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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
University of Colorado Boulder
RECRUITING
Boulder
Contact Information
Primary
Marta Ceko, Ph.D.
Marta.Ceko@colorado.edu
+1 443-835-6587
Backup
Amanda Way, MS
+1 4016597016
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 200
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Colorado, Boulder
Leads: CognifiSense Inc.

This content was sourced from clinicaltrials.gov