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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
Date results information 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] 289377 0
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 299012 0
Condition category
Condition code
Alternative and Complementary Medicine 299068 299068 0 0
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] 294963 0
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] 298545 0
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] 298545 0
before and after acupuncture intervention, and again 30 min later after removal of needle
Primary outcome [2] 298546 0
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] 298546 0
before and after acupuncture intervention, and again 30 min later after removal of needle
Secondary outcome [1] 324529 0
measure blood pressure by using digital sphygmomanometer
Timepoint [1] 324529 0
before and after acupuncture intervention, and again 30 min later after removal of needle
Secondary outcome [2] 324530 0
measure heart rate by using digital sphygmomanometer
Timepoint [2] 324530 0
before and after acupuncture intervention, and again 30 min later after removal of needle
Secondary outcome [3] 324531 0
measure core body temperature by using tympanic digital thermometer
Timepoint [3] 324531 0
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7939 0
Taiwan, Province Of China
State/province [1] 7939 0
Taoyuan

Funding & Sponsors
Funding source category [1] 293757 0
Hospital
Name [1] 293757 0
Taoyuan Chang Gung Memorial Hospital
Address [1] 293757 0
Chang Gung memorial Hospital, No.123, Dinghu Rd., Guishan Dist., Taoyuan City 333.
Country [1] 293757 0
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] 292584 0
Individual
Name [1] 292584 0
Yu-Sheng Chen
Address [1] 292584 0
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] 292584 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295193 0
Chang Gung Memorial Hospital Institutional Review Board
Ethics committee address [1] 295193 0
Chang Gung memorial Hospital, No.123, Dinghu Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.)
Ethics committee country [1] 295193 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 295193 0
23/09/2015
Approval date [1] 295193 0
02/10/2015
Ethics approval number [1] 295193 0
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 66462 0
Dr Bo-Yan Yeh
Address 66462 0
Department of acupuncture and traumatology, Taoyuan Chang Gung memorial Hospital, No.123, Dinghu Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.)
Country 66462 0
Taiwan, Province Of China
Phone 66462 0
+886-3-3196200 ext. 2613
Fax 66462 0
+886-3-3298995
Email 66462 0
cypressrock@gmail.com
Contact person for public queries
Name 66463 0
Dr Bo-Yan Yeh
Address 66463 0
Department of acupuncture and traumatology, Taoyuan Chang Gung memorial Hospital, No.123, Dinghu Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.)
Country 66463 0
Taiwan, Province Of China
Phone 66463 0
+886-3-3196200 ext. 2613
Fax 66463 0
+886-3-3298995
Email 66463 0
cypressrock@gmail.com
Contact person for scientific queries
Name 66464 0
Dr Bo-Yan Yeh
Address 66464 0
Department of acupuncture and traumatology, Taoyuan Chang Gung memorial Hospital, No.123, Dinghu Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.)
Country 66464 0
Taiwan, Province Of China
Phone 66464 0
+886-3-3196200 ext. 2613
Fax 66464 0
+886-3-3298995
Email 66464 0
cypressrock@gmail.com

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?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary