Chinese Pediatric Massage on Children With Acute Diarrhea: a Randomized Sham Massage Controlled Trial

The purpose of this study is to evaluate the efficacy of Chinese pediatric massage as an add-on therapy while comparing with sham massage both on the basis of usual care for 0-6 years old children with acute diarrhea.

Study Overview

• Status: Completed
• Conditions: Diarrhea
• Intervention / Treatment: Other: Chinese pediatric massage therapy + usual care; Other: Sham massage therapy + usual care

Detailed Description

Chinese pediatric massage has been practised as an option for the treatment of pediatric diarrhea for hundreds of years (since Ming Dynasty). The history of Chinese pediatric massage for health promotion is much longer, it can be traced back to more than one thousand years ago (652 AD). Many of the acupoints adopted in Chinese pediatric massage are unique if it is compared with those for adult massage. The manipulation is found to be easily accepted by children, as the strength of massage is gentle and soft. No severe adverse reaction in regards of Chinese pediatric massage was reported, the mild adverse reaction such as skin abrasion can be completely avoided with correct operating instructions.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China, 523080
      • Dongguan Kanghua Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject's symptoms meet the diagnosis criteria of acute diarrhea.
2. The occurrence of diarrhea is no more than 72 hours.
3. Stool frequency is equal or more than 5 times a day.
4. Subject has not been involved in any other clinical trials at the same period of time.
5. Subject's guardian may coordinate during the clinical trial.
6. Subject's guardian have signed the informed consent.

Exclusion Criteria:

1. A history of experiencing Chinese pediatric massage on hands
2. Subject has cholera or malaria
3. Subject with the following conditions on the manipulating part: phlebitis，open wound，fracture，tissue damage
4. Subject has the follow complications: severe dehydration，metabolic acidosis，disorders of consciousness, seizures or twitching, shock, azotemia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pediatric massage; Patients will receive Montmorillonite Powder and racecadotril granules as usual care according to different age or weight. Intravenous infusion, Oral Rehydration Salts (ORS), Zn,and antibiotics will be used if the pediatrician in charge considers necessary. Patients will receive Chinese pediatric massage once per day and for three days continuously. A cloak which can cover the child's hands and upper body will be required to put on, all the manipulations will be done under the cloak. Six acupoints will be adopted,i.e. Neibagua, Dachang,Xiaochang, Banmen, Fu, Tuishang Qijiegu. Each visit, children who are under 2 years old will receive manipulations on Neibagua for 500 times, 300 times for the other 5 acupoints each; if they are from 2-3 years old, the manipulations on Neibagua will be 700 times and 500 times for the other 5 acupoints respectively; while the manipulations on Neibagua will be 1000 times, and 800 times for the other 5 acupoints if the children are from 4-6 years old.	Other: Chinese pediatric massage therapy + usual care
Sham Comparator: sham massage; Patients will receive the same usual care as the experimental group. For the sham massage, the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead childrens' hand or childrens' body. Patients will be required to put on the same kind of cloak as that for the the experimental group, all the manipulations will be done under the cloak. The manipulation times for each acupoints will be the same as those for experimental group in accordance with different age. The sham massage will be given once per day for 3 days continuously.	Other: Sham massage therapy + usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diarrhea days		Within 14 days, the period of days from baseline to the first day that the diarrhea time reduces to equal to or less than 2 times per day.
The diarrhea times	The baseline and the 1st day of intervention are on the same day.	On the 3rd day.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global change rating	much better，slightly better，unchanged，slightly worse，much worse	On the 7th day and 14th day from baseline (the baseline and the 1st day of intervention are on the same day).
Period of days when the stool character turns to normal		Within 14 days, the period of days from baseline to the first day that the stool character turns to normal.
Incidence of Treatment-Emergent Adverse Events	monitor adverse events	Within 14 days

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine
• Collaborators: Dongguan Kanghua Hospital

Publications and helpful links

General Publications

• Lu T, Yin L, Chen R, Zhang H, Cai J, Li M, Dai L, Zhu C, Zhang Y, Xiang F, Wang L, Li L, Wang L, Wu D. Chinese pediatric Tuina on children with acute diarrhea: a randomized sham-controlled trial. Health Qual Life Outcomes. 2021 Jan 6;19(1):4. doi: 10.1186/s12955-020-01636-1.
• Lu T, Zhang H, Yin L, Cai J, Li M, Dai L, Zhu C, Zhang Y, Xiang F, Wang L, Li L, Wang L, Wu D. Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial. Trials. 2019 Dec 9;20(1):689. doi: 10.1186/s13063-019-3818-1.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): October 25, 2019
• Study Completion (Actual): October 25, 2019

Study Registration Dates

• First Submitted: December 25, 2016
• First Submitted That Met QC Criteria: December 25, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 25, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: acute diarrhea; pediatric massage; Tuina therapy
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: 2013B032500014