If you or someone you love lives with chronic pain, you likely understand how truly debilitating and exhausting this condition can be. Whether the pain was the result of an injury or degenerative disease, long-standing pain is more than just a physical problem. Impacting a person’s mental, social, spiritual, emotional, and even financial health, chronic pain can interrupt many facets of a person’s life — which puts people with this condition at greater risk of experiencing a decrease in their overall quality of life.
Unfortunately, despite our understanding of the many negative impacts that chronic pain can have on a person’s lifestyle, more and more people are diagnosed with the condition every year. Data collected from the National Health Information Survey in 2019 indicated that up to 20.4% of American adults were living with chronic pain, with 7.4% of these people living with high-impact chronic pain (a condition that impairs their ability to participate in their daily routine within the past three months).¹
As the numbers of people living with chronic pain continue to increase, our available treatment options have begun to stagnate. Instead of finding ways to better manage the pain, traditional medicine has relied more heavily on covering the symptoms of chronic pain, often through the use of prescription drugs. Analgesic medications (particularly addictive opioid medications like codeine, oxycodone, and morphine) are a popular choice for chronic pain treatment, despite the lack of evidence that they are an effective option for long-term therapy. With as much as 14% of insured Americans looking for treatment for lower back pain receiving opioids (and an estimated 9 million Americans misusing an opioid prescription in the past year alone), it is clear that we need to find safer alternative treatment options when it comes to treating chronic pain.²,³
With this in mind, driven by the popularity of virtual and augmented reality services, many healthcare software companies have been experimenting with the idea of virtual immersive pain therapy. With large and internationally acclaimed healthcare facilities like the non-profit Cedars-Sinai hospital in Los Angeles even hosting an annual VR in healthcare symposium every year, it is clear that virtual reality treatment is gaining traction — and this is further supported by the recent FDA approval of the first virtual reality treatment option for chronic pain.
Virtual reality (which is also sometimes referred to as augmented reality) is most commonly thought of as an entertaining technology used to simulate an environment that is different from a person’s current surroundings. Used for video games, immersive experiences, and even learning opportunities, virtual reality is facilitated through a wearable headset and hand-held controllers. Able to make a person feel like they are truly immersed in their virtual space, it is no wonder that this technology has carried over into the healthcare industry as a possible patient therapy option.
As one of the most common causes of disability across the United States, part of the difficulty of adequately treating chronic pain is associated with its many different causes. While most people are familiar with muscular or inflammatory pain in their lower back, neck, or joints, other sources of pain such as degenerative diseases and neurological damage can also cause significant symptoms that can be very difficult to manage.⁴
While the long-term pain caused by these conditions is part of the umbrella term of chronic pain, each specific cause requires unique treatment options that can vary from patient to patient.
Looking to expand the options available for all patients with chronic pain, the U.S. Food and Drug Administration (FDA) approved the EaseVRx in November 2021 as the first prescription virtual reality device aimed to treat patients aged 18 or older living with chronic lower back pain.⁵ As an FDA approved treatment, the EaseVRx had to undergo extensive testing and was the subject of multiple studies to prove its efficacy and benefit for those living with chronic pain — which is one of the reasons why its approval is such an exciting push forward for virtual-based healthcare therapy.
Designed to offer an immersive experience that provides support through cognitive behavioural therapy (CBT) techniques, the EaseVRx has been proven to be a successful treatment option for lower back pain that does not rely heavily on addictive narcotic medications.
Just like many other chronic pain treatment options, a patient is given a prescription in order to start their EaseVRx treatment. Most commonly used in at-home settings, this device can be set up for use in any room with adequate space. Similar to traditional VR sets, the EaseVRx comes with a headset and hand controllers — but it also comes with a specialised breathing amplifier attachment that is added to the headset to more accurately track a patient’s breathing during the breathing exercises that are part of the therapy.⁶
The primary purpose of the EaseVRx is to provide patients with access to immersive and high-quality cognitive behavioural therapy from the comfort of their own homes. This form of treatment is commonly used by therapists worldwide, offering support in the development of healthier coping mechanisms and skills for dealing with psychological symptoms of pain.⁷ Focused on changing a person’s perception of their thoughts, emotions, and behaviours, the CBT programming that the EaseVRx is designed to help the participant experience⁵:
Improved healthy movement
Once a patient has received their prescription for the EaseVRx, they can set up their device and begin their treatment quickly and easily. As part of the program, the participant will partake in up to 56 different virtual CBT sessions using the system, ranging in length from 2-16 minutes.⁵ The EaseVRx program is created to be completed daily over an eight-week period for the best possible results.⁵
As part of the FDA approval process, the EaseVRx was the central focus of a study to determine both its effectiveness and safety. With a group of 179 participants diagnosed with chronic lower back pain, the randomised, double-blind clinical study divided the group into two sections — one who received the EaseVRx virtual reality system that utilised immersive CBT techniques, and the other who received a control program that was not a VR experience and also did not contain CBT techniques⁸. Over an eight and half month period, the participants were observed to better understand their baseline pain, their experience using the program they were assigned, and their follow-up feelings and symptoms. Throughout the duration of the program, the participants were asked to report their daily lower back pain levels on a scale from zero to ten, with zero being no pain and ten being severe pain that is as bad as it could be.⁸ After the completion of the study, these were the findings reported⁸:
The group who participated in the EaseVRx program reported pain levels more than 30% lower than the control group, indicating that the VR program offered significant benefits for controlling lower back pain symptoms.
On average, participants who used the EaseVRx system recorded a decrease in their pain by 1.31 points throughout the study, showing improvement from their baseline pain values.
There were no significant adverse effects reported throughout the duration of this study, but minor side effects were experienced by both groups. Throughout the study, roughly 20% of participants expressed discomfort from wearing the headset, and nearly 10% of people experienced some form of nausea or motion sickness from the devices.
Through the completion of this study, the EaseVRx was granted status as a breakthrough device, a designation used by the FDA to indicate that this treatment option is used to treat debilitating disease.⁹ To meet the criteria of the breakthrough device program, the EaseVRx had to meet at least one of the following criteria⁹:
The device must represent a new or breakthrough technology
There must be no other easier or available treatment alternatives
The device must offer significant advantages over previously approved treatment options
The increasing availability of the device would be in the best interests of patients in need
Finally, the EaseVRx was approved using the De Novo premarket review pathway, which is the regulatory pathway most commonly used for low-moderate risk medical devices.¹⁰ As the first device of its kind to be an FDA approved treatment option, there is still lots of work to do from both the FDA and AppliedVR (the vendor who created EaseVRx) to ensure that patients are getting the best possible outcomes from using the technology. Additionally, AppliedVR plans to expand its services further, looking to create VR programs designed to help those living with other chronic pain conditions such as fibromyalgia, burns, and childbirth. ¹¹
As more research is being conducted to better understand the mental aspects of chronic pain, we have found that psychological factors and treatment options like cognitive behavioural therapy can significantly impact a person’s perceived pain level. ¹²
Currently, the most effective and well-studied psychological treatment that is used to treat a wide variety of medical conditions is CBT. Commonly used as a therapeutic option for those living with anxiety, depression, post-traumatic stress disorder (PTSD) and more, it can also be used to successfully offer relief to patients living with chronic pain. The goal of participating in CBT is to help a person come to a new understanding and build a new relationship with their pain.
“I’ve treated so many people who, because they thought they’re weak with back pain or leg pain, they’ve started to use a walking stick. And then they started getting pain in their shoulders and neck. But, when you teach them to walk without the stick, they realise it was the stick that was causing the pain,” says Amanda Williams, the University College London clinical psychologist who was a leading researcher on an expansive meta-review on the benefits of CBT. ¹³
In another meta-analysis conducted on 48 studies, more conclusive evidence of the positive effects of CBT were reported. ¹⁴ Exploring the results of these studies that were conducted on over 7000 participants with anxiety or depression, it was found that patients were more likely to experience less severe symptoms when they were treated with CBT rather than their traditional treatment options. ¹⁴
While the new FDA approval of the EaseVRx is an exciting accomplishment, it may still have some barriers to becoming a household name and choice for patients across the country. With traditional chronic pain treatment options relying on pain medications, steroid injections, and invasive surgery, it may be hard for some patients to wrap their heads around the psychological benefits of virtual reality CBT for their pain.
But, this being said, the expected interest and investment in augmented and virtual reality treatment in healthcare are currently on the rise. With survey results showing a 43% increase in expected interest in VR/AR in healthcare in 2019, the continued development and adoption of these products as mainstream options for treating common diseases is also sure to rise¹⁵
With the North American VR/AR market projected to be worth more than 460 million dollars in the year 2025, it is clear that the general public and investors are interested in learning more about what this technology can do in the healthcare space. ¹⁶
As the first virtual reality treatment option approved by the FDA, many people believe that the EaseVRx is just the first of many new innovative healthcare technologies that are designed to make effective psychological therapy more accessible to a broader range of people around the world. From mental health VR headsets designed to provide narrative therapy for those living with PTSD to smart glasses being created to help people meditate more effectively, it is clear that the healthcare technology industry is committed to integrating VR/AR options into their available services.
While there still is lots of work to be done to better understand the full range of benefits and challenges that virtual reality technologies offer in the medical field, the FDA approval of the EaseVRx is an exciting first step towards integrating advanced healthcare technology into patient’s day-to-day routines. Researchers and medical providers alike are looking forward to seeing the future of this space expand over the next following years, with hopeful optimism that these styles of technology will help reduce the number of people living with chronic pain or dependent upon narcotic pain medications for pain relief.
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 from the Journal of Medical Internet Research
The author, Claire Bonneau, is a medical writer and certified trauma operating room nurse.
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