A Multisite Randomized Clinical Trial to Examine the Efficacy and Mechanisms of Immersive Virtual Walking Treatment for Neuropathic Pain in Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- Change in Pain Intensity
研究概览
简要总结
The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with chronic spinal cord injury.
详细描述
Many people with SCI experience neuropathic pain. Neuropathic pain is often described as sharp, burning, or electric. 'Traditional' treatments often do not do a good job of reducing neuropathic pain. Therefore, it is important to see if 'non-traditional' treatments might work. Scientists think that neuropathic pain occurs in SCI because the sensations coming from the eyes and up the spinal cord to the brain do not match what the brain thinks it told the body to do. This 'mis-match' may result in changes in the brain that make neuropathic pain possible. Virtual reality walking reduces this 'mis-match.' It does this by creating the 'illusion' that the person is walking. The brain then thinks it is telling the body to walk AND the information coming from the eyes matches its instructions. This 'matching' may reverse the brain changes that made neuropathic pain possible. The current study is specifically focused on individuals whose SCI has been classified as complete (ASIA A).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will recruit individuals with complete injury (American Spinal Injury Association [ASIA] classification A) with lumbar, paraplegic, or low tetraplegic (C5-C7) injury. Additional criteria will include:
- •Must have persistent NP symptoms that are of daily severity of at least 4/10 for 3 or more months
- •Must endorse more than 2 items on a 7-item Spinal Cord Injury Pain Instrument, SCIPI
- •Must be 18 years of age or older
- •Must be more than one year post-injury to begin study (can be screened at an earlier time for eligibility)
- •Must have mobile connectivity with usable service
- •Must be stable on pain medication for 1 or more months
- •Must be cleared on the VRWalk physical activity clearance scale
- •Must not have motion sickness that interferes with daily life
排除标准
- •Individuals with Injury levels between C1 and C4
- •Individuals under the age of 18
- •Individuals who were injured within the past year
- •Individuals who cannot comprehend spoken English
- •Individuals who are in prison
- •Individuals who are blind
- •Individuals who experience severe motion sickness
结局指标
主要结局
Change in Pain Intensity
时间窗: Baseline - final follow up (up to 18 months)
The Numeric Rating Scale (NRS) measures pain intensity via 0-10 numeric rating scale 0-10 where 0 is no pain and 10 is the worst pain imaginable.
次要结局
- Post treatment change(at follow up (up to 18 months))
- Change in Pain Interference(Baseline - final follow up (up to 18 months))
- Change in mood(Baseline - final follow up (up to 18 months))
- Change in Pain Quality(Baseline - final follow up (up to 18 months))
- Neurological changes(Baseline - 6 months)
- Change in quality of life(Baseline - final follow up (up to 18 months))