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

Not Applicable

Recruiting

• Conditions: Constipation; Constipation - Functional

• Registration Number: NCT07077044
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed Description

Eligibility Criteria

Inclusion Criteria:

Children aged 4 to 14 years.

Diagnosis of functional constipation (FC) established prior to study enrollment. FC is defined according to the Rome IV diagnostic criteria, in the absence of identifiable organic or anatomical causes (e.g., no endocrine, metabolic, anatomical, or neuromuscular dysfunction). No additional diagnostic testing is required for inclusion.

Ability to complete daily diaries and TTNS sessions, either independently or with caregiver support.

Documented failure of conservative medical treatment following at least three months of therapy.

Exclusion Criteria:

Malformations of the digestive system or rectal anatomical anomalies (e.g., large intestinal atresia or stenosis, Hirschsprung's disease, congenital anorectal malformations).

Neurological or psychiatric conditions (e.g., cerebral palsy, spina bifida, intellectual disability, anorexia nervosa).

Major cognitive impairments.

Metabolic disorders (e.g., diabetes mellitus, diabetes insipidus, scurvy, phenylketonuria).

Endocrine disorders (e.g., hypothyroidism).

Cardiovascular conditions such as heart disease or arrhythmias, or presence of ventriculoperitoneal shunts or cardiac pacemakers, due to potential electrical interference.

History of thoracic or abdominal surgery.

Presence of dermatological lesions in the area of electrode application.

Presence of active electronic implants.

Study Timeline

• Study Start: 2024-02-21
• Status Verified: 2025-02
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-07-20
• Last Update Submitted: 2025-07-20
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Primary Completion: 2026-02-25
• Study Completion: 2026-02-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Severity of constipation using the Wexner Constipation Scoring System (WCSS)	From enrollment to the end of treatment 8 weeks. Then 4 month after this end- will be US final reassessment	The Wexner Constipation Scoring System (WCSS) will be used to quantify the severity of constipation and evaluate treatment effectiveness. The scale includes 8 items assessing: (1) frequency of defecation, (2) painful defecation, (3) incomplete evacuation, (4) abdominal pain, (5) time per attempt, (6) type of assistance, (7) number of unsuccessful attempts per 24 hours, and (8) duration of symptoms. Items are rated 0-4, except for assistance (0-2), with total scores ranging from 0 to 30 (higher scores = more severe constipation).; Time Frame: Baseline and 4 weeks after intervention start; Unit of Measure: Score on a 0-30 scale; Secondary Outcome Measures Each outcome must be listed separately, with clear title, description, time frame, and unit.; 1. Stool consistency using the Bristol Stool Form Scale (BSFS) Description: The BSFS classifies stool on a 7-point scale (1 = separate hard lumps; 7 = watery), used to monitor stool consistency.; Time Frame: Daily entries over 4 weeks Unit of

Secondary Outcome Measures

Name	Time	Method
stool consistency using the Bristol Stool Form Scale (BSFS)77,78 (Appendix 5). The BSFS classifies and categorizes stool consistency on a 7-point scale according to cohesion and surface cracking	24 hours	: 1) stool consistency using the Bristol Stool Form Scale (BSFS)77,78 (Appendix 5). The BSFS classifies and categorizes stool consistency on a 7-point scale according to cohesion and surface cracking, as follows: 1, separate hard lumps (like nuts); 2, sausage-shaped but lumpy; 3, like a sausage or snake but with cracks on its surface; 4, like a smooth and soft sausage or snake; 5, soft blobs with a clearcut edge; 6, fluffy pieces with ragged edges and mushy; and 7, watery without solid pieces (1 to 3 indicate constipation; 4-5 is "ideal" stools; 6-7 show paradoxical diarrhea); Numbers of episodes per day will be recorded for 2) defecation; 3) soiling; 4) abdominal pain; 5) presence of bloody stool; A Hebrew version of the visual analog scale (VAS) (Appendix 6) will be used to document a) sensation or urge to defecate79; b) straining and pain during each documented defecation.79 In addition, data on the use of medications for defecation and enemas and/or special diets, as well

Trial Locations

Locations (1)

Hadassah Hebrew University Hospital; 🇮🇱 Jerusalem, Israel