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NCT05587140 Clinical Trial

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

Electroencephalography Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05587140
Other study ID # TENS & pain control
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 31, 2022
Est. completion date April 30, 2023

Study information
Verified date June 2022
Source National Yang Ming University
Contact Li-Wei Chou, PhD
Phone +886228267092
Email lwchou@ym.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Acupuncture like TENS
Frequency: 4 Hz, pulse duration: 200 µs, intensity: 3/10 painful sensation with muscle contraction , time: 30 minutes
• Conventional TENS
Frequency: 100 Hz, pulse duration: 200 µs, intensity: strong but comfortable tingling sensation , time: 30 minutes
• 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

Locations
Country Name City State
Taiwan National Yang-Ming University Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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