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

Part of paid clinical trials in Boulder, Colorado.

Sponsor
CognifiSense Inc.
Study ID
NCT07033195
Status
Recruiting
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Conditions

  • Chronic Back Pain
  • Chronic Lower Back Pain (CLBP)
  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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
  • 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.

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
Apr 2026
Primary completion
Feb 20, 2027
Completion
May 20, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Change in Pain Intensity and Interference [ Time Frame: Change from pre-treatment to post-treatment = 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado BoulderBoulderColorado80309
Marta Ceko, ph.D.
[email protected]
+1 443-835-6587
Amanda Way, MS
+1 4016597016
Marta Ceko, ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado Boulder· Boulder, CO

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