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

October 16, 2022 updated by: National Yang Ming University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • National Yang-Ming University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pressure pain threshold after the intervention
Time Frame: The change between baseline and the time after 30 minutes 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
Time Frame: The change between baseline and the time after 30 minutes 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
Time Frame: The change between baseline and the time after 30 minutes 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
Time Frame: The change between baseline and the time after 30 minutes 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
Time Frame: The change between baseline and the time after 30 minutes 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
Time Frame: The change between baseline and the time after 30 minutes 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
Time Frame: The change between baseline and the time after 30 minutes 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
Time Frame: The change between baseline and the time after 30 minutes 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
Time Frame: The change between baseline and the time after 30 minutes intervention
Evaluate brain activity after the intervention
The change between baseline and the time after 30 minutes intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pressure pain tolerance after the 30 minutes break
Time Frame: The change between 30 minutes intervention and 30 minutes break 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 30 minutes intervention and 30 minutes break after the intervention
Pressure pain threshold after the 30 minutes break
Time Frame: The change between 30 minutes intervention and 30 minutes break 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 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in delta band after the 30 minutes break
Time Frame: The change between 30 minutes intervention and 30 minutes break after the intervention
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
Time Frame: The change between 30 minutes intervention and 30 minutes break after the intervention
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
Time Frame: The change between 30 minutes intervention and 30 minutes break after the intervention
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
Time Frame: The change between 30 minutes intervention and 30 minutes break after the intervention
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
Time Frame: The change between 30 minutes intervention and 30 minutes break after the intervention
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
Time Frame: The change between 30 minutes intervention and 30 minutes break after the intervention
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
Time Frame: The change between 30 minutes intervention and 30 minutes break after the intervention
Evaluate brain activity after the 30 minutes break
The change between 30 minutes intervention and 30 minutes break after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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