Investigating the effect of central stability exercises on lumbar-pelvic rhythm, lumbar lordosis, pain and balance in men with non-specific chronic back pain
Design
A clinical trial with two control and experimental randomized groups on 40 patients
Settings and conduct
The current study is semi-experimental, in the form of 2 experimental and control groups, pre-test - post-test. The statistical population of this research includes men suffering from non-specific chronic back pain referring to Aria Salamat massage and correction center located in Shahrekord, based on the doctor's diagnosis and the entry and exit criteria in a targeted and available manner, 40 people were selected randomly in 2 The experimental and control groups will be divided into 20 people
Participants/Inclusion and exclusion criteria
All male patients with non-specific chronic back pain in the age range of 30 to 55
Having moderate pain intensity based on VAS questionnaire
No surgery in the lumbopelvic region
Intervention groups
The current study is semi-experimental, in the form of 2 experimental and control groups, pre-test - post-test. The statistical population of this research includes men suffering from non-specific chronic back pain referring to Aria Salamat massage and correction center located in Shahrekord, based on the doctor's diagnosis and the entry and exit criteria in a targeted and available manner, 40 people were selected randomly in 2 The experimental and control groups will be divided into 20 people
Main outcome variables
Lumbar pelvic rhythm
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240210060953N1
Registration date:2024-03-09, 1402/12/19
Registration timing:registered_while_recruiting
Last update:2024-03-09, 1402/12/19
Update count:0
Registration date
2024-03-09, 1402/12/19
Registrant information
Name
Hamzeh Ayazi
Name of organization / entity
Shahrekord University
Country
Iran (Islamic Republic of)
Phone
+98 913 703 9411
Email address
hamzehayazi98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-17, 1402/11/28
Expected recruitment end date
2024-04-29, 1403/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of core stability exercises on lumbar-pelvic rhythm, lumbar lordosis, pain and balance in men with non-specific chronic low back pain
Public title
The effect of central stability exercises on back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All male patients with non-specific chronic back pain in the age range of 30 to 55
Having moderate pain intensity based on VAS questionnaire
No surgery in the lumbopelvic area
Exclusion criteria:
Consecutive absence meeting
Absence of more than 3 training sessions
Instability of the spine in the lumbar region (spondylolisthesis, degenerative changes of the lumbar joints, etc.)
The person's unwillingness to continue cooperation
Age
From 30 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
First, the names of 40 men with non-specific chronic back pain were written on a sheet as a statistical population, and to hide the names, they were folded and thrown into a bowl. 1 unrelated person was asked to choose 20 cards each and 20 cards remained in the bowl. Twenty selected people were selected as the training group and the remaining twenty people in the bowl were selected as the control group.
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
Shahrekord University (Research Ethics Committee)
Street address
one hundred meters down from the Free Road, Sarchshmeha
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818776458
Approval date
2023-05-06, 1402/02/16
Ethics committee reference number
IR.SKU.REC.1402.012
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Lumbar pelvic rhythm
Timepoint
Pre-test and post-test
Method of measurement
kinova
Secondary outcomes
1
Description
Lumbar lordosis
Timepoint
Pre-test - post-test
Method of measurement
Flexible ruler
2
Description
pain
Timepoint
Pre-test - post-test
Method of measurement
visual analogue scale (vas)
3
Description
balance
Timepoint
Pre-test - post-test
Method of measurement
Balance Error Scoring System
Intervention groups
1
Description
Intervention group: Intervention group. The current semi-experimental study will be conducted in the form of 2 intervention and control groups in the form of pre-test and post-test. The statistical population of this research includes men suffering from non-specific chronic back pain referring to Aria Salamat massage and correction center located in Shahrekord, based on the doctor's diagnosis and the entry and exit criteria in a targeted and available manner, 40 people were selected and randomly selected in 2 The experimental and control group of 20 people will be divided, and the intervention group will perform the central stability exercises specified in the current research for 8 weeks.
Category
Treatment - Other
2
Description
Control group: Control group.The current semi-experimental study will be conducted in the form of 2 intervention and control groups in the form of pre-test and post-test. The statistical population of this research includes men suffering from non-specific chronic back pain referring to Aria Salamat massage and correction center located in Shahrekord, based on the doctor's diagnosis and the entry and exit criteria in a targeted and available manner, 40 people were selected and randomly selected in 2 The experimental and control group of 20 people will be divided, and the control group will not receive training during 8 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Aria Health Center
Full name of responsible person
Hamza Ayazi
Street address
The boundary between the four roads of Saadi and enghelab
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 38 3222 4523
Fax
Email
hamzehayazi98@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University
Full name of responsible person
Dr Hamidreza Motaghian
Street address
Rahbar Blvd., Shahrekord University
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 38 3232 4401
Email
hamzehayazi98@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University
Proportion provided by this source
10
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
Shahrekord University
Full name of responsible person
Hamza Ayazi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports pathology and corrective movements
Street address
Rahbar Blvd., Shahrekord University
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 38 3232 4407
Email
hamzehayazi98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Hamzeh Ayazi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports pathology and corrective movements
Street address
Rahbar Blvd., Shahrekord University
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 38 3232 4401
Email
hamzehayazi98@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Hamza Ayazi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports pathology and corrective movements
Street address
Rahbar Blvd., Shahrekord University
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 38 3232 4401
Email
hamzehayazi98@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available