Study of Electrical Nerve Stimulation and Ultrasound Monitoring for Treating Functional Constipation in Children Ages 4 to 14

What this Trial Is About

Researchers are evaluating the effects of transcutaneous tibial nerve stimulation TTNS, TTNS combined with pocket-sized handheld ultrasound PHUS, and conventional therapy with PHUS on children aged 4 to 14 years who have functional constipation FC. This condition is diagnosed using the Rome IV criteria and must have no organic or anatomical causes. Eligible children must have experienced failure of conservative treatment for at least three months before joining the study. Participants will be randomly assigned to one of three groups TTNS treatment without PHUS assessments, TTNS combined with PHUS assessments, or conventional treatment based on prior physician recommendations. The TTNS treatment involves home sessions three times a week for eight weeks, using a portable device delivering electrical stimulation via electrodes placed near the ankle. PHUS is used as a monitoring tool in two of the groups. During the study, participants will complete daily diaries and attend assessments including rectal ultrasound exams and evaluation of constipation severity using the Wexner Constipation Scoring System. Stool consistency will also be monitored with the Bristol Stool Form Scale. Safety monitoring will track any adverse events throughout the treatment phase and beyond, with a final ultrasound reassessment occurring four months after treatment ends. The total participation spans from enrollment through an eight-week treatment period and follow-up assessments.

The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.