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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2023-10-14

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Low Back Pain Fear of Pain Fear of Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The principal investigators, the statistician, and members of the data collection team will remain blinded to intervention assignment throughout the duration of the study. They will be given the identifying codes only at the end of the study when it is necessary to interpret the results. The un-blinded study coordinator, who is responsible for scheduling testing and treatment sessions, will serve to receive the study patients and escort them to the various testing and treatments sites to minimize the interaction between patients; however, the study coordinator will not participate in the assessments.

Study Groups

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Control Group

Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. The control group will play the same immersive video games, but the parameters will be modified such that only small excursions of lumbar flexion are needed to successfully complete gameplay.

Group Type ACTIVE_COMPARATOR

Experimental Group 1

Intervention Type BEHAVIORAL

Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).

Experimental Group 2

Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions.

Group Type EXPERIMENTAL

Experimental Group 2

Intervention Type BEHAVIORAL

Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).

Interventions

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Experimental Group 1

Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).

Intervention Type BEHAVIORAL

Experimental Group 2

Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No