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

Last updated: July 3, 2025
Sponsor: CognifiSense Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Back Pain

Pain

Chronic Pain

Treatment

Virtual Reality Therapy for Chronic Pain

Standard of Care VR

Clinical Study ID

NCT07033195
24-0138
  • Ages 18-85
  • All Genders

Study 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 treatment group ("Therapy Group") or a control intervention group ("Control Group") with a ratio of 1:1 (treatment:control). 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

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 daysin the last 6 months.

  • Lower back pain as primary chronic pain complaint (greater than pain in other bodilyregions).

  • 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

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 responsiveto 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 otherconditions 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 diseaseof cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructivepulmonary disease), hepatic, or renal systems; including: history of cardiovasculardisease or issues (e.g., recent heart attack), stroke; brain surgery, or braintumor; Diabetes; cancer (last 12 months); diagnosis of a specific inflammatorydisorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus;polymyositis; or Cauda Equina syndrome.

  • History of seizure disorder, epilepsy, convulsions, or increased intracranialpressure 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-reportedhistory of (digital) eye strain or computer vision syndrome. Unable or unwilling tomeet study attendance requirements. MRI contraindications as determined by MRIsafety screen (e.g., pregnancy, metal in body, claustrophobia, using the standardscreen conducted by the MRI imaging facility).

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Virtual Reality Therapy for Chronic Pain
Phase:
Study Start date:
June 01, 2025
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • University of Colorado Boulder

    Boulder, Colorado 80309
    United States

    Active - Recruiting

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