Protocol summary

Study aim
Comparison of the effect of forward and reverse therapeutic exercises of the serratus anterior muscle on the position of the scapula electromyographic activity of this muscle
Design
Clinical trial with two intervention groups, parallel groups, single-blind, randomized, 24 participants, randomization is done using concealed envelopes. Each of the participants is required to choose randomly from two concealed envelopes (forward group or reverse group). According to the selected envelope, the group of people is determined.
Settings and conduct
The location of the study is the Motion Analysis Laboratory of Tarbiat Modares University. In order to record the electrical activity of the muscles and the position of the scapula, the Mayon electromyography device and the Vicon motion analysis device are used. The study is a randomized single-blind. In this way, the participants choose one of the closed envelopes and hand it to the researcher without looking inside. The researcher is not blind and is aware of the groupings and interventions. The participants are evaluated at the beginning and in the next stage they are treated for 3 weeks according to the program. Finally, in order to check the effects of the intervention, they are re-evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Positive lateral scapular slide test Diagnosis of type 1 and 2 scapular dyskinesis based on Kibler's division Exclusion criteria: History of surgery and traumatic events of shoulder girdle in the last 6 months Received scapula or shoulder treatment in the past 6 months
Intervention groups
The participants of the first group are given the reverse Serratus anterior exercise and the participants of the second group are given the forward Serratus anterior exercises.
Main outcome variables
Position of the scapula; Shoulder girdle pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230215057431N1
Registration date: 2023-05-07, 1402/02/17
Registration timing: prospective

Last update: 2023-05-07, 1402/02/17
Update count: 0
Registration date
2023-05-07, 1402/02/17
Registrant information
Name
Omid Abouzari Rayhani
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 6661 7885
Email address
omid.abouzari@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of forward and reverse serratus anterior muscle therapeutic exercises on electromyographic activity and static and dynamic position of scapula in scapular dyskinesis
Public title
Comparison of the effects of forward and reverse therapeutic exercises of the serratus anterior muscle in the treatment of scapula dyskinesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men between the ages of 20 and 40 Body mass index between 18.5 and 24.9 Presence of pain between 3 and 5 based on VAS in the scapula region Muscle strength of at least 4 for the serratus anterior, upper trapezius, middle trapezius, lower trapezius and deltoid muscles based on Kendall's criteria Positive lateral scapular slide test Diagnosis of type 1 and 2 scapular dyskinesis based on Kibler's division (inferior angle prominence - medial border prominence)
Exclusion criteria:
Missing one of the inclusion criteria Patients with rheumatoid arthritis Patients with neurological disorders Patients with scoliosis History of surgery and traumatic events of shoulder girdle in the last 6 months Rotator cuff tear Received scapula or shoulder treatment in the past 6 months Individuals with pectoralis minor shortness Other serious musculoskeletal disorders such as cervical disc herniation Reluctance of people to participate and continue treatment for any reasons
Age
From 20 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple Randomization Unit: Individual Randomization tool: Concealed envelope This study is single-blind and individuals are not aware of the group they are in.
Blinding (investigator's opinion)
Single blinded
Blinding description
Study participants are blinded. In this way, they are placed in one of the two groups through the selection of the concealed envelope, and they are not aware of which of the intervention groups they are in.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Tarbiat Modares University
Street address
Tehran, Jalale Alahmad, Nasr bridge
City
Tehran
Province
Tehran
Postal code
331-14115
Approval date
2023-04-29, 1402/02/09
Ethics committee reference number
IR.MODARES.REC.1402.009

Health conditions studied

1

Description of health condition studied
Scapular dyskinesis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Internal rotation of the scapula in degrees
Timepoint
Before the start of the intervention and 2 days after the end of the intervention
Method of measurement
Vicon motion analysis device

Secondary outcomes

1

Description
Pain based on Visual Analog Scale
Timepoint
Before the intervention and 2 days after the intervention
Method of measurement
Visual Analogue Scale

2

Description
Anterior tilt of the scapula in degrees
Timepoint
Before the intervention and 2 days after the intervention
Method of measurement
Vicon motion analysis device

3

Description
Electromyographic activity of the serratus anterior muscle in terms of RMS and Peak RMS
Timepoint
Before the intervention and 2 days after the intervention
Method of measurement
Mayon electromyography device

Intervention groups

1

Description
Intervention group: Participants in the first group are given reverse serratus anterior exercises. The exercises in the first group are performed without applying any external forces, such as weights, Thera bands, etc. The progress of the exercises in the first group will happen by increasing the repetition of the exercises and increasing the hold time. At the beginning of the exercises, the number of repetitions of each exercise is 6 times per session and hold for 2 seconds each time, which eventually reaches 10 times and holds for 10 seconds each time with the progress of the treatment program. Training sessions start with 3 sets, and in order to comply with the principle of overload, 2 sets are added to the number of previous sets at the beginning of each week. The number of training sessions is 3 times a day and the duration of the treatment period is 3 weeks. How to perform exercise 1: To perform this exercise, we ask the person to place the upper limb in 90 degrees of abduction and 45 degrees posterior to the frontal plane and take fixed surface. After ensuring the correct positioning of the upper limb, the person is taught to rotate the trunk to the involved side while keeping the head and neck stable and looking at a fixed point at eye level on the opposite wall. Move sternum upwards and do a deep inhale and exhale at the same time. How to perform exercise 2: To perform this exercise, while the upper limb is placed next to the body and in anatomical position, both upper limbs should be extended by 30 degrees and take a fixed surface, and at the same time, while the head and neck are fixed and He looks at the opposite wall at a fixed point at the level of the eyes, moves the sternum upwards and simultaneously inhales and exhales deeply. How to do exercise 3: To do this exercise, the person is taught to keep his head and neck fixed when the upper limb is at 130 degrees of abduction and take a fixed surface and look at a fixed point at the level of the eyes. Then while moving the sternum upwards and rotating the trunk to the affected side, inhale and exhale deeply at the same time.
Category
Rehabilitation

2

Description
Intervention group: Participants in the second group are given Forward Serratus Anterior exercises. The exercises in the second group are performed without applying any external forces, such as weights, Thera bands, etc. The progress of the exercises in the second group will happen by increasing the repetition of the exercises and increasing the hold time. At the beginning of the exercises, the number of repetitions of each exercise is 6 times per session and hold for 2 seconds each time, which eventually reaches 10 times and holds for 10 seconds each time with the progress of the treatment program. Training sessions start with 3 sets, and in order to comply with the principle of overload, 2 sets are added to the number of previous sets at the beginning of each week. The number of daily training sessions is 3 times and the duration of the treatment period is 3 weeks. How to perform the Dynamic hug plus exercise: To perform this exercise, the shoulders should be in 60 degrees of abduction and the elbows should be in 45 degrees of flexion. Then the arms are moved forward and inward. When the arms are straight in the midline, the person is asked to move their arms further forward with an additional force. How to perform Wall slide exercise: To perform this exercise, a person must stand facing the wall and put his forearm and elbow in contact with the wall while the upper limbs are shoulder width apart. Then the person is asked to raise his hands slowly with the help of the wall up to about 150 degrees and bring them back. How to perform Side-lying forward flexion: To perform this exercise, the person is side-lying and raises his arm from the side of the trunk to the end of the flexion range of motion.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tarbiat Modares University
Full name of responsible person
Omid Abouzari Rayhani
Street address
Tehran, Jalale Alahmad, Nasr bridge
City
Tehran
Province
Tehran
Postal code
3169918833
Phone
+98 21 6510 2951
Email
omid.abouzari@modares.ac.ir
Web page address
https://modares.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Omid Abouzari Rayhani
Street address
Block Five West, Noor One complex, Saadi street, Sarasiab, Malard
City
Malard
Province
Tehran
Postal code
3169918833
Phone
+98 21 6510 2951
Email
omid.abouzari@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
20
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
Tarbiat Modares University
Full name of responsible person
Omid Abouzari Rayhani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Block Five West, Noor One complex, Saadi street, Sarasiab, Malard
City
Malard
Province
Tehran
Postal code
3169918833
Phone
+98 21 6510 2951
Email
omid.abouzari@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Omid Abouzari Rayhani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Block Five West, Noor One complex, Saadi street, Sarasiab, Malard
City
Malard
Province
Tehran
Postal code
3169918833
Phone
+98 21 6510 2951
Email
omid.abouzari@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Omid Abouzari Rayhani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Block Five West, Noor One complex, Saadi street, Sarasiab, Malard
City
Malard
Province
Tehran
Postal code
3169918833
Phone
+98 21 6510 2951
Email
omid.abouzari@modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"There is no further information"
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data can be shared, such as the position of the scapula, the electromyographic activity of the muscles, and the amount of pain.
When the data will become available and for how long
The access period starts 6 months after the results are published. Unlimited period of access.
To whom data/document is available
All researchers and people working in the field of treatment.
Under which criteria data/document could be used
There are no other special criteria.
From where data/document is obtainable
oar1377@gmail.com
What processes are involved for a request to access data/document
Examining the mentioned conditions for a maximum length of one month.
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