Effects of interferential electrical stimulation and functional pelvic floor muscle exercises on functional constipation and painful defecation in children
Objectives: To evaluate the effects of interferential electrical stimulation and pelvic floor muscle exercises on functional constipation and painful defecation in children
Design: A double blind clinical trial study.
Setting and conduct: Ninety children with functional constipation were enrolled in the study and were randomly divided into two treatment groups.
Participants including major eligibility criteria: Inclusion criteria including: age more than 4 years old, abnormal stool form and defecation frequency less than 3 times per week. Exclusion criteria including: neuropathic bowel dysfunction, inflammatory and metabolic disease.
Intervention: Case group (n=45 children) underwent transabdominal interferential electrical stimulation, behavioral therapy and pelvic floor muscle exercises for 10 sessions, 2 times per week. Control group (n=45 children) underwent sham transabdominal electrical stimulation, behavioral therapy and pelvic floor muscle exercises for 10 sessions, 2 times per week. All patients were evaluated by a complete bowel diary with data on the frequency of defecation per week, stool form and the number of fecal soiling episodes, a constipation score and a visual pain score before, after treatment and 6 months later. Then outcomes were compared between two groups.
Main outcome measures (variables): Primary outcome is an increase in defecation frequency of 2 times per week more than baseline. Secondary outcomes are presence or absence of fecal soiling, stool form and pain score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030617876N2
Registration date:2017-04-07, 1396/01/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-07, 1396/01/18
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
Tehran University of Medical Sciences
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of interferential electrical stimulation and functional pelvic floor muscle exercises on functional constipation and painful defecation in children
Public title
Effects of interferential electrical stimulation and pelvic floor muscle exercises on functional constipation in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 4 years old; abnormal stool form; painful defecation; defecation frequency less than 3 times per week
Exclusion criteria: Neuropathic bowel dysfunction; inflammatory disease; metabolic disease
Age
From 4 years old to 12 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Qhods St, Keshavarz Bolv.
City
Tehran
Postal code
Approval date
2016-11-27, 1395/09/07
Ethics committee reference number
IR.TUMS.REC.1395.2889
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
At the end of treatment sessions and 6 months later
Method of measurement
Filling out bowel habit diary by parents
Secondary outcomes
1
Description
Fecal soiling episods
Timepoint
At the end of treatment sessions and 6 months later
Method of measurement
Bowel habit diary
2
Description
Stool form
Timepoint
At the end of treatment sessions and 6 months later
Method of measurement
Bristol Stool Form
3
Description
Pain
Timepoint
At the end of treatment sessions and 6 months later
Method of measurement
A visual pain score
Intervention groups
1
Description
Children in case group underwent 10 therapeutic sessions , 2 times per week.In each session, patients underwent functional pelvic floor muscle exercises, toilet training and IF electrical stimulation. IF therapy was applied for 20 minutes, frequency of 5–25 Hz for a duration of 250 μs, and a repeat time of 6 s with adjustable amplitude (0–50 mA). .Two rectangular (2.5×3.5 cm) 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.The current from each channel crossed inside the abdomen. The intensity was increased until the patient declared a strong but comfortable level of sensory awareness with no muscle contractions. Maximum current intensity was below the pain threshold and was tolerated well by the patients.
Category
Rehabilitation
2
Description
Children in control group underwent 10 therapeutic sessions , 2 times per week.In each session, patients underwent functional pelvic floor muscle exercises, toilet training and sham IF electrical stimulation. Sham IF therapy was applied for 20 minutes .Two rectangular (2.5×3.5 cm) 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. The intensity was not increased.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Physical Therapy, Children Hospital Medical Center
Full name of responsible person
Lida Sharifi Rad
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Tehran University of Medical Sciences
Full name of responsible person
Dr. Younesian
Street address
6th floor, Central of Organization, Ghods St, Keshavarz Bolv.
City
Tehran
Grant name
Grant code / Reference number
30373
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
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/Head of Physical Therapy Department
Other areas of specialty/work
Street address
Children's Hospital Medical Center, No. 62, Dr. Qarib’s St, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6147 2090
Fax
Email
l-sharifirad@farabi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hossein Alimadadi
Position
Pediatric gastroentrologist
Other areas of specialty/work
Street address
Children's Hospital Medical Center, No. 62, Dr. Qarib’s St, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6147 2090
Fax
Email
Hoseinalimadadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Lida Sharifi Rad
Position
Physiotherapist/Head of Physical Therapy Department
Other areas of specialty/work
Street address
Children's Hospital Medical Center, No. 62, Dr. Qarib’s St, Keshavarz Blvd
City
Tehran
Postal code
Phone
00
Fax
Email
l-sharifirad@farabi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)