The impact of six weeks of combined rotator cuff retraining exercises with vibration exercises on pain, strength ratio, proprioception, grip strength, and scapular kinematics in handball players with shoulder impingement syndrome.
The aim of this study is to investigate the effect of rotator cuff and vibration training exercises on pain, strength ratio, proprioceptive sensation, grip strength, and shoulder kinematics of handball players with shoulder impingement syndrome. Translate to English
Design
This study involves three groups where subjects will be randomly assigned using simple randomization and randomization software. Additionally, this study will be conducted as a double-blind trial.
Settings and conduct
The research is designed as a pre-test and post-test, quasi-experimental, and applied study. The study will be conducted on male handball players with shoulder impingement syndrome in Isfahan Province, Isfahan City.
Participants/Inclusion and exclusion criteria
inclusion criteria: Normal Body Mass Index (BMI) 2. Membership in Provincial Teams: 4. Pain Score Between 3 to 7 out of 106. Presence of Impingement Syndrome Symptoms
7. Average Duration of Syndrome Symptoms: The average duration of syndrome symptoms is 16 months (range of 4 to 36 months).
exclusion criteria:History of Neck and Arm Pain:The individual has a history of neck and arm pain in the past or present....
2.Previous Shoulder Impact Injury:The individual has had a previous impact injury in the shoulder area
4.Referred Pain from Cervical and Thoracic Spine:The individual has referred pain from the cervical and thoracic spine.
5.Shoulder Joint Instability:The individual has instability in the shoulder joint
6..Use of Glucocorticoids:The individual has had a glucocorticoid injection in the shoulder in the past three months
Intervention groups
In this study, the subjects are divided into three groups: 1. Retraining exercises 2. A combination of retraining and vibration exercises 3. Control.
Main outcome variables
Pain, Strength ratio, Scapula Kinematic, Strength Grip and Proprioception
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200314046777N1
Registration date:2024-07-07, 1403/04/17
Registration timing:prospective
Last update:2024-07-07, 1403/04/17
Update count:0
Registration date
2024-07-07, 1403/04/17
Registrant information
Name
Mojtaba Babaei khorzoghi
Name of organization / entity
Isfahan University of technology
Country
Iran (Islamic Republic of)
Phone
+98 31 3391 2940
Email address
babaei@iut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-15, 1403/05/25
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of six weeks of combined rotator cuff retraining exercises with vibration exercises on pain, strength ratio, proprioception, grip strength, and scapular kinematics in handball players with shoulder impingement syndrome.
Public title
The effect of rotator cuff retraining and vibration exercises on various shoulder and scapular components in handball players with shoulder impingement syndrome.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Normal Body Mass Index (BMI):Having a BMI within the normal range. Membership in Provincial Teams: .
2.ctive membership in one of the provincial-level teams for at least the past three years.
3.A Presence of Activity-Limiting Pain: Having pain that has limited sports activity for more than a week or requires treatment.
4. Pain Score Between 3 to 7 out of 10:Having a pain score between 3 to 7 out of 10
5. Occurrence of Shoulder Pain in the Subacromial Region: Experiencing pain in the subacromial region of the shoulder.
6. Presence of Impingement Syndrome Symptoms: Symptoms of impingement syndrome, including recurrent shoulder pain with overhead arm movements accompanied by shoulder rotation.
7. Average Duration of Syndrome Symptoms: The average duration of syndrome symptoms is 16 months (range of 4 to 36 months).
Exclusion criteria:
1.History of Neck and Arm Pain:The individual has a history of neck and arm pain in the past or present....
2.Previous Shoulder Impact Injury:The individual has had a previous impact injury in the shoulder area
3.Neurological Diseases:The individual has neurological diseases
4.Referred Pain from Cervical and Thoracic Spine:The individual has referred pain from the cervical and thoracic spine.
5.Shoulder Joint Instability:The individual has instability in the shoulder joint
6..Use of Glucocorticoids:The individual has had a glucocorticoid injection in the shoulder in the past three months
7.Undergoing Other Treatments:The individual is undergoing other treatments to reduce pain and improve function.
Age
From 20 years old to 32 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study is of the simple randomization type. Each individual was assigned a number from 1 to 45 and was randomly divided into three study groups using the Randomizer+ Random Pick software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is done in such a way that the outcome assessor and data analyst, without knowledge of group allocation, will only assess the variable and analyze the received data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of the Isfahan Islamic Azad University, Khorasgan Branch, .
Street address
School of Nursing and Midwifery, Islamic Azad University( Khorasgan Branch), University Boulevard, Arghavanieh, Eastern Jey Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.412
Health conditions studied
1
Description of health condition studied
Shoulder Impingement syndrome
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder
Primary outcomes
1
Description
Pain
Timepoint
Before and after 6 weeks
Method of measurement
Pain in the calf is measured using a visual analog scale (VAS). A 100 mm line is drawn where 0 indicates no pain and 10 represents the maximum pain intensity. Participants mark their level of pain over the past 24 hours by placing stickers on the line corresponding to their perceived pain intensity. The distance in millimeters from the starting point to the sticker is measured to quantify the pain intensity. Measurements in the range of 0-10 mm indicate no pain, 10-30 mm indicate mild pain, 40-60 mm indicate moderate pain, and 70-100 mm indicate severe pain.
2
Description
Strength
Timepoint
Before and after 6 weeks
Method of measurement
Position the subject comfortably with the shoulder in a standardized position (e.g., 90 degrees shoulder abduction and 90 degrees elbow flexion). Place the dynamometer next to the wrist or hand to prevent unnecessary movements during the test. The subject performs a maximal voluntary contraction (MVC) of the shoulder rotator muscles (e.g., internal or external rotation). The dynamometer records the peak force generated during the contraction, providing a quantitative measure of muscle strength
3
Description
Grip Strength
Timepoint
Before and after 6 weeks
Method of measurement
To measure grip strength using a hand dynamometer, the subject should stand with their head in a neutral position, looking straight ahead, and hold the dynamometer's handle. To adjust the dynamometer handle, the subject is instructed to position the angle between the second and third phalanges of the middle finger vertically. For the test, the subject may position their forearm at any angle from 90 to 180 degrees, while the entire arm should hang down and be perpendicular to the ground. The examiner will instruct the subject using four commands (Ready, Start, Squeeze as hard as you can, and Stop). Two consecutive trials will be performed for each hand, with a one-minute rest between each trial. The examiner will record the score of each trial in kilograms and round the scores.
4
Description
Proprioception
Timepoint
Before and after 6 weeks
Method of measurement
Proprioception of the shoulder joint will be measured using the angle reproduction test and a goniometer. For the angle reproduction test, the subject will lie supine, and the examiner will apply pressure to the anterior shoulder joint to ensure the scapula is stabilized. The target angles for this test are 45 degrees and 80 degrees of external rotation. To minimize the use of tactile sense, the subject's elbow will be positioned about 10 centimeters off the edge of the table. To eliminate visual input, the subject's eyes will be covered with a blindfold during the entire test. In this test, the examiner will first move the subject's arm to 90 degrees of abduction and the elbow to 90 degrees of flexion, then passively rotate the arm to one of the two target angles (45 degrees or 80 degrees of external rotation) randomly. The subject will be asked to hold and memorize this position for five seconds. Then, the examiner will passively return the arm to the starting position. After a five-second pause, the subject will be asked to actively reproduce the target angles.
5
Description
Scapula kinematic
Timepoint
Before and after 6 weeks
Method of measurement
To evaluate scapular kinematics, two inclinometers are used. One is fixed on the distal and lateral part of the arm, above the lateral epicondyle, with tape, and the other is placed on the scapular spine. The starting position for the arm is at rest, slightly externally rotated, and the inclinometers are calibrated in this position. The subject is then asked to abduct their arm and hold it at 15, 30, 45, and 90 degrees, and at the end of the range of motion. At each angle, the reading from the inclinometer on the scapula is recorded.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: rotator cuff retraining exercises for 6 weeks (3 sessions per week and each session lasts 60 minutes).The goal of utilizing rotator cuff exercises is to restore muscle strength and correct movement patterns to achieve proper motion and suitable range of motion. A resistance band will be used to implement the retraining exercise protocol, and the exercises will be performed slowly throughout the protocol period. The exercise regimen was carried out over six weeks, with three sessions per week. Each exercise session included 3 sets of 10 repetitions, with each repetition involving a 5-second hold . These exercises include external rotation, internal rotation, shoulder flexion, and shoulder extension.
Category
Rehabilitation
2
Description
Intervention group: combined rotator cuff retraining exercises with vibration exercises for 6 weeks (3 sessions per week and each session lasts 60 minutes).The vibration exercise protocol is performed using the Bodyblade vibrating rod. The vibrating rod is a flexible polycarbonate rod that is 120 cm long and weighs .68g. These exercises are performed in three planes: sagittal, frontal, and transverse.
Category
Rehabilitation
3
Description
Control group: With out intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Parvaz Sports Complex
Full name of responsible person
Mojtaba Babaei Khorzoghi
Street address
End of Shahid Kalini Street (Mardavij), Parvaz Sports Complex.
City
Isfahan
Province
Isfehan
Postal code
8166865961
Phone
+98 913 212 7291
Email
babaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Taghiani
Street address
University Blvd, Arghvanieh, East J St., Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
toghiani@hotmail.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
Proportion provided by this source
1
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Technology
Full name of responsible person
Mojtaba Babaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Sciences
Street address
Physicals Education Center, Isfahan University of Technology, University Boulevard, Esteghlal Square, Isfahan, Iran,
City
Isfahan
Province
Isfehan
Postal code
8415683111
Phone
+98 31 3391 2511
Email
Babaei@iut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of technology
Full name of responsible person
Mojtaba Babaei khorzoghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport injury and corective exercise
Street address
Center of Physical Education, isfahan University of technology, emam khomini ave
City
Isfahan
Province
Isfehan
Postal code
8415683111
Phone
+98 31 3391 2940
Fax
Email
babaei@iut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of technology
Full name of responsible person
Mojtaba Babaei khorzoghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport injury and corective exercise
Street address
Center of Physical Education, isfahan University of technology, emam khomini ave
City
Isfahan
Province
Isfehan
Postal code
8415683111
Phone
+98 31 3391 2940
Fax
Email
babaei@iut.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
Not applicable
Informed Consent Form
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data related to people who participate as a sample in this research will be shared after de-identification.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The documents of this research are available to researchers working in academic institutions, physiotherapists and physical medicine specialists.
Under which criteria data/document could be used
In order to prevent harm, in the centers where there are people with the problem mentioned in the research.