Actively Recruiting
The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.
Led by Hadassah Medical Organization · Updated on 2025-07-22
64
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, controlled trial designed to evaluate the effects of transcutaneous tibial nerve stimulation (TTNS), TTNS combined with pocket-sized handheld ultrasound (PHUS), and conventional therapy with PHUS on children with functional constipation (FC). Participants will be stratified into three intervention arms (n=20 per group). FC will be defined based on the Rome IV diagnostic criteria, in the absence of organic or anatomical causes. Participants will be between 4 and 14 years old and will have experienced failure of conservative treatment for at least three months prior to enrollment. The primary outcomes include changes in rectal ultrasound parameters and symptom severity scores. Ultrasound assessments will be conducted by trained clinicians using standardized protocols. Monitoring for adverse events will be performed throughout the intervention phase. Safety considerations include predefined exclusion criteria, such as underlying neurological, metabolic, or cardiac conditions.
CONDITIONS
Official 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
- Diagnosis of functional constipation based on Rome IV criteria without organic or anatomical causes
- Ability to complete daily diaries and TTNS sessions independently or with caregiver support
- Failure of conservative medical treatment for at least three months
You will not qualify if you...
- Malformations of the digestive system or rectal anatomical anomalies such as large intestinal atresia or Hirschsprung's disease
- Neurological or psychiatric disorders including cerebral palsy, spina bifida, intellectual disability, or anorexia nervosa
- Major cognitive impairments
- Metabolic disorders such as diabetes mellitus, diabetes insipidus, scurvy, or phenylketonuria
- Endocrine disorders including hypothyroidism
- Cardiac conditions like heart disease, arrhythmias, presence of pacemakers or ventriculoperitoneal shunts
- History of thoracic or abdominal surgery
- Skin lesions in the area where electrodes would be applied
- Presence of active electronic implants
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hadassah Hebrew University Hospital
Jerusalem, Israel, 91120
Actively Recruiting
Research Team
M
Mordechai Slae, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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