Transcutaneous Electrical Nerve StimulationNCT05587140
Effects of TENS on Pain Threshold and Brain Activities in Healthy Adults
A study testing Acupuncture like TENS and Conventional TENS in people with Transcutaneous Electrical Nerve Stimulation and Electroencephalography, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The purpose of this study was to understand the effects of conventional versus acupuncture-like TENS on pain threshold, brain activities, and their relationships. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcutaneous Electrical Nerve Stimulation, Electroencephalography, Pressure Pain Threshold
- What is being tested?
- Acupuncture like TENS and Conventional TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Aug 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20~65 y adults
- No cognitive function problem
- Without taking any type of pain medication or substances that could affect the cognitive functions
Who cannot join
- Peripheral or central nervous system disease
- Sensory lose
- TENS application is contraindication
- Cardiac pacemaker
- Any type of pain
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang-Ming University
Taipei, 112
Li-Wei Chou, +886 2 28267092, lwchou@ym.edu.tw
About this study
Official title: Effects of Conventional Versus Acupuncture-like TENS on Pain Threshold and Brain Activities in Healthy Adults
The purpose of this study was to understand the effects of conventional versus acupuncture-like TENS on pain threshold, brain activities, and their relationships.
Read the detailed description
Transcutaneous electrical nerve stimulation (TENS) is a pain modulation tool which is commonly used clinically. TENS has 2 major modes: "conventional TENS'' and "acupuncture like TENS". Conventional TENS induces a local pain modulation, whereas acupuncture like TENS induces central pain modulation mechanism. The pain threshold at treatment area and outside of area is regarded as local pain modulation and central pain modulation respectively. However, the effect of acupuncture like TENS on pain threshold was remained unclear. TENS also induces cortical activities changed in the central nervous system. Recent Electroencephalography (EEG) studies suggested that TENS induces event-related potential and power spectrum changes, however, the time and frequency bands of EEG changes and its relationship with pain threshold were still unclear. Therefore, the purpose of this study was to understand the effects of conventional versus acupuncture-like TENS on pain threshold, brain activities, and their relationships.
- Conditions
- Transcutaneous Electrical Nerve Stimulation, Electroencephalography, Pressure Pain Threshold
- Being tested
- Acupuncture like TENS, Conventional TENS, Sham TENS
- Keywords
- Transcutaneous electrical nerve stimulation, Electroencephalography, Pressure pain threshold, Pressure pain tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture like TENSDevice
Frequency: 4 Hz, pulse duration: 200 μs, intensity: 3/10 painful sensation with muscle contraction , time: 30 minutes
Conventional TENSDevice
Frequency: 100 Hz, pulse duration: 200 μs, intensity: strong but comfortable tingling sensation , time: 30 minutes
Sham TENSDevice
Frequency: 4 Hz, pulse duration: 200 μs, intensity: tingling sensation, time: turn on the electricity for 15 seconds, then turn off the machine for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture like TENS | Experimental | The study would use acupuncture like TENS for 30 minutes Receives: Device: Acupuncture like TENS |
| Conventional TENS | Experimental | The study would use conventional TENS for 30 minutes Receives: Device: Conventional TENS |
| Sham TENS | Experimental | The study would use sham TENS for 30 minutes Receives: Device: Sham TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold after the intervention
Use a pressure algometer to press on the first dorsal interosseous muscle and the pressure would stop until the feeling changes from non-painful feeling to painful feeling.
Measured: The change between baseline and the time after 30 minutes intervention
Pressure pain tolerance after the intervention
Use a pressure algometer to press on the first dorsal interosseous muscle and the pressure would stop until the feeling reach the pain intensity at 5/10.
Measured: The change between baseline and the time after 30 minutes intervention
EEG power spectrum change in delta band after the intervention
Evaluate brain activity after the intervention
Measured: The change between baseline and the time after 30 minutes intervention
EEG power spectrum change in theta band after the intervention
Evaluate brain activity after the intervention
Measured: The change between baseline and the time after 30 minutes intervention
EEG power spectrum change in alpha band after the intervention
Evaluate brain activity after the intervention
Measured: The change between baseline and the time after 30 minutes intervention
EEG power spectrum change in beta band after the intervention
Evaluate brain activity after the intervention
Measured: The change between baseline and the time after 30 minutes intervention
EEG power spectrum change in low-gamma band after the intervention
Evaluate brain activity after the intervention
Measured: The change between baseline and the time after 30 minutes intervention
EEG power spectrum change in high-gamma band after the intervention
Evaluate brain activity after the intervention
Measured: The change between baseline and the time after 30 minutes intervention
EEG power spectrum change in total gamma band after the intervention
Evaluate brain activity after the intervention
Measured: The change between baseline and the time after 30 minutes intervention
Secondary outcomes (9)
Pressure pain tolerance after the 30 minutes break
Use a pressure algometer to press on the first dorsal interosseous muscle and the pressure would stop until the feeling reach the pain intensity at 5/10.
Measured: The change between 30 minutes intervention and 30 minutes break after the intervention
Pressure pain threshold after the 30 minutes break
Use a pressure algometer to press on the first dorsal interosseous muscle and the pressure would stop until the feeling changes from non-painful feeling to painful feeling.
Measured: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in delta band after the 30 minutes break
Evaluate brain activity after the 30 minutes break
Measured: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in theta band after the 30 minutes break
Evaluate brain activity after the 30 minutes break
Measured: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in alpha band after the 30 minutes break
Evaluate brain activity after the 30 minutes break
Measured: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in beta band after the 30 minutes break
Evaluate brain activity after the 30 minutes break
Measured: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in low-gamma band after the 30 minutes break
Evaluate brain activity after the 30 minutes break
Measured: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in high-gamma band after the 30 minutes break
Evaluate brain activity after the 30 minutes break
Measured: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in total gamma band after the 30 minutes break
Evaluate brain activity after the 30 minutes break
Measured: The change between 30 minutes intervention and 30 minutes break after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start31 Aug 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Electrical Nerve StimulationStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Wei Chou, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587140
- Sponsor's protocol ID
- TENS & pain control
- Status last verified
- Jun 2022
- First submitted
- 10 Jul 2022
- Last updated
- 19 Oct 2022
- 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 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Conventional Versus Acupuncture-like TENS on Pain Threshold and Brain Activities in Healthy Adults
- ClinicalTrials.gov ID
- NCT05587140
- Acronym / sponsor ID
- TENS & pain control
- Conditions
- Transcutaneous Electrical Nerve Stimulation, Electroencephalography, Pressure Pain Threshold
- Keywords
- Transcutaneous electrical nerve stimulation, Electroencephalography, Pressure pain threshold, Pressure pain tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 19 Oct 2022 (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 purpose of this study was to understand the effects of conventional versus acupuncture-like TENS on pain threshold, brain activities, and their relationships.
Detailed description
Transcutaneous electrical nerve stimulation (TENS) is a pain modulation tool which is commonly used clinically. TENS has 2 major modes: "conventional TENS'' and "acupuncture like TENS". Conventional TENS induces a local pain modulation, whereas acupuncture like TENS induces central pain modulation mechanism. The pain threshold at treatment area and outside of area is regarded as local pain modulation and central pain modulation respectively. However, the effect of acupuncture like TENS on pain threshold was remained unclear. TENS also induces cortical activities changed in the central nervous system. Recent Electroencephalography (EEG) studies suggested that TENS induces event-related potential and power spectrum changes, however, the time and frequency bands of EEG changes and its relationship with pain threshold were still unclear. Therefore, the purpose of this study was to understand the effects of conventional versus acupuncture-like TENS on pain threshold, brain activities, and their relationships.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture like TENS | Experimental | Device: Acupuncture like TENSThe study would use acupuncture like TENS for 30 minutes |
| Conventional TENS | Experimental | Device: Conventional TENSThe study would use conventional TENS for 30 minutes |
| Sham TENS | Experimental | Device: Sham TENSThe study would use sham TENS for 30 minutes |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20~65 y adults
- No cognitive function problem
- Without taking any type of pain medication or substances that could affect the cognitive functions
Key exclusion criteria (5 listed)
- Peripheral or central nervous system disease
- Sensory lose
- TENS application is contraindication
- Cardiac pacemaker
- Any type of pain
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 |
|---|---|---|
| Acupuncture like TENSFrequency: 4 Hz, pulse duration: 200 μs, intensity: 3/10 painful sensation with muscle contraction , time: 30 minutes | Device | Acupuncture like TENS |
| Conventional TENSFrequency: 100 Hz, pulse duration: 200 μs, intensity: strong but comfortable tingling sensation , time: 30 minutes | Device | Conventional TENS |
| Sham TENSFrequency: 4 Hz, pulse duration: 200 μs, intensity: tingling sensation, time: turn on the electricity for 15 seconds, then turn off the machine for 30 minutes | Device | Sham TENS |
Primary outcome
Pressure pain threshold after the intervention
Time frame: The change between baseline and the time after 30 minutes intervention
Use a pressure algometer to press on the first dorsal interosseous muscle and the pressure would stop until the feeling changes from non-painful feeling to painful feeling.
Pressure pain tolerance after the intervention
Time frame: The change between baseline and the time after 30 minutes intervention
Use a pressure algometer to press on the first dorsal interosseous muscle and the pressure would stop until the feeling reach the pain intensity at 5/10.
EEG power spectrum change in delta band after the intervention
Time frame: The change between baseline and the time after 30 minutes intervention
Evaluate brain activity after the intervention
EEG power spectrum change in theta band after the intervention
Time frame: The change between baseline and the time after 30 minutes intervention
Evaluate brain activity after the intervention
EEG power spectrum change in alpha band after the intervention
Time frame: The change between baseline and the time after 30 minutes intervention
Evaluate brain activity after the intervention
EEG power spectrum change in beta band after the intervention
Time frame: The change between baseline and the time after 30 minutes intervention
Evaluate brain activity after the intervention
EEG power spectrum change in low-gamma band after the intervention
Time frame: The change between baseline and the time after 30 minutes intervention
Evaluate brain activity after the intervention
EEG power spectrum change in high-gamma band after the intervention
Time frame: The change between baseline and the time after 30 minutes intervention
Evaluate brain activity after the intervention
EEG power spectrum change in total gamma band after the intervention
Time frame: The change between baseline and the time after 30 minutes intervention
Evaluate brain activity after the intervention
9 secondary outcomes
Pressure pain tolerance after the 30 minutes break
Time frame: The change between 30 minutes intervention and 30 minutes break after the intervention
Pressure pain threshold after the 30 minutes break
Time frame: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in delta band after the 30 minutes break
Time frame: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in theta band after the 30 minutes break
Time frame: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in alpha band after the 30 minutes break
Time frame: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in beta band after the 30 minutes break
Time frame: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in low-gamma band after the 30 minutes break
Time frame: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in high-gamma band after the 30 minutes break
Time frame: The change between 30 minutes intervention and 30 minutes break after the intervention
EEG power spectrum change in total gamma band after the 30 minutes break
Time frame: The change between 30 minutes intervention and 30 minutes break after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
Related trials for Transcutaneous Electrical Nerve Stimulation
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Not yet recruiting
Parasacral TENS Project
Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
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. This study is not recruiting at the moment.
Li-Wei Chou, PhD principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture like TENS and Conventional TENS in people with Transcutaneous Electrical Nerve Stimulation and Electroencephalography, run by National Yang Ming Chiao Tung University 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li-Wei Chou, PhD (+886228267092, lwchou@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold after the intervention (time frame: The change between baseline and the time after 30 minutes intervention). The study lists 9 primary outcomes in all. 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 19 Oct 2022.