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NCT Number: NCT07267052

Acute Effects of Transcutaneous Electrical Nerve Stimulation at Acupoints on Nociceptive Transmission

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.

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy of China Medical University

Taichung, Beitun, Taiwan, 406040, Taiwan

Location status: Recruiting

Location contact

Department of Physical Therapy of China Medical University

CONTACT

[email protected]

04-22053366 Ext.#7301

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Adult
  • 20 years or older
  • The absence of chronic medical conditions
  • No history of drug allergies
  • No skin disorders
  • No current use of medications that could affect study outcomes
  • Participants maintain a regular daily routine
  • No history of substance or medication abuse

Exclusion criteria

  • History of malignant tumors
  • History of hand disorders
  • Has implanted cardiac pacemakers
  • Pregnancy
  • Epilepsy
  • Any other condition that may interfere with the study procedures

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain-Related Evoked Potentials (PREPs)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yueh-Ling Hsieh

CONTACT

[email protected]

04-22053366 Ext. #7312

Yung-Yu Hsu

CONTACT

[email protected]

0973060827

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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