CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
EaseVRx headset +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04139564
NCT04139564N/ACompleted
CompareCT.gov

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

AppliedVR Inc.·interventional·Posted Oct 25, 2019·Updated Mar 27, 2024

In Brief

A clinical study evaluating EaseVRx headset and Active control VR sham program for Chronic Low-back Pain. Completed, enrolled 108 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low-back Pain
CountriesUnited States
CollaboratorsGeisinger Clinic, National Institute on Drug Abuse (NIDA)

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 25, 2019
Enrollment StartJan 11, 2021
Primary CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.7 years ago

Interventions

EaseVRx headsetdevice

EaseVRx is a virtual reality therapy intended to treat chronic pain

Active control VR sham programdevice

VR, 2d visual wildlife scenes similar to some EaseVRx content