The Food and Drug Administration announced today that it is authorizing a virtual reality system as a prescription treatment for chronic back pain. The treatment, EaseVRx, is one of the digital treatments approved by the agency in the past few years.
EaseVRx includes a virtual reality headset and a device that amplifies the user's breathing sounds to aid breathing exercises. It uses the principles of cognitive-behavioral therapy and aims to help people recognize and understand a variety of thought patterns and emotions. The program relieves pain through relaxation, distraction, and increased awareness of internal signals, the FDA said in a statement.
EaseVRx includes a virtual reality headset and a device that amplifies the user's breathing sounds to aid breathing exercises. It uses the principles of cognitive-behavioral therapy and aims to help people recognize and understand a variety of thought patterns and emotions. The program relieves pain through relaxation, distraction, and increased awareness of internal signals, the FDA said in a statement.
FDA approval of EaseVRx was based on data from an eight-week study of 179 patients with low back pain lasting six months or longer. Half used the EaseVRx program, and the other half took part in another two-dimensional virtual reality program that did not use cognitive behavioral therapy. About two-thirds of participants who used EaseVRx said their pain decreased by more than 30 percent, compared with 41 percent of the control group who had a similar reduction. Patients in the EaseVRx group experienced pain relief lasting up to three months after the study ended, while those in the control group did not.
Christopher Loftus, acting director of the FDA's Office of Neurological and Physical Medical Devices, said in a statement that virtual reality systems could be another option for opioids to treat back pain. Studies have shown that psychotherapy can effectively treat chronic pain for some people, and proponents stress that targeting pain at these components doesn't mean the pain isn't real. Still, cognitive-behavioral therapy for pain is sometimes controversial, and efforts to include it as standard care have run into problems, with concerns that it could serve as an excuse for patients to forgo necessary medications.
EaseVRx was developed by AppliedVR, which is also testing its platform as a treatment for fibromyalgia, burning pain, or labor pain.
About a month ago, the FDA approved another virtual reality therapy for children with visual impairments. The agency also approved a prescription video game called Endeavour RX to treat ADHD in children ages 8 to 12.
Christopher Loftus, acting director of the FDA's Office of Neurological and Physical Medical Devices, said in a statement that virtual reality systems could be another option for opioids to treat back pain. Studies have shown that psychotherapy can effectively treat chronic pain for some people, and proponents stress that targeting pain at these components doesn't mean the pain isn't real. Still, cognitive-behavioral therapy for pain is sometimes controversial, and efforts to include it as standard care have run into problems, with concerns that it could serve as an excuse for patients to forgo necessary medications.
EaseVRx was developed by AppliedVR, which is also testing its platform as a treatment for fibromyalgia, burning pain, or labor pain.
About a month ago, the FDA approved another virtual reality therapy for children with visual impairments. The agency also approved a prescription video game called Endeavour RX to treat ADHD in children ages 8 to 12.
