Comparing the effectiveness of two isometric and isotonic core stability exercise methods on pain and performance in people with non-specific chronic back pain
The purpose of the present study is to compare two isometric and isotonic stability training methods on pain and performance of people with non-specific chronic back pain.
Design
In this research, patients in two training groups will receive therapeutic exercises for 8 weeks, and the control group will not receive any intervention.
For the randomization process, each patient will choose a number in a closed envelope. For the convenience of calculation, the website program "Research Randomize" will be used.
The groups included isometric stability training, isotonic stability training and control. G*Power 3.1 was used to calculate the sample size with an alpha of 0.05, a power (90%) and an effect size (0.5). A total of 36 patients (12 in each group) were required for the study. For this reason, in order to avoid the possible drop rate of participants, the number of 15 people (45 people in total) will be allocated in the groups.
Settings and conduct
These people will be identified by an orthopedic doctor and referred to the sports science laboratory of Shahid Beheshti University to perform exercises (subject courses and evaluators).
Participants/Inclusion and exclusion criteria
Research entry criteria: the subjects of this study include people with chronic back pain. The subjects of this study will not participate in any other sports activities or therapeutic interventions during the research.
Exclusion criteria from the research: having symptoms such as: fever, cough, weakness, and in general suspected people with the corona virus; bone diseases; mental disorders; neurological and muscular disorders; congenital abnormalities; any trauma; history of spinal surgery and In general; having any other disease except non-specific chronic back pain.
Comparing the effectiveness of two isometric and isotonic core stability exercise methods on pain and performance in people with non-specific chronic back pain
Public title
Comparison of two methods of core stability exercises to improve chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with non-specific chronic back pain
Absence of any history of spine surgery
Absence of pathological records (disease) of the spine
Absence of orthopedic and neurological injuries
Absence of structural or functional shortness of more than 2 cm in one of the lower limbs
Exclusion criteria:
The presence of the lumbar disc herniation
The presence of the acute stage of lumbar disc protrusion
The presence of the systematic diseases (such as cardiovascular)
Spine surgery in the past
Having a fracture or inflammatory diseases of the spine
Having any therapeutic intervention in the last two months
Taking medical drugs
Failure to participate in the treatment sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
45
More than 1 sample in each individual
Number of samples in each individual:
45
Three groups including two experimental groups and one control group (15 people for each group)
Randomization (investigator's opinion)
Randomized
Randomization description
For the randomization process, each patient will choose a number in a sealed envelope. For the convenience of calculation, the website program "Research Randomizer" will be used.
Therefore, these patients were equally divided into the following three groups: isometric stability training group (n=15), isotonic stability training group (n=15) and control group (n=15).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, after the subjects were referred to the exercise therapy department by the doctor, they will go through a complete treatment process and will not be informed that they are included in a research.
On the other hand, in order to examine dependent variables before and after therapeutic exercise, we have considered experts who will be unaware of the research process.
Therefore, our study will involve blinding of patients and assessors (double-blind).
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee at the Institute of Physical Education and Sports Science
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran. Research Institute of Physical Education and Sports Sciences
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2023-03-08, 1401/12/17
Ethics committee reference number
IR.SSRC.REC.1401.155
Health conditions studied
1
Description of health condition studied
Chronic non-specific back pain
ICD-10 code
M54.5
ICD-10 code description
Back pain
Primary outcomes
1
Description
Pain
Timepoint
8 weeks. The pain variable will be evaluated one day before the start and one day after the end of the research/treatment period.
Method of measurement
Pain (Using Visual Analog Scale; VAS ).
2
Description
Functional disability.
Timepoint
8 weeks. The functional disability variable will be evaluated one day before the start and one day after the end of the research/treatment period.
Intervention group: Isometric core stability exercises. In this group, the training intervention only includes training movements that are performed in a static position with isometric contractions. Patients in this group will exercise for 8 weeks (three sessions, 45-60 minutes per week) under the direct supervision of a specialist, using equipment such as Swiss ball, Theraband and light weights. The number of movements is from 6 to 12 in each session, which will be progressed from the beginning to the end of the treatment based on the patient's level of adaptation.
Category
Treatment - Other
2
Description
Intervention group: Isotonic core stability exercises. In this group, the exercise intervention only includes exercise movements that are performed in a dynamic position with isotonic contractions (without maintaining a constant contraction). Patients in this group will exercise for 8 weeks (three sessions of 45-60 minutes per week) under the direct supervision of a specialist, using equipment such as Swiss ball, Theraband and light weights. The number of movements is from 6 to 12 in each session, which will be progressed from the beginning to the end of the treatment based on the patient's level of adaptation.
Category
Treatment - Other
3
Description
Control group: (no intervention). During the entire research period, the control group will be under simple supervision and will not receive any therapeutic intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University Faculty of Physical Education laboratory
Full name of responsible person
Mehdi Ghitasi
Street address
Tehran-Evin-Shahid Beheshti University-in front of the Vice-Chancellor of Information and Communication Technology-Faculty of Sports and Health Sciences-Building No. 2
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
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 the above information will be made available in the format of university plan and research articles
When the data will become available and for how long
6 to 15 months after the completion of the research plan
To whom data/document is available
All researchers, therapists and specialists
Under which criteria data/document could be used
In order to help therapists, researchers and specialists to promote academic research and treatment of patients
From where data/document is obtainable
Dr. Arash Khaledi, contact number: 09120078615, email address: arashkhaledi@ut.ac.ir
What processes are involved for a request to access data/document
As soon as possible and after the publication of scientific articles, everything that can help the scientific and therapeutic process will be available.