Study Finds Home-based Virtual Reality Device Creates Greater Relief for High Impact Chronic Pain Patients

Secondary analysis of a randomized, placebo-controlled study of 1,000+ participants indicated that FDA-authorized RelieVRx^® yielded clinically meaningful pain intensity and pain interference reductions that were particularly large for high-impact chronic pain (HICP) patients.

70% of HICP patients were classified as lower-impact chronic pain (LICP) patients at the end of treatment with 67% maintaining LICP status 12 months post-treatment.

LOS ANGELES, Dec. 17, 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 how a virtual reality (VR) therapy to treat chronic low back pain (cLBP) at home affected patients who experience pain more intensely. Researchers sought to determine whether high-impact chronic pain (HICP) patients (patients with chronic pain that is accompanied by at least one major activity restriction, such as being unable to work outside the home, go to school, or do household chores) (referred to as high-impact chronic pain) experienced greater levels of pain relief after completing treatment, relative to lower-impact chronic pain (LICP) patients.

The findings indicated that AppliedVR's FDA-authorized RelieVRx device produced clinically effective results in both patients with high-impact chronic pain (HICP) and lower-impact chronic pain (LICP); however, patients with HICP experienced greater reductions in pain interference and pain intensity compared to those with LICP. In fact, the study found that 70% of HICP patients were classified as LICP at the end of treatment, with 67% maintaining a LICP status at 12 months post-treatment.

These findings are critically important for both payers and providers, as HICP populations often are more costly to treat overall and are more likely to report severe pain, more mental health and cognitive impairments, worsening health and more difficulty with self-care. For payers who are looking for ways to reduce total cost of care, the findings indicate that RelieVRx may be effective at reducing healthcare utilization and thus lowering economic burdens. For providers, the study suggests that VR can be a potentially more impactful treatment method for some of their patients who suffer the most.

"Finding that we can move patients from high-impact to low-impact pain is very notable because it means we can help them get back to the activities that severe pain can interfere with," said AppliedVR Chief Science Advisor Dr. Beth Darnall. "A skills-based VR program trains skills and habits through emotional and behavioral learning centers in the brain, which allows them to self-manage the physiological and psychological impact of chronic pain."

The RelieVRx program is a novel adjunctive pain management program rooted in evidence-based principles for the treatment of patients living with CLBP. It's the first FDA-authorized VR therapy for treating chronic lower back pain (CLBP) and has been shown to promote neuroplasticity and enable patients to build long-term skills to respond to pain. Patients administer the device on themselves in their own homes, conducting 56 sessions that average six minutes each.

"Among the mountain of clinical evidence we've gathered over the years, these findings definitely represent some of the most important. Pain providers will tell you that HICP patients are often the most difficult to treat. So for researchers to find evidence that RelieVRx may be positively affecting that group of patients is a strong indicator that we can both improve the quality of life for patients and potentially reduce the total cost of care associated with those patients," said AppliedVR Co-founder and CEO Matthew Stoudt."

This research follows another secondary analysis of the original RCT AppliedVR conducted, with the previous study finding that RelieVRx's clinical effects were largely invariant across sociodemographic groups.  In the primary analysis, which was published in Mayo Clinic Proceedings: Digital Health, researchers found the RelieVRx device produced clinically meaningful reductions in pain intensity and pain interference in clinically severe and diverse adults with CLBP. Specifically, participants who completed the RelieVRx program achieved an average reduction in pain intensity of 2.0 points on a pain numerical rating scale and reported reductions in pain interference of 2.3 points, on average.

This secondary analysis is yet another milestone for AppliedVR's flagship device over the last two years:

• AppliedVR recently announced its first commercial payer partner Highmark, which will cover the device across its business lines.
• RelieVRx 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 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