TENS Impact Heart Rate Via Vagus Activity

NCT ID: NCT03982472

Last Updated: 2019-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-22
• Study Completion Date: 2018-07-21

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.

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 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.

Conditions

Transcutaneous Electric Nerve Stimulation; Heart Rate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

TENS right side

TENS stimulation at the right side

Group Type: EXPERIMENTAL

transcutaneous electric stimulation

Intervention Type: OTHER

transcutaneous current with an amplitude around ten to hundred milliampere was applied topically to subjects

TENS left side

TENS stimulation at the left side

Group Type: EXPERIMENTAL

transcutaneous electric stimulation

Intervention Type: OTHER

transcutaneous current with an amplitude around ten to hundred milliampere was applied topically to subjects

sham stimulation

Sham stimulation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

transcutaneous electric stimulation

transcutaneous current with an amplitude around ten to hundred milliampere was applied topically to subjects

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

healthy adult

Exclusion Criteria

hypertension diabetes heart diseases neurological diseases othe medical problem

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Tzer-Bin Lin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tzer-Bin Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

References

Badran BW, Mithoefer OJ, Summer CE, LaBate NT, Glusman CE, Badran AW, DeVries WH, Summers PM, Austelle CW, McTeague LM, Borckardt JJ, George MS. Short trains of transcutaneous auricular vagus nerve stimulation (taVNS) have parameter-specific effects on heart rate. Brain Stimul. 2018 Jul-Aug;11(4):699-708. doi: 10.1016/j.brs.2018.04.004. Epub 2018 Apr 6.

Reference Type: BACKGROUND

PMID: 29716843 (View on PubMed)

Brock C, Brock B, Aziz Q, Moller HJ, Pfeiffer Jensen M, Drewes AM, Farmer AD. Transcutaneous cervical vagal nerve stimulation modulates cardiac vagal tone and tumor necrosis factor-alpha. Neurogastroenterol Motil. 2017 May;29(5). doi: 10.1111/nmo.12999. Epub 2016 Dec 12.

Reference Type: BACKGROUND

PMID: 27957782 (View on PubMed)

Connor DE Jr, Nixon M, Nanda A, Guthikonda B. Vagal nerve stimulation for the treatment of medically refractory epilepsy: a review of the current literature. Neurosurg Focus. 2012 Mar;32(3):E12. doi: 10.3171/2011.12.FOCUS11328.

Reference Type: BACKGROUND

PMID: 22380853 (View on PubMed)

Hsieh CM, Lin WC, Peng HY, Chen HC, Ho YC, Li CJ, Wu XG, Chung JY, Lee SD, Lin TB. Shoulder transcutaneous electric nerve stimulation decreases heart rate via potentiating vagal tone. Sci Rep. 2021 Sep 27;11(1):19168. doi: 10.1038/s41598-021-98690-6.

Reference Type: DERIVED

PMID: 34580404 (View on PubMed)

Other Identifiers

TENS-HR

Identifier Type: -

Identifier Source: org_study_id