Effect and Persistence Durability of Selected Functional Restoration Exercise and Pilates on Pain, Functional Disability, Proprioception and Quality Of Life In Female with Non-S Pecific Chronic Low Back Pain.
The main purpose of this research is to determine the effect and sustainability of functional rehabilitation exercises and pilates on pain, disability, proprioception and quality of life of women suffering from non-specific chronic back pain.
Design
According to the nature of the subject and the form of its implementation, the present research is semi-experimental, which will be carried out with the presence of two experimental groups and a control group, and performing the pre-test and post-test stages. and shelf life of one month
Settings and conduct
The statistical population of the current research is women aged 40 to 50 with non-specific chronic back pain in Isfahan.
Among the clients with chronic back pain, 30 women were selected with the approval of an orthopedic specialist based on the criteria for entering the research in a purposeful and accessible manner and were placed in three groups: control (10 people), Pilates (10 people) and functional rehabilitation (10 people).
Participants/Inclusion and exclusion criteria
gender (female)
The participants should participate in this study by signing the consent form and being aware of the research objectives and methods.
People suffering from non-specific chronic back pain
Body mass index between 18 and 25
Women with an age range of 40-50 years
Not having any regular sports activity (at least two days a week) within the last 3 months before starting the protocol (3)
Q
not be an athlete
1- History of spine surgery
2- Disc
3- Osteoporosis
4- Autoimmune disorders
5-Pregnancy
6- Fracture
7- Diabetes
Intervention groups
Pilates group for functional rehabilitation of control
Main outcome variables
Pilates exercises and functional rehabilitation are likely to be effective in reducing pain, increasing proprioception, and range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250208064684N1
Registration date:2025-06-01, 1404/03/11
Registration timing:registered_while_recruiting
Last update:2025-06-01, 1404/03/11
Update count:1
Registration date
2025-06-01, 1404/03/11
Registrant information
Name
Maral Amini
Name of organization / entity
The University of tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 1730
Email address
maral.am28@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-31, 1404/03/10
Expected recruitment end date
2025-09-01, 1404/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect and Persistence Durability of Selected Functional Restoration Exercise and Pilates on Pain, Functional Disability, Proprioception and Quality Of Life In Female with Non-S Pecific Chronic Low Back Pain.
Public title
Effect and Persistence Durability of Selected Functional Restoration Exercise and Pilates on Pain, Functional Disability, Proprioception and Quality Of Life In Female with Non-S Pecific Chronic Low Back Pain.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gender (female) Participants participated in this study by signing a consent form and being aware of the research objectives and methods. Individuals suffering from chronic non-specific low back pain, body mass index between 18 and 25, women with an age range of 40-50 years, not having any regular exercise (at least two days a week) within the last 3 months before starting the protocol (3) History of low back pain for at least 12 weeks to diagnose chronicity of the disease
Exclusion criteria:
1- History of spinal surgery 2- Disc 3- Osteoporosis 4- Autoimmune disorders 5- Pregnancy 6- Fracture 7- Diabetes 8- Suffering from inflammatory spinal disease 9- People with any postural abnormalities 10- Absence of 3 sessions in training sessions (experimental group) 11- Participants' unwillingness to continue their activities at any stage of the research and voluntary withdrawal from participation and cooperation
Age
From 40 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Thirty-six women were selected purposively and conveniently with the approval of an orthopedic specialist based on the inclusion criteria and were placed in three groups and randomly and equally divided into two intervention groups and a control group. In order to randomly assign the subjects to the intervention and control groups, a number was assigned to each subject, and the numbers were randomly divided between the three groups using a random number table. In order to conceal the numbers in each group, they were written on paper, and each was kept in a separate opaque sealed envelope. Each subject was asked to choose one of the envelopes and was placed in one of the groups based on the number.
Blinding (investigator's opinion)
Single blinded
Blinding description
A blind strainIn order not to influence the test method and results, the experimenter was kept blind to which group (intervention or control) the subjects were in, and the subjects also expressed their consent to participate in a study by being fully informed about the research and filling out a consent form.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق درپژوهش دانشکده علوم ورزشی
Street address
west tehran univercity of tehran
City
tehran
Province
Tehran
Postal code
ethicsreserch.sport@
Approval date
2024-09-10, 1403/06/20
Ethics committee reference number
IR.UT.SPORT.REC.1403.072
Health conditions studied
1
Description of health condition studied
Non-SPecific Chronic Low Back Pain.
ICD-10 code
ICD-10 code description
M54.5 Low back pain
Primary outcomes
1
Description
The effect of Pilates exercises and functional rehabilitation on pain, functional disability, range of motion, proprioception, and endurance in patients with non-specific chronic back pain.
Timepoint
Before the intervention, 2 days after the completion of eight weeks, then a shelf life of 1 month
Method of measurement
Goniometer - Schuber test meter - Lumbar extension test - Measuring proprioception with goniometer - Abdominal test - McGill test - Visual pain scale - Quality of life questionnaire and functional disability questionnaire Asustri Bering Sorensen test
Secondary outcomes
1
Description
pilates- functional restoratoin
Timepoint
2 months
Method of measurement
pilates- functional restoratoin
Intervention groups
1
Description
Intervention group: The intervention group did Pilates exercises and functional rehabilitation for 8 weeks, 3 sessions per week and each session lasted 45 to 60 minutes. Pilates - functional rehabilitation - controlThe control did not have any activity during this period and were engaged in daily activities
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
orthopedist
Full name of responsible person
orthopedist
Street address
esfahan
City
esfahan
Province
Isfehan
Postal code
0000
Phone
+98 21 8835 1730
Email
infosport@ut.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
university of tehran
Full name of responsible person
university of tehran
Street address
Tehran - Northern Kargar St. - above Jalal Al Ahmad Intersection - between 15th and 16th Streets - in front of Tehran University Koi
City
tehran
Province
Tehran
Postal code
infosport@ut.ac.ir
Phone
+98 21 8835 1730
Email
infosport@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
university of tehran
Proportion provided by this source
50
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
university of tehran
Full name of responsible person
mohammad hosein alizadeh
Position
full professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports pathology and corrective movements
Street address
university of tehran
City
tehran
Province
Tehran
Postal code
37 - 88351730
Phone
+98 912 348 9807
Email
alizadehm@ut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
university of tehran
Full name of responsible person
mohammad hosein alizadeh
Position
full professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports medicine-sports pathology and corrective movements
Street address
Tehran - Northern Kargar St. - above Jalal Al Ahmad Intersection - between 15th and 16th Streets - in front of Koi University of Teh
City
tehran
Province
Tehran
Postal code
37 - 88351730
Phone
+98 21 8835 1730
Email
alizadehm@ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of tehran
Full name of responsible person
mohammad hosein alizadeh
Position
full professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports pathology and corrective movements
Street address
university of tehran
City
tehran
Province
Tehran
Postal code
37 - 88351730
Phone
+98 21 8835 1730
Email
alizadehm@ut.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
Not applicable
Title and more details about the data/document
Pre- and post-tests and durability
When the data will become available and for how long
1405
To whom data/document is available
Researchers and workers and other people
Under which criteria data/document could be used
Use for rehabilitation
From where data/document is obtainable
Research team maral.am28@gmail.com
What processes are involved for a request to access data/document