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Investigating the effect of core stability and massage training and maintenance on biomechanical variables in low back pain individual during walking

Protocol summary

Study aim
The purpose of this research is to investigate the effect of central body muscle exercises and massage and its durability on the range of biomechanical variables in people with back pain while walking.
Design
A randomized, controlled, parallel-group, single-strain, 30-person clinical trial. A lottery method will be used for randomization.
Settings and conduct
This research will be conducted in the health center of Mohaghegh Ardabili University. The study is semi-experimental with a pre-test-post-test design with a control group. Three devices will be used: force plate, electromyography and foot scan, and the results will be analyzed by software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: female gender, age range of 20 to 30 years, pain index higher than 14 in the lower back. Also, any specific pain in the pelvis or abdomen during the past 12 months, history of spinal surgery and disc herniation, systemic disease, rheumatism, history of neuro-muscular diseases and balance system disorders, use of drugs that affect a person's balance, heart-respiratory disease and metabolic, the presence of abnormalities in the spine and lower limbs, severe mental illnesses, pregnancy and participation in regular sports activities during the last six months will be considered as exclusion criteria.
Intervention groups
The first experimental group includes students with back pain who will perform central stabilization exercises and massage, and the second experimental group will perform only massage. There will also be a group as a control group with all the characteristics of the experimental group, with the difference that the exercises and massage in this group will not be applied.
Main outcome variables
Ground reaction forces, muscle electrical activity, plantar pressure variables

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240529061946N1
Registration date: 2024-06-09, 1403/03/20
Registration timing: prospective

Last update: 2024-06-09, 1403/03/20
Update count: 0
Registration date
2024-06-09, 1403/03/20
Registrant information
Name
Sadaf Salehi
Name of organization / entity
The University of Mohaghegh Ardabili
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 7343
Email address
sadafsalehi@student.uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of core stability and massage training and maintenance on biomechanical variables in low back pain individual during walking
Public title
The effect of core stability and massage training and maintenance on back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender Age range 18 to 30 years Pain index higher than 7 in the lower back
Exclusion criteria:
Any specific pain in the pelvis or abdomen during the past 12 months History of spinal surgery and disc herniation Suffering from a systemic disease Suffering from rheumatism History of neuro-muscular diseases and balance system disorders Taking drugs that affect a person's balance Suffering from cardio-respiratory and metabolic disease Abnormalities in the spine and lower limbs Suffering from severe mental illnesses Pregnancy Participation in regular sports activities during the last six months
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: Using the lottery method, we will number people from 1 to 30. This numbering will be done in no particular order. By randomly drawing a number from the bag, we select people for each group. The sample will be divided into three groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are unaware of the division of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Mohaghegh Ardabili
Street address
University of Mohaghegh Ardabili, Daneshgah St
City
Ardabil
Province
Ardabil
Postal code
5619911367
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.UMA.REC.1403.014

Health conditions studied

1

Description of health condition studied
Healthy students
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Plantar pressure variables
Timepoint
Before the start of the intervention and six and 10 weeks after the start of the intervention
Method of measurement
Foot scan device

2

Description
Electrical activity of muscles
Timepoint
Before the start of the intervention and 6 and 10 weeks after the start of the intervention
Method of measurement
Electromyography device

3

Description
Components of ground reaction force
Timepoint
Before the start of the intervention and 6 and 10 weeks after the start of the intervention
Method of measurement
Force plate device

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: For this group, massage will be applied three times a week for six weeks.
Category
Diagnosis

2

Description
The second intervention group: for this group, massage and central stability exercises will be applied three times a week for six weeks.
Category
Diagnosis

3

Description
Control group: There was no intervention in the control group.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Mohaghegh Ardabili University Health Center
Full name of responsible person
Mohsen Barghamadi
Street address
University of Mohaghegh Ardabili, Daneshgah St
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5000
Email
Barghamadi@uma.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Jabraeil Razmjou
Street address
University of Mohaghegh Ardabili, Daneshgah St
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5000
Email
razmjou@uma.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Mohaghegh Ardabili
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
The University of Mohaghegh Ardabili
Full name of responsible person
Mohsen Barghamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomedical Engineering
Street address
University of Mohaghegh Ardabili, Daneshgah St
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5652
Email
Barghamadi@uma.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Mohsen Barghamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomedical Engineering
Street address
University of Mohaghegh Ardabili, Daneshgah St
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5652
Email
Barghamadi@uma.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Mohsen Barghamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomedical Engineering
Street address
University of Mohaghegh Ardabili, Daneshgah St
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5652
Email
Barghamadi@uma.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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Mean ground reaction forces, Electrical activity of lower limb muscles and plantar pressure variables
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In order for researchers to benefit from the scientific data obtained from the research and use them for treatment
From where data/document is obtainable
After uploading, refer to the scientific databases to get the results and data.
What processes are involved for a request to access data/document
Refer to the e-mail of the researcher. Barghamadi@uma.ac.ir
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