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November 17, 2021

FDA authorises AppliedVR’s EaseVRx for chronic back pain reduction

EaseVRx includes a VR headset, controller and breathing amplifier that assists in deep breathing exercises.

The US Food and Drug Administration (FDA) has authorised AppliedVR’s EaseVRx virtual reality (VR) system as a prescription treatment for chronic lower back pain.

The VR system, designed for self-use at home, leverages cognitive behavioural therapy (CBT) and other behavioural therapy methods to reduce pain in adult patients.

More specifically, it uses several principles of behavioural therapy, such as deep relaxation, attention-shifting, distraction, interoceptive awareness, and knowledge of pain and rehabilitation, to alleviate chronic lower back pain.

EaseVRx includes a VR headset, controller and breathing amplifier, which directs a patient’s breath to the headset’s microphone to assist in deep breathing exercises.

FDA office of neurological and physical medicine devices acting director Christopher Loftus said: “Millions of adults in the US are living with chronic lower back pain that can affect multiple aspects of their daily life.

“Pain reduction is a crucial component of living with chronic lower back pain. Today’s authorisation 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 FDA stated that the EaseVRx treatment includes 56 VR sessions, with durations ranging from two to 16 minutes. The sessions are intended to be used over a daily eight-week treatment programme.

The regulator authorised the device after assessing data of a double-blinded, randomised clinical trial that included 179 chronic lower back pain patients.

In this trial, each participant was assigned to either the EaseVRx immersive 3D eight-week programme or a control 2D eight-week programme that did not use cognitive behavioural therapy methods.

About 66% of participants treated with EaseVRx reported a pain reduction of more than 30% at the end of treatment. In contrast, 41% of the participants in the control segment reported a similar reduction in pain.

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