IRCT | Comparison of the effect of six weeks of open and closed shoulder kinetic chain exercises and core stability on pain, proprioception, strength and electrical activity of muscles in people with shoulder impingement syndrome.

Protocol summary

Study aim: Comparison of the effect of six weeks of open and closed shoulder kinetic chain exercises and core stability on pain, proprioception, strength and electrical activity of muscles in people with shoulder impingement syndrome
Design: A randomized clinical trial study, single-blind, parallel-group,45 randomized to 2 intervention groups and a control group through web-based randomization
Settings and conduct: After evaluation by a physician, and inclusion-exclusion criteria, the researcher records the personal information of patients with the signed consent form. Participants are divided into two groups intervention and control groups. This study was single-blind and the outcome assessor is blind to interventions and groups. This study will be conducted in the laboratory of movement analysis, at Kharazmi University. The protocols are 6 weeks and three 60-minute sessions per week
Participants/Inclusion and exclusion criteria: Entry requirements: Athletes aged 18-30, confirmation from the relevant physician for the diagnosis of shoulder impingement syndrome and having general health (physical and mental health), positive Hawkins-Candy test, and Empty can. Exclusion requirements: abnormalities or injuries affecting research, surgeries, shoulder girdle fractures during interventions, and participation in exercise therapy for shoulder impingement syndrome in the past year
Intervention groups: Intervention group 1: Closed chain exercises of the shoulder and the blind three sessions per week for 6 weeks. Intervention group 2: Open chain exercises of the shoulder and the blind three sessions per week for 6 weeks. The duration of each session is 60 minutes and a 10-minute warm-up and cool-down program is considered for each session. The control group does not do an exercise program and only does daily activity during this period.
Main outcome variables: Electromyography, Pain, Proprioception. Muscle Strength

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20180627040251N9

Registration date: 2025-01-30, 1403/11/11

Registration timing: prospective

Last update: 2025-01-30, 1403/11/11

Update count: 0
Registration date: 2025-01-30, 1403/11/11

Registrant information: Name

Hassan Sadeghi

Name of organization / entity

Kharazmi University

Country

Iran (Islamic Republic of)

Phone

+98 21 2222 8001

Email address

hassan.sadeghi81@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2025-02-03, 1403/11/15
Expected recruitment end date: 2025-03-19, 1403/12/29
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the effect of six weeks of open and closed shoulder kinetic chain exercises and core stability on pain, proprioception, strength and electrical activity of muscles in people with shoulder impingement syndrome.

Public title: The effect of open and closed chain exercises on shoulder pain and strength in individuals with impingement
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Athlete 18-30 years old Confirmation of the relevant doctor to identify shoulder impingement syndrome and having general health (physical and mental health)Pain 7-3 based on VAS scale Having a body mass index between 19 and 25The positivity of Empty can and Hawkins Kennedy tests

Exclusion criteria:

Having any abnormality or injury that could affect the research process, having a history of dislocation and fracture, having uncontrolled pain, having surgery and any fracture in the shoulder girdle, in case of injury during the interventions, not consenting to participate in the research, participating in jet therapy exercise courses, shoulder impingement syndrome in the past year.
Age: From 18 years old to 30 years old
Gender: Both

Phase

N/A

Groups that have been masked

Outcome assessor

Sample size

Target sample size: 45

Randomization (investigator's opinion)

Randomized

Randomization description

After the initial evaluation, randomization was done using randomization blocks of 4 methods. Patients are randomly assigned to one of two groups through four random blocks. A member of the research team who is not involved in the selection of samples will determine the randomization sequence using an online randomization system (randomizer.org). Participants will be notified of their group allocation with a sealed envelope

Blinding (investigator's opinion)

Single blinded

Blinding description

In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of Kharazmi University

Street address

No. 43., Shahid Moftah St., Tehran

City

tehran

Province

Tehran

Postal code

1491115719
Approval date: 2024-06-22, 1403/04/02
Ethics committee reference number: IR.KHU.REC.1403.036

Health conditions studied

1

Description of health condition studied: Shoulder impingement
ICD-10 code: M75.4
ICD-10 code description: Impingement syndrome of shoulder

Primary outcomes

1

Description: Electromyography
Timepoint: The beginning of the study and the end of the study
Method of measurement: Electromyography device

Secondary outcomes

1

Description: pain
Timepoint: The beginning of the study and the end of the study
Method of measurement: visual analog scale (VAS)

2

Description: Muscle strength
Timepoint: The beginning of the study and the end of the study
Method of measurement: Isokinetic device

3

Description: Proprioception
Timepoint: The beginning of the study and the end of the study
Method of measurement: Isokinetic device

Intervention groups

1

Description: Intervention group: In the group of combined shoulder and blind chain exercises, in this group, people perform four exercises of shoulder exercises in open chain and four exercises of blind exercises in 6 weeks.
Category: Rehabilitation

2

Description: Intervention group: Intervention group: In the group of closed shoulder and blind chain exercises, in this group, people perform four exercises of shoulder exercises in closed chain and four exercises of blind exercises in 6 weeks.
Category: Rehabilitation

3

Description: Control group: This group does not receive training or intervention during the study period.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Khwarazmi University, Karaj branch

Full name of responsible person

Atefeh Hassanzadeh Imamqoli

Street address

Faculty of Physical Education and Sports Sciences, Kharazmi University,, University Square, at the end of Shahid Beheshti St. Karaj

City

karaj

Province

Alborz

Postal code

3197937551

Phone

+98 26 3457 9600

Fax

Email

info@khu.ac.ir

1

Sponsor: Name of organization / entity

Kharazmi University

Full name of responsible person

Dr Mohammad Delnavaz

Street address

Vice-Chancellor for Research and Technology., No. 43., South Mofatteh Ave., Tehran

City

Tehran

Province

Tehran

Postal code

15719-14911

Phone

+98 21 2222 8001

Fax

Email

Delnavaz@khu.ac.ir

Web page address

https://research.khu.ac.ir/en
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Kharazmi University
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

Kharazmi University

Full name of responsible person

atefe hasanzade imamgholi

Position

student

Latest degree

Bachelor

Other areas of specialty/work

sport injuries and corrective exercises

Street address

Faculty of Physical Education and Sports Sciences., Kharazmi University., University Square., at the end of Shahid Beheshti St., Karaj

City

Karaj

Province

Alborz

Postal code

۹۱۸۵۹۶۳۱۵۸

Phone

+98 939 233 0436

Email

atefe.hasanzade213@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Kharazmi University

Full name of responsible person

Hassan Sadeghi

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Sport Medicine

Street address

Faculty of Physical Education and Sports Sciences., Shahid Keshvari Complex., Shahid Hesari St., Mirdamad., Tehran

City

Tehran

Province

Tehran

Postal code

1544733111

Phone

+98 21 2222 8001

Fax

Email

hassan.sadeghi81@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Kharazmi University

Full name of responsible person

Hassan Sadeghi

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Sport Medicine

Street address

Faculty of Physical Education and Sports Sciences., Shahid Keshvari Complex., Shahid Hesari St., Mirdamad., Tehran

City

Tehran

Province

Tehran

Postal code

1544733111

Phone

+98 21 2222 8001

Fax

Email

hassan.sadeghi81@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be 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: Not applicable
Analytic Code: Not applicable
Data Dictionary: Not applicable
Title and more details about the data/document: The personal data of people is a personal matter and if the people give permission, this data will be published, and if people do not give permission to publish this data, it will remain confidential.
When the data will become available and for how long: Access starts 6 months after results are published
To whom data/document is available: Academic researchers and those who are engaged in research in this field
Under which criteria data/document could be used: The data of this research is made available to researchers for all review research and meta-analysis
From where data/document is obtainable: To the email address: atefe.hasanzade213@gmail.com
What processes are involved for a request to access data/document: It will be available to the applicant after 10 to 15 days after sending an email to the said address
Comments

Comparison of the effect of six weeks of open and closed shoulder kinetic chain exercises and core stability on pain, proprioception, strength and electrical activity of muscles in people with shoulder impingement syndrome.