The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.
NCT ID: NCT07077044
Last Updated: 2025-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2024-02-21
2026-02-25
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
An a priori power analysis (G-Power software, Version 3.1) with the following parameters: 1-β = 0.80, effect size = 0.6, and α = 0.05 was calculated to determine the sample size for comparing the effects of TTNS, TTNS combined with PHUS, and conventional therapy with PHUS. This indicated that a total sample of 48 participants would be needed to detect the main effects. To address the problem of inflated effect size estimates and possible dropout of participants, we will recruit a sample of 60 subjects, 20 subjects for each group. A participant is entitled to withdraw from the study at a
TREATMENT
TRIPLE
Arm 2 - TTNS + PHUS Monitoring Participants will receive TTNS as in Arm 1, in combination with periodic monitoring using portable handheld ultrasound (PHUS) to assess rectal parameters.
Arm 3 - Conventional Treatment + PHUS Monitoring Participants will continue standard pharmacological and behavioral therapy (toilet training and laxatives), monitored by PHUS at regular intervals.
Study Groups
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TTNS treatment with no PHUS assessments
TTNS treatment with no PHUS assessments
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 urinary and fecal incontinence59,62,67. Two self-adhesive electrodes (5 x 5 cm) will be placed over the ankle area, one approximately 3 to 4 cm above the medial tibial malleolus and a second electrode just below the medial malleolus of the same leg.
TTNS treatment combined with PHUS assessments
TTNS treatment combined with PHUS assessments
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 urinary and fecal incontinence59,62,67. Two self-adhesive electrodes (5 x 5 cm) will be placed over the ankle area, one approximately 3 to 4 cm above the medial tibial malleolus and a second electrode just below the medial malleolus of the same leg.
PSUS
Handheld US
Conventional treatment
conventional treatment recommendations (medications, diets, and behaviors) previously prescribed by their treating physician.
PSUS
Handheld US
Interventions
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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 urinary and fecal incontinence59,62,67. Two self-adhesive electrodes (5 x 5 cm) will be placed over the ankle area, one approximately 3 to 4 cm above the medial tibial malleolus and a second electrode just below the medial malleolus of the same leg.
PSUS
Handheld US
Eligibility Criteria
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Inclusion Criteria
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
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
4 Years
14 Years
ALL
Yes
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Locations
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Hadassah Hebrew University Hospital
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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Hadassah Medical Center trial
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol HMO-0446-23
Identifier Type: -
Identifier Source: org_study_id
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