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IRCT20140527017876N5 IRCT 2022-04-23 Tehran University of Medical Sciences Effect of electrical stimulation on constipation in children Comparative efficacy of inferential electrical stimulation and functional electrical stimulation on functional constipation in children 2022-04-21 anticipated 50 Complete https://irct.ir/trial/63086 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly allocated into two equal treatment groups in a balanced randomization study using random block sizes of 4 (ratio; 1:1). A computer-generated list of random numbers was used to allocate the participants, Blinding description: All patients/parents and physicians were blind to the group enrollment . The physiotherapist was not blind to the treatment interventions, although the outcome assessors were blinded. An independent person recorded the coded trial data in SPSS. N/A Constipation. Intervention group:For both groups 10 sessions treatment program, twice a week were performed. Group 1 = Inferential electrical stimulation ( on the abdomen for 20 minutes). A frequency of 5–25 Hz for duration of 250 μs, and a repeat time of 6 s with adjustable amplitude (0–50 mA). Two electrodes, one from each channel, were placed on the skin of anterior abdominal wall bellow the costal margin bilaterally and two other electrodes from each channel were crossly placed on the back between T12 and L4 on either sides of the patients. Group 2 = Functional electrical stimulation ( beside of anus for 20 minutes ).A frequency of 40 Hz, duration of 250 μs, hold and rest time of 3 seconds with adjustable amplitude (range 0-100 mA). Yes - There is a plan to make this available What will be shared: Final report When: After publication To whom: Researchers Conditions: For performance of other study Where to obtain: Pediatric Gastroenterology and Hepatology Research Center How to obtain: A request form Institute to Pediatric Gastroenterology and Hepatology Research Center Comments:
public Lida Sharifi Rad
No. 62, Dr. Qarib’s St, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 14194 33151 +98 21 6147 2090 lidasharifirad@gmail.com Tehran University of Medical Sciences scientific Lida Sharifi Rad
No. 62, Dr. Qarib’s St, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 14194 33151 +98 21 6147 2090 lidasharifirad@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Defecation frequency of less than 3 times per week Age of 4 years or older Abnormal stool form Confirmed constipation according to the Rome IV criteria 4 years no limit Both Neuropathic bowel dysfunction ; Inflammatory disease Metabolic disease K59.0 Constipation Rehabilitation Intervention group:For both groups 10 sessions treatment program, twice a week were performed. Group 1 = Inferential electrical stimulation ( on the abdomen for 20 minutes). A frequency of 5–25 Hz for duration of 250 μs, and a repeat time of 6 s with adjustable amplitude (0–50 mA). Two electrodes, one from each channel, were placed on the skin of anterior abdominal wall bellow the costal margin bilaterally and two other electrodes from each channel were crossly placed on the back between T12 and L4 on either sides of the patients. Group 2 = Functional electrical stimulation ( beside of anus for 20 minutes ).A frequency of 40 Hz, duration of 250 μs, hold and rest time of 3 seconds with adjustable amplitude (range 0-100 mA) Defecation frequency per week. Timepoint: Before treatment, at the end of treatment sessions and 6 months later. Method of measurement: Bowel diary. Fecal soiling episodes. Timepoint: Before treatment, at the end of treatment sessions and 6 months later. Method of measurement: Bowel diary. Tehran University of Medical Sciences Approved 2022-04-21 Ethical Committe of Children's Medical Center No. 62, Dr. Qarib St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)