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

Not Applicable

Completed

• Conditions: Fear of Pain; Fear of Injury; Chronic Low Back Pain
• Interventions: Behavioral: Experimental Group 2; Behavioral: Experimental Group 1

• Registration Number: NCT03463824
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-13
• Study Start: 2019-01-10
• Primary Completion: 2023-10-14
• Study Completion: 2023-10-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group 2	Experimental Group 2	Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions.
Experimental Group 1	Experimental Group 1	Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions.

Primary Outcome Measures

Name	Time	Method
Change in Disability	Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment	Roland Morris Disability Questionnaire
Change in Pain	Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment	Numerical Pain Rating Score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States