The effect of core stability and strengthening exercises on non-specific chronic pain that disrupts the daily life of Shazand refinery personnel.
Design
A clinical trial with a control and an intervention groups, single blind, randomized, will be conducted on 22 women with non-specific chronic back pain.
Settings and conduct
Place of study: Shazand Refinery sports complex; Study population: 22 women with non-specific chronic back pain; Blinding type: Blinding is not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being female; Having at least 12 weeks of non-specific chronic back pain.
Exclusion criteria:: surgery on the back; Fracture of the spine
Intervention groups
Intervention group: Core stability training including swimming of the hip bridge plank will be done in four sets of 10 during eight weeks, which will increase the intensity of the exercises week after week, but the duration of the exercise will not change.
Control group: without any training period.
Main outcome variables
pain intensity; Functional activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230618058518N1
Registration date:2024-02-16, 1402/11/27
Registration timing:prospective
Last update:2024-02-16, 1402/11/27
Update count:0
Registration date
2024-02-16, 1402/11/27
Registrant information
Name
Mina Shafiei
Name of organization / entity
The university of arak
Country
Iran (Islamic Republic of)
Phone
+98 86 3312 1795
Email address
minashafiei1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-16, 1402/12/26
Expected recruitment end date
2024-05-15, 1403/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Core Stabilization Exercises on Pain and Functional Pain Movements in Women with Non-specific Chronic Low Back Pain
Public title
The effect of core stability training on pain and functional movements in nonspecific chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being female
Chronic nonspecific low back pain
Existence of pain and problems in daily activities during past six months
Exclusion criteria:
Having surgery in the last six months
Lumbar spine fracture
Age
From 25 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
Randomized
Randomization description
The method of allocation in the groups was done by simple random sampling method and blocking method. For this purpose, all 23 samples of the study were sorted according to pain score index. Then they were assigned to one of the control or experimental groups using blocks of size 2.
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 Arak University
Street address
Koi Maskan No. 4, Rezvan Alley
City
arak
Province
Markazi
Postal code
3819787388
Approval date
2023-04-10, 1402/01/21
Ethics committee reference number
IR.ARAKU.REC.1402.015
Health conditions studied
1
Description of health condition studied
none specific low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Chronic non-specific back pain
Timepoint
Atto Binging Off at the Andean Offer It's Weeks of Entertainment.
Method of measurement
Using the VAS questionnaire.
Secondary outcomes
1
Description
Quality of life
Timepoint
At baseline and after eight weeks of intervention
Method of measurement
The VAS Questionnaire
Intervention groups
1
Description
Intervention group: Core stability exercises including bridge, sit-up, bridgeside and etc. Week by week the intensity of training is added and the final two weeks of Swiss Ball are used. These exercises are 4 and each set is 10 seconds. These exercises last 8 weeks and three days a week for 30 to 45 minutes.
Category
Treatment - Devices
2
Description
Control group:There was no intervention.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shazand Refinery
Full name of responsible person
Heybatolah Abbasian
Street address
Shazand Imam Khomeini Oil Refining Company, Shazand Crossroad, 20th km of Borujerd Road
City
Arak
Province
Markazi
Postal code
۳۸۶۷۱۴۱۱۱۱
Phone
+98 86 3822 4610
Fax
Email
minashafiei1998@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shazand Oil Refinery
Full name of responsible person
Heybatolah Abbasian
Street address
Shazand Imam Khomeini Oil Refining Co., Shazand Crossroad, 20 km of Borujerd Road, Arak, Iran
City
arak
Province
Markazi
Postal code
۳۸۶۷۱۴۱۱۱۱
Phone
+98 86 3822 4611
Email
shahrjerdi_shahnaz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is 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
Title and more details about the data/document
All data will be accessible after the research is published.
When the data will become available and for how long
since 2023
To whom data/document is available
Professors and researchers of Arak University and people with non-specific chronic low back pain
Under which criteria data/document could be used
A person who is planning to study will send a message to the researcher via email
From where data/document is obtainable
Anyone who is going to study will refer to Arak University، Basij Square، Karbala Blvd.، Sardasht Library of Arak University or to this email address
It does.shahnaz_shahrjerdi@gmail.com
What processes are involved for a request to access data/document
The applicant can use the information after receiving confirmation from the researcher.