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Chronic Pain Reduction

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Virtual Reality System for Chronic 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.

Chronic lower back pain, which is defined as moderate to severe pain in the lower back lasting longer than three months, is one of the most common chronic pain conditions in the U.S.

Chronic pain may inhibit mobility or daily activities and has been linked to anxiety and depression, poor perceived health or reduced quality of life and dependence on opioids.

Current treatment plans for chronic lower back pain often include, among other options:

prescription and over-the-counter pain medications

exercise

steroid injections

surgery and transcutaneous electrical nerve stimulation.

Cognitive behavioral therapy (CBT) may be used to reduce the burden of chronic pain and increase function through an emotional, cognitive approach to shift negative beliefs held by patients.

So, what is new? At the end of the eight weeks of treatment, greater than 30% – 50% reduction in pain (pain interference on activity, pain interference on mood, pain interference on sleep and pain interference on stress).

EaseVRx FDA Authorization

The U.S. Food and Drug Administration authorized the marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain.

This prescription device, which is intended for at-home self-use, 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.

FDA evaluated the safety and effectiveness of EaseVRx in a randomized, double-blinded clinical study. No serious adverse events were observed or reported, but only discomfort with the headset and motion sickness and nausea.

Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification 510(k) submissions, when applicable.

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