NCT07033195 Virtual Reality Treatment for Adults With Chronic Back Pain (VRNT)
| NCT ID | NCT07033195 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CognifiSense Inc. |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-02-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-06-01 with a primary completion date of 2027-02-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Men and women aged 18 to 85. * Self-reported diagnosis of chronic low back pain without radicular symptoms. * Chronic low back pain duration of 6 months or more, and pain at least half the days in the last 6 months. * Lower back pain as primary chronic pain complaint (greater than pain in other bodily regions). * Average pain intensity of 4 or more out of 10 for the past week (from BPI-SF). * English fluency (8th grade level). * Willing to comply with study procedures/restrictions. * Access to Wi-Fi. * Implicit de facto internet and computer literacy. Exclusion Criteria: * Applicants, who are pregnant, planning pregnancy, or breastfeeding * Back pain associated with compensation / litigation within 1 year. * Leg pain greater than back pain (suggests neuropathic pain; may be less responsive to psychological therapy). * Chronic pain other than chronic back pain. * Diagnoses of schizophrenia, multiple personality dissociative identity disorder. * History of major depressive disorder not controlled with medication or other conditions that produce significant cognitive or emotional disability. * History of substance abuse. * Inability to undergo MRI (determined at screening; see XVI: Risks to Participants). * Any clinically significant unstable medical abnormality or acute or chronic disease of cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems; including: history of cardiovascular disease or issues (e.g., recent heart attack), stroke; brain surgery, or brain tumor; Diabetes; cancer (last 12 months); diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus; polymyositis; or Cauda Equina syndrome. * History of seizure disorder, epilepsy, convulsions, or increased intracranial pressure anytime except pediatric febrile seizures. * History of vertigo, dizziness, susceptibility to motion sickness * History of head injury within 6 months, * Unexplained, unintended weight loss of 'â• 20 lbs in past year. Self-reported history of (digital) eye strain or computer vision syndrome. Unable or unwilling to meet study attendance requirements. MRI contraindications as determined by MRI safety screen (e.g., pregnancy, metal in body, claustrophobia, using the standard screen conducted by the MRI imaging facility).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07033195 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07033195 currently recruiting?
Yes, NCT07033195 is actively recruiting participants. Contact the research team at Marta.Ceko@colorado.edu for enrollment information.
Where is the NCT07033195 trial being conducted?
This trial is being conducted at Boulder, United States.
Who is sponsoring the NCT07033195 clinical trial?
NCT07033195 is sponsored by CognifiSense Inc.. The trial plans to enroll 200 participants.
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