Investigating the effects of tecar therapy with biofeedback in comparison with biofeedback alone on the treatment of fecal incontinence in children (4-16 years): a randomized clinical trial
In this randomized clinical trial, the effects of tecar therapy with biofeedback in comparison with biofeedback alone on the treatment of fecal incontinence in children (4-16 years) will be investigated.
Design
Clinical trial in phase 2 on 56 volunteers with control and intervention groups with parallel groups, single-blind, randomization by random block method with block sizes of 6 and 9 and with allocation ratio of 1:1
Settings and conduct
This study will be done in the physiotherapy clinic of Mashhad medical university. Participants will complete pediatrics constipation and incontinence questionnaire and quality of life questionnaires and the number of bowel incontinence per week. Then the patients will be randomized into two intervention and control groups. The control group receive , two biofeedback sessions a week for 6 weeks , and the intervention group receive , two biofeedback and tecar therapy sessions a week for 6 weeks. This study will have a 6-week follow-up.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children age range from 4 to 16 years fecal incontinence for 6 months according to the diagnosis of the referring specialist doctor
Exclusion criteria: children under 4 years of age over 16 years of age traumatic sphincter injury with/or following surgery anorectal and anatomical abnormalities of the excretory system with/or digestive system and sexual disorders psychological and psychiatric disorders comprehension problems and children who are unable to cooperate with a physiotherapist for any reason Spine with/or nerve diseases that lead to fecal incontinence patients with sensory disorders in the anus and perineum
Intervention groups
Control group: biofeedback therapy alone
Intervention group: biofeedback with tecar therapy.
Main outcome variables
The number of bowel incontinence per week
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140811018760N9
Registration date:2023-06-15, 1402/03/25
Registration timing:prospective
Last update:2023-06-15, 1402/03/25
Update count:1
Registration date
2023-06-15, 1402/03/25
Registrant information
Name
Fariba Ghaderi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 4647
Email address
ghaderif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-05, 1402/04/14
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of tecar therapy with biofeedback in comparison with biofeedback alone on the treatment of fecal incontinence in children (4-16 years): a randomized clinical trial
Public title
The effects of tecar therapy with biofeedback on the treatment of fecal incontinence in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of children is 4 to 16 years
Fecal incontinence for 6 months according to the diagnosis of the referring specialist
Exclusion criteria:
Children under 4 years old and over 16 years old
Traumatic sphincter injury or following surgery
Anorectal and anatomical abnormality of the excretory system or digestive system and sexual disorders
Psychological and psychiatric disorders
Understanding problems and children who are not able to cooperate with the physiotherapist for any reason.
Diseases of the spine or nerves that lead to fecal incontinence
Patients with sensory disorders in the anus and perineum
Age
From 4 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by random block method with block sizes of 6 and 9 and will be assigned to two groups with 1:1 allocation ratio.
Blinding (investigator's opinion)
Single blinded
Blinding description
To hide the allocation of the type of intervention received, it will be written on a piece of paper and placed inside sealed envelopes, consecutively numbered. The envelopes will be opened in the order in which the participants enter the study and the type of group of people will be determined.
Due to the nature of the treatment, it is not possible to blind the patient and the researcher, so only the evaluator will be blind to the grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah Ave, Tabriz University of Medical Sciences, Rehabilitation Faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5167654455
Approval date
2023-05-28, 1402/03/07
Ethics committee reference number
IR.TBZMED.REC.1402.195
Health conditions studied
1
Description of health condition studied
Children fecal incontinence
ICD-10 code
F98.1
ICD-10 code description
Fecal incontinence
Primary outcomes
1
Description
The number of bowel incontinence per week
Timepoint
6 weeks of treatment period, 6 weeks of follow-up
Method of measurement
Report of the patient or the child's parents
2
Description
Severity of fecal incontinence
Timepoint
6 weeks of treatment period, 6 weeks of follow-up
Method of measurement
Rintala questionnaire
3
Description
Quality of Life
Timepoint
6 weeks of treatment period, 6 weeks of follow-up
Method of measurement
Pediatrics Quality of life questionnaire for fecal incontinent
4
Description
Severity of constipation
Timepoint
6 weeks of treatment period, 6 weeks of follow-up
Method of measurement
Pediatrics constipation questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: biofeedback along with thecar therapy
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic, Comprehensive Rehabilitation Center, Faculty of Paramedical Sciences and Rehab
Full name of responsible person
Fariba Ghaderi
Street address
Daneshgah Ave, Tabriz University of Medical Sciences, Rehabilitation Faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5167654455
Phone
+98 912 565 4971
Email
ghaderimailbox@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Street address
Daneshgah Ave, Tabriz University of Medical Sciences, Rehabilitation Faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5167654455
Phone
+98 912 565 4971
Email
ghaderimailbox@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor, PhD of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences ,Rehabilitation faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 413339771
Fax
Email
ghaderimailbox@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor, PhD of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences ,Rehabilitation faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5167654455
Phone
+98 413339771
Fax
Email
ghaderimailbox@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor, PhD of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences ,Rehabilitation faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5167654455
Phone
+98 413339771
Fax
Email
ghaderimailbox@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available