The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-14
SponsorHadassah Medical Organization
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
The transcutaneous posterior tibial nerve stimulation device
DeviceIn 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
Other interventionHandheld US
Treatment groups
64 Participants
are divided into 3 treatment groupsGroup A: TTNS treatment with no PHUS assessmentsExperimental treatment 1 intervention
Group B: TTNS treatment combined with PHUS assessmentsExperimental treatment 2 interventions
Group C: Conventional treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Severity of constipation using the Wexner Constipation Scoring System (WCSS)
The Wexner Constipation Scoring System (WCSS) will be used to quantify the severity of constipation and evaluate treatment effectiveness. The scale includes 8 items assessing: (1) frequency of defecation, (2) painful defecation, (3) incomplete evacuation, (4) abdominal pain, (5) time per attempt, (6) type of assistance, (7) number of unsuccessful attempts per 24 hours, and (8) duration of symptoms. Items are rated 0-4, except for assistance (0-2), with total scores ranging from 0 to 30 (higher scores = more severe constipation). Time Frame: Baseline and 4 weeks after intervention start Unit of Measure: Score on a 0-30 scale Secondary Outcome Measures Each outcome must be listed separately, with clear title, description, time frame, and unit. 1\. Stool consistency using the Bristol Stool Form Scale (BSFS) Description: The BSFS classifies stool on a 7-point scale (1 = separate hard lumps; 7 = watery), used to monitor stool consistency. Time Frame: Daily entries over 4 weeks Unit of
Time frame
From enrollment to the end of treatment 8 weeks. Then 4 month after this end- will be US final reassessmentSecondary outcomes
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
: 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, as follows: 1, separate hard lumps (like nuts); 2, sausage-shaped but lumpy; 3, like a sausage or snake but with cracks on its surface; 4, like a smooth and soft sausage or snake; 5, soft blobs with a clearcut edge; 6, fluffy pieces with ragged edges and mushy; and 7, watery without solid pieces (1 to 3 indicate constipation; 4-5 is "ideal" stools; 6-7 show paradoxical diarrhea); Numbers of episodes per day will be recorded for 2) defecation; 3) soiling; 4) abdominal pain; 5) presence of bloody stool; A Hebrew version of the visual analog scale (VAS) (Appendix 6) will be used to document a) sensation or urge to defecate79; b) straining and pain during each documented defecation.79 In addition, data on the use of medications for defecation and enemas and/or special diets, as well
Time frame
24 hoursSponsors and contacts
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Source ClinicalTrials.gov