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EaseVRx approved by FDA for chronic lower back pain

EaseVRx which is a virtual reality system based on cognitive behavioural therapy has been approved by the FDA for chronic lower back pain.

EaseVRx, a prescription-use immersive virtual reality (VR) system, has been approved by US food and Drug Administration (FDA)to help with pain relief in patients with chronic lower back pain.

Chronic lower back pain, i.e., moderate to severe pain lasting for more than 3 months, is a common condition which increases with age. One systemic review in 2015, estimated a prevalence of 4.2% among those aged 24 to 39 but which increased to 19.6% in those aged up to 50 years.

Several treatment options are available for those with chronic low back pain and in the UK, guidance from NICE does recommend the use of psychological therapies such as cognitive behavioural therapy (CBT) but ‘only as part of a treatment package including exercise, with or without manual therapy (spinal manipulation, mobilisation or soft tissue techniques such as massage).’

The EaseVRx system makes use of CBT and other psychological approaches with a view to a reduction of pain and pain interference. The device is intended for at-home self-use and consists of a virtual reality (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 VR provides an environment comprising 3D visually immersive experiences that are enriched with stereo sounds and elements such as rich colours and scenic environments that enhance elicitation of desired states of arousal and affect. 

Clinical efficacy

The FDA approval was based on the results of a clinical trial in which the EaseVRx was compared with a sham device in patients with chronic lower back pain. The results of the study have been published and included 179 individuals with a mean age of 51.5 years (76.5% female) and self-reported, non-malignant low back pain with duration of 6 months or more and with average pain intensity of 4 or more out of a possible maximum score of 10. These individuals were then randomised 1:1 to EaseVRx or VR sham treatment for a total of 56 days with each VR experience lasting between 2 and 16 minutes (average of 6 minutes). The primary outcome included several measures related to the change in recorded pain scores.

At the end of the study, a moderate clinical importance in pain reduction ( defined as a ≥30% reduction in pain), was achieved by 65% of those using EaseVRx compared to 40% of those given the sham VR. Similarly, 46% of EaseVRx participants reported a greater than 50% reduction in pain compared to 26% of placebo participants.

At one-month follow-up, all participants in the EaseVRx group continued to report a 30% reduction in pain which persisted over the next three months for all aspects of pain except pain intensity. In contrast, the reduction in pain was below 30% in the control group at all follow-up time-points.

Source. FDA press release



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