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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Primary outcomes
#1
total score of SF36 questionnaire
Scores of 8 scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and physical and mental component summary of SF36
total scoreScores of 8 scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and physical and mental component summary of SF36 questionnaire
نمره پرسش نامه SF36
نمره مقیاس های هشت گانه (عملکرد جسمی، مشکلات جسمی، درد جسمی، سلامت عمومی، نشاط، عملکرد اجتماعی، مشکلات روحی، سلامت روان) و دو خلاصه مؤلفه جسمی و روانی در پرسش نامه کیفیت زندگی S36
نمره مقیاس های هشت گانه (عملکرد جسمی، مشکلات جسمی، درد جسمی، سلامت عمومی، نشاط، عملکرد اجتماعی، مشکلات روحی، سلامت روان) و دو خلاصه مؤلفه جسمی و روانی در پرسش نامه SF36کیفیت زندگی S36
before and after of intervention
Before and after of intervention
beforeBefore and after of intervention
#2
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Score of total and 4 scales (physical discomfort, psychosocial discomfort, worries and discomfort and treatment satisfaction) of Patient Assessment Constipation Quality Of Life (PAC-QOL) questionnaire
Score of total and 4 scales (physical discomfort, psychosocial discomfort, worries and discomfort and treatment satisfaction) of Patient Assessment Constipation Quality Of Life (PAC-QOL) questionnaire
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نمره کل و نمره اجزای چهارگانه (ناراحتی جسمی، ناراحتی روانی، نگرانی و ناراحتی و رضایت از درمان) پرسش نامه اختصاصی کیفیت زندگی برای بیماران مبتلا به یبوست
نمره کل و نمره اجزای چهارگانه (ناراحتی جسمی، ناراحتی روانی، نگرانی و ناراحتی و رضایت از درمان) پرسش نامه اختصاصی کیفیت زندگی برای بیماران مبتلا به یبوست
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Before and after of intervention
Before and after of intervention
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قبل و بعد از مداخله
قبل و بعد از مداخله
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PAC-QOL questionnaire
PAC-QOL questionnaire
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پرسش نامه اختصاصی کیفیت زندگی برای بیماران مبتلا به یبوست
پرسش نامه اختصاصی کیفیت زندگی برای بیماران مبتلا به یبوست
Recruitment centers
#1
Name of recruitment center - English: Physical Medicine and Rehabilitation department of Firoozgar Hospital
Name of recruitment center - Persian: بخش طب فیزیکی و توانبخشی بیمارستان فیروزگر
Full name of responsible person - English: Fatemeh Majidirad
Full name of responsible person - Persian: فاطمه مجیدی راد
Street address - English: Behafarin Street, Karimlhane zand Street, Valiasr square
Street address - Persian: میدان ولیعصر، خیابان کریمخان زند، خیابان به آفرین
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593747811
Phone: +98 21 8214 1000
Fax:
Email: fa.majidirad@gmail.com
Web page address:
Name of recruitment center - English: Physical Medicine and Rehabilitation department of Firoozgar Hospital Name of recruitment center - Persian: بخش طب فیزیکی و توانبخشی بیمارستان فیروزگر Full name of responsible person - English: Fatemeh Majidirad Full name of responsible person - Persian: فاطمه مجیدی راد Street address - English: Behafarin Street, Karimlhane zand Street, Valiasr square Street address - Persian: میدان ولیعصر، خیابان کریمخان زند، خیابان به آفرین City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1593747811 Phone: +98 21 8214 1000 Fax: Email: fa.majidirad@gmail.com Web page address:
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:2021-01-08, 1399/10/19
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
Scores of 8 scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and physical and mental component summary of SF36
Timepoint
Before and after of intervention
Method of measurement
SF36 questionnaire
10
Description
Score of total and 4 scales (physical discomfort, psychosocial discomfort, worries and discomfort and treatment satisfaction) of Patient Assessment Constipation Quality Of Life (PAC-QOL) questionnaire
Timepoint
Before and after of intervention
Method of measurement
PAC-QOL 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
2
Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitation department of Firoozgar Hospital