Protocol summary

Study aim
The Effect of Core Stability Exercises on Lumbopelvic Motor Control and Dynamic Balance in Women with Non-specific Chronic Low Back Pain and Follow up one Month After Stopping Training
Design
24 Women with Non-specific Chronic Low Back Pain Randomly Divided into Experimental and Control Groups. The simple Randomization Method was used to Assign Individuals to two Groups that in this Method, Flip the coin was used to Create a Random Sequence.
Settings and conduct
The present study is a quasi-experimental research with a pre-test-post-test design and Follow up with an experimental group and a control group. 24 Women with Non-specific Chronic Low Back Pain Randomly Divided into Experimental and Control Groups. Lumbopelvic Motor Control, Dynamic Balance, Pain and Disability are measured before and after Core stability exercises in Shafa Clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non-specific Chronic Low Back Pain, Age range 30 to 50 years, Ostwestry Disability Index equal to or greater than 15, Female gender Exclusion criteria: Vestibular Disorders, Perform Lumbopelvic Surgery
Intervention groups
The Intervention Group Includes Women with Non-specific Chronic Low Back Pain who Receive Core Stability Training. The Control Group Includes Women with Non-specific Chronic Low Back Pain who did not Receive any Intervention.
Main outcome variables
Lumbopelvic Motor Control, Dynamic Balance, Pain and Disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200107046035N5
Registration date: 2020-12-02, 1399/09/12
Registration timing: registered_while_recruiting

Last update: 2020-12-02, 1399/09/12
Update count: 0
Registration date
2020-12-02, 1399/09/12
Registrant information
Name
Hossein Shahrokhi
Name of organization / entity
Hakim Sabzevari University
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 2756
Email address
h.shahrokhi@hsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Core Stability Exercises on Lumbopelvic Motor Control, Dynamic Balance, Pain and Disability in Women with Non-specific Chronic Low Back Pain and Follow up one Month After Stopping Training
Public title
The Effect of Exercises in Women with Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-specific Chronic Low Back Pain Age range 30 to 50 years Ostwestry Disability Index equal to or greater than 15 Female gender
Exclusion criteria:
Vestibular Disorders Perform Lumbopelvic Surgery
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
The simple Randomization Method was used to Assign Individuals to two Groups that in this Method It was done by Flip the coin method. This method is usually used to create a random sequence in two-group experiments in such a way that one of the study groups considers the A and the other group the B and based on the sample size, coins were tossed and Individuals are assigned to two random groups. Then, in Order not to Determine Which Group the Individuals will be Assigned to before Dividing them into two Groups, or in other words, Allocation Concealment, the Sequentially numbered, sealed opaque envelopes was used. This method is one of the common methods in concealing random allocation, which is abbreviated to SNOSE method. In this method, after a random sequence, a number of envelopes are prepared and each of the random sequences created is recorded on a card and the cards are placed in the envelopes respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed.
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
Sport Sciences Research Institute
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2020-09-16, 1399/06/26
Ethics committee reference number
IR.SSRC.REC.1399.076

Health conditions studied

1

Description of health condition studied
Non-specific Chronic Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low Back Pain

Primary outcomes

1

Description
Lumbopelvic Motor Control
Timepoint
At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention and One Month After Stopping Training
Method of measurement
five tests (the bent knee fall out test, the knee lift abdominal test, the sitting knee extension test, the waiter bow and the transversus abdominis test)

2

Description
Dynamic Balance
Timepoint
At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention and One Month After Stopping Training
Method of measurement
Biodex Balance System

3

Description
Pain
Timepoint
At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention and One Month After Stopping Training
Method of measurement
Visual Analogue Scale

4

Description
Disability
Timepoint
At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention and One Month After Stopping Training
Method of measurement
Ostwestry Disability Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Core Stability Training that Strengthens the Stabilizer muscles of body center for 6 weeks, 3 Sessions per Week, 2 Hour per Session. Core stability exercises are specific exercises that stabilize the spine, which retrains the deep sense of the pelvic lumbar region in different positions (arch, back, squat) and also adds dynamic components to it (movement of limbs, use of Swiss ball) in the next steps. Is. The Core stability exercises suggested by Jeffrey include five levels. Exercises start from level one, which includes static contractions in a fixed position, level two exercises, including holding static contractions and slow movements in a stable environment, level three, including holding static contractions in an unstable environment, and dynamic movements in a fixed environment. Level four includes dynamic movements in an unstable environment, and finally level five exercises include dynamic and resistance movements in an unstable environment. In these exercises, Swiss balls are used.
Category
Treatment - Other

2

Description
Control group: Without any Training and Treatment that just Doing Normal Daily Activities
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Clinic
Full name of responsible person
Zahra Nabizadeh
Street address
Mahmoudabad, Masjedjame Ave
City
Mahmoudabad
Province
Mazandaran
Postal code
3411355721
Phone
+98 11 4474 5487
Email
saqar.sogand@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shafagh University
Full name of responsible person
Mohammad Fallahmohamadi
Street address
20th Mordab Ave
City
Nashtarood
Province
Mazandaran
Postal code
4683165363
Phone
+98 11 5426 6957
Email
info@shafagh.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shafagh University
Proportion provided by this source
20
Public or private sector
Private
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
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Injuries & Corrective Exercise
Street address
Tohid Shahr, Sabzevar, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2756
Fax
Email
h.shahrokhi@hsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Injuries & Corrective Exercise
Street address
Tohid Shahr, Sabzevar, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2756
Fax
Email
h.shahrokhi@hsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Injuries & Corrective Exercise
Street address
Tohid Shahr, Sabzevar, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2756
Fax
Email
h.shahrokhi@hsu.ac.ir

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: h.shahrokhi@hsu.ac.ir
What processes are involved for a request to access data/document
by Email: h.shahrokhi@hsu.ac.ir and the reason for using the documents
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