AppliedVR, a leading therapeutic virtual reality (VR) provider for pain management, has recently received the Breakthrough Device designation for its EaseVRx product by the U.S. Food and Drug Administration (FDA). The device treats chronic lower back pain and fibromyalgia that has been notoriously resistant to other treatments. It is also one of the first VR digital therapeutic devices to receive the designation to treat chronic pain conditions specifically.
The EaseVRx program uses cognitive-behavioral therapy (CBT) principles and other similar behavioral methods to teach patients self-management skills. Applied VR designed the program in close partnership with the most renowned pain experts and researchers to create a reliable way of improving the self-regulation of pain responses. In the process, patients learn to modulate their emotional, physiological, and cognitive reactions to pain, which has been an effective treatment for acute pain in medical facilities.
The FDA Breakthrough Device Program
Thanks to its groundbreaking results, EaseVRx received an award from the FDA Breakthrough Device Program. The program helps provide patients with better healthcare through more punctual access to cutting-edge technologies, providing more successful treatment or diagnosis for fatal, life-threatening, or irremediable debilitating conditions.
EaseVRx’s Clinical Trial Results
AppliedVR’s first randomized control trial (RCT) brought successful results, which earned them the FDA’s prestigious designation. The digital therapeutics pioneer assessed VR-based therapy for patients to manage chronic pain themselves at home. The RCT found that a VR treatment program that was a self-administered program based on skills was a feasible way to treat chronic pain. It also saw the method to be scalable and effective at reducing multiple chronic pains, with each outcome meeting or exceeding the 30 percent threshold to become clinically substantial.
Participants reported a reduction in pain intensity by 30 percent and a further decrease of pain-related activity interference by 37 percent. They also said that any pain-related mood, sleep, and stress interference further reduced by 50 percent, 40 percent, and 49 percent, respectively. These considerable improvements in their symptoms have proven the RCT to be a success, providing better healthcare for patients dealing with chronic pain.
Virtual Reality as a Reliable Method for Pain Management
Many people worldwide struggle with chronic pain, notably lower back pain. The chronic condition is one of the most popular ones that people face, and it doubles as an expensive situation for insurers hoping to reduce back surgery-related costs. When combined with neck pain, research has shown that it costs $77 billion to private insurance, around $45 billion to public insurance, and $12 billion in out of pocket expenses.
Chronic pain has also contributed to other significant health problems in the U.S., cumulatively costing up to $635 billion a year. This figure overtakes the annual costs of diabetes, cancer, and heart disease. However, thanks to cognitive-behavioral therapies that involve VR, many providers now have an alternative to address and manage pain for their patients.
The Future of AppliedVR
AppliedVR has many other trials that they are currently engaged in, including a study on utilizing digital therapeutic platforms to enhance care access for underserved populations. It has two clinical trials that are advancing, one of which is to study VR as an opioid-sparing instrument to treat acute and chronic pain using the company’s RelieVRx and EaseVRx platforms. The company received almost $3 million in grants from the National Institute on Drug Abuse and part of the National Institutes of Health to fund the trials.
Conclusion
Technological breakthroughs have significantly advanced treatment for even the most debilitating conditions, evidenced in AppliedVR’s receipt of the Breakthrough Device designation for its work on the EaseVRx program. The program’s improved health benefits show an optimistic future for other patients who struggle to cope with their chronic pain.
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