To compare the effects of core stability with and without stretching exercises on pain and functional disability in non-specific low back pain.
Design
The study was a Randomized controlled trial. Randomization was done through drawing a number.
Settings and conduct
Study was conducted at layyah city hospital of govt college university Faisalabad layyah campus. The study population was consisted of patients with non specific with low back pain. The study was single blinded. The participants didn't know while they were receiving experimental or conventional treatment.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Age 25 – 65 years;
Both genders;
Non-specific low back pain for at least 3 months ;
Pain intensity of 3 or higher based on Numeric Pain Rating Scale (NPRS).
Non-inclusion Criteria:
History of spinal surgery;
History of ankylosing spondylitis or rheumatoid arthritis;
History of spondylolisthesis or spondylolysis;
History of spinal or pelvic fracture;
History of spinal inflammation or tumor;
History of osteoporosis;
Continuous use of pain medications;
History of respiratory or heart disease;
History of stroke.
Intervention groups
Intervention group: participants performed core stabilization exercises with stretching for 30 min, 3 times/week, for 6 weeks.
Control group: they performed core stabilization exercises i.e abdominal hollowing, straight leg raise from prone, supine extension bridge and prone bridge, for 20 minutes 3 times a week.
Main outcome variables
Pain; Disabilty
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220115053712N3
Registration date:2023-07-19, 1402/04/28
Registration timing:retrospective
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Hifza Arif
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences Multan Pakistan
Country
Pakistan
Phone
+92 309 7697428
Email address
drhizaarif@mimas.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-15, 1401/05/24
Expected recruitment end date
2022-09-15, 1401/06/24
Actual recruitment start date
2022-08-15, 1401/05/24
Actual recruitment end date
2022-10-20, 1401/07/28
Trial completion date
2022-10-22, 1401/07/30
Scientific title
Comparison of effects of Core Stability with and without Stretching Exercises on pain and functional disability in Non-Specific Low Back Pain.
Public title
Core stability with and without stretching exercises on pain and functional disability in non specific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25 – 65 years
Both genders
Non-specific low back pain for at least 3 months
Pain intensity of 3 or higher based on Numeric Pain Rating Scale (NPRS)
Exclusion criteria:
History of spinal surgery
History of ankylosing spondylitis or rheumatoid arthritis
History of spondylolisthesis or spondylolysis
History of spinal or pelvic fracture
History of spinal inflammation or tumor
History of osteoporosis
Continuous use of pain medications
History of respiratory disease or heart disease
History of stroke
Age
From 25 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
21
Actual sample size reached:
14
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly allocated into two groups through drawing a number.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study was single blinded. The participants didn't know while they were receiving experimental or conventional treatment.
Placebo
Not used
Assignment
Parallel
Other design features
toe-tuch test,fair test and ober test used for flexibilty assessment
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional ethics committee of GCUF layyah campus
Street address
Near layyah sugar mills; Layyah
City
Layyah
Postal code
31200
Approval date
2022-07-10, 1401/04/19
Ethics committee reference number
GCUFLC/2022/556
Health conditions studied
1
Description of health condition studied
Non specific low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
Please write: Before and 6 weeks after treatment
Method of measurement
Numerical pain rating scale (NPRS)
2
Description
Disability
Timepoint
Before and 6 weeks after treatment
Method of measurement
Modified oswestry disability index
Secondary outcomes
1
Description
Functional activities
Timepoint
Before and 6 weeks after treatment
Method of measurement
Modified oswestry disabilty index (MODI)
Intervention groups
1
Description
Intervention group: participants performed Core stabilization exercises with stretching for 30 min, 3 times/week, for 6 weeks. Core stabilization consisted of abdominal hollowing, straight leg raise from prone, supine extension bridge and prone bridge and stretching in hip muscle (Hamstrings, Tensor fasciae lata, Piriformis and Gluteus Maximus). All study participants received a total of 18 treatments sessions over a six-week period, which consisted of 3 treatment sessions per week.
Category
Rehabilitation
2
Description
Control group: they performed core stabilization exercises i.e abdominal hollowing, straight leg raise from prone, supine extension bridge and prone bridge, for 20 minutes 3 times a week. All exercises were repeated 3 times. All study participants received a total of 18 treatments sessions over a six-week period, which consisted of 3 treatment sessions per week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Layyah city hospital
Full name of responsible person
Noshaba kanwal
Street address
Near bale chowk bypass road layyah
City
Layyah
Postal code
31200
Phone
+92 309 9709093
Email
zuhahadeed786@gmail.com
Web page address
https://gcuf.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
GCUF Layyah campus
Full name of responsible person
Shahwar Muneer Bhatti
Street address
Near Layyah Sugar Mills Canal colony LAYYAH
City
Layyah
Postal code
31200
Phone
+92 304 4407035
Email
saaniaanaz@gmail.com
Web page address
https://gcuf.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
GCUF Layyah campus
Proportion provided by this source
100
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
GCUF layyah campus
Full name of responsible person
Dr.Sania Naz
Position
professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Near layyah sugar mills; Layyah
City
Layyah
Province
Punjab
Postal code
31200
Phone
+92 304 4407035
Email
saaniaanaz@gmail.com
Web page address
https://gcuf.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
GCUF layyah campus
Full name of responsible person
Dr.Noshaba Kanwal
Position
professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Near layyah sugar mills layyah
City
Layyah
Province
Punjab
Postal code
31200
Phone
+92 309 9709093
Email
zuhahadeed786@gmail.com
Web page address
https://gcuf.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
GCUF layyah campus
Full name of responsible person
Dr.Nida Ilahi
Position
professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Near layyah sugar mills layyah
City
Layyah
Province
punjab
Postal code
31200
Phone
+92 331 6213700
Email
nidailahi78@gmail.com
Web page address
https://gcuf.edu.pk/
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
Demographic data and data related to final outcome will be shared by maintaining the confidentiality
When the data will become available and for how long
data will be available from april 2024 to june 2024 after the 6 months of publication. The data sharing plan for a clinical trial (i.e., what data will be shared when and under what conditions) will be publicly available at a third-party site that shares data with and meets the data requirements of WHO's International Clinical Trials Registry Platform; this occur before the first participant is enrolled.
To whom data/document is available
dr.Sania Naz (corresponding author) professor at GCUF layyah campus.
Under which criteria data/document could be used
for research purpose
From where data/document is obtainable
To the corresponding author of the study; dr sania naz and can contact on +923044407035saaniaanaz@gmail.com can visit these search engines, you can find my study easily here https://www.researchgate.net/ https://scholar.google.com/
What processes are involved for a request to access data/document
open-access and There is the traditional public data release where anyone can get access to the data with no registration or conditions. The request will be reviewed by Director in Charge and in case of eligibility, it would be shared in two weeks