Comparing the effects of stability exercises with general exercises in water, on the cross-sectional area and thickness of the multifidus muscle and the thickness of the transversus abdominis muscle in women with non-specific chronic low back pain.
The aim of present study is to compare the effect of stabilization exercise with general exercise in water on cross sectional area and thickness of multifiduse and thickness of transversus abdominis muscles and on pain and functional disability in women with nonspecific chronic low back pain.
Design
The present randomized controlled trial study is single blind, have two groups: control and exprimental including 27 subjects.
Settings and conduct
Patients were selected in Shahid Yaheinejad Hospital and after measuring the variables, they entered the swimming pool to perform the intervention and at the end the intervention, relevant variables were measured again.
Participants/Inclusion and exclusion criteria
Women with nonspecific low back pain
Intervention groups
Experimental group perform the stabilization exercise in water and control group perform general exercise in water.
Main outcome variables
Thickness and cross sectional area of the multifidus muscle, thickness of thickness of the transversus abdominis muscle, pain, functional disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221019056245N1
Registration date:2023-01-03, 1401/10/13
Registration timing:prospective
Last update:2023-01-03, 1401/10/13
Update count:0
Registration date
2023-01-03, 1401/10/13
Registrant information
Name
Khodabakhsh Javanshir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 6419
Email address
k.javanshir@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-15, 1401/10/25
Expected recruitment end date
2023-05-15, 1402/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of stability exercises with general exercises in water, on the cross-sectional area and thickness of the multifidus muscle and the thickness of the transversus abdominis muscle in women with non-specific chronic low back pain.
Public title
Comparison of the effect of stabilization exercise with general exercise in water on women with chronic nonspecific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
woman
25-45 years old
chronic low back pain
low back pain with instability
Exclusion criteria:
tumor and cancer
epidural abscess
spondyloarthropathy
osteoporosis
spinal fractures
deformities
inflammatory process
disc herniation
spondylolysis
spondylosis
lumbosacral radicular syndrome
radiculopathy
cauda equina syndrome
spinal stenosis
previous spinal surgery
rehomatic diseases
limb discrepancy
uncontrolled increased blood pressure
heart failure
infectious diseases
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
27
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants did not know which group they were in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganj afrooz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2020-06-20, 1399/03/31
Ethics committee reference number
IR.MUBABOL.REC.1399.331
Health conditions studied
1
Description of health condition studied
nonspecific low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Thickness of right and left transversus abdominis muscle
Timepoint
Before intervention and after intervention
Method of measurement
Using ultrasonography instrument made by south corea (SONOACE R7-EX)
2
Description
Thickness and cross sectional area
Timepoint
Before and after intervention
Method of measurement
Using ultrasonography instrument made by south corea (SONOACE R7-EX)
Secondary outcomes
1
Description
Functional disability
Timepoint
Before and after intervention
Method of measurement
Modified Modified Oswestry
2
Description
Pain
Timepoint
Before and after intervention
Method of measurement
Numeric rating scale
Intervention groups
1
Description
Intervention group: Performing stabilization exercise in water based on the protocol
Category
Rehabilitation
2
Description
Control group: Performing general exercise in water
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid yahyanejad hospital
Full name of responsible person
Maede Jarrahi
Street address
Shahid mostafa khomini
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 2225 0357
Email
yahyanejad@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Ganj afrooz Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
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
Babol University of Medical Sciences
Full name of responsible person
Khodabakhsh Javanshir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ganjafrooz street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
khodabakhshjavanshir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Khodabakhsh Javanshir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ganjafrooz street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
khodabakhshjavanshir@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Khodabakhsh Javanshir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ganjafrooz street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
khodabakhshjavanshir@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
Not applicable
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