Virtual Reality and Pain Perception During Exercises for Patients With Chronic Non-specific Low Back Pain
2020年6月18日 更新者：Thomas Matheve、Hasselt University
The Influence of a Virtual Reality Environment on Pain Perception During Exercises for Patients With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial
Immersion in a virtual reality environment has been shown to reduce pain during a variety of painful medical procedures, such as wound care for burn patients and dental care.
Often, serious games are used to distract patients from this painful procedures.
Recently, serious games have also been developed for patients with low back pain.
Because patients with low back pain frequently experience pain during exercises, the investigators hypothesize that exercising with serious games can reduce the pain intensity and the time spent thinking of pain during exercises.
To test this hypothesis, the investigators will conduct a randomized controlled trial where two groups will be compared: the experimental group will perform one session of exercises with serious games, while the control group will perform one session of the same exercises without the serious games.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
84
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Hasselt、比利时、3500
- Hasselt University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Chronic non-specific low back pain, with or without referred pain to the legs
- Age 18-65
- Able to understand Dutch
- A minimum pain intensity of 3/10 on the numeric pain rating scale at the time of the test
- Being familiar with pelvic tilt exercises
Exclusion Criteria:
- Spinal surgery in the past
- Pregnancy
- Serious underlying pathologies (e.g. multiple sclerosis, tumors,…)
- Signs or symptoms of nerve root involvement
- Known skin-allergy for tape
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Virtual reality group
During a single intervention session, participants will perform 2 sets of 2 minutes of pelvic tilt exercises using serious games.
These serious games have to be controlled by pelvic tilts.
Patients will perform the exercises in a standing position in front a TV-screen, on which the games will be displayed.
Wireless motion sensors will be mounted to the patient's spine and pelvis to track the movements of the pelvis.
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有源比较器：Control group
During a single session intervention, participants will perform 2 sets of 2 minutes of pelvic tilt exercises without a serious game.
Patients will perform the exercises in a standing position.
The number of repetitions and the tempo of the pelvic tilts will be indicated using a metronome.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Average pain intensity during exercises using the numeric pain rating scale
大体时间：Day 1
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Immediately after the intervention, patients will be asked to indicate the average pain they experienced during the exercises using the numeric pain rating scale (0-10)
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Day 1
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Time spent thinking of the pain using a numeric rating scale
大体时间：Day 1
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Immediately after the intervention, patients will be asked to indicate the average time they spent thinking of their pain during the exercises using a numeric rating scale ranging from 0 ("not at all") to 10 ("all the time")
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Day 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain intensity after the exercises using a numeric rating scale
大体时间：Day 1
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Patients will be asked to indicate their pain immediately after the exercises using the numeric pain rating scale (0-10)
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Day 1
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Harmfulness of the exercises using a numeric rating scale
大体时间：Day 1
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Immediately after the intervention, patients will be asked to indicate how harmful they thought the exercises were for their lumbar spine on a numeric rating scale ranging from 0 ("not harmful at all") to 10 ("extremely harmful").
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Day 1
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of pelvic tilts
大体时间：Day 1
|
During the exercises the pelvis and lumbar spine of the participants will be recorded with a digital videocamera to capture the number of pelvic tilts during the exercises.
This outcome measure will primarily be used as possible covariate
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Day 1
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Immersion (questionnaire will be used to measure the level of immersion)
大体时间：Day 1
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Immediately after the intervention, the immersive experience questionnaire will be used to measure the level of immersion
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Day 1
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年1月1日
初级完成 (实际的)
2018年9月1日
研究完成 (实际的)
2018年9月1日
研究注册日期
首次提交
2016年2月4日
首先提交符合 QC 标准的
2016年2月6日
首次发布 (估计)
2016年2月10日
研究记录更新
最后更新发布 (实际的)
2020年6月22日
上次提交的符合 QC 标准的更新
2020年6月18日
最后验证
2020年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.