Transcutaneous Electrical Nerve Stimulation in Children With Functional Constipation Monitored by Pocket-sized Point-of-care Ultrasound.

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 14
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Israel
Hadassah Hebrew University Hospital
RECRUITING
Jerusalem
Contact Information
Primary
Mordechai Slae, M.D.
mord@hadassah.org.il
+972585356200
Time Frame
Start Date: 2024-02-21
Estimated Completion Date: 2026-02-25
Participants
Target number of participants: 64
Treatments
Experimental: TTNS treatment with no PHUS assessments
TTNS treatment with no PHUS assessments
Experimental: TTNS treatment combined with PHUS assessments
TTNS treatment combined with PHUS assessments
Active_comparator: Conventional treatment
conventional treatment recommendations (medications, diets, and behaviors) previously prescribed by their treating physician.
Related Therapeutic Areas
Sponsors
Leads: Hadassah Medical Organization

This content was sourced from clinicaltrials.gov