About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Skills-based Virtual Reality Therapy
- Distraction-based Virtual Reality Therapy
Treatment groups
Sponsors and collaborators
CognifiSense Inc.
Lead sponsor
University of Colorado, Boulder
Collaborator