FDA Approves Virtual Reality System for Treating Lower Back Pain
By Admin | January 17, 2022
The US Food and Drug Administration has authorized the marketing of a virtual reality (VR) system, available by prescription only, that uses the principles of cognitive-behavioral therapy (CBT), mindfulness and other behavioral methods for the relief of chronic lower back pain.
The approval was based on a double-blind trial, published in February, involving 179 participants randomized either to the VR system or a control 2-D program that did not include training previously shown to improve chronic pain. Participants were instructed to use the devices at home for 56 sessions lasting two to 16 minutes each over an eight-week period.
At the conclusion of the treatment protocol, 66 percent of the participants using the VR system reported greater than 41 percent reduction in pain, versus 30 percent of control participants. In addition, 46 percent of the VR participants reported greater than 50 percent reduction in pain, compared to 26 percent of the control participants. The effect remained significant, but diminished, at three months post-treatment.
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 prepared statement on November 16: “Today's authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other...(More)
For more info please read, FDA Approves Virtual Reality System for Treating Lower Back Pain, by Neurology Today