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Recruiting NCT07267052

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

No phase Interventional Pain Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcutaneous electrical nerve stimulation (TENS), EEG machine.
Who it may be relevant to
Registry conditions: Pain Management. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

  • Device 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.
  • 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.

Primary outcome measures

  • Pain-Related Evoked Potentials (PREPs) [Time frame: Participants were assessed at time points: prior to the intervention (baseline), immediately after TENS application]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Department of Physical Therapy of China Medical University — Taichung

Identifiers

NCT: NCT07267052 · CMUH114-REC3-149

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗