Virtual immersive gaming to optimize recovery (VIGOR) in low back pain: A phase II randomized controlled trial

Abstract

The virtual immersive gaming to optimize recovery (VIGOR) study is a randomized controlled trial of the effects of virtual reality games to encourage lumbar spine flexion among individuals with chronic low back pain and fear of movement. Whereas traditional graded activity or graded exposure therapies for chronic low back pain have high attrition and poor long-term efficacy, we believe that virtual reality games have distinct advantages that can enhance adherence and clinical outcomes. First, they are engaging and enjoyable activities that can distract from pain and fear of harm. In addition, because they gradually reinforce increases in lumbar spine flexion to achieve game objectives, continued engagement over time is expected to promote recovery through restoration of normal spinal motion. The study design includes two treatment groups which differ in the amount of lumbar flexion required to achieve the game objectives. All participants will play the games for nine weeks, and pre-treatment to 1-week post-treatment changes in pain and disability will serve as the co-primary clinical outcomes. In addition, changes in lumbar flexion and expectations of pain/harm will be examined as potential treatment outcome mediators. Maintenance of treatment outcomes will also be assessed for up to 48-weeks post-treatment. In brief, we hypothesize that the virtual reality games will reduce pain and disability by promoting spinal motion and allowing participants to develop an implicit understanding that they are capable of engaging in significant lumbar spine motion in their daily lives without a risk of injury to their back.

Trial registration: ClinicalTrials.gov NCT03463824.

Keywords: Clinical trial; Kinesiophobia; Low back pain; Virtual reality.

Conflict of interest statement

Conflict of interest statement

CRF and JST have read and approved the final manuscript and certify that they have no conflicts of interest or financial, personal, or other relationships that could inappropriately influence or be perceived to influence this manuscript.

Copyright © 2018 Elsevier Inc. All rights reserved.

Figures

Figure 1

Study protocol flowchart.

Figure 2

Target locations are determined mathematically based on participant hip height, trunk length, and arm length. The high target is located such that the subject could, in theory, reach the target by flexing the hips 15° with the shoulder flexed 90° and the elbow extended. Similarly, the lowest target could be reached by flexing the hips 60°.

Figure 3

Column 1 shows a participant with the head-mounted display and instrumented with the marker clusters. Column 2 shows images from the “Matchality” game environments, including day one on earth (top), day two in earth orbit (middle), and day 3 on an alien planet (bottom). Column 3 shows images from the “Fishality” game environment. Column 4 shows images from the “Dodgeality” game environment, including inside an arena (top, middle) and on an alien planet (bottom).