Virtual Reality Treatment for Adults With Chronic Back Pain (VRNT) (NCT07033195) | Clinical Trial Compass
RecruitingNot Applicable
Virtual Reality Treatment for Adults With Chronic Back Pain (VRNT)
United States200 participantsStarted 2025-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity and Interference
Timeframe: Change from pre-treatment to post-treatment = 8 weeks