RecruitingNot ApplicableNCT07033195

Virtual Reality Treatment for Adults With Chronic Back Pain (VRNT)

Efficacy of a Virtual Reality Neuroscience-based Therapy (VRNT) for Chronic Low Back Pain


Sponsor

CognifiSense Inc.

Enrollment

200 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Participants with chronic back pain will complete an online Qualtrics eligibility survey. After signing a consent form, eligible participants enter a two-week baseline period ("Baseline Period"), during which they complete two assessments of the Primary and Secondary Outcome Measures and Potential Mediators. After the baseline period, participants are randomized into a Virtual Reality group: VR Distraction-based Therapy or VR Skills-based Therapy, with a 1:1 allocation ratio of participants to each treatment. Both groups receive education on pain neuroscience and complete training on the use of the VR hardware and software. Next, both groups complete an intervention for 8 weeks ("Treatment Period"), after which they return the VR equipment. Several surveys are administered online during the Treatment Period. After the Treatment Period, both groups complete three post-treatment surveys at weeks 8, 20, and 32.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Distraction-based Virtual Reality Therapy and a medical device called Skills-based Virtual Reality Therapy for people with chronic back pain, chronic lower back pain (clbp), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESkills-based Virtual Reality Therapy

1. A 34-minute education video session on the science behind chronic pain and the scientific principles of the therapy. 2. VR skills-based therapy: a virtual reality therapy consisting of different psychological training exercises

DEVICEDistraction-based Virtual Reality Therapy

1\. A 7-minute education video session on the science behind pain-focused attention and distraction. 2. VR distraction-based therapy: a virtual reality therapy that encourages passive attention and minimizes external cognitive demands.


Locations(1)

University of Colorado Boulder

Boulder, Colorado, United States

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NCT07033195


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