Autonomic Nervous System DisorderAcu-TENSNCT01804192
Is Acupoints Sensation Necessary for Acu-TENS to Elicit Physiological Changes in Healthy Subjects?
A study testing Acu-TENS in people with Autonomic Nervous System Disorder, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
Traditional Chinese Medicine (TCM) practitioners believe that health can be maintained if the body has a balanced ying-yang or the qi flows in correct strength and quality along the meridians.Stimulation of the acupoints such as by acupuncture can awaken and modulate qi in the channels and is able to regulate and… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Disorder
- What is being tested?
- Acu-TENS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Aug 2013
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy subjects who were naïve to Acu-TENS and able to read Chinese were recruited for study
Who cannot join
- history of cardiopulmonary, neurological and psychologic disorders or they required taking drugs within one week that might affect the cardiovascular and neurological status
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Queen Elizabeth Hospital
Hong Kong, Hong Kong, 852
David TW Yu, Master, 852-26986216, davidyu03@yahoo.com.hk
About this study
Traditional Chinese Medicine (TCM) practitioners believe that health can be maintained if the body has a balanced ying-yang or the qi flows in correct strength and quality along the meridians.Stimulation of the acupoints such as by acupuncture can awaken and modulate qi in the channels and is able to regulate and restore yin-yang balance.However, there are some drawbacks associated with acupuncture which may limit its applications. These include transmission of infectious disease, pneumothorax and other problems associated with organ punctures, cardiac tamponade, and broken needles with remnants migrating to other locations.Studies have shown that when TENS is applied over acupoints (Acu-TENS), it is effective in reducing dyspnoea in patients with chronic obstructive pulmonary disease,facilitate early haemodynamic recovery after open-heart surgery,relieve labor pain,increase in blood β-endorphin level,reduce blood pressure changes in normal healthy subjects and decrease airway resistance.Despite these promising results, how Acu-TENS works still remain unclear.This study aimed to investigate the effects of Acu-TENS over Hegu (LI4) and Quichi (LI4) on the autonomic nervous system activities and to investigate whether the subject could experience distinct sensation as deqi.
Read the detailed description
Eligibility criteria: Normal healthy subjects who were naïve to Acu-TENS and able to read Chinese.
Outcome Measures: Heart rate, Mean arterial blood pressure, Heart rate variability
- Conditions
- Autonomic Nervous System Disorder
- Being tested
- Acu-TENS
- Keywords
- Acu-TENS, MAP, HR, HRV
- Medical subject headings
- Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acu-TENSOther
Also called A dual channel portable TENS unit
Systolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany). The mean arterial pressure (MAP) will be recorded from the machine. Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany). The heart rate (HR) will be measured. The ECG signals will be transferred to the PowerLab 16/30 (ADInstruments Pty Ltd. NSW, Australia) for data acquisition and analysis of the HRV.
| Study group | Role | What they receive |
|---|---|---|
| Acu-TENS to LI4 and LI11 | Experimental | Acu-TENS Group (Experimental Group), subjects received TENS over right L14 and LI11.
Systolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor. The mean arterial pressure (MAP) will be recorded from the machine. Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device. The heart rate (HR) will be measured. The ECG signals will be transferred to the PowerLab 16/30 for data acquisition and analysis of the HRV. Receives: Other: Acu-TENS |
| Control group | Active comparator | Control Acu-TENS Group (Control Group), subjects received TENS over tips of bilateral knee caps.
Systolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor. The mean arterial pressure (MAP) will be recorded from the machine. Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device. The heart rate (HR) will be measured. The ECG signals will be transferred to the PowerLab 16/30 for data acquisition and analysis of the HRV. Receives: Other: Acu-TENS |
| Placebo group | Placebo comparator | Placebo Acu-TENS Group (Placebo Group), subjects received the same protocol as the Acu-TENS group and TENS was applied over right LI4 and LI11 that covered with non-conducting plastics (with the same dimension as the TENS electrodes) Systolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor. The mean arterial pressure (MAP) will be recorded from the machine. Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device. The heart rate (HR) will be measured. The ECG signals will be transferred to the PowerLab 16/30 for data acquisition and analysis of the HRV. Receives: Other: Acu-TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Three ECG electrodes will beapplied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany). The ECG signals will be transferred to the PowerLab 16/30 (ADInstruments Pty Ltd. NSW, Australia) for data acquisition and analysis of the HRV.
Measured: One month after the intervention
Secondary outcomes (1)
Heart rate
Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany). The heart rate (HR) will be measured.
Measured: One month after the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System DisorderStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Tai Wai David, The Hong Kong Polytechnic University
- Investigators
- Tai Wai David Yu, MSc, Principal investigator, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804192
- Sponsor's protocol ID
- HSEARS20080514001
- Acronym
- Acu-TENS
- Status last verified
- Mar 2013
- First submitted
- 11 Feb 2013
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Acupoints Sensation Necessary for Acu-TENS to Elicit Physiological Changes in Healthy Subjects?
- ClinicalTrials.gov ID
- NCT01804192
- Acronym / sponsor ID
- Acu-TENS / HSEARS20080514001
- Conditions
- Autonomic Nervous System Disorder
- Keywords
- Acu-TENS, MAP, HR, HRV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 5 Mar 2013 (estimated)
- 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.
Traditional Chinese Medicine (TCM) practitioners believe that health can be maintained if the body has a balanced ying-yang or the qi flows in correct strength and quality along the meridians.Stimulation of the acupoints such as by acupuncture can awaken and modulate qi in the channels and is able to regulate and restore yin-yang balance.However, there are some drawbacks associated with acupuncture which may limit its applications. These include transmission of infectious disease, pneumothorax and other problems associated with organ punctures, cardiac tamponade, and broken needles with remnants migrating to other locations.Studies have shown that when TENS is applied over acupoints (Acu-TENS), it is effective in reducing dyspnoea in patients with chronic obstructive pulmonary disease,facilitate early haemodynamic recovery after open-heart surgery,relieve labor pain,increase in blood β-endorphin level,reduce blood pressure changes in normal healthy subjects and decrease airway resistance.Despite these promising results, how Acu-TENS works still remain unclear.This study aimed to investigate the effects of Acu-TENS over Hegu (LI4) and Quichi (LI4) on the autonomic nervous system activities and to investigate whether the subject could experience distinct sensation as deqi.
Detailed description
Eligibility criteria: Normal healthy subjects who were naïve to Acu-TENS and able to read Chinese.
Outcome Measures: Heart rate, Mean arterial blood pressure, Heart rate variability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acu-TENS to LI4 and LI11 | Experimental | Other: Acu-TENSAcu-TENS Group (Experimental Group), subjects received TENS over right L14 and LI11. Systolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor. The mean arterial pressure (MAP) will be recorded from the machine. Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device. The heart rate (HR) will be measured. The ECG signals will be transferred to the PowerLab 16/30 for data acquisition and analysis of the HRV. |
| Control group | Active comparator | Other: Acu-TENSControl Acu-TENS Group (Control Group), subjects received TENS over tips of bilateral knee caps. Systolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor. The mean arterial pressure (MAP) will be recorded from the machine. Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device. The heart rate (HR) will be measured. The ECG signals will be transferred to the PowerLab 16/30 for data acquisition and analysis of the HRV. |
| Placebo group | Placebo comparator | Other: Acu-TENSPlacebo Acu-TENS Group (Placebo Group), subjects received the same protocol as the Acu-TENS group and TENS was applied over right LI4 and LI11 that covered with non-conducting plastics (with the same dimension as the TENS electrodes) Systolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor. The mean arterial pressure (MAP) will be recorded from the machine. Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device. The heart rate (HR) will be measured. The ECG signals will be transferred to the PowerLab 16/30 for data acquisition and analysis of the HRV. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal healthy subjects who were naïve to Acu-TENS and able to read Chinese were recruited for study
Key exclusion criteria (1 listed)
- history of cardiopulmonary, neurological and psychologic disorders or they required taking drugs within one week that might affect the cardiovascular and neurological status
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 |
|---|---|---|
| Acu-TENSAlso: A dual channel portable TENS unitSystolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany). The mean arterial pressure (MAP) will be recorded from the machine. Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany). The heart rate (HR) will be measured. The ECG signals will be transferred to the PowerLab 16/30 (ADInstruments Pty Ltd. NSW, Australia) for data acquisition and analysis of the HRV. | Other | Acu-TENS to LI4 and LI11, Control group, Placebo group |
Primary outcome
Heart rate variability
Time frame: One month after the intervention
Three ECG electrodes will beapplied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany). The ECG signals will be transferred to the PowerLab 16/30 (ADInstruments Pty Ltd. NSW, Australia) for data acquisition and analysis of the HRV.
1 secondary outcome
Heart rate
Time frame: One month after the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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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. This study is not recruiting at the moment.
Tai Wai David Yu, MSc principal investigator
The Queen Elizabeth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acu-TENS in people with Autonomic Nervous System Disorder, run by The Hong Kong Polytechnic University at 1 site in China.
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 1 inclusion and 1 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 5 Mar 2013. 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 China. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: One month after the intervention). 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 5 Mar 2013.