Protocol summary

Summary
The objective of this clinical trial is the comparison of the effect of abdominal hollowing and bracing exercises on transverse abdominis thickness and static balance in recurrent nonspecific low back pain patients. In this study 45 recurrent nonspecific low back pain participants will be randomly assigned into three abdominal hollowing, abdominal bracing and control group (15 persons in each group). After 6 weeks training, both groups and participants in control group, will be assessed for static balance and transverese abdominis muscle thickness.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201206235112N5
Registration date: 2013-06-30, 1392/04/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-30, 1392/04/09
Registrant information
Name
Rozita Hedayati
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
hedayati@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Neuromuscular Rehabilitation Research Center,Semnan University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of abdominal hollowing and abdominal bracing exercises on transverse abdominis thickness and balance in recurrent nonspecific low back pain patients.
Public title
A comparison of two stabilizing exercises on transverse abdominis thickness and balance in low back pain patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of recurrent non specific low back pain; 18-40 years old; pain fewer than 3 according to VAS questionnaire Exclusion criteria: Presence of diabetes, musculoskeletal disorders, neuromuscular, cardiovascular, respiratory disorders; systemic disease; spondylolysis and spondylolystesis; previous surgery in the spinal region; no history of trauma to lumbar during a year previous the study; disk herniation; nerve root compression; polyneuropathy; carcinoma; malignancy of the spinal region; pregnancy; no history of lumbar region training during 12 months before the study; drugs using with side effects on the postural control system.
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
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
Semnan University of Medical Sciences
Street address
The 5th kilometers of Damghasn road- Semnal University of Medical Science
City
Semnan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
it is going to be evaluated in this comeetee

Health conditions studied

1

Description of health condition studied
Recurrent non-specific low back pain
ICD-10 code
M05, M06,
ICD-10 code description
Inflammatory polyarthropathies

Primary outcomes

1

Description
Transverse abdominis thickness
Timepoint
Beggining of the study and 6 weeks after the first session of intervention
Method of measurement
Sonography

2

Description
COP velocity and displacement
Timepoint
Beggining of the study and 6 weeks after the first session of intervention
Method of measurement
force plate

Secondary outcomes

empty

Intervention groups

1

Description
The abdominal hollowing group do ten repetitions of abdominal hollowing, three times a day for 6 weeks.
Category
Treatment - Other

2

Description
The abdominal bracing groups do ten repetitions of each exercise, tree times a day for 6 weeks.
Category
Treatment - Other

3

Description
The control group receives no intervention in and do not a specific activity other than routine during 6 weeks.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Dr Rozita Hedayati
Street address
Neuromuscular Rehabilitation Research Center, Mashahir Square, Semnan
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Raheb Ghorbani
Street address
Semnal Sniversity of Medical Sciences, The 5th kilometers of Damghasn road
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Rozita Hedayati
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, The 5th kilometers of Damghan road
City
Semnan
Postal code
Phone
+98 23 1333 3895
Fax
Email
rosehed@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Rozita Hedayati
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, The 5th Kilometer of Damghan road
City
Semnan
Postal code
Phone
+98 23 1333 3895
Fax
Email
rosehed@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Rozita Hedayati
Position
Ph.D of Physiotherapy/ Assisted Professor
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, The5th kilometers of Damghan road
City
Semnan
Postal code
Phone
00
Fax
Email
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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