Virtual, placebo-controlled study indicates AppliedVR’s EaseVRx platform creates high engagement; produces “clinically meaningful” impact on five key pain indicators
LOS ANGELES–(BUSINESS WIRE)–#AppliedVR—AppliedVR, a pioneer advancing the next generation of digital medicine, today announced results from its pivotal randomized controlled trial (RCT), evaluating virtual reality (VR) therapy for treating chronic pain at home. The study, which was published in Journal of Medical Internet Research (JMIR), found that AppliedVR’s EaseVRx device produced “clinically meaningful” improvement in multiple pain outcomes, and had high participant satisfaction and engagement.
This study comes on the heels of EaseVRx receiving FDA Breakthrough Device Designation last October. EaseVRx is an eight-week program delivered via a virtual reality medical device which teaches participants how to recognize and adjust cognitive, emotional, and physical responses to chronic pain using one session per day.
Conducted remotely due to COVID-19, the double-blinded national study analyzed data from 179 individuals in the U.S. who reported experiencing chronic low-back pain for at least six months. On average, participants in the EaseVRx group reported substantial improvements at post-treatment, including:
- 42% reduction in pain intensity;
- 49% reduction in activity interference;
- 52% reduction in sleep interference;
- 56% reduction in mood interference; and
- 57% reduction in stress interference.
Overall, EaseVRx had a high treatment-response rate compared to the control, including:
- 87% of participants experienced reduction in pain;
- 65% of participants experienced at least a 30% reduction in pain; and
- 46% of participants experienced at least a 50% reduction in pain – average pain reduction in this group of 71%.
Researchers also reported that 91% of participants completed the full eight-week program. Of note, system usability for EaseVRx was in the 96-100th percentile based on the System Usability Scale rating, representing an A+ usability grade, a score that beats some of the prolific digital products used by consumers (e.g. an ATM, top email provider and a major e-commerce platform). Engagement and usability data are critical to providers and payers who must evaluate the likelihood that members/patients will use a digital therapeutic — especially on themselves outside of clinical settings.
“Most often pain is treated with a purely biomedical approach, using medications or procedures. Currently, lower-risk treatment options are not available at scale,” said Dr. Beth Darnall1, AppliedVR chief science advisor, who co-authored the study. “Our findings show that VR for chronic pain can provide effective on-demand, home-based pain care at scale. Home-based VR may improve the risk-benefit profile well above the current standard of care.”
The COVID-19 pandemic has created an urgent need for effective digital therapeutics to address the nation’s largest health problems. To meet the surge in demand, providers, insurers and policymakers have taken measures to expand access to digital therapeutics. In January, the Centers for Medicare and Medicaid Services (CMS) finalized a rule that creates a new, accelerated Medicare coverage pathway for innovative products that the FDA deems “breakthrough.” Under the rule, Medicare can provide national coverage simultaneously with FDA approval for a four-year evaluation period, allowing device developers to build a greater body of evidence for their solutions.
This development, along with similar moves by some commercial insurers, comes as welcomed news to people suffering from chronic pain, many of whom are seniors, who traditionally have relied on pharmaceuticals. Chronic pain is an extremely costly and complex problem in the U.S, with The Institute of Medicine estimating2 that one in three (approximately 100 million) Americans are living with some type of ongoing pain. A previous Johns Hopkins study published in The Journal of Pain3 found that the annual cost of chronic pain could be as high as $635 billion a year, which is more than the yearly costs for cancer, heart disease and diabetes combined.
“After yet another successful clinical trial, we’ve reinforced AppliedVR’s unwavering commitment to being the most effective, cost-conscious and data-backed VR-based solution for chronic pain on the market,” said Josh Sackman, co-founder and president of AppliedVR. “And now that CMS and forward-thinking commercial payers are seeing the outcomes that digital therapeutics like ours can deliver, we fully expect EaseVRx to soon be a provider-prescribed, payer-reimbursed treatment for multiple chronic-pain indications.”
Already the most evidence-backed VR provider in healthcare, AppliedVR is engaged with multiple big-name insurers to evaluate its platform as a covered treatment for chronic pain.
Last June, AppliedVR published the first scientific study using VR to treat chronic pain at home, and has previously partnered with University of California at San Francisco (UCSF) to study how digital therapeutic platforms, including virtual and augmented reality, can be used to improve care access for underserved populations. Additionally, partly funded by $2.9 million in grants from the National Institute on Drug Abuse (NIDA), the company also is advancing two clinical trials with Geisinger and Cleveland Clinic to study VR as an opioid-sparing tool for acute and chronic pain.
AppliedVR is a leader in digital therapeutics, pioneering virtual reality-based treatments that address the complexity of chronic pain. Our mission is to empower patients with the tools to live life, beyond chronic pain. Rooted in cognitive behavioral therapy and mindfulness, AppliedVR’s EaseVRx is the first VR-based prescription therapeutic to receive ‘Breakthrough Therapy Designation’ by the FDA. Offering a comprehensive approach that encompasses the biological, psychological and social factors that influence how people experience chronic pain, EaseVRx enables patients to change the way they process pain and develop new, positive habits and coping skills that improve quality of life. Patients can easily self-administer EaseVRx in the comfort of their own homes, at any time, without restrictions tied to a healthcare professional’s schedule – advancing remote care as well as quality, equity and efficiency in chronic pain management.
To learn more about AppliedVR, Inc., visit: https://appliedvr.io/.
1 Beth Darnall, PhD also is associate professor at Stanford University School of Medicine and is Director of the Stanford Pain Relief Innovations Lab. She leads NIH and PCORI-funded large clinical trials involving behavioral treatments for acute and chronic pain.
2 Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: The National Academies Press; 2011.
3 Darrell J. Gaskin, Patrick Richard. The Economic Costs of Pain in the United States. The Journal of Pain, 2012; 13 (8): 715 DOI: 10.1016/j.jpain.2012.03.009