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Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain

Primary Purpose

Chronic Lower Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EaseVRx headset with active intervention
EaseVRx headset without active intervention
Sponsored by
AppliedVR Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lower Back Pain focused on measuring Virtual Reality, Chronic Lower Back Pain, Analgesia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women 18-85 years old
  • Diagnosis of low back pain without radicular symptoms
  • Pain duration of at least 6 months
  • Average pain intensity of at least 4 on the 0-10 DoD/VA Pain Scale for the past month at screening
  • English fluency
  • Willing to comply with study procedures/restrictions

Exclusion Criteria:

  • Unable to understand the goals of the study due to cognitive difficulty
  • Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines or other neurological disease that may prevent the use of VR
  • Medical condition predisposing to nausea or dizziness
  • Hypersensitivity to flashing light or motion
  • No stereoscopic vision or severe hearing impairment
  • Injury to eyes, face or neck that prevents comfortable use of VR
  • Pain related to cancer
  • Active suicidal ideation or severe depression
  • Previous use of EaseVR for pain
  • Current participation in any interventional research study or completed participation in past 2 months
  • Currently pregnant or planning to become pregnant
  • Does not have access to WIFI during participation in study
  • Currently works at or has an immediate family member who works for a digital health company or pharmaceutical company that provides treatments for acute or chronic pain

Sites / Locations

  • AppliedVR, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VR Program A

VR Program B

Arm Description

Software with active intervention

Software without active intervention

Outcomes

Primary Outcome Measures

Department of Defense (DoD)/VA Pain scale
DoD/VA Pain scale measures pain intensity, and inference around activity, sleep, mood, and stress, each on an 11-point scale. The max score is 50 and the minimum is 0. The higher the score the worse the outcome. This will be assessed twice weekly during the 8-week intervention intervention period.

Secondary Outcome Measures

Patient's Global Impression of Change Scale
Single item Patient's Global Impression of Change Scale (PGIC), self-reported the level of change (if any) in activity limitations, symptoms, emotions, and overall quality of life-related to your painful condition on a 7-point scale. The higher the number the better the outcome.

Full Information

First Posted
May 27, 2020
Last Updated
January 7, 2022
Sponsor
AppliedVR Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04415177
Brief Title
Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain
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
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

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

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
Randomized, 2-arm parallel group clinical trial evaluating the effectiveness of a self-administered Virtual Reality program for the treatment of chronic lower back pain compared to a placebo VR program.
Detailed Description
A randomized, 2-arm parallel-group clinical trial evaluating the effectiveness of a self-administered Virtual Reality (VR) program for the treatment of chronic lower back pain. The primary objective of this study is to assess the impact of skills-based VR on changes in patient-reported pain and pain interference over the course of an 8-week intervention as well as compared to a placebo VR condition. The secondary objective is to assess the impact of skill-based VR on changes in patient-reported satisfaction over the course of an 8-week intervention and compared to a placebo VR condition. A tertiary objective is to assess the impact of skills-based VR on changes in patient-reported opioid use, physical function, behavioral skills development, and health outcomes immediately following the intervention relative to a pre-intervention baseline and compared to a placebo VR condition. An exploratory objective is to assess the impact of skills-based VR on changes in patient-reported pain levels, opioid use, physical function, behavioral skills development, health outcomes, and satisfaction at the 24-week post-intervention time point and compared to a placebo VR condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lower Back Pain
Keywords
Virtual Reality, Chronic Lower Back Pain, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR Program A
Arm Type
Experimental
Arm Description
Software with active intervention
Arm Title
VR Program B
Arm Type
Active Comparator
Arm Description
Software without active intervention
Intervention Type
Device
Intervention Name(s)
EaseVRx headset with active intervention
Intervention Description
VR software developed by AppliedVR informed by evidence-based cognitive behavioral therapy principles, biofeedback and mindfulness strategies for pain management.
Intervention Type
Device
Intervention Name(s)
EaseVRx headset without active intervention
Intervention Description
VR software developed by AppliedVR with neutral non-interactive content.
Primary Outcome Measure Information:
Title
Department of Defense (DoD)/VA Pain scale
Description
DoD/VA Pain scale measures pain intensity, and inference around activity, sleep, mood, and stress, each on an 11-point scale. The max score is 50 and the minimum is 0. The higher the score the worse the outcome. This will be assessed twice weekly during the 8-week intervention intervention period.
Time Frame
The primary efficacy endpoint is the change from study baseline to Day 56
Secondary Outcome Measure Information:
Title
Patient's Global Impression of Change Scale
Description
Single item Patient's Global Impression of Change Scale (PGIC), self-reported the level of change (if any) in activity limitations, symptoms, emotions, and overall quality of life-related to your painful condition on a 7-point scale. The higher the number the better the outcome.
Time Frame
twice weekly during 8-week intervention, Day 56
Other Pre-specified Outcome Measures:
Title
Device utilization Questionnaire
Description
Self-reported number of VR sessions completed since the participant last reported. The scale is 0-4 or more. The higher than number the higher the usage.
Time Frame
twice weekly during 8-week intervention, Day 56
Title
VR Satisfaction Scale
Description
Satisfaction ratings regarding the ability of the VR program to relieve pain symptoms on a 5-point scale. One is defined as strongly disagree with the statement and five is defined as strongly agree. The higher the number the better the outcome.
Time Frame
Day 56
Title
Custom Opioid Use Survey
Description
Custom survey assesses the use of opioids, frequency of use, dose of medication, happiness with regimen, and interest in change in treatment.
Time Frame
Baseline, Day 56
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
Description
This 6-item PROMIS physical function measure assesses physical function such as (chores, running errands) on a 5-point scale. The max score is 30 and the minimum is 6. The higher the score the better the outcome.
Time Frame
Baseline, Day 56
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance
Description
6-item PROMIS sleep disturbance measure assesses the level of sleep disturbance on a 5-point scale. The max score is 30 and the minimum is 6. The higher the score the worse the outcome.
Time Frame
Baseline, Day 56
Title
Pain Self-efficacy Questionnaire
Description
2-item PSEQ (PSEQ-2) assesses pain self-efficacy on a 7-point scale. The max score is 12 and the minimum is 0. The higher the score the better the outcome.
Time Frame
Baseline, Day 56
Title
Pain Catastrophizing Scale
Description
4 items from the Pain Catastrophizing Scale (PCS) assesses frequency of pain-related thoughts and feelings on a 5-point scale. The max score is 16 and the minimum is 0. The higher the score the worse the outcome.
Time Frame
Baseline, Day 56
Title
Chronic Pain Acceptance Questionnaire
Description
8-item Chronic Pain Acceptance (CPAQ-8) questionnaire assesses acceptance or psychological flexibility associated with chronic pain on a 7-point scale. The max score is 56 and the minimum is 8. The higher the score the better the outcome.
Time Frame
Baseline, Day 56
Title
Behavioral Skills Assessment
Description
Custom survey assesses the development of skills to manage pain outside of the VR headset. This is only included in the EaseVRx condition. There are 4 knowledge questions. These are on a 1-5 scale from do not agree to completely agree. The skills questions are on a 0 to 10 scale with 0 being not at all confident and 10 being very confident.
Time Frame
Day 56
Title
Health Utilization Outcomes Questionnaire
Description
Questionnaire on the frequency of steroid injections, lower back surgery, emergency department visits, hospital admissions, and unplanned physician visits over various time periods. The first part of each of these questions asks if they have had the service and then the second part asks for the frequency.
Time Frame
Day 56
Title
VR Use Data
Description
VR use calculated as the total number of sessions launched. It will be continuous data stored on the headset.
Time Frame
Day 1 through Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women 18-85 years old Diagnosis of low back pain without radicular symptoms Pain duration of at least 6 months Average pain intensity of at least 4 on the 0-10 DoD/VA Pain Scale for the past month at screening English fluency Willing to comply with study procedures/restrictions Exclusion Criteria: Unable to understand the goals of the study due to cognitive difficulty Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines or other neurological disease that may prevent the use of VR Medical condition predisposing to nausea or dizziness Hypersensitivity to flashing light or motion No stereoscopic vision or severe hearing impairment Injury to eyes, face or neck that prevents comfortable use of VR Pain related to cancer Active suicidal ideation or severe depression Previous use of EaseVR for pain Current participation in any interventional research study or completed participation in past 2 months Currently pregnant or planning to become pregnant Does not have access to WIFI during participation in study Currently works at or has an immediate family member who works for a digital health company or pharmaceutical company that provides treatments for acute or chronic pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Garcia, PhD
Organizational Affiliation
AppliedVR Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
AppliedVR, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35612905
Citation
Garcia L, Birckhead B, Krishnamurthy P, Mackey I, Sackman J, Salmasi V, Louis R, Castro C, Maddox R, Maddox T, Darnall BD. Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial. J Med Internet Res. 2022 May 25;24(5):e37480. doi: 10.2196/37480. Erratum In: J Med Internet Res. 2022 Jun 8;24(6):e40038.
Results Reference
derived
PubMed Identifier
34902548
Citation
Garcia LM, Birckhead BJ, Krishnamurthy P, Mackey I, Sackman J, Salmasi V, Louis R, Maddox T, Darnall BD. Three-Month Follow-Up Results of a Double-Blind, Randomized Placebo-Controlled Trial of 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality (VR) for Chronic Low Back Pain. J Pain. 2022 May;23(5):822-840. doi: 10.1016/j.jpain.2021.12.002. Epub 2021 Dec 11.
Results Reference
derived
PubMed Identifier
33484240
Citation
Garcia LM, Birckhead BJ, Krishnamurthy P, Sackman J, Mackey IG, Louis RG, Salmasi V, Maddox T, Darnall BD. An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19. J Med Internet Res. 2021 Feb 22;23(2):e26292. doi: 10.2196/26292.
Results Reference
derived
PubMed Identifier
33464215
Citation
Garcia LM, Darnall BD, Krishnamurthy P, Mackey IG, Sackman J, Louis RG, Maddox T, Birckhead BJ. Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jan 19;10(1):e25291. doi: 10.2196/25291. Erratum In: JMIR Res Protoc. 2021 Feb 12;10(2):e27652.
Results Reference
derived
Links:
URL
https://appliedvr.io/study-enrollment/
Description
webpage to assess if the study is right for you

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Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain

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