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临床试验/NCT03982472
NCT03982472已完成不适用

Shoulder Transcutaneous Electric Nerve Stimulation Decelerates Heart Rhythm of Subjects Via Potentiating Vagal Tone

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年7月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
heart rate

研究概览

简要总结

Transcutaneous electric nerve stimulation (TENS) is widely used for the treatment of adhesive capsulitis, nevertheless, its potential impact on heart physiology has not been well established.

The investigator explored if TENS at shoulder region affect heart rhythm and the machinery involved.

Subjects were stratified into groups received sham stimulation (TENS-S) and TENS on either the right (TENS-R) or left (TENS-L) shoulder. A built-in waveform for treating adhesive capsulitis with a maximal tolerable intensity below the pain threshold was applied to subjects form a commercial TENS equipment for 5 min. The electrocardiogram (ECG) and heart rate (HR) were continuously recorded and the ECG was off-line transferred into power spectrum for analysis.

详细描述

Study design This study complied with the Declaration of Helsinki, and all protocols were approved by the ethics committee of Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan. All the participants gave written informed consent before experiments. 32 subjects (20-51 years old) were included in the statistical analysis. Participants were eligible if they have cardiovascular illnesses, major mental conditions, or severe inflammation. Participants were allocated to groups that received sham stimulation (TENS-S) and TENS on the right and left shoulder (TENS-R and TENS-L, respectively).

ECG and HR recordings Using a monitor lead, electrocardiogram (ECG) was recorded through electrodes connected to a recording system with a sampling rate of 5,000 samples/sec. The ECG and the HR calculated by a built-in rate meter were continuously recorded and displayed on a monitor. For TENS caused marked artifacts in ECG tracings, HR derived from ECG were confirmed off-line by manual examination.

TENS stimulation To mimicking clinical scenarios, a commercial TENS equipment was used throughout this study. A built-in waveform recommended for treating capsulitis in the user's manual was used for stimulation (triple pulses with 1 ms pulse durations separated by a 1 ms intervals were ramps up and down between 2 to 10 Hz within 20 sec for 3 min and then ramps up from 10 to 200 Hz within 20 sec and kept at 200 Hz for 2 min; supplementary data 1). The current intensity was adjusted to the maximal tolerance level below the pain threshold. A pair of stimulating electrode was placed in the front of the should at the level of the sternal notch at about 2 finger-width from the mid-clavicle line, and a pair of dispersive electrode was placed at the back of shoulder opposite to the stimulating electrodes. Participants kept a stationary supine position and was asked to refrain from moving during recording. Before the stimulation, there was an equilibrium period for at least 10 min, and then the recording started. TENS was turned on for 5 min at 5 min after the baseline recording, and the recording continued until 10 min after the offset of stimulation. Parameters of the sham stimulation was identical to TENS stimulation on the right shoulder excepting the equipment was left un-powered.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • healthy adult

排除标准

  • hypertension diabetes heart diseases neurological diseases othe medical problem

研究组 & 干预措施

TENS right side

Experimental

TENS stimulation at the right side

干预措施: transcutaneous electric stimulation (Other)

TENS left side

Experimental

TENS stimulation at the left side

干预措施: transcutaneous electric stimulation (Other)

sham stimulation

No Intervention

Sham stimulation

结局指标

主要结局

heart rate

时间窗: 5 min

TENS stimulation modified HR

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

Tzer-Bin Lin

Professor

Taipei Medical University

研究点 (1)

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