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

NCT07033195 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Colorado, Boulder

    collaborator OTHER

  • CognifiSense Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-02-20
Completion
2027-05-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07033195 on ClinicalTrials.gov