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

Official title

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

Overview

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.

Interventions

• Device The transcutaneous posterior tibial nerve stimulation device
  In addition to their conventional treatment, subjects in both TTNS groups will complete eight weeks of home TTNS treatment (3 sessions per week), and each session will last for 20 minutes. Stimulation will be provided by a portable device (Chattanooga®, ContinuumTM, Hixson, TN, USA). The device will be pre-programmed to apply a bi-phasic squared wave with a pulse width of 200μsec, and a pulse frequency of 20 Hz. These are default settings for TTNS that have been used in previous studies for urin
• Other PSUS
  Handheld US

Primary outcome measures

• Severity of constipation using the Wexner Constipation Scoring System (WCSS) [Time frame: From enrollment to the end of treatment 8 weeks. Then 4 month after this end- will be US final reassessment]

Secondary outcome measures (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 [Time frame: 24 hours]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Israel · 1 center

• Hadassah Hebrew University Hospital — Jerusalem

Identifiers

NCT: NCT07077044 · Protocol HMO-0446-23 · Hadassah Medical Center trial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗