An immersive virtual reality (VR) system that uses behavioral therapies to treat chronic lower back pain can now be marketed to the public, the Food and Drug Administration announced Tuesday.
EaseVRx, manufactured by AppliedVR, is available by prescription to patients with clinically diagnosed lower back conditions and is designed for home use for adults aged 18 years and older. The system includes 56 VR sessions that are 2 to 16 minutes in length, with treatment designed to be accessed daily for eight weeks.
The treatment program applies the principles of behavioral therapy to address physiological symptoms of pain with skills-based training. Users learn deep relaxation, attention-shifting and a technique called interoceptive awareness — the ability to identify, understand and respond appropriately to patterns of internal signals — among many other skills. An amplifier on the system’s headset directs a patient’s breath toward the headset’s microphone for use in deep breathing exercises.
The system was evaluated for safety and effectiveness in a randomized, double-blinded clinical study of 179 participants with chronic lower back pain. Participants had greater pain reduction and decreased pain intensity when compared to a control group, FDA reported.
