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Behavioural Intervention

Virtual Reality Therapy for Chronic Lower Back Pain (AVR_HEOR Trial)

N/A
Waitlist Available
Led By Todd Maddox, Ph.D.
Research Sponsored by AppliedVR Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pain duration of at least three months
Self-reported chronic low back pain that will be confirmed with claims data when available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment. anticipated reporting date june 2027
Awards & highlights

AVR_HEOR Trial Summary

This trial will compare outcomes for people with chronic low back pain who receive virtual reality therapy against those who don't.

Who is the study for?
Adults aged 18-85 with chronic lower back pain for at least three months, experiencing significant pain and interference in daily life. Participants must have internet access, a smartphone or computer, speak English fluently, and be willing to follow study procedures. Excluded are those with certain medical conditions that prevent VR use, recent or planned back-related medical procedures, involvement in litigation or worker's compensation for injury, participation in other research studies recently or plans within the next 24 months.Check my eligibility
What is being tested?
This trial is testing EaseVRx virtual reality therapy against a Sham VR (placebo) to see if it helps reduce pain intensity and improve physical function among people with chronic low back pain. It also looks at how this therapy affects anxiety, depression, sleep quality and healthcare costs over time.See study design
What are the potential side effects?
While not explicitly listed here as this is a non-drug intervention trial involving virtual reality therapy (EaseVRx), potential side effects may include nausea or dizziness due to VR usage especially for individuals predisposed to motion sickness.

AVR_HEOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been experiencing pain for at least three months.
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I have chronic low back pain.
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My average pain and its interference with my daily life are both rated 4 or higher.
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I am between 18 and 85 years old.

AVR_HEOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment. anticipated reporting date june 2027
This trial's timeline: 3 weeks for screening, Varies for treatment, and the outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment. anticipated reporting date june 2027 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brief Pain Inventory (BPI) Pain Intensity Questionnaire
Secondary outcome measures
Oswestry Disability Index Score (ODI v2.1b)
PROMIS Anxiety
PROMIS Depression
+1 more

AVR_HEOR Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 56-day skills-based VR program followed by an extended 56-day on-demand periodExperimental Treatment1 Intervention
participants in the EaseVRx-8w plus extended on-demand arm will enroll in an 8-week interventional program and be offered an extended 8-week ondemand period, and continue to be followed for 24 months after the completion of treatment
Group II: 56-day skills-based VR programExperimental Treatment1 Intervention
participants in the EaseVRx-8w arm will participate in an 8-week interventional program and continue to be followed for 24 months following completion of tx
Group III: 56-day control (Sham VR)Placebo Group1 Intervention
participants in the first control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and continue to be followed for 24 months after the completion of treatment. participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting. The experience of Sham VR is similar to watching a large-screen TV, but it is not interactive. The advantage of Sham VR is that it controls for the novelty and immersion of the hardware and isolates the effect of VR skill-based training
Group IV: • 56-day control (Sham VR plus 8w extended on-demand)Placebo Group1 Intervention
participants in the second control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and be offered an extended 8-week on-demand period, after which they will continue to be followed for 24 months after the completion of treatment.Participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EaseVRx
2021
N/A
~100

Find a Location

Who is running the clinical trial?

AppliedVR Inc.Lead Sponsor
10 Previous Clinical Trials
1,978 Total Patients Enrolled
Todd Maddox, Ph.D.Principal InvestigatorAppliedVR Inc.

Media Library

EaseVRx (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05263037 — N/A
Chronic Lower Back Pain Research Study Groups: 56-day skills-based VR program, 56-day skills-based VR program followed by an extended 56-day on-demand period, 56-day control (Sham VR), • 56-day control (Sham VR plus 8w extended on-demand)
Chronic Lower Back Pain Clinical Trial 2023: EaseVRx Highlights & Side Effects. Trial Name: NCT05263037 — N/A
EaseVRx (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05263037 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical trial accept volunteers aged sixty or higher?

"This trial has set the minimum age for participation at 18 and a maximum of 85 in compliance with its selection criteria."

Answered by AI

Are my characteristics compatible with the requirements of this trial?

"This medical trial is currently looking to enrol 1000 people aged between 18 and 85 who suffer from depression. Additional eligibility criteria encompass being male or female, having experienced chronic low back pain for no less than three months, granting voluntary written consent to participate in the study, owning an internet-enabled device such as a computer or smartphone throughout their involvement with the research (24 months), possessing a physical mailing address that isn't associated with PO boxes, exhibiting average levels of 4/10 on both BPI Pain Scale intensity and interference over the previous month at screening points, adhering to all protocol restrictions during their time within the investigation, and speaking English"

Answered by AI

Are recruitment efforts ongoing for this clinical research?

"As evidenced by the clinicaltrials.gov portal, this medical experiment is still open for recruitment and was initially announced on January 31st 2022 with a subsequent edit made in March of that same year."

Answered by AI

What is the current enrollment limit for participants in this trial?

"Affirmative, details on clinicaltrials.gov suggest that this medical trial is currently recruiting participants. Initially posted on January 31st 2022 and last modified the 8th of March 2021, a total of 1000 patients need to be enrolled from one different site."

Answered by AI
~354 spots leftby Mar 2025