Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03982472
Status:
COMPLETED
Last Update Posted:
2019-06-14
First Post:
2019-06-10
Brief Title:
TENS Impact Heart Rate Via Vagus Activity
Sponsor:
Taipei Medical University
Organization:
Taipei Medical University
Study Overview
Official Title:
Shoulder Transcutaneous Electric Nerve Stimulation Decelerates Heart Rhythm of Subjects Via Potentiating Vagal Tone
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 5000 samplessec 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 users 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
ECG and HR recordings Using a monitor lead electrocardiogram ECG was recorded through electrodes connected to a recording system with a sampling rate of 5000 samplessec 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 users 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None