Protocol summary

Summary
The purpose of this study is to find the effect of lumbar support belts, on the thickness of transverse abdominis, internal oblique and external oblique. The target population that will be studied consists of sixty volunteer healthy men. Some of the inclusion criteria are: age between 18 to 55 years; having no history of low back pain before the study; having no history of systemic and local diseases that might affect the abdominal muscles. Also some of the exclusion criteria are: 1) beginning regular abdominal resistance training during the study; not wearing the belt for 24 hours or more. Subjects will be randomly recruited in two groups: a group that will wear the lumbar support belt (intervention) and a group that will not wear the belt (control). At the beginning of the study and after 4 and 8 weeks of the intervention all subjects will be evaluated to measure their lateral abdominal muscles thicknesses in rest and drawing-in maneuver by ultrasound.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107314231N2
Registration date: 2011-08-28, 1390/06/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-08-28, 1390/06/06
Registrant information
Name
Pardis Noormohamadpour
Name of organization / entity
Sport Medicine Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 0227
Email address
normohamadpour@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services - Vice chancellor for research
Expected recruitment start date
2011-08-01, 1390/05/10
Expected recruitment end date
2011-10-01, 1390/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of changes due to application of lumbar support belts in thickness of lateral abdominal muscles measured by ultrasound in healthy subjects: a single blinded randomized controlled trial
Public title
Effect of lumbar support belts on the lateral abdominal muscle thickness
Purpose
Other
Inclusion/Exclusion criteria
inclusion criteria : age between 18 to 55 year; having no history of low back pain before the study; having no history of systemic and local diseases that might affect the multifidus and abdominal muscles like systemic scleroderma, muscular dystrophy, abdominal wall hernia and open abdominal or lumbar surgery. Exclusion criteria: beginning regular abdominal resistance training during the study; not wearing the belt for 24 hours or more; employing medication or methods that could affect the abdominal muscles such as abdominal vibrators, massage ; skin wound or problems in the ultrasound area.
Age
From 18 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Tehran University of Medical Sciences and Health Services - Ethics committee
Street address
Faculty of Medicine, Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2008-12-14, 1387/09/24
Ethics committee reference number
87-04-53-8181

Health conditions studied

1

Description of health condition studied
Diseases of the musculoskeletal system and connective tissue
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
lateral Abdominal muscles thicknesses (transverse abdominis, internal oblique, and external oblique thickness)
Timepoint
Before the intervention, 4 week after & 8 week after
Method of measurement
ultrasound

Secondary outcomes

empty

Intervention groups

1

Description
Control: They will not use the belt
Category
N/A

2

Description
Intervention: using lumbar support belts during the day except when sleeping, for 8 weeks.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Ramin Kordi
Street address
No. 7, Opposite Shariati Hospital Clinic, After the overpass Nasr, Crossing Jalal Al Ahmad
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services - Vice chancellor for research
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Faculty of Medicine, Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
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 and Health Services - Vice chancellor for research
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
Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Ramin Kordi
Position
Assistant Professor of Tehran University of Medical Sciences and Health Services
Other areas of specialty/work
Street address
No. 7, Opposite Shariati Hospital Clinic, After the overpass Nasr, Crossing Jalal Al Ahmad
City
Tehran
Postal code
14395578
Phone
+98 21 8863 0227
Fax
+98 21 8800 3539
Email
ramin_kordi@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Pardis Noormohammadpour
Position
Resident of sports and exercise medicine, Sport Medicine Research Center, Tehran University of Medic
Other areas of specialty/work
Street address
No. 7, Opposite Shariati Hospital Clinic, After the overpass Nasr, Crossing Jalal Al Ahmad
City
Tehran
Postal code
14395578
Phone
+98 21 8863 0227
Fax
+98 21 8800 3539
Email
normohamadpour@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services - Sport Medicine Research Center
Full name of responsible person
Dr. Mohsen Rostami
Position
Medical Student & Research Fellow, Tehran University of Medical Sciences and Health Services
Other areas of specialty/work
Street address
No. 7, Opposite Shariati Hospital Clinic, After the overpass Nasr, Crossing Jalal Al Ahmad
City
Tehran
Postal code
14395578
Phone
+98 21 8863 0227
Fax
+98 21 8800 3539
Email
rostami.moh@gmail.com
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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