Randomized, 2-arm parallel group clinical trial evaluating the effectiveness of a self-administered Virtual Reality program for the treatment of chronic lower back pain compared to a placebo VR program.
A randomized, 2-arm parallel-group clinical trial evaluating the effectiveness of a self-administered Virtual Reality (VR) program for the treatment of chronic lower back pain. The primary objective of this study is to assess the impact of skills-based VR on changes in patient-reported pain and pain interference over the course of an 8-week intervention as well as compared to a placebo VR condition. The secondary objective is to assess the impact of skill-based VR on changes in patient-reported satisfaction over the course of an 8-week intervention and compared to a placebo VR condition. A tertiary objective is to assess the impact of skills-based VR on changes in patient-reported opioid use, physical function, behavioral skills development, and health outcomes immediately following the intervention relative to a pre-intervention baseline and compared to a placebo VR condition. An exploratory objective is to assess the impact of skills-based VR on changes in patient-reported pain levels, opioid use, physical function, behavioral skills development, health outcomes, and satisfaction at the 24-week post-intervention time point and compared to a placebo VR condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
188
VR software developed by AppliedVR informed by evidence-based cognitive behavioral therapy principles, biofeedback and mindfulness strategies for pain management.
VR software developed by AppliedVR with neutral non-interactive content.
AppliedVR, Inc.
Los Angeles, California, United States
Department of Defense (DoD)/VA Pain scale
DoD/VA Pain scale measures pain intensity, and inference around activity, sleep, mood, and stress, each on an 11-point scale. The max score is 50 and the minimum is 0. The higher the score the worse the outcome. This will be assessed twice weekly during the 8-week intervention intervention period.
Time frame: The primary efficacy endpoint is the change from study baseline to Day 56
Patient's Global Impression of Change Scale
Single item Patient's Global Impression of Change Scale (PGIC), self-reported the level of change (if any) in activity limitations, symptoms, emotions, and overall quality of life-related to your painful condition on a 7-point scale. The higher the number the better the outcome.
Time frame: twice weekly during 8-week intervention, Day 56
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