AppliedVR continues to build out clinical evidence to support the use of immersive therapeutics to address chronic pain.
The company’s flagship virtual reality device for chronic lower back pain delivered meaningful reductions in pain intensity for patients, particularly for high-impact chronic pain patients, according to a recent clinical study.
A secondary analysis of a large randomized controlled trial evaluated how AppliedVR’s VR therapy to treat chronic low back pain at home affected patients who experience pain more intensely. Researchers sought to determine whether the therapy could produce greater levels of pain relief for high-impact chronic pain patients, or individuals 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.
These patients are often the most difficult and costly to treat. This patient population is more likely to report severe pain, more mental health and cognitive impairments, worsening health and more difficulty with self-care.
“High-impact chronic pain patients represent roughly 25% of the entire chronic pain population. But because they are high impact, they consume a lot more of the resources and can be much more challenging,” AppliedVR co-founder and CEO Matthew Stoudt said in an interview. “They tend to use significantly higher doses of opioids compared to those with less severe chronic pain, and they have about five times the hospital use.”
The study findings, based on a randomized, placebo-controlled study of more than 1,000 participants, indicated that AppliedVR’s FDA-authorized RelieVRx device produced clinically effective results in both patients with high-impact chronic pain and lower-impact chronic pain. But, patients with high-impact pain experienced greater reductions in pain interference and pain intensity compared to those with low-impact pain.
Essentially, AppliedVR’s immersive therapy was able to convert a large number of high-impact pain patients to low-impact chronic pain patients.
The study found that 70% of high-impact chronic pain patients were classified as low-impact at the end of treatment, with 67% maintaining that status at 12 months post-treatment.
“If you can deliver a solution that can almost convert these high-impact chronic pain patients to low-impact chronic pain patients, then you’re able to make a huge impact in the world of chronic pain on both sides, from the sufferer side as well as from the system side,” Stoudt said.
The company has prioritized conducting research to demonstrate the therapeutic benefits of its VR therapy for treating chronic lower back pain at home. In November 2023, the company unveiled the results of a large randomized controlled trial (RCT) that found AppliedVR’s RelieVRx program produced clinically meaningful improvements in clinically severe and diverse adults with CLBP.
AppliedVR’s RelieVRx device and program consists of a headset and software guiding patients in pain management exercises. It represents a novel home-based solution for treating chronic pain. The company says RelieVRx serves as a cost-effective, non-pharmacologic adjunctive therapy clinically proven to significantly reduce pain intensity and interference across sociodemographic groups.
Patients administer the device on themselves in their own homes, conducting 56 sessions that average six minutes each. It’s a multimodal program, featuring daily VR sessions that address the bio-psycho-social aspects of pain.
“It’s a multi-therapy approach that we take. It’s not just cognitive behavioral therapy that we’re teaching, but includes concepts of acceptance commitment therapy, and it includes diaphragmatic breathing and pain education,” Stoudt said. “It’s ultimately helping them to understand and then manage their own pain so they can better regulate their central nervous system. We use different examples of mindfulness meditation. We do breathing exercises where they’re literally seeing their breath materialized in the virtual world, and that gives them the control over the virtual world.”
The objective with chronic pain patients is to reduce pain intensity and improve the quality of life, he noted.
“The way we’ve historically treated chronic pain, we’ve always been focusing on the pain itself. That’s why we give patients opioids, injections and surgeries, because we’re trying to fix that problem of pain, but we’re not addressing the comorbidities of depression, anxiety, all the other factors that go into really impacting the quality of life,” he said. “What we care about is trying to improve that quality of life so the patient or the person can get up and they can do more with their life and that’s why we want to teach them the skills they need to be able to cope with the pain so they can have that better life.”
Chronic pain imposes a significant economic burden on the U.S., estimated at $635 billion annually, and is a primary driver of the opioid crisis. More than 72 million Americans suffer from chronic lower back pain, which also is a leading cause of disability.
The study findings are critically important for both payers and providers. For health insurers looking for ways to reduce total cost of care, the findings indicate that RelieVRx may be effective at reducing healthcare utilization, which lowers 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.
“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,” Stoudt said. “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,” Stoudt said.
As AppliedVR continues to build out clinical evidence around its immersive therapy products, it’s also expanding its payer partnerships. Pittsburgh-based Highmark signed on as AppliedVR’s first commercial payer partner, making its flagship VR device for chronic lower back pain a covered treatment for more than 4 million plan members.
Highmark’s landmark decision to adopt coverage for RelieVRx will make the FDA-authorized device more accessible to individuals to help manage chronic lower back pain at home, and helps to pave the way for more commercial health plans, self-insured employers and other payers to take a closer look at the VR-based therapy, Stoudt said back in September.
VA Immersive, a division of the Veterans Health Administration (VHA), extended its contract with AppliedVR to expand military veterans’ access to virtual reality-based therapy for chronic pain.
AppliedVR says it now works with 200 leading health systems and thousands of healthcare professionals globally, covering more than 60,000 patients.
The company is working with “multiple other payers” in different formats, Stoudt said.
As AppliedVR continues to invest in evidence and data, it helps to distinguish the company and get the attention of payers, he noted. “We’re on a great trajectory right now,” he added.
Workers’ compensation is another area that AppliedVR is exploring, he said.
AppliedVR took a methodical approach to getting its novel device into the marketplace, Stoudt noted. AppliedVR’s flagship product, the RelieVRx program, was granted marketing authorization by the Food and Drug Administration in 2021 for chronic lower back pain.
AppliedVR’s RelieVRx program is the first VR-based, prescription therapeutic to receive Breakthrough Device Designation and De Novo authorization by the FDA for chronic lower back pain.
In March 2023, the Centers for Medicare and Medicaid Services (CMS) granted the company a unique Healthcare Common Procedure Coding System (HCPSC) Level II code for RelieVRx and placed it in an existing benefit category: durable medical equipment.
This article was originally published on fiercehealthcare