Anesthesia in the News
  • FDA Authorizes Virtual Reality Device for Lower Back Pain

    The US Food and Drug Administration has authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain.

    Chronic lower back pain, which is defined as moderate to severe pain in the lower back lasting longer than three months, is one of the most common chronic pain conditions in the US.  Chronic pain may inhibit mobility or daily activities and has been linked to anxiety and depression, and reduced quality of life and dependence on opioids.

    Beyond conventional options

    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. Cognitive behavioral therapy (CBT) may be used to reduce the burden of chronic pain and increase function through an emotional, cognitive, and behavioral approach to shift negative beliefs held by patients about the relationship between their pain and movement.

    The prescription device, which is intended for at-home self-use, 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.  The device’s VR program uses established principles of behavioral therapy intended to address the physiological symptoms of pain and aid in pain relief through a skills-based treatment program. These principles include 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, visualization, knowledge of pain and rehabilitation.  The device is used in a program of 56 brief (2 to 16 minutes) VR sessions over eight weeks.

    “VR substantially modulates pain and pain intensity,” explained Beth Darnall, PhD, about behavioral treatments for chronic pain at the 2021 annual Medicine American Society of Regional Anesthesia and Pain Medicine (ASRA).

    “[This FDA 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,” stated Christopher M. Loftus, MD, the acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in a press statement.

    Breakthrough designation

    The FDA reviewed EaseVRx through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. EaseVRx was granted breakthrough device designation.

    To qualify for such designation, a device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.

    Double-blind tested

    As part of its review, the FDA looked at the safety and efficacy results of a randomized, double-blind study of chronic LBP patients (n=179), who were assigned to eight weeks of treatment with the 3D EaseVRx program or a control group who participated in a 2D, non–CBT-based program for the same length of time.

    Before beginning the treatment program, patients completed a two-week baseline assessment period.  Follow-up was conducted at one, two, three and six months after the VR program.

    Mitigating pain in QOL

    On a 10-point scale, participants self-reported a decrease in pain intensity of 1.31 points on average over the eight weeks of treatment.  In quality-of-life parameters, study participants also reported a decrease in pain interference for activity, mood, sleep and stress (range, 0.95- to 1.27-point difference from baseline).

    At the end of treatment, a 30% or greater reduction in pain was reported by 66% of EaseVRx participants, compared with 41% of control participants.  A 50% or greater pain reduction was reported by 46% of VR participants versus 26% of control participants.  All VR participants reported a 30% reduction in pain at the one-month follow-up, and at the two- and three-month follow-up except for pain intensity.  The control group did not report an average 30% reduction in pain at any time point.

    Furthermore, no serious adverse events (AEs) were observed or reported during the study. The most commonly reported AEs were headset discomfort (20.8%), and motion sickness and nausea (9.7%).

    “There has been quite a sea change [in acceptance of the therapy] facilitated by COVID,” stated Darnall.  “Now, we need to make it really convenient and attend to the needs of each patient.

     

     

     

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