FDA authorises marketing of a VR system to treat chronic lower back pain

Lena Weib

On November 16, 2021, the US Food and Drug Administration (FDA) authorised the marketing of AppliedVR’s EaseVRx, a virtual reality (VR) system that uses cognitive behavioural therapy (CBT) and other behavioural methods to reduce pain in patients with chronic lower back pain.

This authorisation provides an option for patients with lower back pain to treat their pain without the use of opioid medications, which are notorious for having a high risk of abuse.

Chronic lower back pain, which is defined as moderate to severe levels of pain in the lower back lasting longer than three months, is one of the most common chronic pain conditions in the U.S. Current treatments for lower back pain would include prescribed or over-the-counter pain medication, exercise, steroid injections and surgery. Chronic lower back pain can get in the way of daily activities and decrease quality of life. This pain condition has been linked to anxiety and depression. With CBT, patients will be aided in disassociating their pain with negative emotions.

EaseVRx makes use of principles of CBT as well as other behavioural therapy techniques to reduce pain in chronic lower back pain patients. The device to designed to be used at home, and consists of three parts: the headset, controller, and a ‘Breathing Amplifier,’ which is used during deep breathing exercises. The device’s VR programme uses established principles of behavioural therapy techniques such as deep relaxation and attention-shifting to aid in pain relief.

The EaseVRx programme includes eight-week treatment programmes that consist of 56 short VR sessions. 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 each assigned to one of two eight-week VR programmes: the EaseVRx immersive 3-D programme or a control 2-D programme 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 programme, a post-treatment assessment and follow-up at one, two, three and six months after completion of the programme.

At the end of treatment, 66% of EaseVRx participants reported more than 30% reduction in pain, compared to 41% of control participants who reported more than 30% reduction in pain. At one-month follow-up, all participants in the EaseVRx group continued to report a 30% reduction in pain and at the two- and three-month follow-up marks, the 30% reduction in pain remained for all outcomes except pain intensity. In contrast, the control group reported a reduction in pain below 30% at one, two and three-month follow-up for all outcomes.

No serious adverse events were observed or reported during the study. However, about 20.8% of participants reported discomfort with the headset and 9.7% reported motion sickness and nausea.

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 labelling 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.

Virtual reality systems have the potential to revolutionize psychotherapeutic treatments. Traditionally, treatments for psychological conditions are done in person. However, with the pandemic, these therapy sessions have been taking place virtually. With the uncertainties of the effects of Covid-19 on our day-to-day healthcare treatments, VR may have the potential to provide accessible and readily available options for therapy, without the need for in-person sessions.

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