Clinical trial NCT03463824: The VIGOR Study - Virtual Immersive Gaming to Optimize Recovery in Low Back Pain
Official title: The VIGOR Study - Virtual Immersive Gaming to Optimize Recovery in Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Fear of Pain
Fear of Injury
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Ohio University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-03-13
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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. One is a control group and the other is the experimental.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS)
timeFrame: Baseline measure through the 48-weeks post-treatment measure
measure: Change in Disability Using the Roland Morris Disability Questionnaire
timeFrame: Baseline measurement through 48-weeks post-treatment measurement change
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: James S Thomas, P.T., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: France CR, Thomas JS. Virtual immersive gaming to optimize recovery (VIGOR) in low back pain: A phase II randomized controlled trial. Contemp Clin Trials. 2018 Jun;69:83-91. doi: 10.1016/j.cct.2018.05.001. Epub 2018 May 3.