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

NCT ID: NCT03005821

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-10-25

Brief Summary

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.

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.

Conditions

Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Chinese pediatric massage therapy + usual care

Intervention Type: OTHER

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.

Group Type: SHAM_COMPARATOR

Sham massage therapy + usual care

Intervention Type: OTHER

Interventions

Chinese pediatric massage therapy + usual care

Intervention Type: OTHER

Sham massage therapy + usual care

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongguan Kanghua Hospital

OTHER

Sponsor Role: collaborator

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Darong Wu

MD, PhD, Director,Program for Outcome Assessment in TCM, Professor, Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dongguan Kanghua Hospital

Dongguan, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33407547 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31815655 (View on PubMed)

Other Identifiers

2013B032500014

Identifier Type: -

Identifier Source: org_study_id