Protocol summary
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Study aim
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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.
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Design
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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
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Settings and conduct
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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).
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Pilates group for functional rehabilitation of control
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Main outcome variables
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Pilates exercises and functional rehabilitation are likely to be effective in reducing pain, increasing proprioception, and range of motion
General information
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Reason for update
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The actual patient enrollment date has been entered.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20250208064684N1
Registration date:
2025-06-01, 1404/03/11
Registration timing:
prospective
Last update:
2026-10-27, 1405/08/05
Update count:
1
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Registration date
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2025-06-01, 1404/03/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-07-06, 1404/04/15
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Expected recruitment end date
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2025-11-08, 1404/08/17
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Actual recruitment start date
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2025-07-06, 1404/04/15
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Actual recruitment end date
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2025-11-08, 1404/08/17
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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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.
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 40 years old to 50 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
54
Actual sample size reached:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Fifty-four 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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Factorial
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-09-10, 1403/06/20
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Ethics committee reference number
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IR.UT.SPORT.REC.1403.072
Health conditions studied
1
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Description of health condition studied
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Non-SPecific Chronic Low Back Pain.
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ICD-10 code
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ICD-10 code description
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M54.5 Low back pain
Primary outcomes
1
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Description
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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.
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Timepoint
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Before the intervention, 2 days after the completion of eight weeks, then a shelf life of 1 month
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Method of measurement
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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
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Description
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pilates- functional restoratoin
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Timepoint
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2 months
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Method of measurement
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pilates- functional restoratoin
Intervention groups
1
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Description
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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
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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university of tehran
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Pre- and post-tests and durability
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When the data will become available and for how long
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1405
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To whom data/document is available
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Researchers and workers and other people
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Under which criteria data/document could be used
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Use for rehabilitation
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From where data/document is obtainable
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Research team maral.am28@gmail.com
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What processes are involved for a request to access data/document
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email
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Comments
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