The American start-up AppliedVR has received an authorization from the Food and Drug Administration (FDA), the American agency in charge of regulating foodstuffs, medicines and medical devices, for its “EaseVRx” device. This digital therapy can therefore now be marketed throughout the United States.
Treating chronic low back pain
EaseVRx is for patients over the age of 18 who have been suffering from chronic low back pain, pain in the lumbar region for at least three months. Traditionally, this pathology is treated by prescribing opioid analgesics (morphine, codeine…) in order to reduce the pain and disability it represents on a daily basis.
EaseVRx’s bet is to relieve these people without medication through cognitive behavioral therapy (CBT), whose objective is to modify the negative beliefs and thoughts that the patient cultivates about himself.
Therapy through virtual reality
In practice, the person is equipped with a virtual reality headset (here a Pico G2 4K), a controller as well as a “breathing amplifier”. This is attached to the headset and directs the patient’s breathing to the headset microphone for use in deep breathing exercises.
The program lasts 8 weeks and consists of 56 sessions lasting 2 to 16 minutes. They include sessions of deep relaxation, shifting attention, perspective-taking, distraction and immersive fun, the FDA details in its statement. The objectives are to provide skills to the user to benefit from relief and reduction of pain interference in their daily activities.
A reduction in pain of more than 30%
To evaluate the safety and effectiveness of this new generation therapy, the American authority conducted a randomized double-blind clinical study (people evaluating the results of treatment in each participant do not know which participants received the treatment) involving 179 participants with chronic low back pain. Half of the cohort benefited from the EaseVRx program and the other from a virtual reality device not based on CBT methods.
At the end of the treatment, 66% of the participants who received EaseVRx reported a reduction in pain of more than 30% compared to 41% of the participants in the second group. In addition, 46% of EaseVRx participants reported a pain reduction greater than 50%, compared to 26% of control participants.
At the end of the eight-week program, participants were asked to rate the results on a 10-point scale, 10 being the highest value: pain intensity, interference of pain on activity, on mood, sleep and stress. On average, participants experienced a decrease in pain intensity by 1.31 points over the eight weeks of treatment.
Motion sickness and nausea
No serious adverse events were observed or reported during the study, the FDA says. In contrast, 20.8% of participants reported discomfort with the headset and 9.7% reported motion sickness and nausea.
The so-called “digital” therapies (DTx for digital therapeutics) are exploding. However, not all of them have been studied to confirm their effectiveness and safety. Far from it: most of it, offered in the form of mobile applications, has never been scientifically tested.