What side effects are associated with this type of intervention?

Common treatments for chronic lower back pain similar to virtual reality therapy include distraction techniques, cognitive behavioral therapy (CBT), and physical therapy. Distraction techniques, such as immersive VR, generally have few negative side effects and are considered safe. CBT may cause temporary emotional discomfort as patients confront and change negative thought patterns. Physical therapy can sometimes lead to temporary soreness or discomfort as the body adjusts to new exercises. Overall, these treatments are well-tolerated and have minimal side effects compared to pharmacologic options.

What prior FDA approvals exist?

The FDA has approved various treatments for chronic lower back pain, including both pharmacologic and nonpharmacologic methods. While specific FDA approvals for virtual reality therapy are not detailed, immersive VR has shown promise in reducing pain, anxiety, and depression, and improving physical function and behavioral skills. These therapies work by providing distraction and engaging patients in immersive experiences, which can be effective as adjuncts to traditional pain management strategies.

What other types of research exist?

Promising novel alternatives to Virtual Reality Therapy for Chronic Lower Back Pain patients include: 1) Cognitive Behavioral Therapy (CBT), which has shown efficacy in pain reduction and improving functional health. 2) Mind-Body Techniques such as Mindfulness-Based Stress Reduction (MBSR) and guided imagery, which can help manage pain and reduce anxiety and depression. 3) Integrative Movement Therapies like yoga and tai chi, which improve physical function and reduce pain. 4) Neurofeedback, which has shown long-term impact on symptom burden and pain interference. These therapies offer comprehensive benefits and are supported by recent research.

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Behavioural Intervention

Virtual Reality Therapy for Chronic Lower Back Pain (AVR_HEOR Trial)

N/A

Waitlist Available

Led By Todd Maddox, Ph.D.

Research Sponsored by AppliedVR Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pain duration of at least three months

Average pain intensity score of ≥ 4 and average pain interference score of ≥ 4 on the 0-10 Brief Pain Inventory (BPI) Pain Scale for the past month at screening

Must not have

Injury to eyes, face, or neck that prevents comfortable use of VR

Index back pain is linked to a cancer-related diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment. anticipated reporting date june 2027

Summary

This trial is testing virtual reality therapy to help people with chronic low back pain. The therapy uses a VR headset to provide immersive experiences that can reduce pain and teach coping skills. The study aims to see if this approach can improve health outcomes and reduce healthcare costs. Virtual reality (VR) has been shown to improve pain intensity and disability in patients with chronic low back pain compared to traditional methods.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here as this is a non-drug intervention trial involving virtual reality therapy (EaseVRx), potential side effects may include nausea or dizziness due to VR usage especially for individuals predisposed to motion sickness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been experiencing pain for at least three months.

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My average pain and its interference with my daily life are both rated 4 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot use VR comfortably due to an injury to my eyes, face, or neck.

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My back pain is caused by my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment. anticipated reporting date june 2027

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment. anticipated reporting date june 2027

This trial's timeline: 3 weeks for screening, Varies for treatment, and the outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment. anticipated reporting date june 2027 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brief Pain Inventory (BPI) Pain Intensity Questionnaire

Secondary study objectives

Oswestry Disability Index Score (ODI v2.1b)

PROMIS Anxiety

PROMIS Depression

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 56-day skills-based VR program followed by an extended 56-day on-demand periodExperimental Treatment1 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 programExperimental Treatment1 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 Group1 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 Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EaseVRx

2021

N/A

~100

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Virtual Reality Therapy (VR) for Chronic Lower Back Pain (CLBP) operates by immersing patients in engaging experiences that distract from pain, reduce anxiety and depression, and enhance physical function and behavioral skills. This is achieved through cognitive-behavioral techniques and simulated physical exercises, which help patients manage pain perception and overcome fear-avoidance behaviors. These mechanisms are vital for CLBP patients as they address both psychological and physical dimensions of chronic pain, offering a comprehensive approach to pain management.

Virtual Reality and the Mediation of Acute and Chronic Pain in Adult and Pediatric Populations: Research Developments.Virtual Reality Analgesia With Interactive Eye Tracking During Brief Thermal Pain Stimuli: A Randomized Controlled Trial (Crossover Design).Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial.