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New treatment option for Constipation
Official title The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.
ClinicalTrials.gov ID: NCT07077044
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 14. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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)
You likely can't join if
- Malformations of the digestive system and rectal anatomical anomalies (e.g., large intestinal atresia/stenosis, Hirschsprung's disease, congenital...
- 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...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 14 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.