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NCT Number: NCT07033195

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

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location status: Recruiting

Location contact

Amanda Way, MS

CONTACT

+1 4016597016

Marta Ceko, ph.D.

CONTACT

[email protected]

+1 443-835-6587

Marta Ceko, ph.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Skills-based Virtual Reality Therapy

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

Distraction-based Virtual Reality Therapy

Device
  • 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.

Primary outcomes

  1. Change in Pain Intensity and Interference

    Time frame: 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 outcomes

  1. Pain Interference

    Time frame: 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.

  2. Disability

    Time frame: 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.

  3. Physical Function

    Time frame: 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).

  4. Sleep Disturbance

    Time frame: Change from pre-treatment to post-treatment = 8 weeks

    Sleep Disturbance (PROMIS). 5-point Likert scale: 1 = very good, 5 = very poor (worst outcome).

  5. Depression

    Time frame: Change from pre-treatment to post-treatment = 8 weeks

    Depression (PROMIS). 5-point Likert scale: 1 = never, 5 = always (worst outcome).

  6. Anxiety

    Time frame: Change from pre-treatment to post-treatment = 8 weeks

    Anxiety (PROMIS). 5-point Likert scale: 1 = never, 5 = always (worst outcome).

  7. Fatigue

    Time frame: Change from pre-treatment to post-treatment = 8 weeks

    Fatigue (PROMIS). 5-point Likert scale: 1 = not at all, 5 = very much (worst outcome).

  8. Stress

    Time frame: 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.

Other outcomes

  1. Cybersickness

    Time frame: Assessed at Week 8

    Single item questionnaire: "Did you experience any motion sickness or nausea while using VR?". 4-point Likert Scale: 0 = never, 3 = always (worst outcome).

  2. Global Improvement

    Time frame: Assessed at Week 8

    Patient's Global Impression of Change (PGIC). 10-point Likert scale: 0 = much better, 10 = much worse (worst outcome).

  3. Treatment Satisfaction

    Time frame: Assessed at Week 8

    Treatment satisfaction (single item). 7-point Likert scale: extremely satisfied, extremely dissatisfied (worst outcome).

  4. System Usability

    Time frame: Assessed at Week 8

    System usability (SUS). 5-point Likert scale: 1 = strongly disagree, 5 = strongly agree.

  5. Virtual Reality Device Use

    Time frame: Throughout treatment = 8 weeks

    Data collected from VR Device

  6. Chronic Pain Acceptance

    Time frame: Change from pre-treatment to post-treatment = 8 weeks

    Chronic Pain Acceptance Questionnaire (CPAQ-8). 7-point Likert scale: 6 = always true, 0 = never true (worst outcome).

  7. Pain catastrophizing

    Time frame: Change from pre-treatment to post-treatment = 8 weeks

    Pain catastrophizing (PCS). 5-point Likert scale: 0 = not at all, 4 = all the time (worst outcome).

  8. Pain self-efficacy

    Time frame: Change from pre-treatment to post-treatment = 8 weeks

    Pain Self-Efficacy Questionnaire (PSEQ-2). 7-point Likert scale: 6 - completely Confident, 0 = not at all confident (worst outcome).

  9. Positive and Negative affect

    Time frame: Change from pre-treatment to post-treatment = 8 weeks

    Positive and Negative Affect Schedule (PANAS-SF). 5-point Likert scale: 1 = very slightly, 5 = extremely.

  10. Fear of movement

    Time frame: Change from pre-treatment to post-treatment = 8 weeks

    Tampa Scale Kinesiophobia (TSK). 4-point Likert scale: 1 = strongly disagree, 4 - strongly agree (worst outcome).

  11. Immersive tendencies

    Time frame: Change from pre-treatment to post-treatment = 8 weeks

    Immersive Tendencies Questionnaire (ITQ). 7-point Likert scale: never, often.

  12. Expectations of treatment success

    Time frame: Change from pre-treatment to post-treatment = 8 weeks

    Expectations of Treatment Success. 10-point Likert scale: 10 = most, 0 = none.

  13. Adherence

    Time frame: Throughout treatment = 8 weeks

    Data collected from VR Device

  14. Medication Use

    Time frame: Change from pre-treatment to post-treatment = 8 weeks

    Custom analgesic medication use survey. Data collection of medication type, frequency of use, and dose standardized with "Opioid Oral Morphine Milligram Equivalent (MME) Conversion Table"

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Way, MS

CONTACT

+1 4016597016

Marta Ceko, Ph.D.

CONTACT

[email protected]

+1 443-835-6587

Sponsors and collaborators

Lead sponsor

CognifiSense Inc.

Industry

Collaborators

  • University of Colorado, Boulder

Registry information

Official study title

Efficacy of a Virtual Reality Neuroscience-based Therapy (VRNT) for Chronic Low Back Pain

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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