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EaseVRx for the Reduction of Chronic Pain and Opioid Use

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EaseVRx headset
Active control VR sham program
Sponsored by
AppliedVR Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geisinger Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EaseVRx group

Active control group VR Sham

Arm Description

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.

Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 23, 2019
Last Updated
September 29, 2022
Sponsor
AppliedVR Inc.
Collaborators
Geisinger Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04139564
Brief Title
EaseVRx for the Reduction of Chronic Pain and Opioid Use
Official Title
Safety and Effectiveness of Virtual Reality Utilizing EaseVRx for the Reduction of Chronic Pain and Opioid Use
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AppliedVR Inc.
Collaborators
Geisinger Clinic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EaseVRx group
Arm Type
Experimental
Arm Description
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.
Arm Title
Active control group VR Sham
Arm Type
Active Comparator
Arm Description
Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content
Intervention Type
Device
Intervention Name(s)
EaseVRx headset
Intervention Description
EaseVRx is a virtual reality therapy intended to treat chronic pain
Intervention Type
Device
Intervention Name(s)
Active control VR sham program
Intervention Description
VR, 2d visual wildlife scenes similar to some EaseVRx content
Primary Outcome Measure Information:
Title
pain: Numerical Pain Rating Scale
Description
Numerical Pain Rating Scale; worst 0-10 best
Time Frame
12 weeks
Title
opioid consumption
Description
Morphine Milligram Equivalents (MME)
Time Frame
12 weeks
Title
patient compliance
Description
number of completed EaseVRx modules; worst 0 - 20 best
Time Frame
8 weeks
Title
program retention
Description
number of days that participants completed all outcome assessments; worst 0 - 34 best
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chulhyun Ahn, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States

12. IPD Sharing Statement

Learn more about this trial

EaseVRx for the Reduction of Chronic Pain and Opioid Use

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