The VIGOR Study - Virtual Immersive Gaming to Optimize Recovery in Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS)
研究概览
简要总结
This study will measure the effects of interactive, whole-body video games on movement behavior in people with chronic low back pain.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Experimental Group 1 (Behavioral)
Experimental Group 2
Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions.
干预措施: Experimental Group 2 (Behavioral)
结局指标
主要结局
Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS)
时间窗: 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
时间窗: 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
次要结局
未报告次要终点