The therapy, called EaseVRx, is intended for at-home self-use and consists of a VR headset and a controller, along with a "Breathing Amplifier" attached to the headset that directs a patient's breath toward the headset's microphone for use in deep breathing exercises.
EaseVRx, which will help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain, joins the short list of digital therapeutics cleared by the agency over the past few years.
"Pain reduction is a crucial component of living with chronic lower back pain. Today's authorisation 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," said Christopher M. Loftus, from FDA's Center for Devices and Radiological Health, in a statement.
Millions of adults live with chronic lower back pain that can affect multiple aspects of their daily life. Chronic lower back pain lasting longer than three months is one of the most common chronic pain conditions that may inhibit mobility or daily activities. It has also been linked to anxiety and depression, poor perceived health or reduced quality of life and dependence on opioids.
Current treatment plans for chronic lower back pain often include, among other options, prescription and over-the-counter pain medications, exercise, steroid injections, surgery and transcutaneous electrical nerve stimulation.
EaseVRx's VR programme, which consists of daily 56 VR sessions for eight-weeks, employs the principles of CBT and includes deep relaxation, attention-shifting, interoceptive awareness - the ability to identify, access, understand and respond appropriately to the patterns of internal signals - and perspective-taking, distraction, immersive enjoyment, self-compassion, healthy movement, acceptance, visualisation, knowledge of pain and rehabilitation.
The FDA authorisation was based on an eight-week study of 179 participants with chronic lower back pain who were assigned to one of two eight-week VR programmes: the EaseVRx immersive 3D programme or a control 2D programme that did not utilise skills-based CBT methods of treatment.
EaseVRx participants (66 per cent) reported more than 30 per cent reduction in pain, compared to control participants (41 per cent). The reduced pain lasted for up to three months for people in the EaseVRx group but not for the control group.
EaseVRx was developed by the company AppliedVR. Its clearance for back pain comes around a month after the FDA approved another VR treatment, used to treat a visual disorder in children. The agency has also cleared a prescription video game called EndeavorRx to treat ADHD in kids between eight and 12 years old.