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临床试验/NCT02679300
NCT02679300已完成不适用

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

Hasselt University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
2
主要终点
Average pain intensity during exercises using the numeric pain rating scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Average pain intensity during exercises using the numeric pain rating scale

时间窗: Day 1

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)

Time spent thinking of the pain using a numeric rating scale

时间窗: Day 1

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")

次要结局

  • Pain intensity after the exercises using a numeric rating scale(Day 1)
  • Harmfulness of the exercises using a numeric rating scale(Day 1)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Matheve

PT, MSc

Hasselt University

研究点 (2)

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