EaseVRx for the Reduction of Chronic Pain and Opioid Use

Study Overview
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Brief Summary
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EaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a prescription pain management tool that manages the symptoms associated with chronic pain and reduces or eliminates the risk of opioid dependence. The investigators will conduct a proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home program among 100 chronic low back pain patients by gathering pilot data on the efficacy of the intervention in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving pain-related quality of life.

Detailed Description
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EaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a prescription pain management tool that manages the symptoms associated with chronic pain and reduces or eliminates the risk of opioid dependence. EaseVRx is based on principles of cognitive behavioral therapy, pain psychology, mindfulness-based stress reduction, biofeedback, and distraction therapy commonly used in interdisciplinary pain rehabilitation programs. The investigators will conduct a proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home program among 100 chronic low back pain patients by gathering pilot data on the efficacy of the intervention in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving pain-related quality of life. While VR has been tested in academic medical centers and shown to be efficacious in the management of acute pain, this study will investigate the feasibility of VR use at home to manage chronic pain in preparation for a larger efficacy trial.

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 Low-back Pain

Intervention / Treatment
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* Device: EaseVRx headset
* Device: Active control VR sham program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years old Low back pain experienced ≥ 3 days per week on average for ≥ 6 months Pre-medication NPRS score ≥ 5 stable for ≥ 3 months Exclusion Criteria: Exclusions based on potential medical or lifestyle confounders: Has a body mass index (BMI) > 40 kg/m2 Pain related to cancer, fibromyalgia, or disk herniation History of a major psychiatric disorder not controlled with medication or has behavioral factors that would interfere with proper study procedures Is not ambulatory/has significant motor impairment Surgery in the past 3 months Open workers compensation claim Planning to have surgery in the next 3 months Planning to start a new exercise program in the next 3 months Planning to start a new treatment for their pain (e.g. medication, physiotherapy, acupuncture, electrical nerve stimulation) in the next 3 months Exclusions based on potential drug-related cofounders: Current or recent history (in past year) of substance abuse disorder Currently pregnant/breastfeeding or planning to in the next 3 months Was administered an epidural steroid during the 3 months prior to screening Exclusions based on ability to use EaseVR effectively: Comorbidities including neurological, psychosocial, sensory, or other disorders that may impact pain perception Diagnosis of epilepsy, dementia, migraines, or other neurological disorders that may prevent VR usage, and/or other medical conditions predisposed to nausea and dizziness Hypersensitivity to flashing lights or motion Claustrophobia Lack of stereoscopic vision Severe hearing impairment Injury to eyes, face, or neck that prevents comfortable VR usage Planning to take a vacation from their home for more than one week in the next 8 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EaseVRx group<br>Each subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program. | Device: EaseVRx headset<br>* EaseVRx is a virtual reality therapy intended to treat chronic pain<br>|
| Active Comparator: Active control group VR Sham<br>Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content | Device: Active control VR sham program<br>* VR, 2d visual wildlife scenes similar to some EaseVRx content<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain: Numerical Pain Rating Scale | Numerical Pain Rating Scale; worst 0-10 best | 12 weeks | 
| opioid consumption | Morphine Milligram Equivalents (MME) | 12 weeks | 
| patient compliance | number of completed EaseVRx modules; worst 0 - 20 best | 8 weeks | 
| program retention | number of days that participants completed all outcome assessments; worst 0 - 34 best | 12 weeks |