THE ANGEL–(BUSINESS WIRE) – AppliedVR, a pioneer driving the next generation of digital medicine, today announced the results of its centralized randomized controlled trial (RCT) evaluating virtual reality therapy (VR) for the management of chronic pain at home. The study, published in the Journal of Medical Internet Research (JMIR), found that AppliedVR’s EaseVRx device produced “clinically meaningful” improvement in multiple pain outcomes and demonstrated high levels of satisfaction and engagement from participants.
This study follows EaseVRx, which received the FDA Breakthrough Device Designation last October. EaseVRx is an eight-week program delivered via a virtual reality medical device that shows participants how to identify and adjust cognitive, emotional, and physical responses to chronic pain in one session per day.
The double-blind national study, conducted remotely due to COVID-19, analyzed data from 179 people in the United States who reported having had chronic lower back pain for at least six months. On average, participants in the EaseVRx group reported significant improvements in follow-up treatment, including:
42% less pain intensity;
49% fewer activity disorders;
52% fewer sleep disorders;
56% fewer mood disorders; and
Reduction of voltage disturbances by 57%.
Overall, EaseVRx had a high rate of treatment response compared to controls, including:
87% of the participants showed a reduction in pain;
65% of the participants showed a pain reduction of at least 30%; and
46% of the participants showed a pain reduction of at least 50% – average pain reduction in this group of 71%.
The researchers also reported that 91% of participants completed the entire eight-week program. It is noteworthy that the system usability for EaseVRx in the 96-100. The percentile, based on the system usability scale rating, which is an A + usability rating, was a rating that beats some of the productive digital products used by consumers (e.g., an ATM, a top email Provider and an important e-commerce platform). Engagement and usability data is critical for providers and payers who need to assess the likelihood that members / patients will use a digital therapeutic – especially for themselves outside the clinical setting.
“Most of the time, pain is treated with a purely biomedical approach using drugs or procedures. Currently, lower risk treatment options are not widely available, “said Dr. Beth Darnall1, ChiefVR science advisor to AppliedVR, who co-authored the study.” Our results show that VR can be effective for chronic pain when needed at home, on-scale pain management. Home-based VR can improve the benefit-risk profile well above the current standard of care. ”
The COVID-19 pandemic has created an urgent need for effective digital therapeutics to address the country’s biggest health problems. To meet the increasing demand, providers, insurers and policy makers have taken steps to expand access to digital therapeutics. In January, the Centers for Medicare and Medicaid Services (CMS) passed a rule that creates a new, accelerated Medicare coverage pathway for innovative products that the FDA sees as a “breakthrough”. Typically, Medicare can provide national coverage for a four-year evaluation period concurrent with FDA approval, so device developers can build more evidence of their solutions.
This development, along with similar actions by some commercial insurers, is welcome news for those living with chronic pain, many of whom are seniors who have traditionally been drug dependent. Chronic pain is an extremely costly and complex problem in the United States. The Institute of Medicine2 estimates that one in three (approximately 100 million) Americans lives with persistent pain. A previous Johns Hopkins study published in the Journal of Pain3 found that the annual cost of chronic pain can be as high as $ 635 billion a year, which is more than the annual cost of cancer, heart disease, and diabetes combined.
“Following another successful clinical trial, we reaffirmed AppliedVR’s unwavering commitment to be the most effective, cost-conscious, and data-driven VR-based chronic pain solution on the market,” said Josh Sackman, Co-Founder and President of AppliedVR. “And now that CMS and predictive commercial payers see the results that digital therapeutics like ours can deliver, we anticipate that EaseVRx will soon be a provider-prescribed, payer-reimbursed treatment for multiple chronic pain indications.”
AppliedVR is already the most evidence-based VR provider in healthcare, working with several big-name insurers to evaluate its platform as a covered treatment for chronic pain.
In June of last year, AppliedVR published the first scientific study using VR to treat chronic pain at home and previously worked with the University of California at San Francisco (UCSF) to study how digital therapy platforms, including virtual and augmented reality, are being used to improve it can provide care access for underserved populations. The company is also advancing two clinical trials with Geisinger and Cleveland Clinic to investigate VR as an opioid-sparing tool for acute and chronic pain.
AppliedVR is a leader in digital therapy, delivering breakthrough virtual reality treatments that address the complexities of chronic pain. Our mission is to give patients the tools to lead a life beyond chronic pain. AppliedVR’s EaseVRx is based on cognitive behavioral therapy and mindfulness and is the first prescription VR-based therapeutic to receive the Breakthrough Therapy Designation from the FDA. EaseVRx offers a comprehensive approach that encompasses the biological, psychological and social factors that influence the onset of chronic pain, and enables patients to change the way they process pain and develop new, positive habits and coping skills. that improve the quality of life. Patients can self-administer EaseVRx anytime from the comfort of their own home, with no restrictions tied to a healthcare professional’s schedule. This promotes remote care as well as quality, equity and efficiency in the management of chronic pain.
For more information on AppliedVR, Inc. please visit: https://appliedvr.io/.
1 Beth Darnall, PhD, is also an Associate Professor at Stanford University School of Medicine and Director of the Stanford Pain Relief Innovations Lab. She leads major clinical trials in behavior therapy for acute and chronic pain, funded by NIH and PCORI.
2 Institute of Medicine. Pain Relief 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 Cost of Pain in the United States. The Journal of Pain, 2012; 13 (8): 715 DOI: 10.1016 / j.jpain.2012.03.009