Seniors Surprisingly Eager To Try Virtual Reality Therapy for Pain

By Pat Anson, PNN Editor

When it comes to using new technology or acquiring new skills, older people have a reputation for being a little slow on the uptake. A Baby Boomer nearing 70, for example, might not rush out to buy the latest iPhone, while someone from GenZ or a Millennial would.

A new study of virtual reality (VR) therapy is proving how misguided that assumption is. Older people can indeed learn new things and benefit from them.

In a secondary analysis of a placebo controlled clinical trial, people over 65 were significantly more likely to use RelieVRx, a virtual reality program that distracts patients with back pain by immersing them in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery.   

A demographically diverse group of over 1,000 patients with chronic low back pain participated in the 8-week trial, with the goal of spending a few minutes at home each day watching a RelieVRx program.

By the end of the study, pain scores were reduced by an average of 2 points on a zero to 10 pain scale.

The positive results were across the board, regardless of a person’s age, sex, ethnicity, income or education.

What stood out to researchers is that seniors were significantly more likely to use the devices daily – 47 times on average – compared to those under age 65 (37.6 times)

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“We had the opportunity to do a deeper dive, and really see how the results were unfolding in younger adults versus older adults, and really found very good engagement with older adults 65 or older,” says Beth Darnall, PhD, Chief Science Advisor for AppliedVR, which makes the RelieVRx headset and programming. 

“What's important about this study and also interesting is that it challenges a very common misperception about older adults. That older people are low tech, disinterested in engaging with newer innovations. We actually saw great engagement among the older adults, as well as a great reduction in symptoms. It suggests that older adults are much more receptive to this type of an approach and that it's also very effective in this population.” 

There are a few caveats to the findings. Many older people are retired and have more time on their hands to participate in a home-based study like this. And since all the patients were recruited online, they may have already been tech savvy enough to wear the VR headset and make it work for them.

RelieVRx is currently being used in hundreds of hospitals and in the Veterans Affairs (VA) system. Patients who’ve tried VR seem to like it, regardless of their backgrounds.

“The VA patients are generally pretty different than the rest of the civilian populations,” says Josh Sackman, president and co-founder of AppliedVR. “The usage is fairly consistent, even with a VA patient prescribed by a doctor who has no exposure to what VR is ahead of time.” 

VR therapy is a form of mindfulness or cognitive behavioral therapy. It doesn’t cure or relieve physical pain, but distracts patients long enough that their symptoms seem less severe. A 2022 study found that VR therapy has long-lasting benefits up to six months after treatment stopped.

The FDA has authorized the marketing of EaseVRx for chronic low back pain in adults, the first medical device of its kind to receive that designation. EaseVRx is only available by prescription and can’t be purchased directly by consumers.

In the coming months, AppliedVR hopes to expand coverage of the device through Medicare, Medicaid, and at least one large commercial insurer.

FDA Approves First Virtual Reality Device for Chronic Low Back Pain

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has authorized the marketing of the first home-based virtual reality (VR) device for the treatment of chronic lower back pain in adults.

The EaseVRx headset uses guided VR programs to help patients relax, meditate and distract themselves from their pain, using the principles of cognitive behavioral therapy (CBT). The device is made by AppliedVR, a Los Angeles-based company that is developing therapeutic VR programs to help treat pain and other conditions.

"Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life," Christopher Loftus, MD, acting director of the FDA’s Office of Neurological and Physical Medicine Devices, said in a statement. “Today's authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain."

Chronic lower back pain is defined as moderate to severe pain in the lower back lasting longer than three months. It is one of the most common chronic pain conditions and a leading cause of disability.

The FDA’s marketing approval is based a clinical study of 179 participants with chronic lower back pain. Half were given an EaseVRx headset to watch immersive 3-D programs daily for 8 weeks. The other half also used the headset, but only watched routine nature scenes as a sham treatment.

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At the end of treatment, 66% of those who watched VR programs reported at least a 30% reduction in pain, compared to 41% of participants in the sham control group.

Nearly half of those in the EaseVRx group reported at least a 50% reduction in lower back pain.

No serious adverse events were reported during the study. About 20% of participants reported discomfort with the headset and nearly 10% reported motion sickness and nausea.

EaseVRx was given a Breakthrough Device Designation by the FDA in 2020 for treating fibromyalgia and chronic lower back pain. The designation speeds up the development and review of new medical devices.

Marketing approval of EaseVRx – known as a "De Novo pre-market review" – creates a new regulatory classification for VR devices. It clears the way for similar devices with the same intended use to obtain marketing authorization – a significant development for the fledgling virtual reality industry.

"We worked tirelessly over the past few years to build an unmatched body of clinical evidence that demonstrates the power of VR for the treatment of pain, and couldn't be more thrilled to achieve this important milestone," said Josh Sackman, AppliedVR’s co-founder and president. "But, our mission does not stop with this one approval. We're committed to continuing research that validates our efficacy and cost-effectiveness for treating chronic pain and other indications."

EaseVRx will only be available by prescription. Its software programs immerse users in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery.  The content also incorporates biopsychosocial pain education, diaphragmatic breathing, mindfulness, and relaxation exercises.

AppliedVR headsets are already being used for pain management in over 200 hospitals and healthcare systems. A company spokesman told PNN that EaseVRx will be available on a limited basis through select providers toward the middle of 2022, with a full commercial launch expected in 2023. AppliedVR's is currently building a distribution network and working with insurers -- Medicare, Medicaid and commercial -- to establish reimbursement levels. No pricing plans have been announced for its VR headset or programs.