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Trial registered on ANZCTR

Registration number

ACTRN12616000913471

Ethics application status

Approved

Date submitted

6/06/2016

Date registered

8/07/2016

Date last updated

19/12/2018

Date data sharing statement initially provided

19/12/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of acupuncture on capillary refill time (CTR)

Scientific title

Effect of performing acupuncture at specific acupoints on capillary refill time in healthy adults

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1183-9585

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

capillary refill time

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

We will perform acupuncture on bilateral KI3, LI4 and ST36 acupoints in 60 healthy volunteers. KI3 locates on the medial aspect of the foot, posterior to the medial malleolus, in the depression between the tip of the medial malleolus and tendo calcaneus. LI4 locates on the dorsum of the hand, between the 1st and 2nd metacarpal bones, in the middle of the 2nd metacarpal bone on the radial side. ST36 locates on the anterior aspect of the lower leg, 3 cun below ST 35, one finger-breadth (middle finger) from the anterior crest of the tibia. Only one acupoint (bilateral) will be performed at one time with total two needles for each intervention, thus one subject will receive acupuncture for three times with each treatments separated at least 2 days. Needles will remain in place for 30 minutes for each intervention. Two Taiwan trained and licensed acupuncturists with a median of
15 years of experience will apply the needle.

Intervention code [1]

Other interventions

Comparator / control treatment

We will compare the effect of performing acupuncture between KI3, LI4 and ST36.

Control group

Active

Outcomes

Primary outcome [1]

capillary refill time (CRT)
It will be measured by holding a hand higher than heart-level and pressing the fingernail until it turns white, then taking note of the time needed for the color to return once pressure is released.
Two measurements will be taken for a mean to avoid bias.

Timepoint [1]

before and after acupuncture intervention, and again 30 min later after removal of needle

Primary outcome [2]

Quantitative CRT (Q-CRT) We use Laser Doppler blood flow monitor (moorVMS-LDF1, Moor Instruments Ltd, United Kingdom) measure tissue perfusion, blood cell concentration, backscattered light. Then left index will be compressed by a pressure-adjustable finger cuff for 20 seconds to induce temporary ischemia and then be released. We defined Q-CRT as a time from the time of pressure release to the time the tissue perfusion restore to the resting level.

Timepoint [2]

before and after acupuncture intervention, and again 30 min later after removal of needle

Secondary outcome [1]

measure blood pressure by using digital sphygmomanometer

Timepoint [1]

before and after acupuncture intervention, and again 30 min later after removal of needle

Secondary outcome [2]

measure heart rate by using digital sphygmomanometer

Timepoint [2]

before and after acupuncture intervention, and again 30 min later after removal of needle

Secondary outcome [3]

measure core body temperature by using tympanic digital thermometer

Timepoint [3]

before and after acupuncture intervention, and again 30 min later after removal of needle

Eligibility

Key inclusion criteria

subjects scheduled for acupuncture treatment in our clinic of acupuncture department

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

subjects enrolled into other clinical trials, have infection disease or use antibiotics in recent two weeks, have impaired renal or liver function, an initial body temperature more than 38.0 degrees Celsius or less than 36.0 degrees Celsius, a known history of alcohol or substance abuse

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

We will compare the data before and after acupuncture intervention by using paired t- test, the data between the different acupoints by using t- test and ANOVA test.
In preliminary study, we measured the CRT before and after acupuncture intervention on KI3 for 3 subjects. According to the mean difference and standard deviation of difference (0.81+/-0.14), a power calculation (a = 0.05 and beta =0.2) indicated the sample size required is 3.
In our design, the total sample size is 60, and it is far more than the estimated sample size.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

15/07/2016

Actual

9/09/2016

Date of last participant enrolment

Anticipated

31/01/2017

Actual

31/01/2017

Date of last data collection

Anticipated

Actual

6/02/2017

Sample size

Target

60

Accrual to date

Final

15

Recruitment outside Australia

Country [1]

Taiwan, Province Of China

State/province [1]

Taoyuan

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Taoyuan Chang Gung Memorial Hospital

Address [1]

Chang Gung memorial Hospital, No.123, Dinghu Rd., Guishan Dist., Taoyuan City 333.

Country [1]

Taiwan, Province Of China

Primary sponsor type

Individual

Name

Bo-Yan Yeh

Address

Department of acupuncture and traumatology, Taoyuan Chang Gung memorial Hospital, No.123, Dinghu Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.)

Country

Taiwan, Province Of China

Secondary sponsor category [1]

Individual

Name [1]

Yu-Sheng Chen

Address [1]

Department of acupuncture and traumatology, Taoyuan Chang Gung memorial Hospital, No.123, Dinghu Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.)

Country [1]

Taiwan, Province Of China

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Chang Gung Memorial Hospital Institutional Review Board

Ethics committee address [1]

Chang Gung memorial Hospital, No.123, Dinghu Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.)

Ethics committee country [1]

Taiwan, Province Of China

Date submitted for ethics approval [1]

23/09/2015

Approval date [1]

02/10/2015

Ethics approval number [1]

104-5687C

Summary

Brief summary

Pulse examination, that reveals information about qi and blood circulation of the human body, is a very important diagnostic tool in Traditional Chinese Medicine. According to Shanghan Lun (Treatise on Cold Damage Diseases), a hard press to the bone (hence have the pulse diminish) followed by a very slight lifting to detect the presence and quickness of a re-pulsation or refilling, a manipulation called “examining the root”, is to evaluate the original (Shao Yin) qi. Based on clinical observation, performing acupuncture on specific acupoints could recover the root of pulse toward normal, and it is regarded working through deploying body qi to Shao Yin area to restore inner energy. Therefore, acupuncture physician would adjust qi and blood circulation depending on this thinking process. This model is reasonable, but the problem is “physician’s fingers” lacks objective parameters to quantify the pulse.
Capillary refill time (CRT), determined by applying pressure on a finger and measuring the time until perfusion returns, is a simple bedside tool for assessing the circulation status. Prolonged CRT has been shown to be an early marker of inadequate tissue perfusion in acute circulatory shock. Interestingly, this maneuver has similar manipulation with “examining the root of pulse but different on the site performed and in the parameter measured. Therefore, we designed this trial to evaluate whether acupuncture intervention could change CRT.
60 subjects will be enrolled into this trial. We measure CRT, Q-CRT, blood pressure, heart rate, and core body temperature before and after acupuncture intervention, and again 30 min later after removal of needle.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Bo-Yan Yeh

Address

Department of acupuncture and traumatology, Taoyuan Chang Gung memorial Hospital, No.123, Dinghu Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.)

Country

Taiwan, Province Of China

Phone

+886-3-3196200 ext. 2613

Fax

+886-3-3298995

Email

[email protected]

Contact person for public queries

Name

Bo-Yan Yeh

Address

Department of acupuncture and traumatology, Taoyuan Chang Gung memorial Hospital, No.123, Dinghu Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.)

Country

Taiwan, Province Of China

Phone

+886-3-3196200 ext. 2613

Fax

+886-3-3298995

Email

[email protected]

Contact person for scientific queries

Name

Bo-Yan Yeh

Address

Department of acupuncture and traumatology, Taoyuan Chang Gung memorial Hospital, No.123, Dinghu Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.)

Country

Taiwan, Province Of China

Phone

+886-3-3196200 ext. 2613

Fax

+886-3-3298995

Email

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effect of acupuncture on capillary refill time in healthy adults: A clinical study.	2021	https://dx.doi.org/10.1016/j.mvr.2021.104135

N.B. These documents automatically identified may not have been verified by the study sponsor.