FDA slates VR for lower back pain and fibromyalgia for expedited review

AppliedVR's EaseVRx landed an FDA Breakthrough Device designation for its tool that combines VR and cognitive behavioral therapy.
By Laura Lovett
12:10 pm
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Virtual reality company AppliedVR has landed an FDA Breakthrough Device designation for its technology designed to treat fibromyalgia and chronic lower back pain. The tool, named EaseVRx, combines a VR headset with visual and audio programs that deliver cognitive behavioral therapy (CBT), relaxation, and mindfulness training, as well as other behavioral methods to give what it calls “self-management skills” to its users. 

In July, JMIR Formative Research published a study that found that patients with lower back pain or fibromyalgia using the technology had a significant reduction in pain, compared to their peers who received an audio-only version. Participants of the study used the tool in a home setting. In the past, the tool was used in acute hospital settings. 

WHY IT MATTERS 

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Lower back pain is very common in the U.S. population. In fact, the CDC reports that in the last three months 25% of US adults report having lower back pain. Of those with the condition around 14% are prescribed opioids. 

Fibromyalgia is not as common as lower back pain, but still impacts about 2% of the adult U.S. population, according to the CDC. Symptoms include pain and stiffness, fatigue, depression and headaches. 

Today digital health companies are looking to ease the pain of those conditions, and the use of opioids to treat specifically lower back pain. 

“Virtual reality is a promising skills-based behavioral medicine that has been shown to have high patient-engagement and satisfaction,” Dr. Beth Darnall, AppliedVR’s chief science advisor, said in a statement. “However, chronic pain patients to date have had very limited access to it, so we’re excited to continue working with the FDA to develop our platform and get it into the market faster.”

THE LARGER TREND 

This is far from the first effort to curb pain by using virtual reality. For example, a Cedars-Sinai clinical study published in PloS One in 2019 found that VR is not only an effective approach for hospital inpatients experiencing a wide variety of pain, but likely retains its impact when it's provided over multiple days under real-world circumstances.

Startup Karuna Labs raised $3 million in seed funding last year to support clinical validation of its research on VR and pain. In Europe, Oncomfort, a VR system designed to relieve pain and anxiety, raised €10 million ($11.8 million) in Series A funding in September.

While the use cases for virtual reality are growing, there is still much to be hammered out in terms of reimbursement and implementation.

 

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