Assessment of applicability and results of nerve electrical stimulation in the treatment of children with intractable intestinal constipatio
- Conditions
- ConstipationK59.0
- Registration Number
- RBR-344jq8
- Lead Sponsor
- niversidade Estadual Paulista Júlio de Mesquita Filho” Faculdade de Medicina de Botucatu-FMB/UNESP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Patients between the ages of 7 and 18 years of age, of both sexes, with a diagnosis of CIC, established according to the criteria of Rome IV, and classified as having intractable intestinal constipation, according to the definition of the European Societies ( ESPGHAN) and North American (NASPGHAN) Gastropediatrics, represented by patients unresponsive to standard treatment, after a period of threE months
Patients whose parents and / or guardians do not agree to participate in the study and who do not sign the Free and Informed Consent Term, as well as patients between the ages of 12 and 18 who do not sign their consent form, will be excluded. Patients with any identifiable organic cause for intestinal constipation will be excluded from the study. Exclusion criteria will also be considered: neurological and / or cognitive deficits, skin lesions in the region of application of electrodes, changes in local sensitivity, presence of cardiac pacemaker, children presenting with cardiac arrhythmias or cardiac arrhythmias, patients presenting incomplete questionnaires or that are subject to drug changes and the standard
during the intervention period or who abandon the proposed electrostimulation treatment during the intervention period
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in the evacuation pattern and in the quality of life of the children submitted to the intervention. The following instruments will be used to evaluate and quantify this expected improvement: Asked about the evaluation of the current clinical state; Modified Bristol scale for children (mBSFS-C) for stool consistency analysis; Intestine Function Index (BF-S); Fecal continence index; PEDs 4.0 questionnaire for quality of life assessment; the last 7 days.;The possibility of applying the electrostimulation therapy in a home environment, identified through a directed questionnaire to evaluate the applicability of the sessions.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are not expected