Virtual reality therapy for adults with chronic lower back pain
Efficacy of a Virtual Reality Neuroscience-based Therapy (VRNT) for Chronic Low Back Pain
NA · CognifiSense Inc. · NCT07033195
This project will try two types of virtual reality therapy to see if they help reduce chronic lower back pain in adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | CognifiSense Inc. (industry) |
| Locations | 1 site (Boulder, Colorado) |
| Trial ID | NCT07033195 on ClinicalTrials.gov |
What this trial studies
Adults with chronic low back pain complete an online eligibility survey and, if eligible, a consent form followed by a two-week baseline period with repeated outcome and mediator assessments. After baseline, participants are randomized 1:1 to either distraction-based VR or skills-based VR; both groups receive pain neuroscience education and training on the VR hardware and software. Participants use the assigned VR intervention at home for an 8-week treatment period while completing online surveys, then return the VR equipment and complete follow-up surveys at weeks 8, 20, and 32. Primary and secondary outcomes and potential mediators are measured repeatedly throughout the study to track changes over time.
Who should consider this trial
Good fit: Adults aged 18–85 with self-reported chronic low back pain for at least six months, average pain ≥4/10, fluent in English, and able to use Wi‑Fi and VR equipment are the intended participants.
Not a fit: People whose leg pain is worse than back pain (suggesting radicular/neuropathic pain), those with other dominant chronic pain conditions, active psychotic disorders, pregnancy, or current compensation/litigation related to back pain may not benefit or are excluded.
Why it matters
Potential benefit: If successful, the VR approaches could offer a non-drug, at-home option to reduce pain intensity and improve function for people with chronic low back pain.
How similar studies have performed: Previous VR for pain studies have shown short-term pain relief and promising early results for skills-based VR, but evidence for durable benefits in chronic low back pain is limited and still emerging.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Boulder, Colorado
- University of Colorado Boulder — Boulder, Colorado, United States (RECRUITING)
Study contacts
- Study coordinator: Marta Ceko, Ph.D.
- Email: Marta.Ceko@colorado.edu
- Phone: +1 443-835-6587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Pain, Chronic Back Pain, Chronic Lower Back Pain, chronic pain relief, back pain, chronic back pain, chronic lower back pain