Virtual Reality Therapy for Chronic Lower Back Pain

(AVR_HEOR Trial)

Overseen By Todd Maddox, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AppliedVR Inc.

Disqualifiers: Epilepsy, Seizure disorder, Migraines, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

1093 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment EaseVRx for chronic lower back pain?

Research shows that virtual reality (VR) treatments like EaseVRx can significantly reduce pain intensity and fear of movement in people with chronic lower back pain. Studies have found that VR is more effective than no VR or sham VR in reducing pain and improving mood and stress levels. ^{1 2 3 4 5}

Is virtual reality therapy safe for treating chronic lower back pain?

Virtual reality therapy for chronic lower back pain appears to be generally safe, with no significant adverse events reported in studies. One study noted a serious adverse event in a sham placebo group, but it was not related to the treatment. ^{3 5 6 7 8}

How is the EaseVRx treatment different from other treatments for chronic lower back pain?

EaseVRx is unique because it uses virtual reality (VR) to provide a home-based, immersive experience that teaches pain relief skills, which has shown to reduce pain intensity and improve physical function more effectively than a placebo VR program. This non-drug approach offers a novel way to manage chronic pain without the side effects associated with medications. ^{2 3 9 10 11}

What is the purpose of this trial?

This trial is testing virtual reality therapy to help people with chronic low back pain. The therapy uses a VR headset to provide immersive experiences that can reduce pain and teach coping skills. The study aims to see if this approach can improve health outcomes and reduce healthcare costs. Virtual reality (VR) has been shown to improve pain intensity and disability in patients with chronic low back pain compared to traditional methods.

Research Team

Todd Maddox, Ph.D.

Principal Investigator

AppliedVR Inc.

Eligibility Criteria

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.

Inclusion Criteria

Access to Internet for the duration of their study participation (24 months)

I have been experiencing pain for at least three months.

Completed the Baseline Survey plus at least two of the five sets of participant surveys that are administered during the 10-day pretreatment assessment period

Exclusion Criteria

You have thoughts of hurting yourself, as shown in the 9th question of the Participant Health Questionnaire-9 (PHQ-9).

I have medical procedures planned for my current health condition.

Current or recent participation (i.e., within the last 2 months) in any other research study involving a drug, device, vaccine, or other interventional treatment product; or plans to participate in another research study over the next 24 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week interventional program using EaseVRx or Sham VR

8 weeks

Extended On-Demand

Participants in certain arms are offered an additional 8-week on-demand period

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• EaseVRx
• Sham VR

Trial Overview 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.

Participant Groups

Group I: 56-day skills-based VR program followed by an extended 56-day on-demand period Experimental Treatment 1 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 program Experimental Treatment 1 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 Group 1 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 Group 1 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.

Who Is Running the Clinical Trial?

AppliedVR Inc.

Lead Sponsor

Trials

11

Recruited

3,100+

Findings from Research

The 8-week home-based virtual reality (VR) program, EaseVRx, significantly reduced pain intensity and pain-related interference with activities, stress, and sleep for up to 6 months after treatment in adults with chronic low back pain, based on a study of 188 participants.

No adverse events were reported during the study, indicating that the VR program is a safe intervention for managing chronic pain without causing nausea or motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Garcia, L., Birckhead, B., Krishnamurthy, P., et al.[2022]

The study developed graded exposure (GEXP) virtual reality (VR) modules for individuals with chronic low back pain (cLBP) and high pain-related fear, showing that participants could safely engage in progressively challenging physical activities over three sessions.

Participants found the VR application to be feasible and acceptable, with no significant changes in pain or pain-related fear, indicating that they could complete the modules without exacerbating their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Graded Exposure, Locomotion-Enabled Virtual Reality App During Walking and Reaching for Individuals With Chronic Low Back Pain: Cohort Gaming Design. Hennessy, RW., Rumble, D., Christian, M., et al.[2020]

An 8-week home-based therapeutic virtual reality (VR) program significantly reduced pain intensity and improved various pain-related factors (like activity and stress) compared to a Sham VR program, with effects lasting up to 3 months after treatment in adults with chronic low back pain.

The therapeutic VR program demonstrated sustained benefits and maintained superiority over Sham VR for most outcomes, indicating its potential as an effective long-term pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Garcia, LM., Birckhead, BJ., Krishnamurthy, P., et al.[2022]

The NIH BACPAC VR trial will evaluate the effectiveness of three types of virtual reality interventions for chronic lower back pain in 360 patients over 12 weeks, focusing on skills-based, distraction-based, and sham VR programs.

The primary outcome measured will be pain interference using the PROMIS scale, along with secondary outcomes like anxiety and sleep disturbance, aiming to provide insights into non-pharmacological pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial. Birckhead, B., Eberlein, S., Alvarez, G., et al.[2022]

References

1. Pakistan pubmed.ncbi.nlm.nih.gov

Effects of virtual reality exercises and routine physical therapy on pain intensity and functional disability in patients with chronic low back pain. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality in the Treatment of Adults with Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of a Behavioral Therapy-Based Virtual Reality Application on Quality of Life in Chronic Low Back Pain. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Get Your Head in the Game: A Replicated Single-Case Experimental Design Evaluating the Effect of a Novel Virtual Reality Intervention in People With Chronic Low Back Pain. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A prospective, double-blind, pilot, randomized, controlled trial of an "embodied" virtual reality intervention for adults with low back pain. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

A Graded Exposure, Locomotion-Enabled Virtual Reality App During Walking and Reaching for Individuals With Chronic Low Back Pain: Cohort Gaming Design. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Virtual immersive gaming to optimize recovery (VIGOR) in low back pain: A phase II randomized controlled trial. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality in Back Pain Rehabilitation: A Systematic Review and Meta-Analysis. [2022]