Tibial nerve stimulation, with or without handheld ultrasound, versus conventional therapy with handheld ultrasound for children with functional constipation
Transcutaneous Electrical Nerve Stimulation in Children With Functional Constipation Monitored by Pocket-sized Point-of-care Ultrasound.
NA · Hadassah Medical Organization · NCT07077044
We will test whether transcutaneous tibial nerve stimulation (TTNS), alone or combined with a pocket-sized handheld ultrasound (PHUS), helps children aged 4–14 with functional constipation who have not improved after at least three months of standard treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 4 Years to 14 Years |
| Sex | All |
| Sponsor | Hadassah Medical Organization (other) |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT07077044 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled trial that assigns children with Rome IV–defined functional constipation to one of three 20-participant arms: TTNS alone, TTNS plus PHUS, or conventional therapy with PHUS. Participants are 4 to 14 years old and must have failed conservative treatment for at least three months prior to enrollment. Primary outcomes include changes in rectal ultrasound parameters and symptom severity scores measured by trained clinicians using standardized ultrasound protocols and clinical scoring tools. Adverse events will be monitored throughout the intervention period and standard exclusion criteria (organic causes, major neurological/metabolic/endocrine disorders, active implants, skin lesions at electrode sites) are applied for safety.
Who should consider this trial
Good fit: Ideal candidates are children aged 4–14 with functional constipation defined by Rome IV criteria, who have failed at least three months of conservative therapy and can complete daily diaries or receive caregiver support.
Not a fit: Children with organic or anatomical causes of constipation, major neurological, psychiatric, metabolic, or endocrine disorders, active electronic implants or pacemakers, significant cognitive impairment, or skin lesions at electrode sites are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive therapy that reduces constipation symptoms and improves bowel function in children who have not responded to standard treatments.
How similar studies have performed: TTNS has shown some supportive results in pediatric and adult bowel and bladder disorders, but combining TTNS with a pocket-sized handheld ultrasound is a newer approach with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Children aged 4 to 14 years Clinical diagnosis of functional constipation (FC), with no identifiable organic or anatomical cause (e.g., endocrine, metabolic, anatomical, or neuromuscular dysfunction) FC diagnosis established according to Rome IV criteria No additional tests required to confirm eligibility Ability to complete daily diaries and TTNS sessions (by participant or caregiver) Failure of conservative medical treatment (including toilet training and laxatives) after at least three months Exclusion Criteria Malformations of the digestive system and rectal anatomical anomalies (e.g., large intestinal atresia/stenosis, Hirschsprung's disease, congenital anorectal anomalies) Neurological or psychiatric disorders (e.g., cerebral palsy, spina bifida, intellectual disability, anorexia nervosa) Major cognitive impairment Metabolic conditions (e.g., diabetes mellitus, diabetes insipidus, scurvy, phenylketonuria) Endocrine disorders (e.g., hypothyroidism) Cardiac conditions (e.g., heart disease, arrhythmias, presence of pacemaker or ventriculoperitoneal shunt) due to possible interference with electrical stimulation History of thoracic or abdominal surgery Presence of skin lesions in the area of electrode application Presence of active electronic implants
Where this trial is running
Jerusalem
- Hadassah Hebrew University Hospital — Jerusalem, Israel (RECRUITING)
Study contacts
- Study coordinator: Mordechai Slae, M.D.
- Email: mord@hadassah.org.il
- Phone: +972585356200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Constipation, Constipation - Functional, children with functional constipation