The FDA has authorized marketing of the first immersive virtual reality (VR) system for adults with chronic lower back pain.1

EaseVRx (Applied VR, Los Angeles) is a prescription-use immersive VR system that uses cognitive behavioral therapy (CBT) and other methods to reduce pain in patients 18 years or older who have diagnosed chronic lower back pain. The VR system is also intended to provide pain interference. It should be used only after nonpharmacologic therapies (including CBT) have been tried.

EaseVRx was granted "breakthrough device" designation by the FDA. To qualify for this designation, a device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and meet at least one of the following criteria:

* Must represent a breakthrough technology;

* There must be no approved or cleared alternatives;

* Must offer significant advantages over existing approved or cleared alternatives; and/or

* Availability of the device is in the best interest of patients.

"Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life," said 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. Loftus is quoted in the FDA's press release1 dated November 16, 2021.

He further was quoted as saying, "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."

EaseVRx is available by prescription for home use and is indicated for moderate to severe back pain of at least 3 months' duration. The system uses principles of cognitive behavioral therapy (CBT) and other techniques. It is intended for at-home self-use.

The system includes a VR headset and a controller, along with a "breathing amplifier," which directs the patient's breath to the headset for use in deep breathing exercises.

Authorization was granted after a randomized, double-blind trial involving 179 patients. The trial compared the device's immersive three-dimensional program (treatment group) with two-dimensional program that did not use CBT treatment methods (control group).

The system's treatment protocol consists of 56 VR sessions lasting 2 to16 minutes as part of an 8-week program. The sessions use elements of behavioral therapy, including deep relaxation, distraction, healthy movement, acceptance and knowledge of pain and rehabilitation. Follow up was for 8.5 months at 1, 2, 3, and 6 months after completion of the program.

Patients using the device had higher satisfaction and greater symptom reduction than those in the control group. At the end of treatment, 66% of the VR participants reported greater than 30% reduction in pain and 46% of EaseVRx participants reported greater than 50% reduction, compared with 41% of control participants who reported greater than 30% reduction in pain and 26% reported greater than 50% reduction.

At 1-month follow-up, all participants in the EaseVRx group continued to report a 30% reduction in pain. After 2 and 3 months of follow-up, 30% reduction in pain remained for all treatment group outcomes, with the exception of pain intensity. In contrast, the control group reported a reduction in pain below 30% at 1-, 2-, and 3-month follow-up for all outcomes.

Current treatment for chronic lower back pain includes prescription and over-the-counter pain medications, exercise, corticosteroid injections, surgery, spinal cord stimulation and transcutaneous electrical nerve stimulation. CBT may be used to reduce the burden of chronic pain and increase function by helping patients shift from negative beliefs about the relationship between their pain and movement.

Reference