Physiological Changes Associated With Deqi During Electroacupuncture to Right LI4 and LI11

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by The Hong Kong Polytechnic University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yu Tai Wai David, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01564927
First received: March 21, 2012
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

The aims of the study are to investigate the physiological responses associated with deqi during stimulation of the LI11 and LI4 acupuncture points and the correlation between the intensity of the deqi sensation to such responses.


Condition Intervention
Healthy
Device: Electroacupuncture to right LI4 and LI11 (ITO, EX-160)
Device: Sham Electroacupuncture to knee caps
Device: Sham electroacupuncture to LI4 and LI11

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Physiological Changes Associated With Deqi During Electroacupuncture to Right LI4 and LI11

Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Physiological Changes Associated with Deqi during Electroacupuncture to Right LI4 and LI11 [ Time Frame: One day ] [ Designated as safety issue: Yes ]
    heart rate variability


Estimated Enrollment: 36
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electroacupuncture to right LI4 and LI11 Device: Electroacupuncture to right LI4 and LI11 (ITO, EX-160)
Electroacupuncture at 2Hz, 0.4m/sec pulse duration
Other Name: Electroacupuncture device, ITO, EX-160, Hannover, Germany
Sham Comparator: Electroacupuncture to knee caps
Electroacupuncture to knee caps
Device: Sham Electroacupuncture to knee caps
Electroacupuncture at 2Hz, 0.4m/sec pulse duration
Placebo Comparator: Sham electroacupuncture to LI4 & LI11 Device: Sham electroacupuncture to LI4 and LI11
Electroacupuncture at 2Hz, 0.4m/sec pulse duration

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Normal healthy subjects who were naïve to acupuncture
  2. Able to read Chinese and no communication barrier

Exclusion Criteria:

  1. Subjects with medical disorders, including neurological and psychologic disorder
  2. Use of medications that may affect the cardiovascular system within one week
  3. Subjects with painful or uncomfortable sensations of upper and lower limbs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564927

Contacts
Contact: David TW YU, Master 852-29586216 davidyu03@yahoo.com.hk

Locations
China, Hong Kong
Queen Elizabeth Hospital Recruiting
Hong Kong, Hong Kong, China, 852
Contact: David TW Yu, Master    852-26986216    davidyu03@yahoo.com.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Principal Investigator: David TW YU, Master Hong Kong Polytechnic University
  More Information

No publications provided

Responsible Party: Yu Tai Wai David, Senior Physiotherapist, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01564927     History of Changes
Other Study ID Numbers: HSEARS20110510001
Study First Received: March 21, 2012
Last Updated: March 27, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The Hong Kong Polytechnic University:
deqi electroacupuncture
BP HR HRV

ClinicalTrials.gov processed this record on October 22, 2014