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

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.

NCT Number	NCT07033195
Lead Sponsor	CognifiSense Inc. Collaborators: University of Colorado, Boulder
Conditions	Chronic Pain, Chronic Back Pain, Chronic Lower Back Pain (CLBP)
Enrollment	200 participants
Start Date	2025-06-01
Primary Completion	2027-02-20 (estimated)
Study Completion	2027-05-20 (estimated)
Updated on ClinicalTrials.gov	2026-04-02