Virtual Reality Program for Chronic Pain Treatment Received FDA Approval

To help reduce pain in patients aged 18 and over diagnosed with chronic low back pain, the US Food and Drug Administration (FDA) authorized a virtual reality (virtual reality – VR) system using cognitive behavioral therapy and other behavioral methods, called EaseVRx, for prescription marketing on November 16, 2021.

Millions of adults live with chronic low back pain that can affect many aspects of daily life. Reducing pain is a very important part of living with chronic low back pain. This approval offers a new treatment option that does not use opioid painkillers but may reduce pain when used with other treatments for low-level chronic low back pain.

Lasting longer than three months and classified as moderate to severe, chronic low back pain is one of the most common chronic pain conditions. Chronic pain can interfere with mobility or daily activities and is associated with anxiety and depression, feeling unwell or having a low quality of life, and dependence on opioids. Chronic low back pain is usually treated with prescription and over-the-counter pain medications, exercise, steroid injections, surgery and transcutaneous electrical nerve stimulation, among other options.

Cognitive behavioral therapy (CBT) can be used to reduce the burden of chronic pain and improve function through an emotional, cognitive and behavioral approach that changes patients' negative beliefs about the relationship between their pain and movement.

EaseVRx uses CBT principles and other behavioral therapy techniques to reduce pain and pain interference. Designed for people to use on their own at home, the prescription device consists of a VR (virtual reality) headset and controller, together with a “Breathing Amplifier” attached to the headset that directs the patient's breath toward its microphone. The device's VR program uses certain behavioral therapy principles intended to address the physiological symptoms of pain and helps relieve pain through a skills-based treatment program. These principles include:

• Deep relaxation
• Interoceptive awareness
• The ability to identify, access, understand and respond appropriately to internal signal patterns, and gain perspective
• Attention shifting
• Three-dimensional entertainment
• Self-love
• Healthy movement
• Acceptance
• Visualization
• Pain education
• Rehabilitation

The EaseVRx treatment program consists of sessions lasting 2-16 minutes, with 56 VR sessions intended for daily use as part of an eight-week treatment program. Each session includes elements of the principles above to give users skills to relieve pain and reduce its impact on daily activities.

The FDA evaluated the safety and effectiveness of EaseVRx in a randomized, double-blind clinical trial of two eight-week VR programs (the comprehensive EaseVRx 3D program or a 2D control program that did not use skills-based CBT treatment methods) involving 179 participants with chronic low back pain. Participants enrolled in the trial were followed for a total of 8 to 9 months, including a two-week baseline assessment period, an eight-week VR program and post-treatment assessment, with follow-up at 1, 2, 3 and 6 months after completing the program.

At the end of treatment:

• 66% of EaseVRx participants reported more than a 30% reduction in pain
• 41% of control participants reported more than a 30% reduction in pain
• 46% of EaseVRx participants reported more than a 50% reduction in pain
• 26% of control participants reported more than a 50% reduction in pain

To evaluate the effectiveness of EaseVRx, participants were asked at the end of the eight-week program to rate the following outcomes on a 10-point scale:

• Pain intensity
• The effect of pain on mobility
• The effect of pain on mood
• The effect of pain on sleep
• The effect of pain on stress

During the study, no serious adverse events were observed. Approximately 20.8% of participants reported discomfort from the headset, while 9.7% reported nausea due to motion.

The FDA granted EaseVRx, manufactured by AppliedVR, the designation "Breakthrough Device" .