FDA Authorizes Breakthrough Virtual Reality for Back Pain

A prescription-based VR system for at-home therapeutic use may change the way chronic low back pain is managed, with Beth Darnall, PhD.

Once the stuff of science fiction, virtual reality technology now extends into modern medical care, including pain management. Chronic low back pain (LBP) in particular remains a source of stress and discomfort for millions of individuals, according to the FDA. A newly approved virtual reality device now gives people with chronic LBP a novel drug-free option for at-home pain relief.

In November 2021, FDA authorized breakthrough device approval of EaseVRx, a virtual reality (VR) system available by prescription only that uses cognitive behavioral therapy (CBT) and other behavioral strategies to reduce chronic low back pain in patients aged 18 years and older. The system is manufactured by Applied VR, a developer of virtual reality-based treatments for chronic pain.


FDA Authorizes Breakthrough Virtual Reality for Back PainThrough the EaseVRx virtual reality system, cognitive behavioral therapy sessions address the mental and emotional components of chronic low back pain (iStock).

Virtual Reality for Managing Back Pain

Virtual reality has been studied and used to relieve stress and depression, as well as the pain associated with migraine and other chronic conditions, for many years. Chronic LBP, in particular, is the most common chronic pain complaint. Chronic LBP is associated with not only physical effects of impaired mobility and difficulty with activities of daily living but also mental health effects of anxiety, depression, poor quality of life, and opioid dependence, according to the FDA approval.

Current treatment options for low back pain include prescription and OTC medications, exercise, steroid injections, surgery, and transcutaneous electrical nerve stimulation. CBT addresses the mental and emotional components of pain, and uses strategies – including pain education, visual imagery, deep breathing, and muscle relaxation – to help reduce pain intensity and its impact on daily life.

How EaseVRx Works for Back Pain

EaseVRx includes several CBT pain management skills and other behavioral therapy strategies to reduce pain. The device is designed for self-use at home and consists of a VR headset and controller. A “Breathing Amplifier” attached to the headset is used in deep breathing exercises. The VR program includes 56 sessions, each 2 to 16 minutes long. The sessions, which address topics such as self-compassion and health movement,  are meant to be used as a daily, 8-week treatment program.

The FDA endorsement was based on a randomized, double-blind trial of 179 individuals aged 18 to 85 years with chronic lower back pain. After 2 months, approximately two-thirds (65%) of patients in the VR group reported a reduction in pain greater than 30%, and 46% reported a pain reduction greater than 50%, compared to 41% and 26%, respectively, of controls.

No serious adverse events were reported. In a 1-month post-treatment survey, 9.7% of the EaseVRx users and 6.7% of the control device users reported motion sickness and nausea during the treatment phase of the study.

Self-Directed Pain Management Empowers Patients

The development of the EaseVRx for chronic low back pain was important to fill a niche in pain management for self-delivered, at-home care, Beth Darnall, PhD, of Stanford University, Calif., chief science advisor for Applied VR, told PPM in an interview.

“Up to 100 million Americans are living with ongoing pain of some type,” said Dr. Darnall, Chief Science Advisor at AppliedVR and contributor to the trial. “We have lacked accessible behavioral approaches that allow for ‘whole person’ pain care…. Now, clinicians can prescribe behavioral pain care that is standardized, effective, and convenient.”

In an earlier pilot study, published in 2020, Dr. Darnall and colleagues showed that “VR delivered treatment is more effective than when the same treatment content is delivered in audio-only format. The immersive 3D modality appears to enhance treatment effectiveness,” she explained.

Challenges to Virtual Reality Use

Barriers to successful use of virtual reality may include vertigo, seizure disorder, or a current facial or problem that would preclude comfortable use of headset, noted Dr. Darnall. However, data suggest that it is effective for most people, regardless of education level, given the ease of use for the device.

This device opens up new opportunities for people with chronic pain, said Dr. Darnall. “Since 2011, federal agencies and institutes have called for better integration of behavioral treatment into pain care pathways, but providers have lacked options to offer their patients…. Patients report wanting home-based care options, and VR makes this possible,” she added.  

Next steps for research include the publication of longer-term outcomes data for virtual reality.

“We also need pragmatic studies and national cost-effectiveness studies; those are either underway or current launching,” noted Dr. Darnall. “Finally, we need research in varied pain conditions,” she emphasized.  

Last updated on: December 1, 2021

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