Clinical trial NCT05587140: Effects of TENS on Pain Threshold and Brain Activities in Healthy Adults
Official title: Effects of Conventional Versus Acupuncture-like TENS on Pain Threshold and Brain Activities in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcutaneous Electrical Nerve Stimulation
Electroencephalography
Pressure Pain Threshold
Keywords: Transcutaneous electrical nerve stimulation
Electroencephalography
Pressure pain threshold
Pressure pain tolerance
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pressure pain threshold after the intervention
timeFrame: The change between baseline and the time after 30 minutes intervention
measure: Pressure pain tolerance after the intervention
timeFrame: The change between baseline and the time after 30 minutes intervention
measure: EEG power spectrum change in delta band after the intervention
timeFrame: The change between baseline and the time after 30 minutes intervention
measure: EEG power spectrum change in theta band after the intervention
timeFrame: The change between baseline and the time after 30 minutes intervention
measure: EEG power spectrum change in alpha band after the intervention
timeFrame: The change between baseline and the time after 30 minutes intervention
measure: EEG power spectrum change in beta band after the intervention
timeFrame: The change between baseline and the time after 30 minutes intervention
measure: EEG power spectrum change in low-gamma band after the intervention
timeFrame: The change between baseline and the time after 30 minutes intervention
measure: EEG power spectrum change in high-gamma band after the intervention
timeFrame: The change between baseline and the time after 30 minutes intervention
measure: EEG power spectrum change in total gamma band after the intervention
timeFrame: The change between baseline and the time after 30 minutes intervention
Secondary outcomes:
measure: Pressure pain tolerance after the 30 minutes break
timeFrame: The change between 30 minutes intervention and 30 minutes break after the intervention
measure: Pressure pain threshold after the 30 minutes break
timeFrame: The change between 30 minutes intervention and 30 minutes break after the intervention
measure: EEG power spectrum change in delta band after the 30 minutes break
timeFrame: The change between 30 minutes intervention and 30 minutes break after the intervention
measure: EEG power spectrum change in theta band after the 30 minutes break
timeFrame: The change between 30 minutes intervention and 30 minutes break after the intervention
measure: EEG power spectrum change in alpha band after the 30 minutes break
timeFrame: The change between 30 minutes intervention and 30 minutes break after the intervention
measure: EEG power spectrum change in beta band after the 30 minutes break
timeFrame: The change between 30 minutes intervention and 30 minutes break after the intervention
measure: EEG power spectrum change in low-gamma band after the 30 minutes break
timeFrame: The change between 30 minutes intervention and 30 minutes break after the intervention
measure: EEG power spectrum change in high-gamma band after the 30 minutes break
timeFrame: The change between 30 minutes intervention and 30 minutes break after the intervention
measure: EEG power spectrum change in total gamma band after the 30 minutes break
timeFrame: The change between 30 minutes intervention and 30 minutes break after the intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Li-Wei Chou, PhD
role: PRINCIPAL_INVESTIGATOR
References: