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Prescription VR pain relief earns FDA nod
The FDA has OK’d a prescription-only virtual reality system that patients with chronic back pain can use at home to relieve their suffering.
The 3-D system, Applied VR’s EaseVRx, uses psychotherapy techniques and is now cleared for prescribing by physicians and other qualified clinicians.
It administers 56 VR sessions of cognitive behavioral therapy (CBT) in installments of two to 16 minutes over eight weeks.
The offering applies principles of deep relaxation, attention-shifting and “interoceptive awareness,” along with simple distraction, immersive fun and other measures, according to an announcement FDA posted Nov. 16.
The agency says it tested the system’s safety and efficacy in a randomized, double-blinded clinical study of 179 participants with chronic lower back pain.
Patients who received the experimental VR regimen reported greater and longer-lasting pain reduction compared with those in a control group using a less sophisticated approach.
Christopher Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, says millions of adults live with chronic back pain that’s severe enough to significantly crimp their level of functioning.
“Pain reduction is a crucial component of living with chronic lower back pain,” he adds. “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.”
Full announcement here.