[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598865":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":58,"collaborators":28,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":28,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":42,"whyStopped":28,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Hadassah Medical Organization","OTHER",[8,13,17],{"label":9,"type":10,"description":9,"interventionNames":11},"TTNS treatment with no PHUS assessments","EXPERIMENTAL",[12],"Device: The transcutaneous posterior tibial nerve stimulation device",{"label":14,"type":10,"description":14,"interventionNames":15},"TTNS treatment combined with PHUS assessments",[12,16],"Other: PSUS",{"label":18,"type":19,"description":20,"interventionNames":21},"Conventional treatment","ACTIVE_COMPARATOR","conventional treatment recommendations (medications, diets, and behaviors) previously prescribed by their treating physician.",[16],[23,29],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"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 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.",[14,9],null,{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"PSUS","Handheld US",[18,14],[34],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"Mordechai Slae, M.D.","CONTACT","+972585356200","mord@hadassah.org.il",[40],{"facility":41,"status":42,"city":43,"state":28,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hadassah Hebrew University Hospital","RECRUITING","Jerusalem","91120","Israel","IL",{"type":48,"coordinates":49},"Point",[50,51],35.21633,31.76904,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":56,"phoneExt":28,"email":57},"Irina Rabkin","0528709824","irinar@hadassah.org.il",{"type":59,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100598865","the-effects-of-ttns-ttns-combined-with-phus-and-conventional-therapy-with-phus-in-the-treatment-of-pfc-100598865",false,"NCT07077044","The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.","Transcutaneous Electrical Nerve Stimulation in Children With Functional Constipation Monitored by Pocket-sized Point-of-care Ultrasound.","constipation","Inclusion Criteria Children aged 4 to 14 years\n\nClinical diagnosis of functional constipation (FC), with no identifiable organic or anatomical cause (e.g., endocrine, metabolic, anatomical, or neuromuscular dysfunction)\n\nFC diagnosis established according to Rome IV criteria\n\nNo additional tests required to confirm eligibility\n\nAbility to complete daily diaries and TTNS sessions (by participant or caregiver)\n\nFailure of conservative medical treatment (including toilet training and laxatives) after at least three months\n\nExclusion Criteria Malformations of the digestive system and rectal anatomical anomalies (e.g., large intestinal atresia\u002Fstenosis, Hirschsprung's disease, congenital anorectal anomalies)\n\nNeurological or psychiatric disorders (e.g., cerebral palsy, spina bifida, intellectual disability, anorexia nervosa)\n\nMajor cognitive impairment\n\nMetabolic conditions (e.g., diabetes mellitus, diabetes insipidus, scurvy, phenylketonuria)\n\nEndocrine disorders (e.g., hypothyroidism)\n\nCardiac conditions (e.g., heart disease, arrhythmias, presence of pacemaker or ventriculoperitoneal shunt) due to possible interference with electrical stimulation\n\nHistory of thoracic or abdominal surgery\n\nPresence of skin lesions in the area of electrode application\n\nPresence of active electronic implants",true,"ALL","4 Years","14 Years",{"count":73,"type":74},64,"ESTIMATED","INTERVENTIONAL",[77],"NA","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).\n\nFC 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.\n\nThe 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.",[80,81],"Constipation","Constipation - Functional",[83],"children with functional constipation","2025-07-20",{"date":86,"type":87},"2025-07-22","ACTUAL",{"date":89,"type":87},"2024-02-21",{"date":91,"type":74},"2026-02-25",{"name":5,"class":6},1]