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Breakthrough Virtual Reality Therapy Targets Fibromyalgia and Chronic Low Back Pain

January 11, 2021
Stanford's Beth Darnall explains how this type of distraction therapy can reduce pain intensity as well as sleep, mood, and stress interference.

Virtual reality has been used for many years to treat acute pain, often during or after in-patient medical procedures, especially among children, but the therapy has been less studied in correlation with chronic pain. Now, the FDA has awarded breakthrough designation for EaseVRx, a virtual reality therapy in development by Los Angeles-based startup AppliedVR. that is designed to treat chronic fibromyalgia and low back pain. 

"VR has typically worked by distracting patients from their pain," explains Beth Darnall, PhD, director of Stanford University School of Medicine's Pain Relief Innovation Lab and lead researcher for AppliedVR. "This new approach is aimed at helping people with chronic pain by offering skills training in a variety of self-management techniques. The virtually reality headset is intended to be a training aid," Dr. Darnall told PPM, “so that eventually people would acquire skills to be able to self-regulate outside the headset.”

VR technology could also conceivably address clinical challenges around cost and accessibility. An at-home training program that provides patients with the tools to self-manage their pain would give clinicians a potentially powerful tool to treat pain and potentially reduce the need for opioids. 

In their pilot study of virtual reality, pain-related sleep interference was reduced by 40%; pain-related mood interference by 50%; and pain-related stress interference by 49%. (Image: iStock)

Pilot Study

FDA granted the virtual video device breakthrough designation after a randomized controlled pilot study demonstrated a significant reduction in pain with the use of the device as compared with an audio version of the therapy.1 In the study, 97 adults between 18- and 75-years-old (67% male) with self-reported low back pain (LBP or fibromyalgia were randomly assigned to one of two unblinded groups. The program consisted of 21 days of four to eight sessions (either VR or audio only) lasting from 1 to 15 minutes.

Participants in the VR group received a virtual reality headset preloaded with the experimental software. Those in the audio group received a link to the audio recordings which they could stream or download to their phones, laptops, or computers.

Both programs included cognitive behavior therapy, mindfulness exercises, relaxation training, and an educational component that included information about how thoughts and emotions influence the perception of pain. Because both groups received the same treatment program – only the presentation format differed – “we were able to demonstrate that VR had greater analgesic benefit and was superior in reducing pain-related interference to the exact same treatment delivered in a different form. It was a very high bar to exceed,” explains Dr. Darnall.



Pain intensity was measured using an 11-point numeric pain scale with pain levels assessed at baseline, seven times during treatment, and on Day 21, the treatment’s final day. Also used to evaluate pain were the 13-item Pain Catastrophizing Scale (PCS) and the Pain Self-Efficacy Questionnaire (PSEQ-2). Patients were asked to rate how much their pain interfered with mood, activity, sleep, and stress. At the end of the program, patients rated their satisfaction with the therapy on a 5-point scale ranging from “extremely dissatisfied” to “extremely satisfied” and reported any adverse effects, such as motion sickness.

Of the 54 patients who completed the post-intervention survey, 84% in the VR group and 72% in the audio group reported that they were either “very satisfied” or “extremely satisfied” with the therapy. Six participants from the VR group reported motion sickness, and five of those reported that the symptom occurred only “sometimes.”

More importantly, pain scores were reduced significantly over time with results strengthening after two weeks. Although both groups experienced a reduction in all measures of pain, the effect was stronger in the VR group, particularly over time. Patients in the VR group reported >30% reduction in pain intensity and a 37% reduction in pain interference measures. Pain-related sleep interference was reduced by 40%; pain-related mood interference by 50%; and pain-related stress interference by 49%. These improvements strengthened over the course of treatment.

While this pilot looked at chronic LBP and fibromyalgia pain, the researchers plan to expand their work to other types of chronic pain. “We think of these as tools to broadly empower individuals to better self-regulate and manage pain,” says Dr. Darnall. “Many research groups are currently launching studies or have active studies [looking at this] in different pain conditions.”

Last updated on: January 11, 2021
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