Protocol summary

Study aim
This study is conducted with the aim of evaluating the effectiveness of RNS with and without taping exercises on improving the condition of shoulder impingement syndrome and reducing its symptoms.
Design
This clinical trial consists of three groups: the first group receives RNS exercises, the second group receives a combination of RNS exercises and taping, and the third group is the control group.
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
1.Normal Body Mass Index (BMI). 2. Membership in Provincial Teams 3. Pain Score Between 3 to 7 out of 10 4. Presence of Impingement Syndrome Symptoms: 5. Average Duration of Syndrome Symptoms: The average duration of syndrome symptoms is 16 months (range of 4 to 36 months). exclusions criteria: History of Neck and Arm Pain: 2.Previous Shoulder Impact Injury 3.Referred Pain from Cervical and Thoracic Spine 4.Shoulder Joint Instability 5.Use of Glucocorticoids: The individual has had a glucocorticoid injection in the shoulder in the past three months
Intervention groups
The reflexive neuromuscular stabilization exercise program consists of three sessions per week. Scapular retraction was the first exercise in this program. The Reach, Roll, and Lift technique and the Pillow Press technique are two techniques included in the final phase of the reactive neuromuscular stabilization exercises. The taping protocol in this study is applied to three muscles, specifically the supraspinatus, deltoids, and teres minor Which in the second group is combined with RNS exercises. The control group does not receive any specific intervention.
Main outcome variables
Pain. Muscle strength ratio, Scapula Kinematic

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200314046777N2
Registration date: 2024-07-10, 1403/04/20
Registration timing: prospective

Last update: 2024-07-10, 1403/04/20
Update count: 0
Registration date
2024-07-10, 1403/04/20
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
2024-07-20, 1403/04/30
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of reflex neuromuscular stabilization exercises with and without taping on strength ratio, pain and scapula kinematics in youth handball boys with shoulder impingement syndrome
Public title
Comparing the effects of reflexive neuromuscular stabilization exercises with and without taping on the shoulder of handball players with shoulder impingement syndrome.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Youth handball boys With shoulder impingement syndrome With an active membership in handball teams in the past three year
Exclusion criteria:
History of surgery in the past year Having a history of collision injury in the shoulder area The presence of instability in the shoulder joint.
Age
From 13 years old to 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
After the survey shoulder impingement syndrome, the candidates are enrolled in the study, and after the examination, based on the criteria of entry and exit from the study, 36 youth handball players are selected as a sample. 36 samples are selected through available sampling and randomly divided into one of 3 groups: RNS training (12 people), combined RNS and Taping training (12 people) and control (12 people). Randomization is done by block method . In this way, the samples are randomized in the form of 3:3:3 blocks in each of the studied groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware of which group they belong to, and exercises are conducted on different days.
Placebo
Not used
Assignment
Other
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.1402.411

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
In this study, the Visual Analog Scale (VAS) is used to measure the intensity of pain in the participants. The VAS is set up as a straight line, with one end representing the reference point for a pain-free state, marked as zero. The other end of the line represents the maximum possible pain, marked as one hundred. Participants use this scale to indicate their pain intensity. For example, if a participant experiences a highly painful sensation that is rated as 70 on the VAS, it means that their pain intensity is 70 out of 100.

2

Description
Strength Ratio
Timepoint
Before and after 6 weeks
Method of measurement
The strength of internal and external rotators is measured in two positions: the neutral position (0 degrees shoulder abduction) and the 45 degrees shoulder abduction position. For all measurements, the dynamometer is placed on the styloid process of the ulna. Each test is repeated three times, and the highest strength value is recorded as the strength measurement. Participants are allowed a 3-minute rest between each test.

3

Description
Scapula kinematic
Timepoint
Before and after 6 weeks
Method of measurement
Two inclinometers are used for measuring kinematics. One inclinometer is placed on the distal lateral arm, above the lateral epicondyle of the humerus, and is secured with tape. The other inclinometer is placed on the scapular spine. Initially, the arm is positioned in a resting state, slightly externally rotated relative to the body, to calibrate the inclinometers. Then, the participant is asked to abduct (raise) the arm and hold it at specific angles of 45°, 90°, and 135°. At each angle, the readings from the scapular inclinometer are recorded.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Reflex Neuromuscular Stabilization exercises
Category
Rehabilitation

2

Description
Intervention group: Reflex Neuromuscular Stabilization exercises with taping
Category
Rehabilitation

3

Description
Control group: Without Intervention
Category
Other

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
Isfahan 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
Academic

Person responsible for general 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
841563111
Phone
+98 31 3391 2940
Fax
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
Undecided - It is not yet known if there will be 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
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, Handball federation and sports coaches.
Under which criteria data/document could be used
Responsible people in sports in order to prevent injury, educational centers where there are people with problems mentioned in the research.
From where data/document is obtainable
Mojtaba Babaei phone: 00989131705676 Email: babaei@itu.ac.ir
What processes are involved for a request to access data/document
Checking the application, checking the applicant's documents, sending the required documents
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