Pain ManagementNCT07267052
Acute Effects of Transcutaneous Electrical Nerve Stimulation at Acupoints on Nociceptive Transmission
A study testing transcutaneous electrical nerve stimulation (TENS) and EEG machine in people with Pain Management, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- transcutaneous electrical nerve stimulation (TENS) and EEG machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Sep 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of malignant tumors
- History of hand disorders
- Has implanted cardiac pacemakers
- Pregnancy
- Epilepsy
- Any other condition that may interfere with the study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Therapy of China Medical University
Taichung, Beitun, Taiwan, 406040
Department of Physical Therapy of China Medical University, 04-22053366 Ext.#7301, aca70@mail.cmu.edu.tw
About this study
Official title: Acute Effects of Transcutaneous Electrical Nerve Stimulation at Acupoints on Nociceptive Transmission: A Mechanism Study Using Pain-Related Evoked Potentials
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?
Read more
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.
Read the 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.
- Conditions
- Pain Management
- Being tested
- transcutaneous electrical nerve stimulation (TENS), EEG machine
- Keywords
- Somatosensory Evoked Potentials, Transcutaneous Electrical Nerve Stimulation, Pain-Related Evoked Potentials, Zhongzhu, Hegu
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 machineDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: transcutaneous electrical nerve stimulation (TENS); Device: EEG machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants were assessed at time points: prior to the intervention (baseline), immediately after TENS application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start5 Sep 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267052
- Sponsor's protocol ID
- CMUH114-REC3-149
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Transcutaneous Electrical Nerve Stimulation at Acupoints on Nociceptive Transmission: A Mechanism Study Using Pain-Related Evoked Potentials
- ClinicalTrials.gov ID
- NCT07267052
- Acronym / sponsor ID
- CMUH114-REC3-149
- Conditions
- Pain Management
- Keywords
- Somatosensory Evoked Potentials, Transcutaneous Electrical Nerve Stimulation, Pain-Related Evoked Potentials, Zhongzhu, Hegu
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TENS Group | Experimental | Device: transcutaneous electrical nerve stimulation (TENS), Device: EEG machineAcupoint 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy Adult
- 20 years or older
- The absence of chronic medical conditions
- No history of drug allergies
- No skin disorders
Key exclusion criteria (6 listed)
- History of malignant tumors
- History of hand disorders
- Has implanted cardiac pacemakers
- Pregnancy
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | TENS Group |
| EEG machineEEG 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. | Device | TENS Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical nerve stimulation (TENS) and EEG machine in people with Pain Management, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueh-Ling Hsieh (04-22053366 Ext. #7312, sherrie@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-Related Evoked Potentials (PREPs) (time frame: Participants were assessed at time points: prior to the intervention (baseline), immediately after TENS application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.