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To compare the effects of neuromodulation (transcutaneous tibial nerve stimulation(TTNS)) with manometric biofeedback on physiological and clinical factors in female with functional constipation

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History
# Registration date Revision Id
3 2021-01-07, 1399/10/18 166520
2 2020-05-09, 1399/02/20 145629
1 2018-04-22, 1397/02/02 43216
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  • General information

    2017-09-23, 1396/07/01
    2018-05-07, 1397/02/17
    2019-09-24, 1398/07/02
    2020-03-10, 1398/12/20
    empty
    our research was register in the old version of IRCT, therefore for updating the information, we prefer to do in the new version
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    ما مطالعه خود را در ورژن قبلی IRCT ثبت کرده بودیم. بنابراین برای به روز رسانی اطلاعات مطالعه ، ترجیح دادیم آن را در ورژن جدید نیز ثبت کنیم.
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  • Recruitment centers

    #1
    Name of recruitment center - English: digestive disease Research Institute(DDRI)
    Name of recruitment center - Persian: پژوهشکده بیمارهای گوارش و کبد
    Full name of responsible person - English: Fatemeh Majidirad
    Full name of responsible person - Persian: فاطمه مجیدی راد
    Street address - English: Shariati hospital, North kargar
    Street address - Persian: کارگر شمالی، بیمارستان شریعتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411713135
    Phone:
    Fax:
    Email: fa.majidirad@gmail.com
    Web page address:
    Name of recruitment center - English: digestive disease Research Institute(DDRI)
    Name of recruitment center - Persian: پژوهشکده بیمارهای گوارش و کبد
    Full name of responsible person - English: Fatemeh Majidirad
    Full name of responsible person - Persian: فاطمه مجیدی راد
    Street address - English: Shariati hospital, North kargar
    Street address - Persian: کارگر شمالی، بیمارستان شریعتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411713135
    Phone: +98 21 8490 2122
    Fax:
    Email: fa.majidirad@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: amir ali sohrab pour
    Full name of responsible person - Persian: دکتر امیر علی سهراب پور
    Street address - English: 7th floor, main building, keshavarz Blvd.
    Street address - Persian: تهران، بلوار کشاورز- ستاد مرکزی - طبقه 7
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 6649 2271
    Fax:
    Email: tums_edu@tums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amir Ali Sohrab Pour
    Full name of responsible person - Persian: دکتر امیر علی سهراب پور
    Street address - English: 7th floor, main building, keshavarz Blvd.
    Street address - Persian: تهران، بلوار کشاورز- ستاد مرکزی - طبقه 7
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 6649 2271
    Fax:
    Email: tums_edu@tums.ac.ir
    Web page address:

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Rehabilitation Faculty, Tehran University of Medical Scienses
    Name of organization / entity - Persian: دانشکده توانبخشی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Fatemeh Majidirad
    Full name of responsible person - Persian: فاطمه مجیدی راد
    Position - English: PhD candidate
    Position - Persian: دانشجوی دکتری تخصصی فیزیوتراپی
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rehabilitation Faculty, Enghelab street
    Street address - Persian: خ انقلاب ، دانشکده توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1148965111
    Phone: 00
    Mobile: +91 27977167
    Fax:
    Email: fa.majidirad@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Rehabilitation Faculty, Tehran University of Medical Scienses
    Name of organization / entity - Persian: دانشکده توانبخشی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Fatemeh Majidirad
    Full name of responsible person - Persian: فاطمه مجیدی راد
    Position - English: PhD candidate
    Position - Persian: دانشجوی دکتری تخصصی فیزیوتراپی
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rehabilitation Faculty, Enghelab street
    Street address - Persian: خ انقلاب ، دانشکده توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1148965111
    Phone: +98 21 7753 6586
    Mobile: +98 912 797 7167
    Fax:
    Email: fa.majidirad@gmail.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Mohammad Reza Hadian
    Full name of responsible person - Persian: دکتر محمدرضا هادیان
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rehabilitation Faculty, Enghelab Ave
    Street address - Persian: خ انقلاب، دانشکده توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 65111-11489
    Phone: +98 21 7753 3939
    Mobile: +98 910 929 4639
    Fax:
    Email: hadianrs@sina.tums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Mohammad Reza Hadian
    Full name of responsible person - Persian: دکتر محمدرضا هادیان
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rehabilitation Faculty, Enghelab Ave
    Street address - Persian: خ انقلاب، دانشکده توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 65111-11489
    Phone: +98 21 7753 3939
    Mobile: +98 910 134 5368
    Fax:
    Email: hadianrs@sina.tums.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Rehabilitation Faculty of Tehran University of Medical Sciense
    Name of organization / entity - Persian: دانشکده توانبخشی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr. Mohammad Reza Hadian
    Full name of responsible person - Persian: دکتر محمد رضا هادیان
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rehabilitation Faculty, Enghelab Ave
    Street address - Persian: خ انقلاب دانشکده توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 65111-11489
    Phone: +98 21 7753 3939
    Mobile: +98 910 929 4639
    Fax:
    Email: hadianrs@sina.tums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Rehabilitation Faculty of Tehran University of Medical Sciense
    Name of organization / entity - Persian: دانشکده توانبخشی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr. Mohammad Reza Hadian
    Full name of responsible person - Persian: دکتر محمد رضا هادیان
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rehabilitation Faculty, Enghelab Ave
    Street address - Persian: خ انقلاب دانشکده توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 65111-11489
    Phone: +98 21 7753 3939
    Mobile: +98 910 134 5368
    Fax:
    Email: hadianrs@sina.tums.ac.ir
    Web page address:

  • Sharing plan

    empty
    There is no further information
    empty
    اطلاعات بیشتری وجود ندارد

Protocol summary

Study aim
To compare the effects of neuromodulation (transcutaneous tibial nerve stimulation(TTNS)) with manometric biofeedback on physiologial and clinical factors in female with functional constipation
Design
This will be a clinical trial including two interventional groups.Thereafter, the results will be compared in the groups. Based on previous studies, the sample size will be 15 patients per group (total 30). Patients will randomly be allocated in either biofeedback or TTNS
Settings and conduct
This study will be performed at the Shariati Hospital's Digestive Disease Research Institute and patients will receive consent form when they will be screened and examined by a gastroenterologist if they meet the inclusion criteria.
Participants/Inclusion and exclusion criteria
Female with functional constipation aged between 25 – 60 years, Definition of constipation based on Rome III criteria, No history of previous large-bowel surgery or cancer, Pregnant patient exclude from study
Intervention groups
In this study patients with functional constipation are examined by colorectal specialist, then Para clinical tests including: anorectal manometry,BET and CTT study, are performed for them. Baseline evaluation include patient completion of the SF36 QOL and the Wexner questionnaire, food and stool diary for three weeks. Nutritional advices, proper defecation technique, diaphragmatic breathing technique, physical activity and massage are trained for three weeks also. After one month, based on inclusion criteria, they will randomly assign to biofeedback or TTNS group. Intervention in the biofeedback group will be given for 5 sessions once a week, and in the TTNS group, 12 sessions, three times a week
Main outcome variables
Wexner and SF36 QOL questionnaire Score; Physiological parameter based on Anorectal manometry; Time of balloon expulsion test

General information

Reason for update
our research was register in the old version of IRCT, therefore for updating the information, we prefer to do in the new version
Acronym
IRCT registration information
IRCT registration number: IRCT20090301001722N18
Registration date: 2018-04-22, 1397/02/02
Registration timing: prospective

Last update: 2020-08-02, 1399/05/12
Update count: 2
Registration date
2018-04-22, 1397/02/02
Registrant information
Name
Samira Karimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
hadianrs@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for education
Expected recruitment start date
2018-05-07, 1397/02/17
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare the effects of neuromodulation (transcutaneous tibial nerve stimulation(TTNS)) with manometric biofeedback on physiological and clinical factors in female with functional constipation
Public title
Effects of transcutaneous nerve stimulation with biofeedback on physiological and clinical factors in female with constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female with functional constipation aged between 25 – 55 years Definition of constipation based on Rome III criteria
Exclusion criteria:
The patient withdrew cooperation Pregnant or wishing to become pregnant History of neurologic diseases such as multiple sclerosis, stroke, or spinal cord injury Metabolic disorder such as diabetes, hypothyroidism, hypercalcaemia History of Congenital anorectal malformations History of previous large-bowel surgery or cancer History of irritable bowel syndrome Take anticholinergic or other constipating medications Skin eruptions at the site of stimulation History of recent surgery to the lower limb Metal implant in the lower limb Abnormal rectal sensation Failure of Traditional treatment
Age
From 25 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization The name of each group is written on a separate paper and the patient randomly chooses the own intervention group
Blinding (investigator's opinion)
Not 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 Rehabilitation Faculty of Tehran University of Medical Sciense
Street address
Piche shemiran, Enghelab Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
6511111489
Approval date
2017-08-30, 1396/06/08
Ethics committee reference number
IR.TUMS.FNM.REC.1396.3299

Health conditions studied

1

Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation

Primary outcomes

1

Description
anal canal resting pressure
Timepoint
before and after of intervention
Method of measurement
anorectal manometry

2

Description
rectoanal inhibitory reflex
Timepoint
before and after of intervention
Method of measurement
anorectal manometry

3

Description
urge volume
Timepoint
before and after of intervention
Method of measurement
anorectal manometry

4

Description
max tolerable volume
Timepoint
before and after of intervention
Method of measurement
anorectal manometry

5

Description
max rectal pressure during sraining
Timepoint
before and after of intervention
Method of measurement
anorectal manometry

6

Description
balloon expulsion test
Timepoint
before and after of intervention
Method of measurement
stopwatch

7

Description
bowel movement
Timepoint
before and after of intervention
Method of measurement
wexner questionnaire

8

Description
total score of wexner questionnaire
Timepoint
before and after of intervention
Method of measurement
wexner questionnaire

9

Description
total score of SF36 questionnaire
Timepoint
before and after of intervention
Method of measurement
SF36 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
biofeedback intervention: 5 sessions once a week
Category
Rehabilitation

2

Description
Transcutaneous Tibial Nerve Stimulation intervention : 12 sessions, three times a week
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
digestive disease Research Institute(DDRI)
Full name of responsible person
Fatemeh Majidirad
Street address
Shariati hospital, North kargar
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2122
Email
fa.majidirad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Ali Sohrab Pour
Street address
7th floor, main building, keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Fax
Email
tums_edu@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
Rehabilitation Faculty, Tehran University of Medical Scienses
Full name of responsible person
Fatemeh Majidirad
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Enghelab street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 6586
Fax
Email
fa.majidirad@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Hadian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Fax
Email
hadianrs@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rehabilitation Faculty of Tehran University of Medical Sciense
Full name of responsible person
Dr. Mohammad Reza Hadian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Fax
Email
hadianrs@sina.tums.ac.ir
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
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