EaseVRx for the Reduction of Chronic Pain and Opioid Use

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Device: EaseVRx headset; Device: Active control VR sham program

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EaseVRx group; 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; EaseVRx is a virtual reality therapy intended to treat chronic pain
Active Comparator: Active control group VR Sham; 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; VR, 2d visual wildlife scenes similar to some EaseVRx content

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain: Numerical Pain Rating Scale	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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Outcome Assessments Completed by Participant	Thirty four assessments were attempted. This measure notes the total number of assessments completed by each participant	12 weeks
Patient Compliance	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.	8 weeks
Opioid Consumption	Morphine Milligram Equivalents (MME)	12 weeks

Collaborators and Investigators

• Sponsor: AppliedVR Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); Geisinger Clinic
• Investigators: Principal Investigator: Chulhyun Ahn, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: 2019-1017; 5R44DA050231 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No