Is Acupoints Sensation Necessary for Acu-TENS to Elicit Physiological Changes in Healthy Subjects?

Not Applicable

• Conditions: Autonomic Nervous System Disorder
• Interventions: Other: Acu-TENS

• Registration Number: NCT01804192
• Lead Sponsor: The Hong Kong Polytechnic University

Brief 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 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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-11
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-02
• Last Update Submitted: 2013-03-02
• Study First Posted: 2013-03-05
• Last Update Posted: 2013-03-05
• Primary Completion: 2013-05
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Acu-TENS to LI4 and LI11	Acu-TENS	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.
Control group	Acu-TENS	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.
Placebo group	Acu-TENS	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.

Primary Outcome Measures

Name	Time	Method
Heart rate variability	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.

Secondary Outcome Measures

Name	Time	Method
Heart rate	One month after the study	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.

Trial Locations

Locations (1)

Queen Elizabeth Hospital; 🇨🇳 Hong Kong, Hong Kong, China