Autonomic Nervous System Disorder Clinical Trial
— Acu-TENSOfficial title:
Is Acupoints Sensation Necessary for Acu-TENS to Elicit Physiological Changes in Healthy Subjects?
| Verified date | March 2013 |
| Source | The Hong Kong Polytechnic University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Hong Kong: Ethics Committee |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 36 |
| Est. completion date | August 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Normal healthy subjects who were naïve to Acu-TENS and able to read Chinese were recruited for study Exclusion Criteria: - history of cardiopulmonary, neurological and psychologic disorders or they required taking drugs within one week that might affect the cardiovascular and neurological status |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Queen Elizabeth Hospital | Hong Kong | Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| The Hong Kong Polytechnic University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Mean Blood pressure | 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). | One month afterwards | No |
| Primary | 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. | One month after the intervention | No |
| Secondary | 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. | One month after the study | No |