EaseVRx for the Reduction of Chronic Pain and Opioid Use

Not Applicable

Completed

Conditions: Chronic Low-back Pain

Interventions: Device: Active control VR sham program
Device: EaseVRx headset

Registration Number: NCT04139564

Lead Sponsor: AppliedVR Inc.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 108

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active control group VR Sham	Active control VR sham program	Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content
EaseVRx group	EaseVRx headset	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.

Primary Outcome Measures

Name	Time	Method
Pain: Numerical Pain Rating Scale	12 weeks	Numerical Pain Rating Scale; scale from 0 to 10 with higher numbers implying greater pain The outcome values presented below are the difference between baseline pain and pain at 12 weeks. Specifically, baseline pain score minus 12 week pain score A positive difference implies that pain was reduced

Secondary Outcome Measures

Name	Time	Method
Patient Compliance	8 weeks	number of VR modules completed. For the EaseVRx group this would be the number of EaseVRx modules completed with worst 0 - 56 best. For the Active control VR Sham group this would be the number of ShamVR modules completed with worst 0 - 56 best.
Number of Outcome Assessments Completed by Participant	12 weeks	Thirty four assessments were attempted. This measure notes the total number of assessments completed by each participant
Opioid Consumption	12 weeks	Morphine Milligram Equivalents (MME)