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EaseVRx for the Reduction of Chronic Pain and Opioid Use

NCT04139564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2024-03-27

Study results available
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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.

Conditions

  • Chronic Low-back Pain

Interventions

DEVICE

EaseVRx headset

EaseVRx is a virtual reality therapy intended to treat chronic pain

DEVICE

Active control VR sham program

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

Sponsors & Collaborators

  • Geisinger Clinic

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • AppliedVR Inc.

    lead INDUSTRY

Principal Investigators

  • Chulhyun Ahn, MD · Geisinger Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04139564 on ClinicalTrials.gov