A virtual reality program intended to treat fibromyalgia and chronic lower back pain received a breakthrough device designation from The Food and Drug Administration. AppliedVR, the Los Angeles-based startup developing it, said the designation was a milestone toward using VR as a digital therapeutic for chronic pain.
“It’s a great statement form the FDA that they believe in this as a modality, broadly speaking,” Co-Founder and CEO Matthew Stoudt said in a call. “It helps accelerate our pathway through the FDA. We’re able to have faster discussions with them as we go through the process.”
The FDA’s Breakthrough Devices program is intended to speed up the review process for medical devices that provide better treatment for life-threatening or debilitating conditions. To be eligible, devices must represent a breakthrough technology, or one with no cleared alternatives.
AppliedVR received the breakthrough designation after publishing the results of a randomized study of 97 people who used a self-administered VR program to manage chronic pain at home. It recruited people with low-back pain or fibromyalgia through online advertisements, and randomly assigned them to a 21-day VR program or an audio-only version of the same program. The study was not blinded.
Stoudt said patients are provided the devices, and are supposed to do short exercises, roughly three to seven minutes, every day.
“We don’t want you to live your life in a headset. Our objective is to drive neurobehavioral change. To teach you skills outside of the headset to self-regulate your pain,” he said. “We hear time and time again from patients that this has retrained me on how to breathe through my pain, control my pain, process my pain.”
Both programs included cognitive behavioral therapy, with information about how thoughts and emotions can impact pain, as well as diaphragmatic breathing exercises and mindfulness content. Patients were asked to rate their pain on a scale from one to 10 using the Defense and Veterans Pain Rating Scale (DVPRS) four times throughout the study.
At the end of the study, participants on average reported their pain intensity was reduced by 30%, and pain-related activity interference was down 37%. They also reported reductions in pain-related mood interference, sleep interference and stress. The results were published in the Journal of Medical Internet Research in July.
Admittedly, pain scores are a subjective measurement, making results difficult to quantify.
“It’s the best we have as an industry. We’re always looking at, are there ways to capture biomarkers that can be good indicators of this? But it is a subjective thing,” Stoudt said.
AppliedVR is testing its software in two more studies with Geisinger and the Cleveland Clinic to test whether VR could reduce the use of opioids as a treatment for chronic pain and acute postoperative pain. The National Institute of Drug Abuse awarded it $2.9 million in grant funding for the trials.
“Immersion and interactivity, those two things together are very powerful,” he said. “We’re scratching the surface, the tip of the iceberg, of all the ways to do this to make an impact in patients’ lives.”