Newly Approved VR Therapeutic for Back Pain Expands Scope of Home Health

November 23, 2021 - As care moves out of the hospital, various devices and solutions are emerging to enable patients to receive care at home. Among these is a device that leverages virtual reality to treat chronic low back pain that just got a major regulatory boost.

Developed by AppliedVR, EaseVRx became the first virtual reality-based digital therapeutic for pain relief to gain Food and Drug Administration approval last week.

"This is a huge accomplishment for us," said Matthew Stoudt, co-founder and CEO of AppliedVR, in a phone interview. "It provides validation that VR is a therapeutic modality."

Chronic pain is a widespread health issue in America. In 2019, 59 percent of adults experienced some kind of pain, according to the latest data from the Centers for Disease Control and Prevention. Of these, 39 percent of adults had back pain, and 36.5 percent had lower limb pain.

AppliedVR's goal is to create a device category called immersive therapeutics, which could add a new dimension to the evolving home healthcare arena.

How the device works

EaseVRx is a virtual reality headset that comes preloaded with software content, which guides chronic low back pain patients through an eight-week program based on cognitive behavioral skills and other methods.

It incorporates biopsychosocial pain education, diaphragmatic breathing training, mindfulness exercises, relaxation-response exercises, and executive functioning games to help patients reduce pain symptoms.

Usually, pain is addressed with only physiology in mind, but AppliedVR aims to go beyond that, according to Stoudt.

"It's that classic journey of, 'Let's give them incense. All right, let's give them opioids. Let's give them injections. Let's give them implants. Let's give them surgery, surgery, surgery,'" he said. "But we're not fundamentally addressing the fact that chronic pain, like a lot of chronic disease conditions, is that biopsychosocial condition, which means that it is not only about the physiology and the pain, but it is also about the psychology, the comorbidity of depression, anxiety, and sleeplessness that gets exacerbated as that patient, the sufferer, ultimately feels more and more isolated from those around them."

In fact, just last year, the International Association for the Study of Pain changed its definition of pain for the first time in about 40 years to include the fact that the condition is influenced by biological, psychological and social factors.

It is this psychological aspect of pain that EaseVRx aims to mitigate.

For example, the diaphragmatic breathing training includes scenes of nature that come to life as the user breathes at the right pace.

"You start to see flowers bloom, and you see a tree grow and start to sway with the pacing of your breathing," Stoudt said. "And it is a really powerful thing. You can connect the mind and the body through an experience like that."

Similarly, one of the relaxation exercises includes virtual reality-based scenes of rain.

"It feels a bit chaotic," Stoudt said. "And as you calm yourself down, from a breathing perspective, then it starts to clear away. The clouds clear away. The rain dissipates. And you're then presented with a beautiful meadow. So, it teaches you again the concept of down regulating your own pain."

The goal is to teach patients these behavioral skills over time so that they can manage their pain more effectively on their own.

Scientific backing

Though research has highlighted some disadvantages of using VR headsets in healthcare, including motion sickness, the pros demonstrated regarding pain reduction may outweigh the cons.

AppliedVR included data from two randomized controlled trials that evaluated the effectiveness of its home-based, self-treatment program for chronic pain.

The first one, which was published in JMIR Formative Research, analyzed data from 97 people suffering from chronic lower back or fibromyalgia pain over a 21-day period. Those who used EaseVRx significantly reduced five key pain indicators, including average pain intensity, pain-related interference with activity and sleep.

The second study, published in the Journal of Medical Internet Research, included 179 individuals, of which 89 used EaseVRx. The rest used a VR headset that provided 2D nature content. The EaseVRx group reported on average a 42 percent reduction in pain intensity, a 49 percent drop in activity interference and a 52 percent decline in sleep interference as compared with their 2D VR headset counterparts.

Provider use

Even before the FDA gave its official blessing, providers have been using the device in pilot programs and for research, including Cedars-Sinai Medical Center in Los Angeles.

The health system has used the device in its research program for several years, said Brennan Spiegel, MD, professor of medicine and public health and director of health services research at Cedars-Sinai, in an email.

The device is currently being used for people with lower back pain, cancer-related pain, and in a study to help manage pain remotely among rural populations.

"We have seen consistent benefits of VR across a range of pain conditions, including both musculoskeletal, oncologic, and visceral forms of pain," Spiegel said.

The organization is also using the EaseVRx device in partnership with its obstetrics department. The program was effective at reducing pain among women in labor as compared with those who received no intervention, a study led by Cedars-Sinai's Melissa Wong, MD, shows.

What's next for AppliedVR

Currently, AppliedVR is focused on of scaling the EaseVRx device and program to successfully bring it to market. But the company is also thinking about its applicability outside of chronic lower back pain.

"The skills that we're teaching, we believe, have transferability to many of the different types of chronic pain that are out there," Stoudt said. "And so that's what we want to do next is start doing these real-world studies where we can actually validate the fact that EaseVRx as a platform has an opportunity to address more than the chronic low back pain."

Other areas of interest for the company include fibromyalgia, osteoarthritis, and total joint pain.

Further, AppliedVR has entered into a partnership with the National Cancer Institute. Together, the organizations are conducting a large feasibility study with a derivative of EaseVRx focused on cancer-related anxiety.

The crux of the AppliedVR product is behavior change, and so, the success of EaseVRx depends on whether it can entice patients to spend seven minutes everyday using the headset for eight weeks straight. Its popularity on a large scale across patient populations remains to be seen, but the company is betting on its unique approach to ensure engagement.

"Traditionally, we think about pain relief as a negative good," Stoudt said. "People don't want to take their pills, don't want to get their shots or injections, their surgery, but they do it because they believe on the other side, you're going to get relief from that affliction. But what we're doing, we have an opportunity to flip it on its head and actually make it a positive good, where patients actually look forward to the journey itself."