Immersive Virtual Walking Treatment for Neuropathic Pain in Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Pain Intensity as assessed by Numeric Rating Scale
研究概览
简要总结
This study will examine the effectiveness of one of two virtual reality treatments on neuropathic pain in individuals with spinal cord injury.
详细描述
The investigators are investigating the effectiveness of one of two possible investigational virtual reality treatments on neuropathic pain in individuals with spinal cord injury. Participants will be randomized to one of these two treatments.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and key research staff assessing outcomes will be blind to condition allocation.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with complete paraplegic spinal cord injury who report chronic neuropathic pain
- •Individuals with persistent spinal cord injury neuropathic pain
- •More than one - year post injury
- •Stable medication regimen for the past month
排除标准
- •Conditions that impair movement of the arms
- •Significant cognitive impairment as suggested by apparent incomprehension of screening questions as judged by the evaluator
- •For those for whom voluntary arm movement would cause sufficient discomfort (>4/10) that could prevent trial completion will be excluded from participation
结局指标
主要结局
Pain Intensity as assessed by Numeric Rating Scale
时间窗: Baseline - Final assessment (average 1 week post treatment)
The Numeric Rating Scale (NRS) measures pain intensity measured via 0-10 numeric rating scale. Range of scores: 0-10
Neuropathic Pain Qualities as assessed by Neuropathic Pain Scale
时间窗: Baseline - Final assessment (average 1 week post treatment)
The Neuropathic Pain Scale (NPS) was designed to assess the distinct pain qualities associated with neuropathic pain.The NPS consists of 10 items. Seven of the 10 items contain the words intense, sharp, hot, dull, cold, and itchy to characterize the patient's pain and the word sensitive to describe the patient's pain reaction to light touch or clothing.One item describes the time quality of the pain (all the time or some of the time). The ninth item describes the overall unpleasantness of the pain, whereas the last item indicates the intensity of the deep and surface pain. In the NPS each item is rated separately. All the items are rated 0-10 scale, with higher score indicative of more neuropathic pain for each type of respective pain. Range of scores: 0-10 for each item.
Neuropathic Pain Diagnosis as assessed by Doleur Neuropatique 4
时间窗: Baseline - Final assessment (average 1 week post treatment)
Doleur Neuropatique 4 is a 10 item survey that evaluates neuropathic pain following central and neurological lesions. It has components of how the pain feels to the patient (e.g. burning, cold, electrical shocks, tingling, hypoaesthesia). Responses to each item is yes or no, with each yes response equaling one point. Range of scores: 0-10. 4/10 and greater indicate neuropathic pain.
Pain Interference specific to spinal cord injury as assessed by International Spinal Cord Injury Pain Basic Data Set version 2.0
时间窗: Baseline - Final assessment (average 1 week post treatment)
Pain interference measured International Spinal Cord Injury Pain Basic Data Set version 2.0 interference items. There are 3 pain interference items using a 0-10 numeric rating scale for each item. Items can be assessed by summing the score or by individual assessment of items. Summed range of scores: 0-30. Individual item range of scores: 0-10
Pain Interference as assessed by Brief Pain Inventory
时间窗: Baseline - Final assessment (average 1 week post treatment)
Pain interference measured by Brief Pain Inventory interference items. 7 items each use a 0-10 scale. Item scores may be assessed individually, or by taking the average score of all items. Range of Scores: 0-10. Increased scores indicate higher levels of interference due to pain.
次要结局
- Patient Treatment Evaluation as assessed by the Ease of Usefulness, Satisfaction, and Ease of Use Questionnaire(Final assessment (average 1 week post treatment))
- Patient Treatment Evaluation as assessed by the Patient Global Impression of Change Scale(Final assessment (average 1 week post treatment))
- Patient Treatment Evaluation as assessed by the Modified Treatment Evaluation Inventory(Final assessment (average 1 week post treatment))
- Patient Treatment Evaluation as assessed by Semi-structured Qualitative Interviewing(Final assessment (average 1 week post treatment))
- Quality of Life and Participation are assessed by the SF-36 Walk-Wheel(Baseline - Final assessment (average 1 week post treatment))
- Quality of Life is assessed by Satisfaction with Life Scale(Baseline - Final assessment (average 1 week post treatment))
- Depression and mood are assessed by the Patient Health Questionnaire -9(Baseline - Final assessment (average 1 week post treatment))
- Perceived Disability is assessed by the Pain Disability Index(Baseline - Final assessment (average 1 week post treatment))
- Absorption is assessed by the Tellegen Absorption Scale(Baseline)
- Immersive Tendencies are assessed by the Immersive Tendencies Questionnaire(Baseline)
- fMRI Imaging(Baseline - Final assessment (average 1 week post treatment))
研究者
Zina Trost
Assistant Professor
University of Alabama at Birmingham