Status:
COMPLETED
The VIGOR Study - Virtual Immersive Gaming to Optimize Recovery in Low Back Pain
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Ohio University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Chronic Low Back Pain
Fear of Pain
Eligibility:
All Genders
18-60 years
Phase:
NA
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 part...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2023
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT03463824
Start Date
January 10 2019
End Date
October 14 2023
Last Update
February 5 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23222