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Pediatric Tuina for functional constipation in children: study protocol for a randomized controlled trail
Xinghe Zhang1,2, Luan Hu3, Li Li4
1School of Second Clinical Medicine, Yunnan University of Chinese Medicine, Kunming, China.
Insights
Pediatric Tuina may be a safe and effective treatment for functional constipation (FC) in children. This study compares pediatric Tuina to probiotics, hypothesizing Tuina is superior for improving bowel movements and related symptoms.
Area of Science:
- Pediatric Gastroenterology
- Complementary and Alternative Medicine
Background:
- Functional constipation (FC) significantly impacts children's quality of life.
- Pediatric Tuina is a potential therapy for FC, but high-quality evidence is lacking.
- This study addresses the need for robust data on pediatric Tuina's efficacy and safety.
Purpose of the Study:
- To evaluate the efficacy and safety of pediatric Tuina for treating functional constipation in children.
- To compare pediatric Tuina with Medilac-Vita (probiotics) in managing pediatric FC.
- To provide reliable evidence for the clinical application of pediatric Tuina.
Main Methods:
- A randomized, controlled, multicenter clinical trial involving 176 children with FC.
- Participants assigned to either pediatric Tuina or Medilac-Vita group.
- Weekly assessments of spontaneous bowel movements, complete spontaneous bowel movements, stool form, distress, and enema rates over a treatment and follow-up period.
Main Results:
- Primary outcomes include weekly spontaneous and complete spontaneous bowel movements.
- Secondary outcomes encompass effective rate, stool form, distress sensation, and glycerine enema rate.
- Adverse events will be monitored throughout the study.
Conclusions:
- The study hypothesizes that pediatric Tuina is more effective than probiotics for pediatric FC.
- Results will offer crucial evidence supporting pediatric Tuina as a treatment for childhood functional constipation.
- This research aims to enhance the management of FC in pediatric populations.
Background:
Functional constipation (FC) is a common functional gastrointestinal disorder, which brings many negative impacts to the children's daily life. Pediatric Tuina has been proved to be a potential therapy for FC. However, the evidence for its effectiveness and safety is insufficient due to the lack of high-quality study. This study aims to evaluate the efficacy and safety of pediatric Tuina for children with FC.
Methods/Design:
This study is a randomized, controlled, multicentre, clinical trial. We will include 176 children with FC from five hospitals. The participants will be randomly allocated into two groups: the pediatric Tuina group and the Medilac-Vita group. This study will include a 1-week actual treatment period and a 2-week follow-up period. Primary outcomes are weekly spontaneous bowel movements and weekly complete spontaneous bowel movements. The secondary outcomes are effective rate, stool form, distress sensation, and glycerine enema rate. The assessment will be performed each week. Adverse event will be monitored in the treatment period and follow-up period.
Discussion:
This study is designed to evaluate the efficacy and safety of pediatric Tuina for children with FC, and we hypothesize that pediatric Tuina is more effective than probiotics. It will provide reliable evidence and support for the treatment of FC by pediatric Tuina.
Trial Registration:
This protocol was registered in the Chinese Clinical Trial Registry (ChiCTR2100046485). .
