Actively Recruiting
Virtual Reality Treatment for Adults With Chronic Back Pain (VRNT)
Led by CognifiSense Inc. · Updated on 2026-04-02
200
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
C
CognifiSense Inc.
Lead Sponsor
U
University of Colorado, Boulder
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Virtual Reality Treatment for Adults With Chronic Back Pain (VRNT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 85.
- Self-reported diagnosis of chronic low back pain without radicular symptoms.
- Chronic low back pain lasting 6 months or more, with pain on at least half the days in the last 6 months.
- Lower back pain is the primary chronic pain complaint.
- Average pain intensity of 4 or more out of 10 in the past week.
- Fluent in English at an 8th grade level.
- Willing to follow study procedures and restrictions.
- Have access to Wi-Fi.
- Have basic internet and computer skills.
You will not qualify if you...
- Pregnant, planning pregnancy, or breastfeeding.
- Back pain related to compensation or litigation within the past year.
- Leg pain greater than back pain.
- Chronic pain conditions other than chronic back pain.
- Diagnosed with schizophrenia or dissociative identity disorder.
- Uncontrolled major depressive disorder or other conditions causing significant cognitive or emotional disability.
- History of substance abuse.
- Unable to undergo MRI.
- Significant unstable medical conditions or diseases affecting cardiovascular, gastrointestinal, respiratory, liver, or kidney systems.
- History of cardiovascular disease, recent heart attack, stroke, brain surgery, or brain tumor.
- Diabetes or cancer within the last 12 months.
- Diagnosed inflammatory disorders such as rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus, polymyositis, or Cauda Equina syndrome.
- History of seizure disorders, epilepsy, convulsions, or increased intracranial pressure (except pediatric febrile seizures).
- History of vertigo, dizziness, or motion sickness.
- Head injury within the past 6 months.
- Unexplained weight loss of 20 pounds or more in the past year.
- History of digital eye strain or computer vision syndrome.
- Unable or unwilling to meet study attendance requirements.
- MRI contraindications such as pregnancy, metal in the body, or claustrophobia.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado Boulder
Boulder, Colorado, United States, 80309
Actively Recruiting
Research Team
M
Marta Ceko, Ph.D.
CONTACT
A
Amanda Way, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here