The U.S. Food and Drug Administration (FDA) authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy (CBT) and other behavioral methods to help with pain reduction in users 18 years of age and older with diagnosed chronic lower back pain. The FDA approved EaseVRx as a Class II medical device. EaseVRx is manufactured by AppliedVR. The system is intended for home use.
The EaseVRx system includes a VR headset and a controller, along with a “Breathing Amplifier” attached to the headset that directs the user’s breath toward the headset’s microphone for use in deep breathing exercises. The treatment program consists of 56 VR sessions that are 2 to 16 minutes in length, which are intended to be used as part of a daily eight-week treatment program. The sessions incorporate behavioral therapy principles to address the physiological symptoms of pain and aid in pain relief. The principles include deep relaxation, attention-shifting, interoceptive awareness–the ability to identify, access, understand and respond appropriately to the patterns of internal signals—and perspective-taking, distraction, immersive enjoyment, self-compassion, healthy movement, acceptance, visualization, knowledge of pain and rehabilitation.
AppliedVR submitted outcomes of two randomized controlled trials (RCTs), evaluating the effectiveness of a VR-based program for self-treatment of chronic pain at home. Both studies concluded that a self-administered, skills-based VR treatment program was not only a feasible and scalable way to treat chronic pain, it also was effective at improving on multiple chronic pain outcomes.
The first study, “Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: Randomized Controlled Pilot Study,” analyzed data from participants with chronic lower-back or fibromyalgia pain over a 21-day period. Participants using EaseVRx significantly reduced five key pain indicators — each of which met or exceeded the 30% threshold for clinical meaningfulness. The second study, “An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19” assessed the safety and efficacy of EaseVRx over eight weeks compared to non-immersive treatment did not use skills-based CBT. The participants in the EaseVRx group on average reported substantial improvements at post-treatment, including a 42% reduction in pain intensity; 49% reduction in activity interference; 52% reduction in sleep interference; 56% reduction in mood interference; and a 57% reduction in stress interference.
The participants in the second study were followed for a period of 8.5 months total, including a two-week baseline assessment period, an eight-week VR program, a post-treatment assessment, and follow-up at one, two, three, and six months after completion of the program. At the end of the treatment program, the participants were asked to rate the following outcomes on a 10-point scale, with 10 being the greatest value: pain intensity, pain interference on activity, pain interference on mood, pain interference on sleep and pain interference on stress. No serious adverse events were observed or reported during the study. Approximately 20.8% of participants reported discomfort with the headset and 9.7% reported motion sickness and nausea.
EaseVRx was granted Breakthrough Device designation. The FDA reviewed EaseVRx through the De Novo premarket review pathway, a regulatory pathway for low-to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
AppliedVR develops and markets immersive prescription digital therapeutics. Its flagship product is EaseVRx, which is the first virtual reality-based treatment for pain to receive FDA approval as a Class II medical device. The technology has been used by approximately 60,000 patients to date in pain management and wellness programs. AppliedVR’s mission is to solve pain through immersive therapeutics with the ultimate goal of a virtual reality pharmacy in every home.
The findings of “Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: Randomized Controlled Pilot Study” were published on July 7, 2020, in JMIR Formative Research at https://formative.jmir.org/2020/7/e17293/ (accessed November 19, 2021).
The findings of “An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19” were published on February 22, 2021, in Journal of Medical Internet Research at https://www.jmir.org/2021/2/e26292/ (accessed November 19, 2021).
This was reported by AppliedVR and the FDA on November 16, 2021.