An interventional study of transcutaneous electric stimulation in Transcutaneous Electric Nerve Stimulation and Heart Rate, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2019-06-14.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Prevention
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.
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.
Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
healthy adult
Exclusion Criteria:
hypertension diabetes heart diseases neurological diseases othe medical problem
TENS stimulation at the right side
Other: transcutaneous electric stimulation
TENS stimulation at the left side
Other: transcutaneous electric stimulation
Sham stimulation
transcutaneous current with an amplitude around ten to hundred milliampere was applied topically to subjects
heart rate
TENS stimulation modified HR
Time frame: 5 min
Plan to share: Undecided — After our results have been published
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Taipei Medical University