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

Hadassah Medical Center

Status: Enrolling

Conditions: Constipation - Functional; Constipation

Treatments: Device: The transcutaneous posterior tibial nerve stimulation device; Other: PSUS

Study type: Interventional

Funder types: Other

Identifiers

NCT07077044

Hadassah Medical Center trial (Other Identifier)

Protocol HMO-0446-23

Details and patient eligibility

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 4 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 3 patient groups

TTNS treatment with no PHUS assessments

Experimental group

Description:

TTNS treatment with no PHUS assessments

Treatment:

Device: The transcutaneous posterior tibial nerve stimulation device

TTNS treatment combined with PHUS assessments

Experimental group

Description:

TTNS treatment combined with PHUS assessments

Treatment:

Other: PSUS

Device: The transcutaneous posterior tibial nerve stimulation device

Conventional treatment

Active Comparator group

Description:

conventional treatment recommendations (medications, diets, and behaviors) previously prescribed by their treating physician.

Treatment:

Other: PSUS