Virtual Reality Therapy for Chronic Lower Back Pain

(AVR_HEOR Trial)

Overseen By Todd Maddox, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AppliedVR Inc.

Disqualifiers: Epilepsy, Seizure disorder, Migraines, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests virtual reality therapy to determine if it can reduce pain and improve life quality for people with chronic lower back pain. Participants will use a VR program called EaseVRx to manage their pain over several weeks. Some will engage with interactive 3D content, while others will view non-interactive 2D nature scenes as a control. This trial suits individuals who have experienced chronic lower back pain for at least three months and significant pain interference in daily life. As an unphased trial, it offers participants the chance to explore innovative pain management techniques that could enhance their quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that virtual reality therapy is safe for chronic lower back pain?

Research has shown that EaseVRx, a virtual reality therapy, is safe for use. Studies have found that most users tolerate it well. The FDA approved EaseVRx based on strong evidence from a study involving 179 people with chronic low back pain. This approval indicates that the treatment has passed strict safety checks. Generally, there have been no major reports of side effects. EaseVRx is designed for home use to help reduce pain and improve daily activities, offering a convenient and non-invasive option for those with chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

EaseVRx is unique because it uses virtual reality (VR) to manage chronic lower back pain, offering an immersive experience that differs from traditional treatments like physical therapy, medications, or surgery. Unlike typical pain management methods, EaseVRx provides a skills-based VR program that engages users in interactive, 3D environments, potentially enhancing pain relief through cognitive-behavioral techniques delivered in a novel way. Researchers are excited about this approach because it could offer a non-invasive, drug-free alternative that harnesses the power of VR to create a more engaging and potentially more effective pain management experience.

What evidence suggests that this trial's virtual reality treatments could be effective for chronic low back pain?

Research shows that the EaseVRx virtual reality program, which participants in this trial may receive, can help reduce chronic lower back pain. In earlier studies, people who used this 8-week VR program reported significantly less pain compared to those who did not use it. These benefits lasted up to 24 months after the program ended. The VR therapy also alleviated anxiety and depression linked to chronic pain. This suggests that EaseVRx might provide lasting relief and improve overall well-being for people with chronic lower back pain. ^{2 6 7 8 9}

Who Is on the Research Team?

Todd Maddox, Ph.D.

Principal Investigator

AppliedVR Inc.

Are You a Good Fit for This Trial?

Adults aged 18-85 with chronic lower back pain for at least three months, experiencing significant pain and interference in daily life. Participants must have internet access, a smartphone or computer, speak English fluently, and be willing to follow study procedures. Excluded are those with certain medical conditions that prevent VR use, recent or planned back-related medical procedures, involvement in litigation or worker's compensation for injury, participation in other research studies recently or plans within the next 24 months.

Inclusion Criteria

Access to Internet for the duration of their study participation (24 months)

I have been experiencing pain for at least three months.

Completed the Baseline Survey plus at least two of the five sets of participant surveys that are administered during the 10-day pretreatment assessment period

Exclusion Criteria

You have thoughts of hurting yourself, as shown in the 9th question of the Participant Health Questionnaire-9 (PHQ-9).

I have medical procedures planned for my current health condition.

Current or recent participation (i.e., within the last 2 months) in any other research study involving a drug, device, vaccine, or other interventional treatment product; or plans to participate in another research study over the next 24 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week interventional program using EaseVRx or Sham VR

8 weeks

Extended On-Demand

Participants in certain arms are offered an additional 8-week on-demand period

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• EaseVRx
• Sham VR

Trial Overview This trial is testing EaseVRx virtual reality therapy against a Sham VR (placebo) to see if it helps reduce pain intensity and improve physical function among people with chronic low back pain. It also looks at how this therapy affects anxiety, depression, sleep quality and healthcare costs over time.

How Is the Trial Designed?

Group I: 56-day skills-based VR program followed by an extended 56-day on-demand period Experimental Treatment 1 Intervention

participants in the EaseVRx-8w plus extended on-demand arm will enroll in an 8-week interventional program and be offered an extended 8-week ondemand period, and continue to be followed for 24 months after the completion of treatment

Group II: 56-day skills-based VR program Experimental Treatment 1 Intervention

participants in the EaseVRx-8w arm will participate in an 8-week interventional program and continue to be followed for 24 months following completion of tx

Group III: 56-day control (Sham VR) Placebo Group 1 Intervention

participants in the first control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and continue to be followed for 24 months after the completion of treatment. participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting. The experience of Sham VR is similar to watching a large-screen TV, but it is not interactive. The advantage of Sham VR is that it controls for the novelty and immersion of the hardware and isolates the effect of VR skill-based training

Group IV: • 56-day control (Sham VR plus 8w extended on-demand) Placebo Group 1 Intervention

participants in the second control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and be offered an extended 8-week on-demand period, after which they will continue to be followed for 24 months after the completion of treatment.Participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting.

Who Is Running the Clinical Trial?

AppliedVR Inc.

Lead Sponsor

Trials

11

Recruited

3,100+

Published Research Related to This Trial

The NIH BACPAC VR trial will evaluate the effectiveness of three types of virtual reality interventions for chronic lower back pain in 360 patients over 12 weeks, focusing on skills-based, distraction-based, and sham VR programs.

The primary outcome measured will be pain interference using the PROMIS scale, along with secondary outcomes like anxiety and sleep disturbance, aiming to provide insights into non-pharmacological pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial. Birckhead, B., Eberlein, S., Alvarez, G., et al.[2022]

An 8-week home-based therapeutic virtual reality (VR) program significantly reduced pain intensity and improved various pain-related factors (like activity and stress) compared to a Sham VR program, with effects lasting up to 3 months after treatment in adults with chronic low back pain.

The therapeutic VR program demonstrated sustained benefits and maintained superiority over Sham VR for most outcomes, indicating its potential as an effective long-term pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Month Follow-Up Results of a Double-Blind, Randomized Placebo-Controlled Trial of 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality (VR) for Chronic Low Back Pain. Garcia, LM., Birckhead, BJ., Krishnamurthy, P., et al.[2022]

The 8-week home-based virtual reality (VR) program, EaseVRx, significantly reduced pain intensity and pain-related interference with activities, stress, and sleep for up to 6 months after treatment in adults with chronic low back pain, based on a study of 188 participants.

No adverse events were reported during the study, indicating that the VR program is a safe intervention for managing chronic pain without causing nausea or motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Garcia, L., Birckhead, B., Krishnamurthy, P., et al.[2022]

The study developed graded exposure (GEXP) virtual reality (VR) modules for individuals with chronic low back pain (cLBP) and high pain-related fear, showing that participants could safely engage in progressively challenging physical activities over three sessions.

Participants found the VR application to be feasible and acceptable, with no significant changes in pain or pain-related fear, indicating that they could complete the modules without exacerbating their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Graded Exposure, Locomotion-Enabled Virtual Reality App During Walking and Reaching for Individuals With Chronic Low Back Pain: Cohort Gaming Design. Hennessy, RW., Rumble, D., Christian, M., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11975703/

In-Home Virtual Reality Program for Chronic Lower Back ... An 8-week self-administered behavioral skills virtual reality program was found to impart clinically meaningful improvements above a strong active control ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05263037

EaseVRx-8w+ for the Treatment of Chronic Lower Back Pain The aim of this randomized controlled trial (RCT) is to assess outcomes for virtual reality therapy (including pain intensity, pain interference, anxiety, ...

3. relievrx.com relievrx.com/

RelieVRx: Now FDA-authorized Durable chronic low back pain reductions up to 24 months after treatment for an accessible, 8-week, in-home behavioral skills-based virtual reality program: a ...

4. frontiersin.org frontiersin.org/journals/virtual-reality/articles/10.3389/frvir.2025.1613188/full

Virtual reality-delivered skills-based therapy for chronic ... Published studies include those showing that the VR solution was successful in managing acute pain, anxiety, anger, and chronic pain pre-, peri-, and post- ...

5. academic.oup.com academic.oup.com/painmedicine/article/24/10/1200/7176373

Durable chronic low back pain reductions up to 24 months ... The present research letter reports extended durability up to 24 months after treatment and examines the time course of “responder” rates.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7939946/

An 8-Week Self-Administered At-Home Behavioral Skills ... A national online convenience sample of individuals with self-reported nonmalignant low back pain with duration of 6 months or more and with average pain ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN210014.pdf

DEN210014 Decision Summary - accessdata.fda.gov The primary objective of this study was to assess the effectiveness ofthe Ease VRx therapeutic program in patients with chronic low back pain ( ...

8. relievrx.com relievrx.com/documents/clinical-resources.pdf

Clinical Resource Library The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain. Contraindications. There are ...

9. clinicaladvisor.com clinicaladvisor.com/news/fda-approves-virtual-reality-system-treat-chronic-back-pain/

FDA Approves Virtual Reality System to Treat Chronic Back ... The approval of EaseVRx was based on the safety and efficacy data from a randomized double-blinded study involving 179 participants with chronic ...