Virtual reality (VR) is increasingly used to enhance personal experience video games and other entertainment applications. Now, a first-of-its-kind clinical trial conducted by digital health startup AppliedVR suggests the computer-based technology is both feasible and effective for treating chronic pain in a patient’s own home.

The randomized, controlled pilot study compared EaseVR, a virtual reality-based treatment for at-home self-management of chronic pain, with an audio-only version of the same program. In all, data from 74 people with chronic low back pain or fibromyalgia pain were analyzed, with EaseVR users showing significant reductions in five key pain indicators, vs. patients in the audio-only group.

Specifically, the EaseVR cohort reported 30% less pain intensity, 37% less pain-related interference in activities and 50% less pain-related mood interference than did controls. Pain-related sleep disturbances and stress were also declined by 40% and 49%, respectively.

The results were published July 7, 2020, in JMIR Formative Research.

Draws on cognitive behavioral therapy, mindfulness

AppliedVR’s chronic pain management program engages people in a sequence of once-daily modules, averaging five to 10 minutes, that present concepts and techniques rooted in proven practices such as cognitive behavioral therapy, biofeedback and mindfulness. The pilot study collected outcomes at 21 days. A newly launched study of low back pain only will take the results out to eight weeks, and will compare EaseVR to a VR sham.

The goal is to augment a patient’s current pain management plan to increase their resilience and options for anywhere/anytime on-demand care, one tool in the larger tool kit of chronic pain treatments, said Josh Sackman, co-founder and president of the Los Angeles-based company. A wellness-based version of the program is currently available in a number of hospitals in the U.S.

“What we’re trying to do is take evidence-based approaches rooted in cognitive behavioral therapy and mindfulness and biofeedback and really techniques that have been studied and proven over time and look to see where virtual reality may be a unique delivery platform with inherently different properties that may lead to better engagement and, in some cases, may lead to better efficacy because of the unique properties of VR,” he told BioWorld.

Sackman said the company wanted to take the program beyond the confines of the hospital to address the 100 million people in the U.S. and 20% of people globally living with chronic pain. “This study showed that virtual reality could transcend the walls of a hospital, be self-administered and, beyond just helping with acute pain flairs … train people using cognitive behavioral methods so when the goggles come off they’re more equipped to deal with their pain.”

Outcomes increased over time

The science behind chronic pain management suggests that its important to empower individuals with the skills that enhance self-regulation, stressed Beth Darnall, associate professor at Stanford University and chief science advisor at Applied VR. The company has looked to other evidence-based programs and usage patterns that achieve high adherence and efficacy in designing its pain management program.

In the pilot study, “we were incredibly pleased to see that the format, the method by which the treatment is delivered, does matter,” Darnall told BioWorld. While user engagement was essentially the same between the audio and VR sessions, “the patients who received their treatment through VR had superior outcomes, and we saw this superiority increasing over time over the course of the treatment,” she said. “This dovetails with what we see in general cognitive behavioral therapy, what we see really in chronic pain treatment, where it takes several weeks for these results to unfold, because people are learning the information and how to apply it in their daily lives.”

The true effects usually start to emerge somewhere between four and eight weeks, she said.

The company had a presubmission meeting with the U.S. FDA last year and is currently working to define the frequency of use, sequencing of modules and protocols to achieve top results and meet regulatory requirements. “We plan on meeting later this year and deciding whether it’s a class I or class II [device], based on the claims and intended use,” Sackman said.

Cost-effectiveness key

AppliedVR closed a series A round in 2018, but has not disclosed either the amount or the investors. Sackman said the company’s backers include institutional investors, as well as a strategic investor that is a multinational biopharmaceutical and medical device company.

Last year, the company received a $2.9 million grant from the National Institute on Drug Abuse and is conducting studies at Geisinger Health System and the Cleveland Clinic into the use of its program in postsurgical recovery following joint replacement, as well as chronic pain management. One of the primary endpoints is whether the VR-based treatment reduces opioid use.

The company also has partnered with the University of California at San Francisco to study how digital health programs, including augmented and virtual reality, can be deployed to expand access to care for underserved populations.

In parallel to its more regulatory-focused studies, AppliedVR is running pilots with several payers to determine what the payment business model should look like and to gather cost-benefit data to support reimbursement, Sackman said. That includes looking at potential variables the company can influence, such as a reduction in emergency room or planned office visits, less medication usage and the impact on opioid addiction risks.

“It’s really important to us not just to have evidence that we’re creating high-quality clinical results, but if it’s not cost-effective, it won’t have a clear place to fit into the market,” he said.

“Right now, the cost of hardware is certainly more expensive than a mobile app. And so a question is, if this could be delivered like an app in the app store, what’s the justification for adding a hardware component,” Sackman said. “It’s really important for us to answer that question over the next year to come.”

In addition to chronic and postoperative pain, AppliedVR’s pipeline includes a treatment for generalized anxiety. All of the products are in early or mid-stage clinical trials.

“We’re aiming to be the evidence-based leader in this space,” Darnall said, “and widespread adoption is predicated on clinical evidence.”

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