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

Effects of Conventional Versus Acupuncture-like TENS on Pain Threshold and Brain Activities in Healthy Adults

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

Study Overview

• Status: Recruiting
• Conditions: Electroencephalography; Transcutaneous Electrical Nerve Stimulation; Pressure Pain Threshold
• Intervention / Treatment: Device: Acupuncture like TENS; Device: Conventional TENS; Device: Sham TENS

Detailed Description

Transcutaneous electrical nerve stimulation (TENS) is a pain modulation tool which is commonly used clinically. TENS has 2 major modes: "conventional TENS'' and "acupuncture like TENS". Conventional TENS induces a local pain modulation, whereas acupuncture like TENS induces central pain modulation mechanism. The pain threshold at treatment area and outside of area is regarded as local pain modulation and central pain modulation respectively. However, the effect of acupuncture like TENS on pain threshold was remained unclear. TENS also induces cortical activities changed in the central nervous system. Recent Electroencephalography (EEG) studies suggested that TENS induces event-related potential and power spectrum changes, however, the time and frequency bands of EEG changes and its relationship with pain threshold were still unclear. Therefore, the purpose of this study was to understand the effects of conventional versus acupuncture-like TENS on pain threshold, brain activities, and their relationships.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heng-Chi Hsu; Phone Number: 0984443386; Email: sidcanfly880122.be10@nycu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Recruiting
    • National Yang-Ming University
    • Contact: Li-Wei Chou; Phone Number: +886 2 28267092; Email: lwchou@ym.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 20~65 y adults
• No cognitive function problem
• Without taking any type of pain medication or substances that could affect the cognitive functions

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acupuncture like TENS; The study would use acupuncture like TENS for 30 minutes	Device: Acupuncture like TENS; Frequency: 4 Hz, pulse duration: 200 μs, intensity: 3/10 painful sensation with muscle contraction , time: 30 minutes
EXPERIMENTAL: Conventional TENS; The study would use conventional TENS for 30 minutes	Device: Conventional TENS; Frequency: 100 Hz, pulse duration: 200 μs, intensity: strong but comfortable tingling sensation , time: 30 minutes
EXPERIMENTAL: Sham TENS; The study would use sham TENS for 30 minutes	Device: Sham TENS; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure pain tolerance after the 30 minutes break	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 30 minutes intervention and 30 minutes break after the intervention
Pressure pain threshold after the 30 minutes break	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 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in delta band after the 30 minutes break	Evaluate brain activity 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	Evaluate brain activity 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	Evaluate brain activity after the 30 minutes break	The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in beta band after the 30 minutes break	Evaluate brain activity after the 30 minutes break	The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in low-gamma band after the 30 minutes break	Evaluate brain activity after the 30 minutes break	The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in high-gamma band after the 30 minutes break	Evaluate brain activity after the 30 minutes break	The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in total gamma band after the 30 minutes break	Evaluate brain activity after the 30 minutes break	The change between 30 minutes intervention and 30 minutes break after the intervention

Collaborators and Investigators

• Sponsor: National Yang Ming University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 31, 2022
• Primary Completion (ANTICIPATED): April 30, 2023
• Study Completion (ANTICIPATED): April 30, 2023

Study Registration Dates

• First Submitted: July 10, 2022
• First Submitted That Met QC Criteria: October 16, 2022
• First Posted (ACTUAL): October 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Transcutaneous electrical nerve stimulation; Electroencephalography; Pressure pain threshold; Pressure pain tolerance
• Other Study ID Numbers: TENS & pain control

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No