Effects of TENS on Pain Threshold and Brain Activities in Healthy Adults

NCT05587140 | Unknown

• 1 other identifier: TENS & pain control
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to understand the effects of conventional versus acupuncture-like TENS on pain threshold, brain activities, and their relationships.

Conditions

Transcutaneous Electrical Nerve Stimulation; Electroencephalography; Pressure Pain Threshold

Keywords

Transcutaneous electrical nerve stimulation; Electroencephalography; Pressure pain threshold; Pressure pain tolerance

Outcome Measures

Primary Outcomes (9)

• Pressure pain threshold after the intervention

  Use a pressure algometer to press on the first dorsal interosseous muscle and the pressure would stop until the feeling changes from non-painful feeling to painful feeling.

  The change between baseline and the time after 30 minutes intervention

• Pressure pain tolerance after the intervention

  Use a pressure algometer to press on the first dorsal interosseous muscle and the pressure would stop until the feeling reach the pain intensity at 5/10.

  The change between baseline and the time after 30 minutes intervention

• EEG power spectrum change in delta band after the intervention

  Evaluate brain activity after the intervention

  The change between baseline and the time after 30 minutes intervention

• EEG power spectrum change in theta band after the intervention

  Evaluate brain activity after the intervention

  The change between baseline and the time after 30 minutes intervention

• EEG power spectrum change in alpha band after the intervention

  Evaluate brain activity after the intervention

  The change between baseline and the time after 30 minutes intervention

• EEG power spectrum change in beta band after the intervention

  Evaluate brain activity after the intervention

  The change between baseline and the time after 30 minutes intervention

• EEG power spectrum change in low-gamma band after the intervention

  Evaluate brain activity after the intervention

  The change between baseline and the time after 30 minutes intervention

• EEG power spectrum change in high-gamma band after the intervention

  Evaluate brain activity after the intervention

  The change between baseline and the time after 30 minutes intervention

• EEG power spectrum change in total gamma band after the intervention

  Evaluate brain activity after the intervention

  The change between baseline and the time after 30 minutes intervention

Secondary Outcomes (9)

• Pressure pain tolerance after the 30 minutes break

  The change between 30 minutes intervention and 30 minutes break after the intervention

• Pressure pain threshold after the 30 minutes break

  The change between 30 minutes intervention and 30 minutes break after the intervention

• EEG power spectrum change in delta band after the 30 minutes break

  The change between 30 minutes intervention and 30 minutes break after the intervention

• EEG power spectrum change in theta band after the 30 minutes break

  The change between 30 minutes intervention and 30 minutes break after the intervention

• EEG power spectrum change in alpha band after the 30 minutes break

  The change between 30 minutes intervention and 30 minutes break after the intervention

Study Arms (3)

Acupuncture like TENS

EXPERIMENTAL

The study would use acupuncture like TENS for 30 minutes

Device: Acupuncture like TENS

Conventional TENS

EXPERIMENTAL

The study would use conventional TENS for 30 minutes

Device: Conventional TENS

Sham TENS

EXPERIMENTAL

The study would use sham TENS for 30 minutes

Device: Sham TENS

Interventions

Acupuncture like TENS DEVICE

Frequency: 4 Hz, pulse duration: 200 μs, intensity: 3/10 painful sensation with muscle contraction , time: 30 minutes

Acupuncture like TENS

Conventional TENS DEVICE

Frequency: 100 Hz, pulse duration: 200 μs, intensity: strong but comfortable tingling sensation , time: 30 minutes

Conventional TENS

Sham TENS DEVICE

Frequency: 4 Hz, pulse duration: 200 μs, intensity: tingling sensation, time: turn on the electricity for 15 seconds, then turn off the machine for 30 minutes

Sham TENS

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~65 y adults
• No cognitive function problem
• Without taking any type of pain medication or substances that could affect the cognitive functions

You may not qualify if:

• Peripheral or central nervous system disease
• Sensory lose
• TENS application is contraindication
• Cardiac pacemaker
• Any type of pain

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang-Ming University

Taipei, 112, Taiwan

RECRUITING

Study Officials

• Li-Wei Chou, PhD

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Wei Chou, PhD

CONTACT

+886228267092; lwchou@ym.edu.tw

Heng-Chi Hsu

CONTACT

0984443386; sidcanfly880122.be10@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: October 19, 2022
• Study Start: August 31, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: October 19, 2022

Record last verified: 2022-06

Locations

TW (1)