U.S. Food and Drug Administration11.17.21
The U.S. Food and Drug Administration 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.
“Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life,” said Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Pain reduction is a crucial component of living with chronic lower back pain. This 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.”
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 U.S. Chronic pain may inhibit mobility or daily activities and has 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. 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.
EaseVRx employs the principles of CBT and other behavioral therapy techniques for the purpose of reduction of pain and pain interference. 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 EaseVRx treatment program consists of 56 VR sessions that are 2-16 minutes in length, which are intended to be used as part of a daily eight-week treatment program. Each session incorporates elements of the aforementioned principles to provide the user with skills to achieve relief and reduction in the interference of pain in daily activities.
The FDA evaluated the safety and effectiveness of EaseVRx in a randomized, double-blinded clinical study of 179 participants with chronic lower back pain who were assigned to one of two eight-week VR programs: the EaseVRx immersive 3D program or a control 2D program that did not utilize skills-based CBT methods of treatment. After enrollment in the trial, participants were followed for a period of 8.5 months total, including a two-week baseline assessment period, an eight-week VR program, a post-treatment assessment, and follow-up at one, two, three, and six months after completion of the program.
At the end of treatment, 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. Furthermore, 46 percent of EaseVRx participants reported a greater than 50 percent reduction in pain compared to 26 percent of control participants. At one-month follow-up, all participants in the EaseVRx group continued to report a 30 percent reduction in pain and at the two- and three-month follow-up marks, the 30 percent reduction in pain remained for all outcomes with the exception of pain intensity. In contrast, the control group reported a reduction in pain below 30 percent at one-, two-, and three-month follow-up for all outcomes.
To evaluate the effectiveness of EaseVRx, at the end of the eight-week program, participants were asked to rate the following outcomes on a 10-point scale, with 10 being the greatest value: pain intensity, pain interference on activity, pain interference on mood, pain interference on sleep and pain interference on stress. On average, participants experienced a decrease in pain intensity of 1.31 points over the eight weeks of treatment. Participants also reported a decrease in pain interference for all measured outcomes that ranged from .95 points to 1.27 points down from their respective scores at the start of treatment.
No serious adverse events were observed or reported during the study. Approximately 20.8 percent of participants reported discomfort with the headset and 9.7 percent reported motion sickness and nausea.
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.
The FDA reviewed EaseVRx through the De Novo premarket review pathway, a regulatory pathway for low-to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
EaseVRx is manufactured by AppliedVR.
“Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life,” said Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Pain reduction is a crucial component of living with chronic lower back pain. This 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.”
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 U.S. Chronic pain may inhibit mobility or daily activities and has 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. 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.
EaseVRx employs the principles of CBT and other behavioral therapy techniques for the purpose of reduction of pain and pain interference. 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 EaseVRx treatment program consists of 56 VR sessions that are 2-16 minutes in length, which are intended to be used as part of a daily eight-week treatment program. Each session incorporates elements of the aforementioned principles to provide the user with skills to achieve relief and reduction in the interference of pain in daily activities.
The FDA evaluated the safety and effectiveness of EaseVRx in a randomized, double-blinded clinical study of 179 participants with chronic lower back pain who were assigned to one of two eight-week VR programs: the EaseVRx immersive 3D program or a control 2D program that did not utilize skills-based CBT methods of treatment. After enrollment in the trial, participants were followed for a period of 8.5 months total, including a two-week baseline assessment period, an eight-week VR program, a post-treatment assessment, and follow-up at one, two, three, and six months after completion of the program.
At the end of treatment, 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. Furthermore, 46 percent of EaseVRx participants reported a greater than 50 percent reduction in pain compared to 26 percent of control participants. At one-month follow-up, all participants in the EaseVRx group continued to report a 30 percent reduction in pain and at the two- and three-month follow-up marks, the 30 percent reduction in pain remained for all outcomes with the exception of pain intensity. In contrast, the control group reported a reduction in pain below 30 percent at one-, two-, and three-month follow-up for all outcomes.
To evaluate the effectiveness of EaseVRx, at the end of the eight-week program, participants were asked to rate the following outcomes on a 10-point scale, with 10 being the greatest value: pain intensity, pain interference on activity, pain interference on mood, pain interference on sleep and pain interference on stress. On average, participants experienced a decrease in pain intensity of 1.31 points over the eight weeks of treatment. Participants also reported a decrease in pain interference for all measured outcomes that ranged from .95 points to 1.27 points down from their respective scores at the start of treatment.
No serious adverse events were observed or reported during the study. Approximately 20.8 percent of participants reported discomfort with the headset and 9.7 percent reported motion sickness and nausea.
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.
The FDA reviewed EaseVRx through the De Novo premarket review pathway, a regulatory pathway for low-to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
EaseVRx is manufactured by AppliedVR.
