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

NCT01804192 | Unknown DMC

• 1 other identifier: HSEARS20080514001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Nervous System Disorder

Keywords

Acu-TENS; MAP; HR; HRV

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Heart rate

  One month after the study

Other Outcomes (1)

• Mean Blood pressure

  One month afterwards

Study Arms (3)

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.

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.

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.

Other: Acu-TENS

Interventions

Acu-TENS OTHER

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.

Also known as: A dual channel portable TENS unit

Acu-TENS to LI4 and LI11; Control group; Placebo group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal healthy subjects who were naïve to Acu-TENS and able to read Chinese were recruited for study

You may not qualify if:

• history of cardiopulmonary, neurological and psychologic disorders or they required taking drugs within one week that might affect the cardiovascular and neurological status

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Queen Elizabeth Hospital

Hong Kong, Hong Kong, 852, China

RECRUITING

MeSH Terms

Conditions

Primary Dysautonomias

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• Tai Wai David Yu, MSc

  The Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: March 5, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

CN (1)