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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT04415177
Study type Interventional
Source AppliedVR Inc.
Contact
Status Completed
Phase N/A
Start date July 1, 2020
Completion date April 30, 2021

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