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Evaluation of pelvic motion in patients with chronic constipation due to dyssynergic defecation after biofeedback therapy by MR defecography

Protocol summary

Summary
Objective- We want to compare the effects of Biofeedback Therapy, on pelvic floor motion indices ie., angle change and vertical motion and also Quality of Life and depression, with Standard Therapy in patients with dyssynergic defecation. Specifically we want to study whether MR defecography enable to show the differences between the dynamic indices of pelvic floor after biofeedback therapy, when compared with those received Standard Therapy. Methods- Twenty-two Patients, with chronic constipation who fulfilled Rome diagnostic criteria for functional constipation for at least 12 weeks, participated in this study, they had a dyssynergic pattern of defecation i.e., paradoxical contraction or failure to relax the pelvic floor and anal muscles during defecation. The subjects are randomly assigned to receive either standard only (11 subjects) or biofeedback and standard (11 subjects) treatment for three months. Dynamic changes of pelvic floor( anorectal angle and perineal descent ) at rest during squeezing and straining, are measured by MR defecography. Two MR defecography dynamic indices, including paradox index (abnormal anorectal angle change), and perineal descent index during simulated defecation, are measured before and after treatment. In order to assess the effects of biofeedback therapy in comparison with standard therapy on symptomatic changes, the quality of life and severity of depression ,a constipation scoring system according to Agachan Scoring System, the culturally adapted version of Short Form-36 and Beck Depression Inventory questionnaires are used respectively .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015011020011N1
Registration date: 2015-01-10, 1393/10/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-10, 1393/10/20
Registrant information
Name
Afsaneh Nikjooy
Name of organization / entity
Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
maroufi.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-01-10, 1393/10/20
Expected recruitment end date
2015-05-10, 1394/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of pelvic motion in patients with chronic constipation due to dyssynergic defecation after biofeedback therapy by MR defecography
Public title
Evaluation of patients with dyssynergic defecation after biofeedback therapy by MR defecography
Purpose
Treatment
Inclusion/Exclusion criteria
The Patients participate in this study, with chronic constipation who fulfill “ Rome diagnostic criteria” for functional constipation for at least 12 weeks: they need to strain in defecation, have lumpy or hard stools, sensation of incomplete evacuation, and need manual maneuvers to facilitate defecation in more than 1/4 of bowel movements. They have a dyssynergic pattern of defecation. The patients also have diagnostic testing evidence (anorectal manometry or defecography or balloon expulsion test) of dyssynergic defecation. The diagnosis of paradoxical contraction of puborectalis muscle during straining is established by digital rectal examination. Patients were excluded from the study if they had previous anorectal surgery, anorectal tumors, or structural anorectal disorders, which needed operation intervention. Other exclusion criteria were significant cardiovascular, respiratory, neurologic, psychiatric illnesses, sever psychological problems, or endocrine and metabolic diseases that could cause constipation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Keshavarz Blvd.; Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2013-05-16, 1392/02/26
Ethics committee reference number
130/284/د/92

Health conditions studied

1

Description of health condition studied
Chronic costipation and dyssynergic defecation
ICD-10 code
M62.9
ICD-10 code description
Disorder of muscle, unspecified

Primary outcomes

1

Description
muscle function((Paradox index & perinal descend index )
Timepoint
before treatment and after its completion (3 months)
Method of measurement
MR defecography

Secondary outcomes

1

Description
symptomatic changes
Timepoint
before tretment and after its completion
Method of measurement
costipation scoring questionnaire

2

Description
The quality of life
Timepoint
before tretment and after its completion
Method of measurement
the culturally adapted version of Short Form-36

3

Description
severity of depression
Timepoint
before tretment and after its completion
Method of measurement
, the culturally adapted version of Beck Depression Inventory questionnaires

Intervention groups

1

Description
For control group; standard therapy [The instructions regarding bowel habit, daily exercise (walking for 20 minutes), diaphragmatic breathing exercises (daily for 15 minutes, three times a day), dietary fiber and fluid intake, toilet timing (the patient was taught to attempt having a bowel movement at least twice a day, 30 minutes after meals or walking and consulted to avoid straining more than 5 minutes during defecation). If patients had no bowel movement for more than 48 hours, they were guided to use laxatives, such as polyethylene glycol. The patients were trained about the correct position of defecation. The duration is 3 months and the patients were supervised at least once a week over phone], cognitive-behavioral therapy (once a week).
Category
Rehabilitation

2

Description
For experimental group; biofeedback therapy(to correct the dyssynergic pattern of defecation, the patients should learn how to appropriately contract or relax anal and pelvic floor muscles, by visual and verbal feedback. A surface electrode on abdominal muscles and an interarectal pressure probe are used to monitor the activity of the muscles. Each biofeedback therapy session is performed 60 minutes twice a week for 12 sessions, then, once a week for 6 sessions, as a whole 18 sessions over 3 months.), exercise therapy ( three times a day for ten minute), cognitive-behavioral therapy (once a week) and standard therapy .
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Coloectal Clinic, Rasoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.
Full name of responsible person
MrS Azeizkhani
Street address
Satarkhan St.;Niyayesh St
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Sayed Ali Javad Moosavi
Street address
Hemat ;Pardis:Iran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Afsaneh Nikjooy
Position
Physiotherapy Clinical Instructor;Ph.D. Candidate
Other areas of specialty/work
Street address
Madadkaran; Shahnazari Av.; Madar Sq.; Tehran
City
Tehran
Postal code
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
afsanehnikjooy@yahoo.com; maroufi.n@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Afsaneh Nikjooy
Position
Physiotherapy Clinical Instructor;Ph.D. Candidate
Other areas of specialty/work
Street address
Madadkaran St.; Shahnazari Av.; Madar Sq.;Tehran
City
Tehran
Postal code
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
afsanehnikjooy@yahoo.com; maroufi.n@iums.ac.ir;
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Afsaneh nikjooy
Position
Physiotherapist; Clinical Instructor; Ph.D. Candidate
Other areas of specialty/work
Street address
Shahnazari St.;Madar Sq.;Mirdamad Blvd.;Tehran
City
Tehran
Postal code
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
afsanehnikjooy@yahoo.com; maroufi.n@iums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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