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

Not Applicable

Recruiting

• Conditions: Chronic Pain; Chronic Back Pain; Chronic Lower Back Pain (CLBP)

• Registration Number: NCT07033195
• Lead Sponsor: CognifiSense Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-13
• Study First Posted: 2025-06-24
• Last Update Submitted: 2025-09-01
• Last Update Posted: 2025-09-08
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity and Interference	Change from pre-treatment to post-treatment = 8 weeks	Brief Pain Inventory-short form (BPI-SF). Measured on a Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Pain Interference	Change from pre-treatment to post-treatment = 8 weeks	Brief Pain Inventory-short form (BPI-SF). Measured on a Scale of 0 to 10, 0 = no interference, 10 = severe interference.
Disability	Change from pre-treatment to post-treatment = 8 weeks	Oswestry Low Back Pain Disability Questionnaire (OLBPQ). Measured on a scale of 0-100%, 0-20% = minimal disability, 80-100% = patients are bed-bound or exaggerating symptoms.
Physical Function	Change from pre-treatment to post-treatment = 8 weeks	Physical Function (PROMIS). 5-point Likert scale: 5 = without any difficulty, 1 = unable to do (worse outcome).
Sleep Disturbance	Change from pre-treatment to post-treatment = 8 weeks	Sleep Disturbance (PROMIS). 5-point Likert scale: 1 = very good, 5 = very poor (worst outcome).
Depression	Change from pre-treatment to post-treatment = 8 weeks	Depression (PROMIS). 5-point Likert scale: 1 = never, 5 = always (worst outcome).
Anxiety	Change from pre-treatment to post-treatment = 8 weeks	Anxiety (PROMIS). 5-point Likert scale: 1 = never, 5 = always (worst outcome).
Fatigue	Change from pre-treatment to post-treatment = 8 weeks	Fatigue (PROMIS). 5-point Likert scale: 1 = not at all, 5 = very much (worst outcome).
Stress	Change from pre-treatment to post-treatment = 8 weeks	Perceived Stress Scale (PSS). Measured on a scale of 0 to 40, 0-13 = low stress, 27-40 = high perceived stress.

Trial Locations

Locations (1)

University of Colorado Boulder; 🇺🇸 Boulder, Colorado, United States