The effect of core stability training and electrical muscle stimulation on pain, disability and trunk endurance in women with chronic non-specific low back pain
Determining the effect of core stability training and electrical muscle stimulation on pain, disability and trunk endurance in women with non-specific chronic back pain.
Design
By lottery, 30 people were selected in three groups of 10 people in a blind way.
Settings and conduct
The health center room of Shazand Refinery sports complex was made available for research work. The space is completely hygienic and has the necessary sports equipment with proper ventilation and lighting. According to the previous appointment, the subjects arrived at the scheduled time and the exercises were done under the supervision of the trainer. The subjects were blinded.
Participants/Inclusion and exclusion criteria
Women with more than three months of back pain without any injury, illness or fracture in the back
Intervention groups
Control group without any training, core stability training group, core stability training group with electrical muscle stimulation
Main outcome variables
Examining the intensity of pain with a visual questionnaire. Investigation of Navati with Oswestry questionnaire. Examining trunk endurance with Sorenson's test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230729058957N1
Registration date:2024-02-17, 1402/11/28
Registration timing:prospective
Last update:2024-02-17, 1402/11/28
Update count:0
Registration date
2024-02-17, 1402/11/28
Registrant information
Name
Maryam Nabiuni
Name of organization / entity
Arak University
Country
Iran (Islamic Republic of)
Phone
+98 86 3368 6942
Email address
s_shahrjerdi@araku.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-09, 1402/12/19
Expected recruitment end date
2024-05-08, 1403/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of core stability training and electrical muscle stimulation on pain, disability and trunk endurance in women with chronic non-specific low back pain
Public title
The effect of core stability training and electrical muscle stimulation on chronic non-specific low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least three months of non-specific low back pain
Exclusion criteria:
History of spinal fracture, lower limb
History of disc herniation
History of spinal tumor
History of rheumatic disease
History of spine and lower limb surgery
Heart disease
Thyroid disease
Diabetes
Age
From 30 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method will be used. The number of 30 envelopes in the package is considered, and in 10 items we put the number 1 (code of the central static exercises group), 10 items 2 (the code of the EMS exercises group) and 10 items the number 3 (code of the control group). Then the person is asked to choose one of the envelopes and be placed in one of the three groups based on the desired code.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University
Street address
Arak, Sardasht, Basij Square, Karbala Boulevard, Arak University
City
Arak
Province
Markazi
Postal code
3848177584
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.ARAKU.REC.1402.013
Health conditions studied
1
Description of health condition studied
chronic non-specific low back pain
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain
Primary outcomes
1
Description
Pain intensity score in the visual VAS questionnaire, disability score in the Osostery disability questionnaire, Sorenson's trunk and hip bridge endurance test and instability to evaluate the central stabilizing muscles, Wells bench test for hamstring flexibility
Timepoint
vBefore the start of the exercises and after the end of the exercises
Method of measurement
The visual analog scale of pain to evaluate pain, Oswestry questionnaire to evaluate disability, Sorenson trunk endurance test
Secondary outcomes
1
Description
Hip bridge and instability to assess central stabilizer muscles, Wells bench test for hamstring flexibility
Timepoint
Before the start of training and after the end of the training period
Method of measurement
Perform movements and record measurements
Intervention groups
1
Description
In order to select the subjects of the research, by presenting the functional disability questionnaire, the degree of disability and with the VAS questionnaire, the pain level of the people was measured and the researcher selected the desired statistical sample based on the entry and exit criteria of this research in a targeted manner and the selected samples were randomly selected. Sadeh are divided into three groups of 10 people (control group, central stability training group, central stability training group with electrical muscle stimulation). The exercises are three sessions a week for eight weeks and then a post-test is taken. The control group does not have any training and intervention and continues their past life.
Category
Rehabilitation
2
Description
Intervention group: The group of central stability exercises includes plank exercises, flying dog, etc., which are held in 30-45 minute sessions. The equipment needed for this group includes: special sports clothes, water bottle and swissball.
Category
Rehabilitation
3
Description
Intervention group: The group of electrical muscle stimulation exercises have the same exercises in 30 minutes, with the difference that they wear clothes with electrical pulses and then exercise. The clothing equipment is special for the device that is available. For practice, the items mentioned in the previous intervention are the same.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shazand Imam Khomeini Oil Refining Company cultural and sports club
Full name of responsible person
Haibollah Abbasian
Street address
Milad_ oil field
City
Shazand_ Mohageran
Province
Markazi
Postal code
۳۸۶۷۱۴۱۱۱۱
Phone
+98 86 3349 1893
Email
Gholami.s@ikorc.ir
Web page address
https://www.ikorc.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shazand Imam Khomeini Oil Refining Company
Full name of responsible person
Mrs. Halakui
Street address
Kilometer 20 of Borujerd road
City
Shazand
Province
Markazi
Postal code
۳۸۶۷۱۴۱۱۱۱
Phone
+98 86 3349 1891
Email
Asgari.s@ikorc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shazand Imam Khomeini Oil Refining Company
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University
Full name of responsible person
Maryam Nabiuni
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
59-moradian-navid
City
Arak
Province
Markazi
Postal code
3818136886
Phone
+98 86 3368 6942
Fax
Email
s_shahrjerdi@araKU.AC.IR
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University
Full name of responsible person
Shahnaz Shahrjerdi
Position
University faculty
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
59-moradian-navid
City
Arak
Province
Markazi
Postal code
3818136886
Phone
+98 86 3368 6942
Fax
Email
s_shahrjerdi@araKU.AC.IR
Person responsible for updating data
Contact
Name of organization / entity
Arak University
Full name of responsible person
Maryam Nabiuni
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
59-moradian-navid
City
Arak
Province
Markazi
Postal code
3818136886
Phone
+98 86 3368 6942
Fax
Email
s_shahrjerdi@araKU.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
Yes - There is a plan to make this available
Title and more details about the data/document
After making people unidentifiable, part of the data, such as information about the main outcome and an abstract of relevant information, will be shared in general.
When the data will become available and for how long
Since 2023
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
A person who intends to study this research can inform the researcher via email. Also, a person can use the information of the article.
From where data/document is obtainable
First, send a message to the email and then call the number below, and finally, you can visit the library of Arak University located in Sardasht, Karbala Blvd.09027776418
What processes are involved for a request to access data/document
The applicant can receive the documents after sending an email to the researcher and receiving confirmation from the researcher.