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

NCT07267052 | Recruiting

• 1 other identifier: CMUH114-REC3-149
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management

Keywords

Somatosensory Evoked Potentials; Transcutaneous Electrical Nerve Stimulation; Pain-Related Evoked Potentials; Zhongzhu; Hegu

Outcome Measures

Primary Outcomes (1)

• Pain-Related Evoked Potentials (PREPs)

  PREPs were recorded using the Neuro-MEP4 EEG system. Participants were seated comfortably in a quiet room and instructed to remain relaxed during the recordings. Surface electrodes were placed according to standard PREP protocols to capture cortical responses to standardized noxious electrical stimuli applied to the forearm. For each trial, multiple stimuli were delivered, and the resulting N2 and P2 components were averaged to improve signal reliability. The primary outcome measures included the peak amplitudes and latencies of the N2 and P2 waves, which reflect cortical processing of nociceptive input.

  Participants were assessed at time points: prior to the intervention (baseline), immediately after TENS application

Study Arms (1)

TENS Group

EXPERIMENTAL

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

Device: transcutaneous electrical nerve stimulation (TENS); Device: EEG machine

Interventions

transcutaneous electrical nerve stimulation (TENS) 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.

TENS Group

EEG machine 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.

TENS Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Department of Physical Therapy of China Medical University

Taichung, Beitun, Taiwan, 406040, Taiwan

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Yueh-Ling Hsieh

CONTACT

04-22053366 Ext. #7312; sherrie@mail.cmu.edu.tw

Yung-Yu Hsu

CONTACT

0973060827; celeste30153@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

TW (1)