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

ConditionsChronic Pain Chronic Back Pain Chronic Lower Back Pain (CLBP)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorCognifiSense Inc.

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Virtual Reality Neuropsychological TherapyExperimental treatment 1 intervention

Group B: Virtual Reality Neuroscience TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Pain Intensity and Interference

Brief Pain Inventory-short form (BPI-SF). Measured on a Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable.

Time frame