NCT03982472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

12 months

First QC Date

June 10, 2019

Last Update Submit

June 13, 2019

Conditions

Transcutaneous Electric Nerve StimulationHeart Rate

Keywords

heart rateTENSvagus nerve

Outcome Measures

Primary Outcomes (1)

  • heart rate

    TENS stimulation modified HR

    5 min

Study Arms (3)

TENS right side

EXPERIMENTAL

TENS stimulation at the right side

Other: transcutaneous electric stimulation

TENS left side

EXPERIMENTAL

TENS stimulation at the left side

Other: transcutaneous electric stimulation

sham stimulation

NO INTERVENTION

Sham stimulation

Interventions

transcutaneous electric stimulationOTHER

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

TENS left sideTENS right side

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adult

You may not qualify if:

  • hypertension diabetes heart diseases neurological diseases othe medical problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

Related Publications (4)

  • 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.

    PMID: 29716843BACKGROUND

  • 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.

    PMID: 27957782BACKGROUND

  • 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.

    PMID: 22380853BACKGROUND

  • 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.

    PMID: 34580404DERIVED

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Tzer-Bin Lin, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Difference of group was compared between groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 11, 2019

Study Start

July 22, 2017

Primary Completion

July 21, 2018

Study Completion

July 21, 2018

Last Updated

June 14, 2019

Record last verified: 2019-06

Locations

TW(1)