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临床试验/NCT06669767
NCT06669767已完成不适用

Behavioral Indicators of Pain Representation

Universite de Picardie Jules Verne1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年11月14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
34
试验地点
1
主要终点
Standard deviation of the position of the center of pressure on the anteroposterior axis (SD-COP-AP)

研究概览

简要总结

The goal of this observational study is to compare the postural response to the mental simulation of everyday situations identified as painful in participants with non-specific low back pain and healthy volunteers.

The main questions it aims to answer are :

Do participants with low-back pain show reduced variability in center of pressure displacements compared with non-painful participants when faced with mental simulation of everyday situations identified as painful? Is the postural response correlated with the level of kinesiophobia? Participants will be faced to pictures of everyday situations identified as painful while several physiological measurements (posturography, electromyography, heart rate) are being recorded.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 55
  • Non-specific chronic low back pain for the concerned group

排除标准

  • Low back pain for 0 to 3 months
  • Unable to stand 1 minute without technical aid
  • Neurological, motor or cognitive know impairment
  • BMI > 30

结局指标

主要结局

Standard deviation of the position of the center of pressure on the anteroposterior axis (SD-COP-AP)

时间窗: Baseline

Movements of the center of pressure (COP) are recorded using a force plate, and the SD-COP-AP is calculated after recording and is an indicator of the postural response.

次要结局

  • Mean position of the center of pressure on the anteroposterior axis (COP-AP)(Baseline)
  • Mean position of the center of pressure on the mediolateral axis (COP-ML)(Baseline)
  • Standard deviation of the position of the center of pressure on the mediolateral axis (SD-COP-ML)(Baseline)
  • Sway length of the center of pressure on the anteroposterior axis (L-COP-AP)(Baseline)
  • Sway length of the center of pressure on the mediolateral axis (L-COP-ML)(Baseline)
  • Tibialis anterior muscle activity(Baseline)
  • Soleus muscle activity(Baseline)
  • Longissimus dorsi muscle activity(Baseline)
  • Co-activation (Soleus/Tibialis anterior)(Baseline)
  • Coefficient of variation for muscle activity of tibialis anterior(Baseline)
  • Coefficient of variation for muscle activity of soleus(Baseline)
  • Coefficient of variation for muscle activity of longissimus dorsi(Baseline)
  • Mean heart rate(Baseline)
  • Mean RR interval(Baseline)
  • Standard deviation of normal RR intervals (SDNN)(Baseline)
  • Root mean square of successive R-R intervals (RMSSD)(Baseline)
  • Power of very low frequency from frequency analysis (VLF)(Baseline)
  • Power of low frequency from frequency analysis (LF)(Baseline)
  • Power of high frequency from frequency analysis (HF)(Baseline)
  • Ratio of LF/HF (post-frequency analysis)(Baseline)
  • Tampa scale for kinesiophobia (TSK) score(Baseline)
  • Brief pain inventory (BPI) score(Baseline)
  • EQ-5D-5L questionnaire score(Baseline)
  • Fear-Avoidance Component Scale (FACS) score(Baseline)
  • Pain catastrophizing scale (PCS) score(Baseline)
  • Hospital Anxiety and Depression scale (HAD) score(Baseline)

研究者

发起方
Universite de Picardie Jules Verne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrien Hakimi

Research engineer

Universite de Picardie Jules Verne

研究点 (1)

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