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

Launched by COGNIFISENSE INC. · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help adults with chronic lower back pain using virtual reality (VR) technology. The goal is to see if a VR program, combined with education about pain, can reduce pain and improve daily life for people who have had back pain for six months or more. Participants will be divided into two groups: one will receive the VR treatment, and the other will get a different type of support. Both groups will learn about how pain works and get training on how to use the VR equipment at home for eight weeks.

Adults between 18 and 85 years old with ongoing lower back pain that is their main pain problem may be eligible to join, as long as their pain is moderate or worse, and they speak English. People with certain health conditions, such as recent serious illnesses, neurological disorders, or pregnancy, cannot participate. If you join, you will first complete some surveys to understand your pain, then use the VR program or control activities at home, with surveys along the way and after the treatment ends to track your progress. The study is currently recruiting participants, so if you have chronic lower back pain and access to Wi-Fi, this might be an opportunity to try a new approach to managing your pain.

Gender

ALL

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).