NCT01564927

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

Same day

First QC Date

March 21, 2012

Last Update Submit

March 27, 2012

Conditions

Healthy

Keywords

deqi electroacupunctureBP HR HRV

Outcome Measures

Primary Outcomes (1)

  • Physiological Changes Associated with Deqi during Electroacupuncture to Right LI4 and LI11

    heart rate variability

    One day

Study Arms (3)

Electroacupuncture to right LI4 and LI11

EXPERIMENTAL
Device: Electroacupuncture to right LI4 and LI11 (ITO, EX-160)

Electroacupuncture to knee caps

SHAM COMPARATOR

Electroacupuncture to knee caps

Device: Sham Electroacupuncture to knee caps

Sham electroacupuncture to LI4 & LI11

PLACEBO COMPARATOR
Device: Sham electroacupuncture to LI4 and LI11

Interventions

Electroacupuncture to right LI4 and LI11 (ITO, EX-160)DEVICE

Electroacupuncture at 2Hz, 0.4m/sec pulse duration

Also known as: Electroacupuncture device, ITO, EX-160, Hannover, Germany
Electroacupuncture to right LI4 and LI11
Sham Electroacupuncture to knee capsDEVICE

Electroacupuncture at 2Hz, 0.4m/sec pulse duration

Electroacupuncture to knee caps
Sham electroacupuncture to LI4 and LI11DEVICE

Electroacupuncture at 2Hz, 0.4m/sec pulse duration

Sham electroacupuncture to LI4 & LI11

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal healthy subjects who were naïve to acupuncture
  • Able to read Chinese and no communication barrier

You may not qualify if:

  • Subjects with medical disorders, including neurological and psychologic disorder
  • Use of medications that may affect the cardiovascular system within one week
  • Subjects with painful or uncomfortable sensations of upper and lower limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital

Hong Kong, Hong Kong, 852, China

RECRUITING

Study Officials

  • David TW YU, Master

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David TW YU, Master

CONTACT

852-29586216davidyu03@yahoo.com.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physiotherapist

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 28, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

March 28, 2012

Record last verified: 2012-03

Locations

CN(1)