“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,” 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, said in a statement.
The treatment will be available for at-home use via prescription.
How It Works
The EaseVRx program consists of 56 VR sessions that are 2 to 16 minutes in length. These are intended to be part of a daily eight-week treatment plan.
The virtual reality program incorporates cognitive behavioral therapy (CBT) techniques intended to address the physiological symptoms of pain and aid in pain relief through a skills-based treatment program. The techniques fall into five different categories: diaphragmatic breathing, pain science education, attention control, interception, and mindful escapes.
“These are multi-session treatments that have been shown to have meaningful effects after treatment," Beth Darnall, PhD, Director of the Stanford Pain Relief Innovations Lab and Chief Science Advisor at AppliedVR, told Verywell. “Most importantly, it’s delivered in the 3D immersive environment which has been shown to impart superior learning through a deep experience that engages multiple regions of the brain for that enhanced learning and therefore treatment effect.”
The VR headset puts the user at the center of scenes they control. In the case of the diaphragmatic breathing module, they are in a virtual world that is brought to life by their breath. Other examples of exercises include challenging negative thoughts, changing a dark, cloudy valley into a beautiful city in the process.
“If we can flood [the brain] with different neural signals, we can get the body to feel less pain,” AppliedVR co-founder and CEO Matthew Stoudt told Verywell.
Road to Approval
In order to test the safety and effectiveness of EaseVRx, the FDA undertook a randomized, double-blind study with 179 participants with chronic lower back pain. They were assigned to either the EaseVRx 3D program or a control 2D program that didn’t utilize CBT for eight weeks. Participants were then followed for an addition 8.5 months.
At the end of the study, 66% of participants who had used EaseVRx reported a greater than 30% reduction in pain, compared to 41% of control participants. Furthermore, 46% of EaseVRx participants reported a greater than 50% reduction in pain compared to 26% of control participants.
EaseVRx was able to speed up the approval process by being granted Breakthrough Device designation. To qualify for this designation, a device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition. It also qualifies as it is a technological breakthrough and the availability of the device is in the best interest of patients.
Is It Accessible?
The price of EaseVRx is not yet established, but the creators are working on getting a piece of code in place that will work with Medicare, Medicare Advantage, and Medicaid. The goal is for insurance to reimburse the price of the treatment to the payer.
Whilst the treatment is only eight weeks long, the focus is on creating lasting pain management skills.
“It’s not simply that a patient gets efficacy while they’re in the headset, but that we’re actually teaching them the skills to self regulate when they don’t have the headset on,” Stoudt said.
AppliedVR hopes that rollout will start in mid 2022.
