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

NCT ID: NCT07033195

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-05-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Neuropsychological Therapy

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.

Group Type: EXPERIMENTAL

Skills-based Virtual Reality Therapy

Intervention Type: 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 Neuroscience Therapy

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.

Group Type: ACTIVE_COMPARATOR

Distraction-based Virtual Reality Therapy

Intervention Type: 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.

Interventions

Skills-based Virtual Reality Therapy

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

Intervention Type: DEVICE

Distraction-based Virtual Reality Therapy

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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Boulder

OTHER

Sponsor Role: collaborator

CognifiSense Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado Boulder

Boulder, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Marta Ceko, Ph.D.

Role: CONTACT

Marta.Ceko@colorado.edu

+1 443-835-6587

Amanda Way, MS

Role: CONTACT

+1 4016597016

Facility Contacts

Marta Ceko, ph.D.

Role: primary

Marta.Ceko@colorado.edu

+1 443-835-6587

Amanda Way, MS

Role: backup

+1 4016597016

Related Links

https://studies.buildclinical.com/bcfs001533-cu-ceko-84-landing-page/

Landing Page for the study

Other Identifiers

24-0138

Identifier Type: -

Identifier Source: org_study_id