Editor’s note: This article is part of PRF’s featured content series, “Investigating Virtual Reality for Pain Management: Past, Present, and Future,” which has been made possible thanks to a generous grant from the MAYDAY Fund.
Chronic low back pain is the most common chronic pain condition in the world and is only becoming more common in spite of advances in medical treatments. Part of the challenge is that pharmacological and surgical approaches often have a poor evidence base supporting their use and have limited efficacy in providing pain relief.
Cognitive behavioral therapy (CBT) is one of a number of different strategies that takes a more psychosocial approach to the self-management of pain and other psychological symptoms. CBT programs typically involve trying to change the way in which people think about their problems and applying a selection of problem-solving skills to help them cope with difficult situations.
CBT has been used extensively as a treatment option for chronic pain – either as a stand-alone option or in combination with other nonpharmacologic approaches (Ho et al., 2022) – but has been shown to be more effective at reducing depressive symptoms, pain bothersomeness, and pain catastrophizing compared to pain self-efficacy (Cherkin et al., 2016; Turner et al., 2016).
However, CBT is an underutilized resource for patients with chronic low back pain, as there are often multiple barriers to accessing it, including a lack of suitably trained or qualified therapists to coordinate the sessions, limits on what treatments can be accessed as part of health insurance plans, and the financial and temporal cost of travel for patients located in regional and rural areas.
Consequently, there has been a lot of interest in identifying and developing ways for patients to access therapy in a digital, on-demand setting. This is where virtual reality (VR) – a treatment approach that involves wearing a headset that only allows the user to see what is displayed on the screen of the headset – comes into play.
Combining existing technology and therapeutic approaches
VR has come a long way since 2000, when it was first used in a pain management setting as a way of distracting burn patients from the intense pain associated with dressing changes. It is now used extensively for both acute and chronic pain management in clinical settings. Could VR also be used to deliver digital and on-demand behavioral interventions straight to the homes of patients?
This is a question that AppliedVR – one of many medical device companies involved in translating proven VR principles from the lab into real-world healthcare solutions – is hoping to answer.
“Our journey began with deploying VR experiences in hospitals and clinics across the country, where we provided immersive tools for managing acute pain and anxiety through distraction and relaxation techniques,” said Josh Sackman, MBA, co-founder and president of AppliedVR, which was launched in 2015.
But things changed when AppliedVR received a request to help a patient experiencing severe chronic pain after being involved in a traumatic accident.
“What started as a compassionate response to an individual’s needs revealed something remarkable,” Sackman told PRF.
“The patient wasn’t just using VR for temporary [pain] relief; he was actually learning and retaining pain management skills that persisted beyond the VR sessions.”
This chance result led to the start of AppliedVR’s collaboration with Professor Beth Darnall, an evidence-based pain psychologist at Stanford University (California, USA), to develop a comprehensive skills-based program that could be used in a VR environment.
Darnall, who is passionate about developing interventions that deliver effective pain treatment using accessible and scalable approaches, also developed Empowered Relief®, a one-session, two-hour intervention that has shown efficacy for reducing chronic low back pain (Darnall et al., 2021; Darnall et al., 2024), as well as post-surgical pain and opioid use (Darnall et al., 2019; Ziadni et al., 2022).
Establishing an evidence base
The collaboration between AppliedVR and Darnall started with a pilot randomized controlled trial (RCT) of 97 patients – living with chronic low back pain or fibromyalgia for at least six months – where participants were assigned to either a 21-day skills-based VR program for chronic pain or an audio-only version of the VR program (Darnall et al., 2020). The skills-based intervention was delivered using an Oculus Go VR headset with custom-made VR software developed by AppliedVR.
The skills-based program involved a range of sessions lasting between one and 15 minutes that guided participants through self-management skills that form a part of CBT programs (e.g., adaptive regulation of pain-related cognition and emotions), as well as relaxation training (diaphragmatic breathing exercises to enhance parasympathetic nervous system function), and mindfulness.
Both groups saw decreases in each of the five patient-reported outcomes over the course of the 21-day intervention, although the average effects were larger in the skills-based intervention compared to the audio-only group: A 30% reduction in pain intensity, a 37% reduction in pain-related activity interference, a 50% reduction in pain-related mood interference, a 40% reduction in pain-related sleep interference, and a 49% reduction in pain-related stress interference.
“Treatment effect sizes suggested that a home-based stand-alone, digital, skills-based treatment program may affect clinically meaningful changes in patient-reported pain and pain correlates, [although] the durability of the treatment effect reported here remains a topic for future research,” Darnall et al. concluded.
Play it (again), Sam
That future research came in the form of an eight-week VR program that was conducted during the COVID-19 pandemic in the United States (Garcia et al., 2021). The double-blinded trial involved 179 individuals with self-reported back pain lasting six or more months randomized to receive one of two daily VR programs over an eight-week period – EaseVRx (the immersive pain relief skills program) or sham VR (2D nature content delivered using a VR headset).
Like the initial pilot study, all patients received a VR headset (this time a Pico G2 4K all-in-one head-mounted VR device rather than the Oculus Go headset) and completed daily sessions lasting between two and 16 minutes in length. The pain relief skills modules covered similar topics to the previous study: Pain education, relaxation and interoception exercises, mindful escapes, pain distraction games, and dynamic breathing exercises.
“We started with the Oculus Go, since it was revolutionary as the first stand-alone [VR] headset. While we expect to upgrade headsets every couple of years to leverage better technology, we handle this differently than consumer VR,” said Sackman.
The EaseVRx group reported greater reductions in pain intensity, activity interference, mood interference, stress interference, and over-the-counter analgesic use compared to the sham VR group, as well as greater improvements in physical functioning. The between-groups effect sizes ranged from 0.40 to 0.49, suggesting moderately clinically meaningful improvement across these outcomes.
The proportion of participants who reported experiencing nausea and motion sickness during the intervention was similar between the EaseVRx (9.7%) and sham VR (6.7%) groups.
However, the recruited sample was fairly non-diverse.
“The study sample was predominantly female, white, college educated, and Internet savvy; thus, findings may not generalize to individuals with disparate demographic characteristics,” Garcia et al. noted.
To address this shortcoming, a second RCT was conducted with the same methodology on a larger, more diverse sample (Maddox et al., 2023a). By this point, EaseVRx had been rebranded as RelieVRx, and received Breakthrough device designation from the FDA after entering the de novo premarket review pathway.
More than 1,000 participants were enrolled and included in the primary analyses, with the skills-based VR group also showing clinically meaningful improvements in pain intensity and interference compared to the sham VR group.
“The Breakthrough designation was valuable, as it enabled a more collaborative process with the FDA during our submission [for a Class II medical device],” Sackman said.
Built to last?
The symptom reduction seen immediately after the VR intervention in the EaseVRx cohort compared to the sham VR was maintained at three (Garcia et al., 2022a), six (Garcia et al., 2022b), 18 (Maddox et al., 2022), and 24 months (Maddox et al., 2023b).
More than two-thirds of patients reported clinically meaningful reductions in pain intensity and/or interference two years after the intervention. In contrast, less than 50% of patients in the sham VR group showed similar benefits at any follow-up time point.
Darnall said the duration of the therapeutic benefits was not particularly surprising.
“I suppose we were less surprised to see the durability of the effects with RelieVRx because the product was engineered to achieve these results. We already knew from our 2020 study, which tests a precursor skills-based VR program, that immersive VR was yielding superior outcomes to the same content delivered in an audio-only format,” she said.
“Building on the [earlier] results and the 2020 study, RelieVRx was deliberately designed with key enhancements to drive skills acquisition and lasting efficacy. Those enhancements include the interoceptive modules, increased skills-based content, and biofeedback elements.”
The patients in the second, more diverse trial have also been followed up at 12 months post-treatment, with the effects of the skills-based VR intervention also maintained in this sample (Maddox et al., 2024).
Specifically, patients who completed the active intervention reported reduced pain intensity and pain interference (1.7- and 1.9-point reductions on an 11-point numerical rating scale) – significantly larger reductions than those seen in the sham VR group. In addition, more than half of the participants in the active group reported at least a two-point reduction in pain intensity and/or interference at the 12-month timepoint.
But this work has not been without its criticism. In 2024, an editorial about the RCT involving a more clinically severe and diverse sample was published and suggested that the conclusions drawn about the effectiveness of VR-based therapies for chronic pain were “too positive and premature.” The authors attributed this to the fact that patients in the sham VR group improved to some (albeit a smaller) extent on the various pain- and mood-related outcomes (Knoop et al., 2024).
The editorial also expressed concerns about the intervention’s content.
“RelieVRx seems to be primarily aimed at pain education and relaxation, whereas based on the importance of physical activity in chronic low back pain, the addition of physical VR exercises could possibly increase the effectiveness of RelieVRx,” it read.
“Moreover, RelieVRx seems to rely primarily on the working mechanisms of distraction, whereas other working mechanisms, such as graded exposure and adherence-related mechanisms seem to be ignored.”
Darnall, who is also the chief science advisor at AppliedVR, acknowledged that while RelieVRx does include engaging games for distraction and focus training, they only account for a small part of the overall component.
“RelieVRx focuses primarily on building self-regulation and coping skills, with distraction playing only a minor role. Eighty percent of the program centers on interactive diaphragmatic breathing exercises with biofeedback, immersive interoceptive awareness training to better control pain and stress responses, mindfulness skill building, and pain neuroscience education,” she told PRF.
Onward and upward
The AppliedVR team aren’t resting on their laurels; rather, they are pursuing several different research paths simultaneously, including partnering with researchers at academic medical centers to study RelieVRx in different clinical settings and patient populations.
“We are collecting real-world evidence as we expand our distribution of RelieVRx into the market, and collaborating with health systems and payors to optimize how RelieVRx can be operationalized and scaled effectively,” Sackman said.
“We’ve seen promising pilot data suggesting potential benefits for other chronic pain conditions, and we’re actively discussing with the FDA what studies would be needed to expand our indication, [as] we’ll need to secure future FDA clearance for new indications and claims.”
The team are also continuing to explore how the RelieVRx system impacts brain activity, and have recently completed a feasibility study that combines RelieVRx with Kernel’s Flow brain measurement technology.
The results of the feasibility study showed that RelieVRx patients experienced enhanced brain activation coherence – a pattern of brain activity previously associated with pain relief – whereas the sham control group showed a decline in the same measure.
“While this was a small pilot study, these findings are exciting because they suggest our treatment creates measurable physiological changes in brain activity,” said Sackman.
“We’re continuing to explore brain imaging studies to better understand these mechanisms, as measuring pain objectively has traditionally been a significant challenge in this field.”
Sackman feels there is also a lot of momentum in the medical extended reality (XR) space, where aspects of the physical and digital world are combined. VR is one aspect of XR, along with augmented reality (AR, where digital information is added to the real world, like a Snapchat filter) and mixed reality (a combination of AR and VR physical and digital objects that can interact in real time).
“However, the key challenge isn’t just developing effective treatments – it’s building [sustainability],” said Sackman.
“We expect to see consolidation in [this] space, with VR therapies potentially being integrated into broader digital health platforms or traditional medical device companies.”
Lincoln M. Tracy, PhD, is a freelance science writer and researcher based in Australia.
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Related Reading
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