To compare efficacy of inferential and functional electrical stimulation on functional constipation in children
Design
Pragmatic, community based, parallel group, double blind, randomized controlled trial
Settings and conduct
Fifty 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. Group 1 (n=25) underwent PFM exercises plus IF electrical stimulation on abdomen while the group 2 (n=25) received PFM exercises plus functional electrical stimulation on beside of anus. 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. All patients underwent 10 sessions treatment program twice a week.
Participants/Inclusion and exclusion criteria
Defecation frequency of less than 3 times per week, passing of hard stool, episodes of fecal soiling, abnormal stool form , age of 4 years or more
Intervention groups
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).
Main outcome variables
An increase in defecation frequency of 2 times per week more than baseline
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140527017876N5
Registration date:2022-04-23, 1401/02/03
Registration timing:registered_while_recruiting
Last update:2022-04-23, 1401/02/03
Update count:0
Registration date
2022-04-23, 1401/02/03
Registrant information
Name
Lida Sharifi Rad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6147 2090
Email address
l-sharifirad@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of inferential electrical stimulation and functional electrical stimulation on functional constipation in children
Public title
Effect of electrical stimulation on constipation in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
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 (investigator's opinion)
Double blinded
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
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committe of Children's Medical Center
Street address
No. 62, Dr. Qarib St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194 33151
Approval date
2022-04-21, 1401/02/01
Ethics committee reference number
IR.TUMS.CHMC.REC.1401.012
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Defecation frequency per week
Timepoint
Before treatment, at the end of treatment sessions and 6 months later
Method of measurement
Bowel diary
Secondary outcomes
1
Description
Fecal soiling episodes
Timepoint
Before treatment, at the end of treatment sessions and 6 months later
Method of measurement
Bowel diary
Intervention groups
1
Description
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)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Lida Sharifi Rad
Street address
No. 62, Dr. Qarib St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 6147 2090
Email
lidasharifirad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Sixth floor, Ghods st, Vice Chancellor for Research of Tehran university of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419888701
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Lida Sharifi Rad
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 62, Dr. Qarib’s St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 6147 2090
Email
lidasharifirad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Lida Sharifi Rad
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 62, Dr. Qarib’s St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 6147 2090
Email
lidasharifirad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyedeh-Sanam Ladi-Seyedian
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No. 62, Dr. Qarib’s St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 6147 2090
Email
ladiseyedian.sanam@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Final report
When the data will become available and for how long
After publication
To whom data/document is available
Researchers
Under which criteria data/document could be used
For performance of other study
From where data/document is obtainable
Pediatric Gastroenterology and Hepatology Research Center
What processes are involved for a request to access data/document
A request form Institute to Pediatric Gastroenterology and Hepatology Research Center