The U.S. Food and Drug Administration authorized a new virtual reality (VR) treatment for chronic lower back pain on Tuesday, which uses breathing exercise to ease suffering.
The prescription treatment, called EaseVRx, comes as a VR headset, controller and a ‘Breathing Amplifier’ that directs the user’s breath toward a microphone on the headset for deep breathing exercises.
The headset utilizes cognitive behavioral therapy and other behavioral methods to help with relaxation, attention-shifting and other therapies to alleviate pain.
The platform, which as developed by AppliedVR, includes 56 sessions that range from two to 16 minutes long, which are to be done each day for eight weeks – and the treatment can be conducted while at home.
The US Food and Drug Administration authorized a new virtual reality (VR) treatment for chronic lower back pain on Tuesday, which uses breathing exercise to ease suffering. The prescription treatment is called EaseVRx and was developed by AppliedVR
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: ‘Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life.
‘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.’
The FDA approval is based on a trial of 179 patients who have chronic lower back pain.
During the testing, each participant was given either the EaseVRx immersive 3D program or a control 2D program that did not utilize skills-based cognitive behavioral therapy (CBT) methods of treatment.
The platform ncludes 56 sessions that range from two to 16 minutes long, which are to be done each day for eight weeks – and the treatment can be conducted while at-home. 46 percent of those using EaseVRx said they found it reduced pain by more than 50 percent
Each participant was asked to use the therapies constantly for eight and a half months and would report back with pain levels.
At the end of the trials, 66 percent of EaseVRx participants reported a greater than 30 percent reduction in pain, compared to 41 percent of control participants who reported a greater than 30 percent reduction in pain.
And 46 percent of those using EaseVRx said they found it reduced pain by more than 50 percent compared to 26 percent of control participants.
At the end of the one-month follow-up, the EaseVRx group continued to report a 30 percent reduction in pain, which remained at two and three months for all measures other than pain intensity.
EaseVRx was previously granted Breakthrough Device designation.
‘No serious adverse events were observed or reported during the study,’ according to statement from the FDA.
‘Approximately 20.8 percent of participants reported discomfort with the headset and 9.7 percent reported motion sickness and nausea.’
In 2019, researches at the Imperial College London found watching calming virtual reality videos including Arctic scenes helps to relieve ‘intense burning pain’ and could treat chronic pain in the future.
Using a virtual reality headset, researchers played full 360 degree views to people in pain and found it helped to reduce how much they were suffering.
It was found that using the technology helped to not only reduced people’s perceived pain levels but also their sensitivity to painful stimuli.
This adds to the ‘growing evidence’ for the potential of virtual reality technology to help patients with chronic pain, according to the team from Imperial College London.