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临床试验/NCT05396820
NCT05396820已完成不适用

Adaptation of the Motor System to Experimental Pain

Universite du Littoral Cote d'Opale2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Kinesiophobia

研究概览

简要总结

This study aims to measure the impact of an experimental pain on electromyography, kinematics of motion and motor cortical excitability.

详细描述

The main objective of this study will be to determine if the influence of pain on the corticospinal excitability of M1 (via the slopes of the I/O curves) is dependent on the level of kinesiophobia.

The secondary objectives are firstly to measure the modifications induced by experimental pain on muscle activation synergies. Secondly, to measure the modifications induced by an experimental pain on the kinematics of the movement during a pointing task during the application of the pain. Finally, to determine if an experimental pain modifies the electrical activity of muscles located in the painful area during a pointing movement and the value of the cumulative sums (CUSUMs).

Inclusion Criteria:

  • Males and females of legal age.
  • Healthy subjects (who do not have self-reported neurological disorders)
  • Subjects who have signed an informed consent (who have a good command of French)
  • Subjects who are affiliated with or benefit from a social security plan

Criteria for non-inclusion:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

A randomized number is allocated for all participants.

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

  • Healthy subjects (who do not have self-reported neurological disorders)
  • Subjects who have signed an informed consent (who have a good command of French)
  • Subjects affiliated with or receiving social security benefits

排除标准

  • Psychiatric history obtained through physician questioning: individuals with mental retardation or severe impairment of cognitive, behavioral, or emotional function that precludes understanding the protocol and signing informed consent
  • Neurological history (epilepsy, stroke, surgeries performed on the brain or spinal cord, and history of neurological diseases affecting motor skills and sensation)
  • Subjects who are unable to receive informed information (dementia, hearing problems, poor French proficiency, etc.)
  • Contraindications to MST (epilepsy, intracranial metal foreign bodies, hearing aids or cochlear implants)
  • Taking psychotropic medications
  • Persons under guardianship or conservatorship
  • Pregnant and nursing women
  • Subjects with pacemakers

结局指标

主要结局

Kinesiophobia

时间窗: 5 minutes

Kinesiophobia will be assessed using the French-Canadian version of the Tampa Kinesiophobia Questionnaire (EKT-CF). It takes the form of a self-reported questionnaire of 17 items using a Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with an acceptable degree of internal consistency (Cronbach's alpha = 0.71), satisfactory construct validity, and high sensitivity to change (intra-class correlation coefficient \> 0.7). The total score is obtained by adding the value of the responses and is between 17 and 68. The value of 40/68 is considered as the threshold value at which kinesiophobia becomes significant.

Corticospinal excitability

时间窗: 1 hour

It will be measured using transcranial magnetic stimulation at different intensities in order to model I/O curves for each participant. Measurements will be taken before (pain-free condition) and after (pain condition) the application of a patch of capsaicin 1%, at the shoulder. Electromyographic signals, induced by the magnetic stimuli, will be captured with surface electrodes glued to the skin the anterior deltoid and upper trapezius muscles. To facilitate obtaining deltoid MEPs, participants will be asked to voluntarily contract 8-12% of their maximum voluntary contraction. The Boltzmann sigmoidal function will be used to fit the data points to construct the I/O curves. The mathematical modeling of the I/O curves allows the calculation of three parameters: the slope, the plateau, and the S50, the intensity allowing to obtain a response twice less than the maximum response. These 3 parameters will be used to compare them with the 2 conditions (before and after pain).

次要结局

  • Kinematic parameters: Smoothness of motion(1 hour)
  • Activation synergies(1 hour)
  • EMG data and cumulative summation: CUSUMs(1 hour)
  • Kinematic parameters: Linearity of motion(1 hour)
  • Kinematic parameters: Maximum directional error(1 hour)
  • EMG data and cumulative summation: The area of the puffs(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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