Development and Validation of a Cloak Shape Device for Sham Pediatric Tuina
Phase: NA
Conditions: Child
Sponsor: Guangzhou University of Traditional Chinese Medicine

 
Protocol Cover Page 
Protocol Title:    Development and Validation of a Cloak Shaped  Device for 
Sham Pediatric Tuina 
NCT Number:    NCT03474172 
Protocol Date:    April 20, 2018 
Version:         Version 3 (final) 
 
Principle        Darong Wu  M.D. 
Investigator   
 
Leading    Darong Wu    2nd Affiliated Hospital of Guangzhou University of Chinese Medicine 
Authors    Jianxiong Cai  2nd Affiliated Hospital of Guangzhou University of Chinese Medicine 
 
Other      Lin Dai       Guangzhou University of Chinese Medicine 
Authors    Lingjia Yin    2nd Affiliated Hospital of Guangzhou University of Chinese Medicine 
           Taoying Lu   2nd Affiliated Hospital of Guangzhou University of Chinese Medicine 
             Li Wang      Dongguan Kanghua Hospital  
             Huiyan Zhang  Guangzhou University of Chinese Medicine 
             Conghao Zhu   Dongguan Kanghua Hospital 
             Meiling Li     Guangzhou University of Chinese Medicine 
 
 
 
 
 
 
 
 

 
 
Abstract 
 
Background: With the overwhelming acceptance of evidence-based medicine, valid placebo device 
or placebo procedure become one of the key issues for randomization and placebo-controlled design 
clinical trials on the validation of treatment modalities. However, few have been developed for 
Pediatric Tuina (PT) which is a therapeutic massage for children. Blinding both the recipients and the 
clinical researcher is considered essential for good research practice. Up to now, no well recognized 
placebo device or procedure for PT has been reported. We developed a Cloak Shaped Device (CSD) , 
and design a RCT to detect whether the device is effective as a placebo in PT researches. 
Methods: This is a two-arm, parallel-group RCT, while participants and researchers will be blinded. 
Sixty eligible children will be randomly assigned to genuine Tuina or sham Tuina group with the 
informed consent signed by their guardians. During the process of Tuina, a CSD will be used to cover 
the children’s body so that the children, guardians, observers and researchers will be blinded. 
Guardians and observers will be asked to ascertain whether they could differentiate genuine Tuina 
from sham Tuina. The primary outcomes are the accuracy judgment rates based on guardians' and 
observers' evaluations of the type of Tuina that participants actually received. 
Discussion: This study will contribute to the development of a valid placebo device which can be 
applied in RCTs regarding pediatric Tuina. 
Keywords: placebo procedure; device; sham control; Pediatric Tuina; Chinese pediatric massage. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Background 
Blinding is one of the important methodological elements in randomized clinical trials (RCTs)based 
on the principles of evidence-based medicine[1,2].A valid placebo device or procedure may 
successfully avoid the stakeholders from detecting the group allocation situation[3,4,5].Blinding can 
minimize the placebo effect as much as possible, therefore the efficacy of the intervention can be 
evaluated with large extent. Besides, in the trial design, placebo or sham control can not only provide 
a valid comparator, but also can well control the unknown variables in order to decrease the bias and 
show the contrasting efficacy of intervention[6]. 
Placebo has been used in the pharmaceutical clinical trials frequently. In decades, researchers 
attempted to develop valid sham controls for non-pharmaceutical therapies in Chinese Medicine 
(CM),including acupuncture[16][17][18], moxibustion[19] and cupping[20].However, in trials 
adopting non-pharmaceutical interventions, the placebo or sham-therapy have yet been well 
recognized. Difficulties in the development of placebo devices or placebo procedures of non-
pharmacological regimens may occur when participants have had similar experiences[7,8], or when 
the placebo procedure is not rationally established, expectation bias may easily be introduced[9]. 
Therefore, to develop appropriate devices for sham massage or sham Tuina is warranted. 
PT is a form of traditional Chinese medicine(TCM) therapy in which trained practitioners manually 
stimulate specific acupoints of the body which are located primarily on the fingers, palms, arms, head, 
abdomen and back. It has been a valuable option for children’s health promotion since more than one 
thousand years ago (652 AD) and it is still widely used nowadays in the prevention or treatment of 
various kinds of pediatric diseases, such as diarrhea, dyspepsia, pneumonia[15]. Although some studies 
showed that PT is effective with few side effects[12,13,14]. More rigorous designed trials are needed 
to evaluate the efficacy of PT. The main obstacle in this field is to develop a valid placebo device or 
procedure which can make the sham Tuina comparison possible. In this study, we will evaluate the 
validity of a newly developed Cloak Shaped Device (CSD)for sham PT. 
 
Methods 
Study design 
We will use the randomized controlled design to assess the validity of the CSD for sham PT. The 
primary outcomes are the accuracy judgement rates based on guardians' and observers' evaluations of 
the type of Tuina that participants actually received.   
One of the guardians for each child will be informed with all the information of the trial before the 
child is included. They will be told that their children may receive genuine PT or sham PT. Once the 
informed consent signed, eligible children will be randomly assigned to genuine PT or sham PT group 
with 1:1 ratio. Computer generated randomization lists will be concealed in the opaque envelopes, 
which performed by irrelevantly authorized expert from the department of medical statistics of The 
2nd Affiliated Hospital of Guangzhou University of Chinese Medicine. 
Trained practitioners will manually do 15 minutes session of Tuina on each participant while the 
guardians and observers are watching. The guardians and observers will be required to record their 
judgements of the type of Tuina, either it is genuine or sham PT, that the participant actually received. 
If the child is equal to or older than 3 years old, researchers will ask the child some questions in terms 
of the experience of Tuina after they finish the Tuina procedure. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study population 
Children will be recruited at the outpatient department of pediatrics in Dongguan Kanghua hospital 
which is a tertiary A western medicine hospital located in Dongguan, Guangdong province, China. 
Inclusion criteria: 
l Children with disease in Pediatric Outpatient Department of Kanghua Hospital 
l Children aged 0-6 years. 
l Guardian and child can be cooperative over the study period. 
l Guardian signed the informed consent. 
l Children have no attendance in other studies simultaneously.  
 
Exclusion criteria: 
l Child with one or more PT experiences on arms, abdomen or back. 
l Child with a previous history of convulsion. 
l Child with any of the following conditions on the area to be manipulated: phlebitis, open wound, 
fracture and tissue damage. 
l Child combined with any of following conditions: disorders of consciousness, seizures or 
twitching, shock, varicella, hand-foot-mouth disease, encephalitis B, and etc. 
 
Sample size 
The aim of this study is to evaluate the validity of CSD whether it may have a balanced accurate rate 
(e.g. 50%) on the type of Tuina that the child actually received in the genuine or sham group, when 
judged by guardians and observers, respectively. About 95% of the subjects can distinguish the 
genuine and sham pediatric Tuina accurately without placebo device in the clinical practice. Based 
on the results from the previous similar researches, an ideal blinding device will be considered have 
Recruitment 
Eligible patients 
Informed consent 
Randomized 60 patient 1:1 
Fill out questionnaires 
Data collection and statistical analysis 
Genuine PT group(n=30) 
ShamPT group(n=30)

a good blinding effect while the accurate rate of subjects (genuine group or sham group) on guessing 
the Tuina type is50%. Therefore, we adopt the single-sample test in the software of PASS 11.0 (NCSS 
LLC) to calculate the sample size, and set accurate rate of subjects with 95% in non-blinding status, 
and 50% in blinding status, powered by 90%, and significance levelwith0.05.After the calculation, 
24 subjects of each group are needed, on account of the 20% subject may drop out, the finally sample 
size is  60 subjects in total with 30 subjects in each group. 
 
Development of the CSD 
The CSD is made of opaque cotton cloth in cloak-shape. It is big enough to cover the upper body, 
including upper limbs and trunk, of a child who is 6 year-old or under old. Two narrow holes are 
present for therapists to insert their hands through and perform Tuina. The entire manipulation process 
will be covered by the CSD. Blinding will be maintained during the whole study process. 
 
Genuine pediatric Tuina and sham pediatric Tuina 
All the techniques and acupoints will be the same in both group, the only difference is that on whose 
skin that the manipulation will be performed. For Genuine PT the manipulation will be performed on 
the children’s skin directly. However, in the Sham PT group, the therapist will put their own hand 
above the same skin areas as those in the Genuine PT group and do the Tuina with the other hand of 
their own. Five acupoints located on the upper limbs and the trunk are involved in both Tuina group, 
including Neibagua, Banmen and Dachang on hands, Fu on the abdomen, and Qijiegu on the sacroiliac 
region. The frequency of the techniques are as normal with  150 times per minute for Neibagua, 200 
times per minute for Banmen, Dachang, and Qijiegu, 80 times per minute for Fu. The acupoints, 
manipulation time and frequency are the same for all subjects in two groups. All manipulations will be 
carried out with light, fast, and soft touch, and coconut oil will be used to protect children’s skin in 
both groups. 
 
Effective measurements 
Primary Outcome Measures 
l Accurate judgement rate of the guardians' estimation 
l Accurate judgement rate of the observers’ estimation 
 
Secondary Outcome Measures 
l Verbal Rating Scale (VRS) of parent's attitude towards pediatric Tuina (We use the VRS-4 with 
the higher score representing the more positive attitude to evaluate the degree of the awareness 
and reliability of the parents towards pediatric Tuina.) 
l VRS of Children's Perception of Pediatric Tuina (Verbal Rating Scale, VRS). (We use the VRS-4 
with the higher score representing the more positive attitude to evaluate the degree of the 
perception of the children equal or more than 3 years old during and after the Tuina.) 
Children equal or more than 3 years old in both genuine Tuina and sham Tuina groups will evaluate 
their sensation, such as pain, warm, discomfort, itch, et al. 
l VRS of Parent's Attitude Towards Pediatric Tuina From the Observers' Perspectives. (Verbal 
Rating Scale, VRS)(We use the VRS-4 with the higher score representing the more positive 
attitude to evaluate the degree of the reliability of the parents towards pediatric Tuina from the 
observers' perspectives.) 

l Compliance of guardians and children on three continuous PT therapies. (Verbal Rating Scale, 
VRS)(We use the VRS-5 with the higher score representing the more positive attitude to follow 
three continuous PT therapies.) 
 
Ethics 
The study will respect the Helsinki declaration. It has been approved by the ethics committee of 
Guangdong Provincial Hospital of Chinese Medicine(Z2017-212-01) and DongGuan Kanghua 
Hospital(2018003), 
and 
has 
been 
registered 
on 
the 
ClinicalTrials.gov 
(Identifier: 
NCT03474172)before the recruitment of subjects. Informed consent must be endorsed by one guardian 
of each child if the child is going to attend the trial. All the participants will receive a bonus for the 
traffic when they complete the trial. 
 
Statistical analysis 
All the data in this study will be recorded in a case report form (CRF). When the trial is complete, data 
will be entered into the database by double entry method. We will use Wilcoxon rank sum test analysis 
for abnormal distribution data, Mann-Whiney U test for ranked outcomes and chi-squared test for 
binary outcomes. 
In the primary outcome, we will calculate accurate judgment rates on type of Tuina the participants 
received by guardians and observers, respectively. 
In the secondary outcomes, Mann-Whiney U test will be used for the comparison of Verbal Rating 
Scale (VRS) of parent's attitude towards pediatric Tuina, VRS of Children's Perception of Pediatric 
Tuina, VRS of Parent's Attitude Towards Pediatric Tuina from the Observers' Perspectives, 
Compliance of guardians and children in terms of three continuous PT therapies between groups. 
Simple Kappa Coefficient will be used to analysis the agreement of the judge results and the attitude 
towards PT between the guardians and observers. We will use Chi-square test to identify the influence 
factor, including the education level, age, Children's Perception, parent's attitude, et al. 
Statistical Packages of Social Sciences (SPSS) for Windows version 18.0 (Chicago, IL) will be used 
to conduct the analyses. For all tests, two-tailed P value less than 0.05 is considered as statistically 
significant. 
The Kappa coefficient ranges from 0 to 1.0. In the study, we define if the coefficient value is less than 
0.2, it presents that the agreement is slight. If it ranges from 0.21-0.40 indicates the agreement is weak; 
ranging from 0.41-0.60 means the agreement is moderate; ranging from 0.61-0.80 implies the 
agreement is favorable. And for those range from 0.81-1.00 it represents that the agreement is perfect. 
 
Quality monitoring 
All the researchers will be trained before the trial conducted, including the communication skills with 
guardians and children, subjects screening, randomization and evaluation procedure. Meanwhile, three 
experienced therapists will receive a well-designed session of manipulation technical training course 
to reach a high level of standardization. Detail information on dropout, adverse event of subjects will 
be recorded on the CRF. During the study period, supervisors will check the CRF aperiodically. 
 
Discussions 
To our knowledge, this trial is the first study aiming for the validity of a placebo device in regards of 
sham PT. On the basis of a rigorous randomized controlled design of our study, the results may provide 

evidence for CSD on whether it is worthy to be applied as a useful placebo device for the evidence-
based researches of pediatrics when PT or other similar massage interventions will be adopted.  
Despite PT, other non-pharmaceutical therapies of Chinese Medicine have developed some sham or 
blinding methods, such as several types of sham acupuncture or sham cupping devices. The effects of 
these methods have been revealed by adopting similar research design as this study[16,21-23]. 
PT has been found to be easily accepted by children based on the light and gentle technique with good 
safety record. Up to now, none severe adverse event due to PT was reported, some mild adverse events 
such as skin abrasion can be easily avoided with clear and correct operating instructions. Therefore, 
guardians and children are very likely to have good compliance to complete the trial. We assume 
children less than 6 years old cannot differ the genuine PT and sham PT when they are lack of former 
experience of PT, and consequently the placebo effect for both groups will not be generated 
systematically. In this case, guardians’ and observers’ judgements will be more important than 
children’s own perspective in the validation evaluation of the CSD.  
In conclusion, this trial may provide valuable evidence on placebo device for the future RCTs in terms 
of PT or other similar kinds of massage. 
 
Declarations 
Ethics approval and consent to participate 
This study was approved by the Ethical Review Board at the Kanghua Hospital in Dongguan, 
Guangdong province, China (February 6, 2018) and Guangdong Provincial Hospital of Chinese 
Medical in Guangzhou, Guangdong province, China(January 12,2018). Signed informed consent will 
be needed for each participant by one of their guardians. 
 
Trial status 
The study initiates to recruit on May 2018, and plans to complete before 30 December 2019. 
 
 
Funding 
The National Key Research and Development Program of China (2018YFC1706006)；Clinical 
Pathway Project of Guangdong Provincial Hospital of Chinese medicine, China(2015, 
No.119).Science and Technology Research Project of Guangdong Provincial Hospital of Chinese 
Medicine, China(YN2015QN13); 
 
Competing interests 
The authors declare that they have no competing interests. 
 
Abbreviations 
RCT: randomized controlled trial; PT: Pediatric Tuina; CM: Chinese Medicine; CRF: case report form. 
CSD: cloak shaped device 
 
 
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