Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain

Study Overview
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Brief Summary
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Randomized, 2-arm parallel group clinical trial evaluating the effectiveness of a self-administered Virtual Reality program for the treatment of chronic lower back pain compared to a placebo VR program.

Detailed Description
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A randomized, 2-arm parallel-group clinical trial evaluating the effectiveness of a self-administered Virtual Reality (VR) program for the treatment of chronic lower back pain. The primary objective of this study is to assess the impact of skills-based VR on changes in patient-reported pain and pain interference over the course of an 8-week intervention as well as compared to a placebo VR condition. The secondary objective is to assess the impact of skill-based VR on changes in patient-reported satisfaction over the course of an 8-week intervention and compared to a placebo VR condition. A tertiary objective is to assess the impact of skills-based VR on changes in patient-reported opioid use, physical function, behavioral skills development, and health outcomes immediately following the intervention relative to a pre-intervention baseline and compared to a placebo VR condition. An exploratory objective is to assess the impact of skills-based VR on changes in patient-reported pain levels, opioid use, physical function, behavioral skills development, health outcomes, and satisfaction at the 24-week post-intervention time point and compared to a placebo VR condition.

Official Title
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Safety and Effectiveness of Virtual Reality Utilizing EaseVRx for the Reduction of Chronic Pain and Opioid Use

Conditions
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Chronic Lower Back Pain

Intervention / Treatment
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* Device: EaseVRx headset with active intervention
* Device: EaseVRx headset without active intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women 18-85 years old Diagnosis of low back pain without radicular symptoms Pain duration of at least 6 months Average pain intensity of at least 4 on the 0-10 DoD/VA Pain Scale for the past month at screening English fluency Willing to comply with study procedures/restrictions Exclusion Criteria: Unable to understand the goals of the study due to cognitive difficulty Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines or other neurological disease that may prevent the use of VR Medical condition predisposing to nausea or dizziness Hypersensitivity to flashing light or motion No stereoscopic vision or severe hearing impairment Injury to eyes, face or neck that prevents comfortable use of VR Pain related to cancer Active suicidal ideation or severe depression Previous use of EaseVR for pain Current participation in any interventional research study or completed participation in past 2 months Currently pregnant or planning to become pregnant Does not have access to WIFI during participation in study Currently works at or has an immediate family member who works for a digital health company or pharmaceutical company that provides treatments for acute or chronic pain

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR Program A<br>Software with active intervention | Device: EaseVRx headset with active intervention<br>* VR software developed by AppliedVR informed by evidence-based cognitive behavioral therapy principles, biofeedback and mindfulness strategies for pain management.<br>|
| Active Comparator: VR Program B<br>Software without active intervention | Device: EaseVRx headset without active intervention<br>* VR software developed by AppliedVR with neutral non-interactive content.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Department of Defense (DoD)/VA Pain scale | DoD/VA Pain scale measures pain intensity, and inference around activity, sleep, mood, and stress, each on an 11-point scale. The max score is 50 and the minimum is 0. The higher the score the worse the outcome. This will be assessed twice weekly during the 8-week intervention intervention period. | The primary efficacy endpoint is the change from study baseline to Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Global Impression of Change Scale | Single item Patient's Global Impression of Change Scale (PGIC), self-reported the level of change (if any) in activity limitations, symptoms, emotions, and overall quality of life-related to your painful condition on a 7-point scale. The higher the number the better the outcome. | twice weekly during 8-week intervention, Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Chronic Lower Back Pain, Analgesia