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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 154

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

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
Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS)	Baseline measure through the 48-weeks post-treatment measure	The Numerical Pain Rating Scale (NPRS) is a pain assessment tool that uses a 11 point scale of 0-10 to help patients rate the intensity of their pain: 0: No pain and 10: The worst pain imaginable. The NPRS is the most commonly used unidimensional pain scale. It can be administered verbally or graphically, and patients are asked to select the number that best reflects their pain intensity over the past 24 hours. The smaller the number (closer to 0), the less pain the subject is enduring, and the larger the number, the more pain they are enduring. Percent change in NPRS rather than raw score change may provide more meaningful information regarding a patient's response to pain treatment.
Change in Disability Using the Roland Morris Disability Questionnaire	Baseline measurement through 48-weeks post-treatment measurement change	Roland Morris Disability Questionnaire: A patient taking the survey agrees or disagrees with these statements (Yes/No). The patient is asked to tick a statement when it applies to him that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The items of the questionnaire are assessed on a 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability. The sum of the seven items equals the total score of the PDI, which ranges from 0 to 70, with higher scores (closer to 70) reflecting higher interference of pain with daily activities and a lower score (closer to 0) has less interference of pain with daily activities.. Test-retest reliability 24-item: intraclass correlation (ICC) ranges from 0.42 - 0.91 T

Secondary Outcome Measures