Q&A With AppliedVR’s Matthew Stoudt on Treating Pain with Virtual Reality

Matthew Stoudt

Matthew Stoudt, co-founder and CEO of AppliedVR, based in Van Nuys, Calif., recently spoke with Medical Devices and Technology to discuss treating pain with virtual reality (VR)–based products. In 2020, FDA granted breakthrough designation to Relievrx, AppliedVR’s VR-based adjunctive treatment for chronic lower back pain. The product was approved by the agency in November 2021.

MDT: What was the genesis of Relievrx?

Matthew Stoudt: This product was decades in the making. In the 1990s, researchers at the University of Washington were looking for ways to ease the pain of burn victims.¹ Opioids do not work on everyone, and the opioid crisis was starting², so researchers at UW were looking for other ways to reduce pain. The initial thoughts were essentially to interrupt the neural pathways carrying those pain messages with other information, then pain might ease. And functional magnetic resonance imaging proved them right (UW has a large body of work on its findings³). The technology, however, wasn’t around that could flood those pathways.

MDT: Could you explain what you mean by “the technology wasn't around?”

MS: The hardware itself. In VR’s earlier days, the computer and the headset were separate. We didn’t want to produce the product in two pieces. If it is not easy to use, patients will get frustrated and not use it.

MDT: How does pain become chronic?

MS: Pain becomes chronic when there is repeated stimulation to a particular nerve. That stimulation creates a pathway to the emotional centers of the brain, which is why pain is not only a biological issue, but psychological and social as well. VR can engage the brain with long-term learning. We can create long-term relief for patients.

MDT: How does AppliedVR’s device work?

MS: In our modules, breathing exercises are paramount. The patient engages in breathing-based biofeedback training, specifically to engage the parasympathetic nervous system, which controls the body’s ability to relax. In essence, the treatment program teaches patients how to live a better life with their pain.

MDT: Please discuss the research involving Relievrx.

MS: During the height of the pandemic, Relievrx was tested⁴ in a remote, randomized controlled trial; 89 patients received Relievrx while 90 were given sham VR. These patients had self-reported at baseline that they had lower back pain for at least six months. Close to the majority in both groups had been in pain for more than 10 years; about one-third in each group were taking an opioid. The treatments lasted for 56 days, an average of six minutes per day.

MDT: What did the treatments involve?

MS: Each day, while using the headset, the patients learned about cognitive behavioral therapy, the neuroscience of pain, and mindfulness. Data from the patients was collected before, during, and after the treatment study was finished.

MDT: What were the results?

MS: Patients in the testing group reported a reduction in pain intensity an average of 42.8%; the sham group reported 25.1%. The treatment group also reported improvement in pain interference with sleep, 54% vs. 39.2%, and mood, 55.7% vs. 40.04%.

MDT: Was there any follow-up?

MS: Yes. Six months later, the participants were surveyed on their pain and its effects on mood, stress, sleep, and more. In every category, the treatment group reported better outcomes than those in the sham group.⁵ We are now recruiting for an interventional, randomized, parallel assignment trial with 1,000 people. It will be triple masked—study investigators, statisticians, and patients.

MDT: How do patients get Relievrx?

MS: Through a prescription from their doctors. It is the same program as the one we used in the clinical trials. After the 56 weeks, the patients return the headsets.

MDT: The second trial showed that patients were still experiencing pain relief after six months. But what about after those six months?

MD: We are looking at that question now. We are recruiting for an HEOR (health economics and outcomes research) trial. Our whole point is that we want people to acquire the skills that will give them lasting change.

References

1. Larry Zalin. Pausing the pain. University of Washington Magazine. December 1996. https://magazine.washington.edu/feature/uw-doctors-explore-novel-ways-to-ease-patients-pain/
2. Understanding the Opioid Overdose Epidemic. Centers for Disease Control and Prevention. https://www.cdc.gov/opioids/basics/epidemic.html#:~:text=The%20first%20wave%20began%20with,overdose%20deaths%20involving%20heroin4
3. PubMed. https://pubmed.ncbi.nlm.nih.gov/?term=patterson%20hoffman%20pain%20burn&sort=date
4. Garcia LM, Birckhead BJ, Krishnamurthy P, et al. An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19. J Med Internet Res. 2021 Feb 22;23(2):e26292.
5. Garcia L, Birckhead B, Krishnamurthy P, et al. Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial. J Med Internet Res. 2022 May 25;24(5):e37480.