Comparing the effect of exercise Therapy with Biofeedback & exercise Therapy with placebo feedback on signs & symptoms of patients with dyssynergic defecation
Background: Biofeedback therapy is a selective treatment for anorectal dyssynergia. However, may be this kind of treatment such as others, has placebo effect. The aim of this study is a comparison between biofeedback therapy and placebo feedback dyssynergic defecation.
Method: 30 patients were selected on the basis of ROMEIII inclusion criteria and were randomly placed in two groups to receive biofeedback & placebo feedback therapies. Then, comparing the ability to defecate the balloon (volume & time) before and after the treatment. Also, chief complain evaluated before and after both treatment
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503016083N5
Registration date:2015-07-24, 1394/05/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Abbas Ali Pourmomeny
Name of organization / entity
School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2024
Email address
pourmomeny@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of exercise Therapy with Biofeedback & exercise Therapy with placebo feedback on signs & symptoms of patients with dyssynergic defecation
Public title
Efficacy biofeedback therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion:all patients with anorectal dyssynergia.
Exclusion criteria: mega colon; irritable colon syndrome;
slow transit colon.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Isfahan University of Medical Scineses
Street address
Department of Vice chancellor for research Isfahan University, Hazar garib Ave, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
392531 /16/5/1392
Health conditions studied
1
Description of health condition studied
Anorectal dyssynergia
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
ROMEIII
Timepoint
before & after treatment
Method of measurement
Qustionnaire
2
Description
Ballon Volume (water)
Timepoint
before & after
Method of measurement
mililiter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:
Biofeedback therapy
Category
Rehabilitation
2
Description
Intervention group 2: placebo biofeedback
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firozgar Haspital
Full name of responsible person
Ali Reza Pakghlab
Street address
Department physiotherapy, Ferozgar Haspital, Feroz Ave.
City
Teharn
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Payman Adibi
Street address
ISfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan 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 physical therapy, School of Rehabilitation Sciences, Isfahan University of Medical Sci
Full name of responsible person
Abbas Ali Pourmomeny
Position
PhD
Other areas of specialty/work
Street address
ISfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2024
Fax
Email
pourmomeny@rehab.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Abbas Ali Pourmomeny
Position
PhD
Other areas of specialty/work
Street address
Department of physical therapy, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
Phone
Fax
Email
pourmomeny@rehab.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Abbas Ali Pourmomeny
Position
PhD
Other areas of specialty/work
Street address
Department of physical therapy, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)