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Comparison of core stability and suspension exercise on some EMG coordinates, beta-endorphin and functional disability in people with lumbar disc herniation

Protocol summary

Study aim
Comparison of core stability and suspension exercise on some EMG coordinates, beta-endorphin and functional disability in people with lumbar disc herniation
Design
A clinical trial on 45 people with two intervention groups and one control group (15 people in each group), with parallel groups, randomized
Settings and conduct
The present study is a randomized controlled trial on people with lumbar disc herniation in rasht city. Subjects will participated in a training course for 8 weeks. Measurement of pain, functional disability, range of motion, electromyographic data and blood samples will be performed before and after intervention .
Participants/Inclusion and exclusion criteria
1-Male participants with Age 25-55 years old 2-Mild to moderate lumbar pain intensity with visual analog scale 2 to 7 and severity of disc herniation with grade 1 and 2 (bulging and protrusion) 3-History of low back pain for more than 3 months 4-Not having neurological diseases, cancer, diabetes and any disease affecting on treatment process 5-Not participating in regular sports exercises 6-Not using other treatments for low back pain
Intervention groups
First Intervention group : Core stability exercises for 8 weeks. them as: bridging, push-up, inverted row, oblique sit-up, femur abduction, femur flexion and plank. Second Intervention group: Suspension exercises for 8 weeks which are similar to the first group in suspension model. Control group: Self-care methods at home
Main outcome variables
Plasma beta-endorphin, functional disability, muscle activity

General information

Reason for update
Acronym
EMG
IRCT registration information
IRCT registration number: IRCT20191016045136N1
Registration date: 2020-08-21, 1399/05/31
Registration timing: retrospective

Last update: 2020-08-21, 1399/05/31
Update count: 0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
yasser mohebbi rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 4093
Email address
yaser.mr2003@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of core stability and suspension exercise on some EMG coordinates, beta-endorphin and functional disability in people with lumbar disc herniation
Public title
Comparison of core stability and suspension exercise in people with lumbar disc herniation
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate lumbar pain intensity with a visual analog scale score between 2-7 and severity of disc herniation with grade 1 and 2 (bulging and protrusion) History of low back pain for more than three months Not having specific diseases such as neurological diseases, cancer, diabetes, osteoporosis, etc. Not participating in regular exercise means 3 sessions per week for at least one year Not using other treatments for low back pain during the intervention
Exclusion criteria:
Absences in training More than two session Dissatisfaction with continuing training Getting Illness or injury during the intervention period
Age
From 25 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization, Individual, random allocation roll, Sequentially numbered, sealed, opaque envelopes (The names are written on a piece of paper and placed in similar envelopes. Then they are randomly placed in containers 1, 2 and 3 as a mark of 3 groups)
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 Islamic Azad University-Rasht Branch
Street address
Navab Tower- Navab Street- Golsar Crossroad
City
Rasht
Province
Guilan
Postal code
4163774654
Approval date
2020-06-22, 1399/04/02
Ethics committee reference number
IR.IAU.RASHT.REC.1399.019

Health conditions studied

1

Description of health condition studied
Lumbar disc herniation
ICD-10 code
M51.26
ICD-10 code description
Other intervertebral disc displacement, lumbar region

Primary outcomes

1

Description
Plasma beta endorphin
Timepoint
12 hours before and after intervention
Method of measurement
Blood sample- ELISA (Enzyme-linked immunosorbent)

2

Description
Functional disability
Timepoint
Before and after intervention
Method of measurement
Oswestry disability index

3

Description
Muscles activity
Timepoint
Before and after intervention
Method of measurement
Electromyography

Secondary outcomes

1

Description
Pain
Timepoint
Before and after intervention
Method of measurement
Mcgill pain questionnaire

2

Description
Lumbar range of motion
Timepoint
Before and after intervention
Method of measurement
Modified Schöber test

Intervention groups

1

Description
First Intervention group : core stability exercises for 8 weeks, 3 sessions per week including warm-up (5 minute), exercise (40 minute) and cool down (5 minute). Exercises include bridging (5 repetitions in form of movement-hold-back with 2-3-2 seconds and 1 minute rest between repetitions), push-up (Similar to the first case), inverted row (Similar to the first case), oblique sit-up (Similar to the first case), femur abduction (Similar to the first case), femur flexion (Similar to the first case) and plank (1 repetition with 10 seconds hold). There are 1 minute rest between each workout and the next
Category
Rehabilitation

2

Description
Second Intervention group: Suspension exercises for 8 weeks, 3 sessions per week including warm-up (5 minute), exercise (40 minute) and cool down (5 minute). Exercises include suspension bridging (5 repetitions in form of movement-hold-back with 2-3-2 seconds and 1 minute rest between repetitions), suspension push-up (Similar to the first case), suspension inverted row (Similar to the first case), suspension oblique sit-up (Similar to the first case), suspension femur abduction (Similar to the first case), suspension femur flexion (Similar to the first case) and suspension plank (1 repetition with 10 seconds hold). There are 1 minute rest between each workout and the next
Category
Rehabilitation

3

Description
Control group: Self-care methods at home (Such as how to properly sit, sleep and carry and lift loads)
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Pardis physiotherapy clinic
Full name of responsible person
Yasser Mohebbi Rad
Street address
Navab Tower, Navab Street, Golsar Crossroads
City
Rasht
Province
Guilan
Postal code
4163774654
Phone
+98 13 3212 4093
Email
yaser.mr2003@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammadreza Fadaei Chafi
Street address
Number 3, Golestan Bulding, Siadati Alley, Mellat Street,
City
Rasht
Province
Guilan
Postal code
4144643199
Phone
+98 13 3211 7387
Email
mfadaei2000@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University- Rasht Branch
Proportion provided by this source
1
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Yasser Mohebbi Rad
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Navab Tower, Navab Street, Golsar Crossroads
City
Rasht
Province
Guilan
Postal code
4163774654
Phone
+98 31 3212 4093
Fax
Email
yaser.mr2003@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Yasser Mohebbi Rad
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Navab Tower, Navab Street, Golsar Crossroads
City
Rasht
Province
Guilan
Postal code
4163774654
Phone
+98 31 3212 4093
Fax
Email
yaser.mr2003@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Yasser Mohebbi Rad
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Navab Tower, Navab Street, Golsar Crossroads
City
Rasht
Province
Guilan
Postal code
4163774654
Phone
+98 31 3212 4093
Fax
Email
yaser.mr2003@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Part of the data, such as primary and secondary outcome information is shared
When the data will become available and for how long
Access starts 12 months after the results are published
To whom data/document is available
Researchers from academic institutions and medical therapists
Under which criteria data/document could be used
There are no other conditions
From where data/document is obtainable
Send request to email yaser.mr2003@gmail.com
What processes are involved for a request to access data/document
First, the official request should be sent to the e-mail and after confirmation, other documents such as ID card and university confirmation documents should be sent. Data documents will be sent in less than a month after verification
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