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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD088417-01A1 | U.S. NIH Grant/Contract | View source | |
| 17-F-11 | Other Identifier | Ohio University |
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| Name | Class |
|---|---|
| Ohio University | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | 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. |
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| Experimental Group 2 | Experimental | Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Group 1 | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS) | 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. | Baseline measure through the 48-weeks post-treatment measure |
| Change in Disability Using the Roland Morris Disability Questionnaire | 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 | Baseline measurement through 48-weeks post-treatment measurement change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James S Thomas, P.T., Ph.D. | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23222 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29730393 | Derived | 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. |
| Label | URL |
|---|---|
| The VIGOR Study | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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). |
| FG001 | Experimental Group 2 | Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The number of subjects enrolled in the two arm of the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group 1 | Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS) | 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. | Study participants who completed this procedure | Posted | Mean | Standard Deviation | percentage change (NPRS) | Baseline measure through the 48-weeks post-treatment measure |
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The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group 1 | Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| A transient ischemic attack TIA | General disorders | Systematic Assessment | TIA attack, not related to the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Thomas | Virginia Commonwealth University | 740-591-1563 | jthomas32@vcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2020 | Oct 9, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2020 | Feb 14, 2024 | ICF_000.pdf |
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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.
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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.
| Experimental Group 2 | 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). |
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| BG001 | Experimental Group 2 | Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Median BMI | Median | Full Range | kg/m^2 |
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| Radiating pain | Count of Participants | Participants |
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Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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). |
| OG001 | Experimental Group 2 | Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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). |
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| Primary | Change in Disability Using the Roland Morris Disability Questionnaire | 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 | Subjects that completed this procedure | Posted | Mean | Standard Deviation | score on Roland Morris Disability Questi | Baseline measurement through 48-weeks post-treatment measurement change |
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| 0 |
| 74 |
| 0 |
| 74 |
| 4 |
| 74 |
| EG001 | Experimental Group 2 | Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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). | 0 | 80 | 0 | 80 | 3 | 80 |
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| Shoulder work injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Injured should at work, not study related |
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| Knee Bone Spurs | Musculoskeletal and connective tissue disorders | Systematic Assessment | Subject developed knee bone spurs, not related to the study |
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| micro-discectomy on L5-L5 and a laminectomy | Musculoskeletal and connective tissue disorders | Systematic Assessment | one subject had a micro-discectomy on L5-L5 and a laminectomy, not related to the study |
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| pulled a muscle in his left hip and lower back while changing a car tire | Musculoskeletal and connective tissue disorders | Systematic Assessment | One subject pulled a muscle in his left hip and lower back while changing a car tire, not related to the study |
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| back surgery prior to coming in for V2 | Musculoskeletal and connective tissue disorders | Systematic Assessment | one subject had to have back surgery prior to coming in for V2, not related to the study procedures |
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| minor surgery and it turned out to be a major surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | one subject was scheduled for a minor surgery and it turned out to be a major surgery |
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