Virtual Reality Therapy for Chronic Back Pain

Overseen By Marta Ceko, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CognifiSense Inc.

Disqualifiers: Pregnancy, Schizophrenia, Substance abuse, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality (VR) can help manage chronic back pain. Participants will try one of two VR therapies: one focuses on distraction, and the other teaches pain management skills. Both groups will receive training on using VR equipment and learn about the science of pain. The trial suits individuals who have experienced chronic low back pain for at least six months and feel pain on most days. Participants should have a reliable internet connection and be comfortable with technology. As an unphased trial, it offers a unique opportunity to explore innovative therapies for managing chronic pain.

Will I have to stop taking my current medications?

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 prior data suggests that this virtual reality therapy is safe for chronic back pain?

Research has shown that virtual reality therapies for chronic back pain are generally safe and well-tolerated. Studies have found that these treatments can help manage pain without significant side effects. For instance, a review concluded that virtual reality is an effective and safe option for treating chronic pain, with participants usually reporting few negative effects.

The virtual reality treatments studied include therapies based on brain and psychological science. Tested in various clinical settings, these therapies have not raised major safety concerns. While individual reactions may differ, most people have used these therapies without serious problems.

These studies suggest that virtual reality therapy is a safe option, but individual experiences can vary. Always consult a healthcare provider about potential risks and benefits before starting any new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about virtual reality therapy for chronic back pain because it offers a fresh approach to pain management. Unlike standard treatments such as medications, physical therapy, or surgery, this therapy uses immersive virtual reality to educate patients about pain and offer a personalized, 3D audiovisual representation of their pain experience. This innovative method leverages the brain's ability to refocus attention and potentially alter pain perception, providing a non-invasive and drug-free alternative that could complement existing treatments. By integrating neuroscience principles with virtual reality, it aims to reduce pain in a unique and engaging way.

What evidence suggests that this trial's Virtual Reality treatments could be effective for chronic back pain?

This trial will compare two different virtual reality therapies for chronic back pain. Studies have shown that virtual reality therapy can help people with chronic back pain. For example, one study found that 60% of participants using a VR program experienced a significant decrease in their pain and its impact on daily life. Research also shows that virtual reality therapy can lower pain levels and improve overall well-being by focusing on how the brain processes pain. Additionally, it reduces inflammation, often a major factor in chronic pain. Overall, these findings suggest that virtual reality therapy has strong potential to relieve chronic back pain. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with chronic back pain who can complete an online survey and consent form. They must be able to participate in a two-week baseline period, followed by an 8-week treatment with virtual reality (VR) therapy or control intervention.

Inclusion Criteria

English fluency (8th grade level)

Willing to comply with study procedures/restrictions

I have chronic low back pain without any pain radiating down my legs.

Exclusion Criteria

Applicants who are pregnant, planning pregnancy, or breastfeeding

I have chronic pain that is not related to my back.

History of substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Online survey

Baseline

Participants complete two assessments of the Primary and Secondary Outcome Measures and Potential Mediators

2 weeks

Online assessments

Treatment

Participants undergo an 8-week intervention with VR therapy or control intervention, including education on pain neuroscience and VR training

8 weeks

Online surveys and VR sessions

Follow-up

Participants complete post-treatment surveys to assess outcomes at weeks 8, 20, and 32

24 weeks

Online surveys at weeks 8, 20, and 32

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Treatment

Trial Overview The study tests VR therapy against standard care for chronic back pain. Participants are randomly assigned to either the Therapy Group receiving VR treatment or the Control Group getting education only, both including pain neuroscience education.

How Is the Trial Designed?

Group I: Virtual Reality Neuropsychological Therapy Experimental Treatment 1 Intervention

Participants start the treatment period with three introductory sessions: 1. A 34-minute pain education video that introduces the neuroscience of acute and chronic pain, drivers of pain chronification, pain triggers, and the scientific principles behind the VRNT. 2. A session to customize the VR experience to match the participant's experience using a display of a personalized 3-dimensional audiovisual representation of each patient's pain. 3. A training session on the use of the VR hardware. The participant will receive a workbook to guide them through each day's session. Participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.

Group II: Virtual Reality Neuroscience Therapy Active Control 1 Intervention

Participants start the treatment period with two introductory sessions: 1. A 7-minute pain education video that introduces the neuroscience of pain-focused attention, distraction, and the scientific principles behind VRNT. 2. A training session on the use of the VR hardware. The participant will receive a workbook (Attachment 'VRNT Workbook') to guide them through each day's session. Participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.

Who Is Running the Clinical Trial?

CognifiSense Inc.

Lead Sponsor

Trials

1

Recruited

70+

University of Colorado, Boulder

Collaborator

Trials

128

Recruited

29,600+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38466872/

The effects of virtual reality neuroscience-based therapy on ... We tested the effectiveness of a novel VR neuroscience-based therapy (VRNT) to improve pain-related outcomes in n = 31 participants with chronic back pain.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04468074

Virtual Reality Treatment for Adults With Chronic Back Pain All participants complete self-reported clinical outcomes and behavioral measures surveys before and after the Baseline Period, 4 weeks after the first MRI (for ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949761223000834

In-Home Virtual Reality Program for Chronic Lower Back ... RelieVRx is highly effective with 60% of participants yielding a clinically meaningful reduction in pain intensity, interference, or both.

4. price.ctsi.ufl.edu price.ctsi.ufl.edu/wordpress/files/2025/03/John-Gilliam-03-26.pdf

The effects of virtual reality neuroscience-based therapy on ... Thus, VRNT showed preliminary efficacy in significantly reducing pain and improving overall functioning, possibly through changes in ...

5. games.jmir.org games.jmir.org/2024/1/e50089

Virtual Reality Therapy for the Management of Chronic Spinal ... VR therapy significantly improved the levels of inflammatory markers, including CRP, TNF-α, and IL-6. Numerous studies have previously reported ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12155277/

Effects of Virtual Reality on Adults Diagnosed with Chronic ... The findings of this systematic review support the efficacy of virtual reality as an effective and safe therapeutic option for the treatment of chronic non- ...

7. medrxiv.org medrxiv.org/content/10.1101/2023.07.24.23293109v1.full

The Effects of Virtual Reality Neuroscience-based Therapy ... We tested the effectiveness of a novel VR neuroscience-based therapy (VRNT) to improve pain-related outcomes in n = 31 participants with chronic ...

8. frontiersin.org frontiersin.org/journals/virtual-reality/articles/10.3389/frvir.2025.1613188/full

Virtual reality-delivered skills-based therapy for chronic ... Published studies include those showing that the VR solution was successful in managing acute pain, anxiety, anger, and chronic pain pre-, peri-, and post- ...