Protocol summary

Study aim
Comparing between forward head position exercise and core stabilization exercise on balance, pain and degree of lordosis in women with nonspecific chronic low back pain
Design
The number of samples is 60 eligible subjects who are selected based on inclusion and exclusion criteria.The samples are divided into three training groups and one control group. The variables of lordosis, balance, and pain intensity are measured before and after exercise.
Settings and conduct
The present study is a quasi-experimental research with a pre-test-post-test design with 3 experimental group and a control group. The number of samples is 60 eligible subjects who are selected based on inclusion and exclusion criteria. The variables of lordosis, balance, and pain intensity are measured before and after exercise.
Participants/Inclusion and exclusion criteria
Non-Athletics women with non-specific chronic low back pain
Intervention groups
Core Exercise, Forward Head Exercise and Combination Exercise
Main outcome variables
Lordosis, Balance, Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200915048730N1
Registration date: 2021-01-16, 1399/10/27
Registration timing: retrospective

Last update: 2021-01-16, 1399/10/27
Update count: 0
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
Atefe Ghorbani
Name of organization / entity
The University of shahid beheshti
Country
Iran (Islamic Republic of)
Phone
+98 21 7727 7908
Email address
at.ghorbani@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing between forward head position exercise and core stabilization exercise on balance, pain and degree of lordosis in women with nonspecific chronic low back pain
Public title
Comparing different exercise on nonspecific chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normal BMI(18.5-24) Don't get any rehabilitation exercise in one years ago Don't have any seriously injury in spinal column(surgery ...) in 3 years ago Oswestry test score under 25 VAS score between 4-7 Low back lordosis degree more than 42 Neck lordosis degree more than 46 Low back pain more than 3 month without structural cause
Exclusion criteria:
Low backpain with structural cause (Hit, Accident, ...) Spinal disc herniation and having tumor in neck and low back VAS score more than 7 and less than 4 Low back lordosis degree less than 42 Neck lordosis degree less than 46 Get rehabilitation exercise
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The simple Randomization Method was used to Assign Individuals to two Groups that in this Method, Random Allocation Software was used to Create a Random Sequence. Then, for not Clearing that People Assigning to which Group before Allocated in other Words Allocation Concealment, was used as a Central Randomization Method.
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 shahid beheshti university
Street address
Shahid Beheshti University, Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
IR.SBU.REC.1399.049

Health conditions studied

1

Description of health condition studied
Nonspecific chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
Degree of low back lordosis
Timepoint
Before started project
Method of measurement
flexible ruler

Secondary outcomes

1

Description
balance
Timepoint
Before started project
Method of measurement
Biodex balance system

Intervention groups

1

Description
Intervention group: core stabilisation exercise
Category
Rehabilitation

2

Description
Intervention group: forward head position exercise
Category
Rehabilitation

3

Description
Intervention group: combination exercise (core and forward head)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Laboratory of physical education college in Shahid Beheshti University
Full name of responsible person
Sirous Sheikhi
Street address
Shahid Beheshti University, Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Email
at.ghorbani69@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid beheshti university
Full name of responsible person
Afshar jafari
Street address
Shahid Beheshti University, Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Email
at.ghorbani69@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid beheshti university
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid beheshti university
Full name of responsible person
Atefe Ghorbani
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Corrective exercise and sport injury
Street address
No.45, Bakhtiyari Ave., Ghadimi, narmak
City
Tehran
Province
Tehran
Postal code
1648675581
Phone
+98 21 7709 2973
Email
at.ghorbani69@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Atefe Ghorbani
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Corrective exercise and sport injury
Street address
No.45, Bakhtiyari Ave., Ghadimi, narmak
City
Tehran
Province
Tehran
Postal code
1648675581
Phone
+98 21 7709 2973
Email
at.ghorbani69@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid beheshti university
Full name of responsible person
Atefe Ghorbani
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Corrective exercise and sport injury
Street address
No.45, Bakhtiyari Ave., Ghadimi, narmak
City
Tehran
Province
Tehran
Postal code
1648675581
Phone
+98 21 7709 2973
Email
at.ghorbani69@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All Potential Data Can be Shared After People have not been Identified
When the data will become available and for how long
Start the Access Period one Year After Printing the Results
To whom data/document is available
Data will be Available to Academic and Scientific Researchers
Under which criteria data/document could be used
Any Kind of Functional Analysis on the Submitted Data is Allowed
From where data/document is obtainable
By Email
What processes are involved for a request to access data/document
By Email
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