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

NCT07033195 | Recruiting FDA Device

• 1 other identifier: 24-0138
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Chronic Back Pain; Chronic Lower Back Pain (CLBP)

Keywords

chronic pain relief; back pain; chronic back pain; chronic lower back pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity and Interference

  Brief Pain Inventory-short form (BPI-SF). Measured on a Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable.

  Change from pre-treatment to post-treatment = 8 weeks

Secondary Outcomes (8)

• Pain Interference

  Change from pre-treatment to post-treatment = 8 weeks

• Disability

  Change from pre-treatment to post-treatment = 8 weeks

• Physical Function

  Change from pre-treatment to post-treatment = 8 weeks

• Sleep Disturbance

  Change from pre-treatment to post-treatment = 8 weeks

• Depression

  Change from pre-treatment to post-treatment = 8 weeks

Other Outcomes (14)

• Cybersickness

  Assessed at Week 8

• Global Improvement

  Assessed at Week 8

• Treatment Satisfaction

  Assessed at Week 8

Study Arms (2)

Virtual Reality Neuropsychological Therapy

EXPERIMENTAL

Participants start the treatment period with three introductory sessions: 1. A 34-minute pain education video that introduces the neuroscience of acute and chronic pain, drivers of pain chronification, pain triggers, and the scientific principles behind the VRNT. 2. A session to customize the VR experience to match the participant's experience using a display of a personalized 3-dimensional audiovisual representation of each patient's pain. 3. A training session on the use of the VR hardware. The participant will receive a workbook to guide them through each day's session. Participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.

Device: Skills-based Virtual Reality Therapy

Virtual Reality Neuroscience Therapy

ACTIVE COMPARATOR

Participants start the treatment period with two introductory sessions: 1. A 7-minute pain education video that introduces the neuroscience of pain-focused attention, distraction, and the scientific principles behind VRNT. 2. A training session on the use of the VR hardware. The participant will receive a workbook (Attachment 'VRNT Workbook') to guide them through each day's session. Participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.

Device: Distraction-based Virtual Reality Therapy

Interventions

Skills-based Virtual Reality Therapy DEVICE

1. A 34-minute education video session on the science behind chronic pain and the scientific principles of the therapy. 2. VR skills-based therapy: a virtual reality therapy consisting of different psychological training exercises

Virtual Reality Neuropsychological Therapy

Distraction-based Virtual Reality Therapy DEVICE

1\. A 7-minute education video session on the science behind pain-focused attention and distraction. 2. VR distraction-based therapy: a virtual reality therapy that encourages passive attention and minimizes external cognitive demands.

Virtual Reality Neuroscience Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CognifiSense Inc.: lead
• University of Colorado, Boulder: collaborator

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

RECRUITING

Related Links

• Landing Page for the study

MeSH Terms

Conditions

Chronic Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marta Ceko, Ph.D.

CONTACT

+1 443-835-6587; Marta.Ceko@colorado.edu

Amanda Way, MS

CONTACT

+1 4016597016

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 24, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)