The VIGOR Study - Virtual Immersive Gaming to Optimize Recovery in Low Back Pain

Study Overview
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Brief Summary
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This study will measure the effects of interactive, whole-body video games on movement behavior in people with chronic low back pain.

Detailed Description
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A fundamental clinical problem in individuals with chronic low back pain is the significant alteration in movement patterns that restrict lumbar spine motion. This restriction of lumbar motion is particularly evident in patients with kinesiophobia; that is, a fear of movement due to possible injury or reinjury. For chronic back pain patients with kinesiophobia it is critical to develop an effective intervention to increase spine motion while minimizing concerns of pain and harm. Accordingly, we have developed a innovative video games that track whole-body motion and are designed to encourage spinal flexion while reducing concerns of pain and harm among individuals with low back pain. Our games have two distinct advantages. First, within this video game environment, visual feedback can be altered by changing the feedback gain of a given movement (e.g., the magnitude of a given joint movement could appear on screen as either larger or smaller than the actual movement). Thus, gain manipulation will result in progressively larger amounts of lumbar spine flexion during game play. Second, video games are potent distractors that can reduce attention to pain.

Official Title
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The VIGOR Study - Virtual Immersive Gaming to Optimize Recovery in Low Back Pain

Conditions
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Chronic Low Back Pain, Fear of Pain, Fear of Injury

Intervention / Treatment
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* Behavioral: Experimental Group 1
* Behavioral: Experimental Group 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-60 years of age Low back pain that has been ongoing for at least half the days in the last 6 months Average pain intensity of greater than 3 over the past week on a 0-10 Numerical Rating Scale Disability greater than 4 on Roland and Morris Disability Questionnaire Agrees with statement It is not really safe for a person with my back problem to be physically active or Tampa Scale of Kinesiophobia score greater than 36 Has sought care or consultation from a health care provider for back pain Meets category 1, 2, or 3 on the Classification System of the Quebec Task Force on Spinal Disorders which reflects low back pain without neurological signs Working proficiency in English Exclusion Criteria: Has a personal history of the following neurological disorders: Alzheimers, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinsons, Neuropathy, Stroke, Seizures Has a personal history of the following cardiorespiratory disorders: Congestive heart failure, heart attack in past 2 years Has a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, Muscular Dystrophy, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis History of spine surgery or a hip arthroplasty Has active cancer Has a chronic disease that may restrict movement or preclude safe participation Has used opioids within 30 days prior to study enrollment Reports being pregnant, lactating, or that they anticipate becoming pregnant within 2-months Reports pending litigation related to CLBP Has current drug or alcohol use or dependence that, in the opinion of the PIs, would interfere with adherence to study requirements Has significant visual impairment that would prevent virtual reality headset use Has significant motion sickness that would prevent virtual reality headset use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of two intervention arms. Both intervention arms involve immersive video games that encourage participants to produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. The two groups are distinguished by the amount of lumbar flexion needed to achieve game objectives.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group 1<br>Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. | Behavioral: Experimental Group 1<br>* Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).<br>|
| Experimental: Experimental Group 2<br>Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. | Behavioral: Experimental Group 2<br>* Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | Numerical Pain Rating Score | Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment | 
| Change in Disability | Roland Morris Disability Questionnaire | Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lumbar Spine Flexion | Standardized Reaching Paradigm | Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment | 
| Change in Pain & Harm Expectancy | Standardized Reaching Paradigm | Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment | 
| Change in Real World Activity | Activity Monitor | Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment |