N/A
N=154
The VIGOR Study - Virtual Immersive Gaming to Optimize Recovery in Low Back Pain
Chronic Low Back Pain · Fear of Pain · Fear of Injury
Bottom Line
View on ClinicalTrials.gov: NCT03463824 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS) — 30.3; 35.2 percentage change (NPRS)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental Group 1 (Behavioral); Experimental Group 2 (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS) |
30.3; 35.2 | — |
| PRIMARY Change in Disability Using the Roland Morris Disability Questionnaire |
37; 25 | — |
Summary
This study will measure the effects of interactive, whole-body video games on movement behavior in people with chronic low back pain.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03463824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.