跳至主要内容
临床试验/NCT04236570
NCT04236570已完成不适用

Evaluation of Endogenous Pain Modulation Mechanisms With Transcutaneous Electrical Nerve Stimulation (TENS)

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月15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
50
试验地点
2
主要终点
Evaluate excitatory mechanisms, specifically temporal summation

研究概览

简要总结

A number of chronic pain conditions are characterized by imbalances in excitatory and/or inhibitory mechanisms and these deficits appear correlated with the response to certain treatments. Evaluating these mechanisms among people who suffer from chronic pain could allow clinicians to adapt the treatment to each patient according to the deficits observed. To evaluate excitatory and inhibitory mechanisms, a thermode (hot plate) and a cold water bath can be used (standardized protocol). Unfortunately, these tools are expensive, time-consuming and require complex equipment and software. As such, it is not realistic for clinicians to use them for routine patient assessment. A potential alternative to study these mechanisms is TENS (transcutaneous electrical nerve stimulation). TENS is frequently used in rehabilitation and unlike thermode and cold water bath, is affordable, easy to use and requires very little time and equipment. The objective of this study are to determine if the TENS can replace the thermode and cold water bath (standardized protocol) for the evaluation of excitatory and inhibitory mechanisms. Also, to determine if there will be a correlation with the standardized protocol. 50 healthy participants between 18 and 60 years old will participate in this study. Each participant will attend two experimental sessions. In one of the two sessions, the evaluation will be done with the TENS; in the other session, the evaluation will be done with the standardized protocol (thermode and cold water bath).

详细描述

To evaluate excitatory and inhibitory mechanisms, the investigators will used the modified CPM testing procedure consisting of test stimulus (TS) administered before and after a conditioning stimulus (CS). For the standardized protocol, the TS will consisted of a noxius heat stimulus generated by a thermode (hot plate), applied for two minutes on the non-dominant anterior forearm. The CS will consisted of a cold pressor test (CT), wherein participants immersed their dominant forearm in a cold water bath for two minutes. For the TENS protocol, the TS will consisted of a noxius electrical stimulus generated by TENS, applied for 5 seconds on the non-dominant knee at a frequency of 1 Hz and 5 Hz. The CS will consisted of a noxius electrical stimulus generated by TENS' applied for 120 seconds on the non dominant knee and ankle at a frequency of 2 Hz.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Man or woman between 18 and 60 years old (inclusive)

排除标准

  • Chronic pain
  • Neurological disorders
  • Musculoskeletal disorders
  • Depression
  • Raynaud syndrome
  • History of non-efficacy with TENS
  • History of epilepsy
  • Presence of a pacemaker or metal implants
  • Antidepressant
  • Anticonvulsant
  • Analgesics

结局指标

主要结局

Evaluate excitatory mechanisms, specifically temporal summation

时间窗: This outcomes (excitatory pain mechanisms) will be evaluated at both sessions (V1 [day 0] and V2 [day 7])

To evaluate excitatory mechanisms ,we will calculated if there is an increase of pain levels during the test stimulus (TS). Pain levels will be measured with a computerized visual analogue scale (CoVAS)

Evaluate inhibitory mechanisms, specifically conditioning pain modulation (CPM)

时间窗: This outcome (mechanisms) will be evaluated at both sessions (V1 [day 0] and V2 [day 7])

To evaluate inhibitory mechanisms ,we will calculated if there is an decrease of pain levels after the conditioning stimulus (CS). Pain levels will be measured with a computerized visual analogue scale (CoVAS)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillaume Léonard

Professor

Université de Sherbrooke

研究点 (2)

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