NCT07033195

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: CognifiSense Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain
• Chronic Back Pain
• Chronic Lower Back Pain (CLBP)

Interventions

Type	Name	Description
DEVICE	Skills-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
DEVICE	Distraction-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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-02-20
• Completion: 2027-05-20
• First posted: 2025-06-24
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study