Actively Recruiting
Transcutaneous Electrical Nerve Stimulation in Children With Functional Constipation Monitored by Pocket-sized Point-of-care Ultrasound
Led by Hadassah Medical Organization · Updated on 2025-07-22
64
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 4 to 14 years
- Clinical diagnosis of functional constipation based on Rome IV criteria
- No identifiable organic or anatomical cause for constipation
- Ability to complete daily diaries and TTNS sessions independently or with caregiver support
- Failure of conservative medical treatment including toilet training and laxatives after at least three months
You will not qualify if you...
- Malformations of the digestive system or rectal anatomical anomalies such as large intestinal atresia, stenosis, Hirschsprung's disease, or congenital anorectal malformations
- Neurological or psychiatric disorders including cerebral palsy, spina bifida, intellectual disability, or anorexia nervosa
- Major cognitive impairment
- Metabolic conditions such as diabetes mellitus, diabetes insipidus, scurvy, or phenylketonuria
- Endocrine disorders such as hypothyroidism
- Cardiovascular conditions including heart disease, arrhythmias, presence of pacemaker or ventriculoperitoneal shunt
- History of thoracic or abdominal surgery
- Presence of skin lesions in the electrode application area
- Presence of active electronic implants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive transcutaneous posterior tibial nerve stimulation (TTNS) sessions at home, three times per week for eight weeks, each lasting 20 minutes. Some participants also undergo handheld ultrasound (PHUS) assessments alongside TTNS, while others receive conventional treatment with medications, diets, and behaviors as previously prescribed.
3 sessions per week for TTNS treatment; additional PHUS assessments depending on group assignment
Duration - 4 months after treatment
Participants have a final ultrasound reassessment approximately 4 months after the end of the treatment period to evaluate long-term effects.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Hadassah Hebrew University Hospital
Jerusalem, Israel, 91120
Actively Recruiting
Research Team
M
Mordechai Slae, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here