FDA approves new virtual reality system for chronic pain treatment

The FDA has approved the release of EaseVRx, a prescription-use immersive virtual reality apparatus intended for patients aged 18 years or older who have been diagnosed with chronic lower back pain.

The device integrates cognitive behavioral therapy (CBT) and other behavioral methods to assist with pain reduction.

“Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life,” Christopher M. Loftus, MD, acting director of the office of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “Pain reduction is a crucial component of living with chronic lower back pain. 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.”

Current treatment plans often include prescription and over-the-counter pain medications, exercise, steroid injections, transcutaneous electrical nerve stimulation and surgical procedures.

EaseVRx combines CBT principles and other behavioral therapy techniques to reduce pain and minimize pain interference. Available with a prescription, the device is intended for at-home use. It consists of a VR headset and a controller, along with a “breathing amplifier” attached to the headset that directs a patient’s breath toward the headset’s microphone for use in deep breathing exercises, according to the release. The device’s VR program utilizes principles of behavioral therapy that address physiological symptoms of pain and aid in pain relief through a skills-based treatment program. Among the techniques used are deep relaxation, attention-shifting, interoceptive awareness, immersive enjoyment, self-compassion, healthy movement, acceptance and visualization.

EaseVRx treatment includes 56 VR sessions over a daily 8-week treatment program, which vary from 2 to 16 minutes.

The FDA evaluated the safety and effectiveness of EaseVRx in a randomized, double-blinded clinical study of 179 participants with chronic lower back pain who were assigned to one of two VR programs: the EaseVRx immersive 3D program or a control 2D program that did not utilize skills-based CBT methods of treatment.

After enrollment in the trial, participants were followed for a period of 8.5 months, including a 2-week baseline assessment period, an 8-week VR program, a post-treatment assessment and follow-ups at 1,2,3 and 6 months.

Significantly more EaseVRx participants than controls reported a reduction in pain greater than 30% at the end of treatment. Participants reported a decrease in pain intensity of 1.31 points over the entire course of treatment and a decrease in pain interference that ranged from 0.95 points to 1.27 points lower than scores reported from the beginning of treatment.

Although participants did not report serious adverse events, 20.8% reported discomfort with the headset and 9.7% reported motion sickness and nausea.