Acute Effects of Transcutaneous Electrical Nerve Stimulation at Acupoints on Nociceptive Transmission: A Mechanism Study Using Pain-Related Evoked Potentials

NCT ID: NCT07267052

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-25

Study Completion Date

2026-07-31

Brief Summary

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The goal of this clinical trial is to learn if transcutaneous electrical nerve stimulation (TENS) applied to acupoints can modulate pain transmission and cortical processing in healthy adult volunteers. The main questions it aims to answer are:

* Does TENS at Zhongzhu (SJ3) and Hegu (LI4) change pain-related evoked potentials (PREPs)?
* Does acupoint electrical stimulation alter nociceptive pathways reflected by PREP waveform modulation?

Researchers will compare PREPs recorded before and after TENS at the two acupoints to see if TENS produces measurable effects on cortical nociceptive responses.

Participants will receive low-frequency TENS applied to Zhongzhu (SJ3) and Hegu (LI4), and undergo PREP assessments before and after the intervention to measure cortical responses to standardized noxious stimuli.

Detailed Description

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This study aims to investigate the modulatory effects of transcutaneous electrical nerve stimulation (TENS) applied to acupuncture points on pain transmission and cortical processing in healthy adults. Pain-related evoked potentials (PREPs) will be used as the primary neurophysiological measure to examine changes before and after TENS applied to two clinically recognized analgesic acupoints, Zhongzhu (SJ3) and Hegu (LI4). A within-subject design will be adopted, and participants aged 18 years or older will undergo two experimental sessions in randomized order. Each session will include baseline PREP assessment, a 20-minute low-frequency TENS intervention at the assigned acupoint, and a follow-up PREP measurement. PREP waveform characteristics, including N2 and P2 amplitudes and latencies, will be analyzed to determine whether acupoint stimulation alters nociceptive transmission. Subjective pain reports and adverse responses will also be collected to assess tolerability. The findings of this research are expected to provide insight into the neurophysiological basis of acupuncture analgesia and contribute to the development of more refined acupoint-based electrical therapies.

Conditions

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Pain Management

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TENS Group

Acupoint TENS Intervention (TENS Group) Participants in this group received low-frequency transcutaneous electrical nerve stimulation (TENS) applied to clinically recognized analgesic acupoints, Zhongzhu (SJ3) and Hegu (LI4). Each participant completed two intervention sessions in a randomized order, with at least 48 hours between sessions. During each session, participants first underwent a baseline assessment of pain-related evoked potentials (PREPs), followed by a 20-minute TENS application delivered through surface electrodes placed directly over the target acupoint. The stimulation parameters included low frequency and low-intensity currents adjusted to a comfortable but perceptible level. Immediately after the stimulation period, participants received a follow-up PREP assessment to evaluate changes in nociceptive cortical processing. Subjective pain responses and any discomfort or adverse reactions were recorded throughout the procedure. The entire protocol was designed to deter

Group Type EXPERIMENTAL

transcutaneous electrical nerve stimulation (TENS)

Intervention Type DEVICE

TENS was applied to the acupoints Zhongzhu (SJ3) and Hegu (LI4) using surface electrodes. Low-frequency electrical currents were delivered at an intensity that was comfortable but perceptible, without causing muscle contraction. Each session lasted 20 minutes, during which participants remained seated and relaxed, and electrode placement and stimulation parameters were monitored for safety and consistency.

EEG machine

Intervention Type DEVICE

EEG signals were recorded using the Neuro-MEP4 system. The device captures cortical electrical activity with high temporal resolution and is suitable for measuring pain-related evoked potentials (PREPs). Standard electrode placement and recording protocols were followed, and signal quality was checked before each session to ensure reliable data collection.

Interventions

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transcutaneous electrical nerve stimulation (TENS)

TENS was applied to the acupoints Zhongzhu (SJ3) and Hegu (LI4) using surface electrodes. Low-frequency electrical currents were delivered at an intensity that was comfortable but perceptible, without causing muscle contraction. Each session lasted 20 minutes, during which participants remained seated and relaxed, and electrode placement and stimulation parameters were monitored for safety and consistency.

Intervention Type DEVICE

EEG machine

EEG signals were recorded using the Neuro-MEP4 system. The device captures cortical electrical activity with high temporal resolution and is suitable for measuring pain-related evoked potentials (PREPs). Standard electrode placement and recording protocols were followed, and signal quality was checked before each session to ensure reliable data collection.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

* Participants with a history of malignant tumors, hand disorders, implanted cardiac pacemakers, pregnancy, epilepsy, or any other condition that may interfere with the study procedures will be excluded from the study.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Physical Therapy of China Medical University

Taichung, Beitun, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yueh-Ling Hsieh

Role: CONTACT

04-22053366 Ext. #7312

Yung-Yu Hsu

Role: CONTACT

0973060827

Facility Contacts

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Department of Physical Therapy of China Medical University

Role: primary

04-22053366 Ext.#7301

Other Identifiers

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CMUH114-REC3-149

Identifier Type: -

Identifier Source: org_study_id

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