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Effect of core stability and massage training and maintenance on plantar peressure amplitude in low back pain individual during runnig

Protocol summary

Study aim
To investigate the effect of central stability exercises and massage on the range of plantar pressure variables of people with back pain during running.
Design
A clinical trial with a control group, with parallel groups, a blind strain, on 36 back pain patients.
Settings and conduct
The location of the study was the health center and physical training hall of Mohaghegh Ardabili University. Subjects were purposefully divided into three groups of 12 people.
Participants/Inclusion and exclusion criteria
The criteria for entering the study included female gender, age range of 18-35 years, and a pain index higher than 4 in the lower back area, and a history of lower back pain longer than 6 months. No history of rheumatic and inflammatory diseases, peripheral nerve lesions, severe lumbar spine disorders, severe mental illnesses, previous surgery in the back area, neuro-muscular or joint disease, systemic disease, pregnancy, cardio-respiratory and metabolic disease, among the exclusion criteria. It was from study.
Intervention groups
The study was conducted in 3 groups, one group of central stabilization exercises and massage, one group received only massage and one group was a control group that had back pain only.
Main outcome variables
The effect of central stability exercises and massage on the range of plantar pressure variables and plantar variables and muscle electrical activity in people with back pain during running

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240109060659N1
Registration date: 2024-01-17, 1402/10/27
Registration timing: prospective

Last update: 2024-01-17, 1402/10/27
Update count: 0
Registration date
2024-01-17, 1402/10/27
Registrant information
Name
Fatemeh Mehralian
Name of organization / entity
Mohagheghe ardabili univercity
Country
Iran (Islamic Republic of)
Phone
+98 31 3773 4649
Email address
fateme.mehralian@student.uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-09, 1402/11/20
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of core stability and massage training and maintenance on plantar peressure amplitude in low back pain individual during runnig
Public title
Investigating the effect of central body muscle exercises and massage and its durability on biomechanical variables in people with back pain during running
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
female gender age range of 18 to 35 years, pain index higher than 4 in the lower back area presence of lower back pain for more than 6 months
Exclusion criteria:
No history of rheumatic and inflammatory diseases, peripheral nerve lesions, severe lumbar spine disorders, severe mental illnesses, previous surgery in the back area, neuro-muscular or joint disease, systemic disease, pregnancy, cardio-respiratory and metabolic disease.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was designed as a double-blinded randomized controlled trial An envelope concealment method was used to allocate study participants. Participants and examiners were unaware of group allocation. In other words, participants and assessors were blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National system of ethics in biomedical research
Street address
daneshgah st
City
ardabil
Province
Ardabil
Postal code
5619913131
Approval date
2023-12-12, 1402/09/21
Ethics committee reference number
IR.UMA.REC.1402.064

Health conditions studied

1

Description of health condition studied
chronic nonspecific low back pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The effect of central stability exercises and massage on the range of plantar pressure variables and plantar variables and muscle electrical activity
Timepoint
Pre-test before exercises and massage and post-test six weeks after exercises and massage and durability after 4 weeks
Method of measurement
Variables were measured using electromyography, foot scan and force plate.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: central stabilization exercises and Swedish massage for 6 weeks and 3 sessions per week, each session includes 10 minutes of warm-up, 30 minutes of exercises and 20 minutes of massage.
Category
Treatment - Other

2

Description
Intervention group: Intervention group: Swedish massage group for 6 weeks, 3 sessions per week for 20 minutes of massage of the lower back with warm stroking movements and rubbing and kneading techniques.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Mohaghegh Ardabili Health Center
Full name of responsible person
Fatemeh Mehralian
Street address
Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
5619913131
Phone
+98 31 3773 4649
Email
F.mehralian78@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mohaghegh Ardabili univercity
Full name of responsible person
Fateme Mehralian
Street address
University of Mohaghegh Ardabili, daneshgah St, Ardadil, Iran
City
Ardabil
Province
Ardabil
Postal code
5619913131
Phone
+98 936 993 9554
Email
F.mehralian78@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mohaghegh Ardabili univercity
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
Mohagheghe ardabili univercity
Full name of responsible person
Fatemeh Mehralian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Daneshgah st
City
اردبیل
Province
Ardabil
Postal code
5619913131
Phone
+98 31 3773 4649
Fax
Email
F.mehralian78@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mohagheghe ardabili univercity
Full name of responsible person
Fatemeh Mehralian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Daneshgah st
City
اردبیل
Province
Ardabil
Postal code
5619913131
Phone
+98 31 3773 4649
Fax
Email
F.mehralian78@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Gabriel Razmjoo
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
treatment
Street address
Daneshgah St, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
5619913131
Phone
+98 31 3773 4649
Email
F.mehralian78@gmail.com

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
mean of ground reaction forces
When the data will become available and for how long
When publishing an article
To whom data/document is available
All people
Under which criteria data/document could be used
it is free.
From where data/document is obtainable
The journal in which the article will publish.
What processes are involved for a request to access data/document
Journal Process and Rules
Comments
Null
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