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

Not Applicable

• Conditions: Autonomic Nervous System Disorder

• 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

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