The U.S. Food and Drug Administration (FDA) has authorized a first-of-its-kind virtual reality (VR) system designed to help reduce chronic lower back pain. The authorization follows a successful clinical trial demonstrating the VR system producing clinically meaningful reductions in pain symptoms compared to a placebo.
Last year the FDA granted AppliedVR’s EaseVRx system a Breakthrough Device designation, making it one of the first VR-based digital therapeutic systems to receive the designation.
Now, a little over a year later, the FDA has issued a formal market authorization allowing the device to be used by prescription, “in patients 18 years of age and older with diagnosed chronic lower back pain.”
“Pain reduction is a crucial component of living with chronic lower back pain,” says Christopher Loftus, acting director of the FDA’s Office of Neurological and Physical Medicine Devices. “Today’s authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain.”
The EaseVRx system comprises a VR headset with controller, and an attachment dubbed a “breathing amplifier” designed to direct sounds of breathing back into the headset’s microphone, aiding breath-based biofeedback exercises. The program is based on pre-existing cognitive behavioral therapy (CBT) principles.
“EaseVRx combines biopsychosocial education, diaphragmatic breathing training, relaxation response exercises that activate the parasympathetic nervous system, and executive functioning games to provide a mind–body approach toward living better with chronic pain,” a team of researchers explain in a study reporting the results of a recent clinical trial testing the device. “The standardized 56-day program delivers a multifaceted combination of pain relief skills training through a prescribed sequence of daily immersive experiences. Each VR experience is 2-16 minutes in length (average of 6 minutes).”
The FDA’s approval comes after the reporting of positive clinical trial results from tests of the device in a large cohort of 179 subjects with chronic back pain. Half the cohort completed the eight-week EaseVRx program, while the other half still received a VR headset but only experienced sessions featuring two-dimensional nature footage with no CBT.
At the end of the eight-week treatment period the trial saw around two-thirds of the EaseVRx cohort report a 30 percent reduction in pain and 46 percent reported over 50 percent reduction in pain. This compared to 41 percent of the control group reporting a 30+ percent drop in pain and 26 percent reporting a 50+ percent drop.
The trial also included a three-month follow up period to investigate the long-term effects of the treatment. Strikingly, the efficacy gap between EaseVRx and control groups expanded over the course of the follow-up, with pain reduction ratings holding strong for three months in the VR group whereas most of the control group saw little benefit after 12 weeks.
The authorization of EaseVRx is part of a new wave of prescription digital therapeutics. Last year the FDA authorized a prescription-based Apple Watch app designed to improve sleep patterns in those suffering from post-traumatic stress disorder (PTSD). The FDA also recently approved the first “prescription video game” designed to treat attention deficit hyperactivity disorder (ADHD) in children.
AppliedVR plans to bring EaseVRx to market very soon. No pricing has been announced for the system yet and clinical work is ongoing to investigate broader uses of the system beyond just chronic lower back pain.
"For too long, we've relied on the notion that people need to take pills or rely on surgery to feel better and lead a better quality of life,” says Matthew Stoudt, CEO of AppliedVR, in a recent statement. “At AppliedVR, we're building an unparalleled body of evidence for providers and payers to demonstrate that immersive therapeutics can fill the massive unmet need for patients who are frustrated by current treatment paradigms. And, we are starting with chronic pain, one of the most complex, costly conditions.”
Source: FDA
