- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05966298
Investigation of the Effectiveness of Core Stabilization Training in Patients With Subacromial Impingement Syndrome
August 21, 2025 updated by: Eren Ozen, Bandırma Onyedi Eylül University
Investigation of The Efficacy of Core Stabilization Training in Patients With Subacromial Impingement Syndrome: A Randomized Controlled Study
Subacromial Impingement Syndrome (SIS) is one of the most common shoulder problems.
The core region is considered a kinetic link that facilitates the transfer of torque and angular momentum between the upper and lower extremities during body movements.
The decrease in core stabilization affects both trunk control and the quality of extremity movements depending on the kinetic chain in the body.
The improvement in core stabilization balances the load transfer between the trunk and the extremities and reduces the asymmetry between the extremities.
Core stabilization training should be included in rehabilitation programs as core stabilization is adversely affected in patients with SIS.
For this reason, this study was planned to examine the effects of core stabilization training applied in addition to conventional treatment in patients with SIS on pain, range of motion, shoulder muscles strenght and core stability.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Balıkesir
-
Bandırma, Balıkesir, Turkey (Türkiye), 10200
- Eren Özen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being diagnosed with subacromial impingement syndrome,
- Being between the ages of 18-65,
- Not having received medical treatment,
- Not having received a shoulder-related physiotherapy program in the last 1 year,
- Not having undergone any shoulder-related surgery,
- Being able to read and understand Turkish
Exclusion Criteria:
- Neurological deficits of the upper extremity and the presence of another orthopedic disease, rheumatic and congenital disease other than CNS
- Presence of mental problems,
- To have received corticosteroid treatment in the last year,
- Having cardiovascular and systemic diseases that prevent work,
- Pregnancy,
- Those with communication problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Core stabilization group
Individuals included in this group will receive 20 minutes of core stabilization training in addition to 40 minutes of standard rehabilitation.
Patients will be trained 5 days a week for first 3 weeks(standart rehabilitation + core stabilization training) then will be trained 3 days a week on 4-6 week (only core stabilization training).
The next 6 weeks will be given a home exercise program including shoulder exercises and core stabilization training.
|
First, while focusing on the activation methods of deep cervical flexor, transversus abdominus and multifidus muscles in individuals; In the next stages, exercises will be performed that will preserve the contraction of the deep cervical flexor, transversus abdominus and multifidus muscles and activate the other muscles of the body.
This treatment includes shoulder exercises and conventional therapy (Infrared, TENS).
|
|
Other: Control group
Individuals included in this group will receive only 40 minutes of standard rehabilitation.
Patients will be trained 5 days a week for first 3 weeks(only standart rehabilitation).
The next 9 weeks will be given a home exercise program including shoulder exercises.
|
This treatment includes shoulder exercises and conventional therapy (Infrared, TENS).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: Baseline
|
It is used to assess the severity of pain.
Pain severity with Visual Analogue Scale,(0-10) higher scores indicate more pain.
|
Baseline
|
|
Visual Analogue Scale
Time Frame: 3 week
|
It is used to assess the severity of pain.
Pain severity with Visual Analogue Scale,(0-10)higher scores indicate more pain.
|
3 week
|
|
Visual Analogue Scale
Time Frame: 6 week
|
It is used to assess the severity of pain.
Pain severity with Visual Analogue Scale,(0-10)higher scores indicate more pain.
|
6 week
|
|
Visual Analogue Scale
Time Frame: 12 week
|
It is used to assess the severity of pain.
Pain severity with Visual Analogue Scale,(0-10)higher scores indicate more pain.
|
12 week
|
|
Digital dynamometer
Time Frame: Baseline
|
It will be used to measure the strength of the shoulder muscles.
|
Baseline
|
|
Digital dynamometer
Time Frame: 3 week
|
It will be used to measure the strength of the shoulder muscles.
|
3 week
|
|
Digital dynamometer
Time Frame: 6 week
|
It will be used to measure the strength of the shoulder muscles.
|
6 week
|
|
Digital dynamometer
Time Frame: 12 week
|
It will be used to measure the strength of the shoulder muscles.
|
12 week
|
|
QuickDASH
Time Frame: Baseline
|
It is a questionnaire that evaluates disorders in all upper extremity functions.
The QuickDASH is an abbreviated 11-question subset from the original Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
The questionnaire's answers are scored on a 1-5 points scale that is then transformed to result in a score that ranges from 0 (indicating least disability) to 100 (indicating most disability).
|
Baseline
|
|
QuickDASH
Time Frame: 3 week
|
It is a questionnaire that evaluates disorders in all upper extremity functions.
The QuickDASH is an abbreviated 11-question subset from the original Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
The questionnaire's answers are scored on a 1-5 points scale that is then transformed to result in a score that ranges from 0 (indicating least disability) to 100 (indicating most disability).
|
3 week
|
|
QuickDASH
Time Frame: 6 week
|
It is a questionnaire that evaluates disorders in all upper extremity functions.
The QuickDASH is an abbreviated 11-question subset from the original Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
The questionnaire's answers are scored on a 1-5 points scale that is then transformed to result in a score that ranges from 0 (indicating least disability) to 100 (indicating most disability).
|
6 week
|
|
QuickDASH
Time Frame: 12 week
|
It is a questionnaire that evaluates disorders in all upper extremity functions.The QuickDASH is an abbreviated 11-question subset from the original Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
The questionnaire's answers are scored on a 1-5 points scale that is then transformed to result in a score that ranges from 0 (indicating least disability) to 100 (indicating most disability).
|
12 week
|
|
Modified "Biering-Sorensen" test
Time Frame: Baseline
|
Test will be applied to assess the endurance of the core muscles.
The subjects are positioned in the prone position.
The subjects are asked to extend their upper body straight forward from the edge of the table.
How long the patient was able to perform the test was recorded in seconds.
|
Baseline
|
|
Modified "Biering-Sorensen" test
Time Frame: 3 week
|
Test will be applied to assess the endurance of the core muscles.
The subjects are positioned in the prone position.
The subjects are asked to extend their upper body straight forward from the edge of the table.
How long the patient was able to perform the test was recorded in seconds.
|
3 week
|
|
Modified "Biering-Sorensen" test
Time Frame: 6 week
|
Test will be applied to assess the endurance of the core muscles.
The subjects are positioned in the prone position.
The subjects are asked to extend their upper body straight forward from the edge of the table.
How long the patient was able to perform the test was recorded in seconds.
|
6 week
|
|
Modified "Biering-Sorensen" test
Time Frame: 12 week
|
Test will be applied to assess the endurance of the core muscles.
The subjects are positioned in the prone position.
The subjects are asked to extend their upper body straight forward from the edge of the table.
How long the patient was able to perform the test was recorded in seconds.
|
12 week
|
|
Trunk flexors endurance test
Time Frame: Baseline
|
Test will be applied to assess the endurance of the core muscles.
Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion.
The evaluator fixes the feet on the ground by supporting them from the toes.
When the 60º trunk flexion is broken, the test will be terminated.
How long the patient was able to perform the test was recorded in seconds.
|
Baseline
|
|
Trunk flexors endurance test
Time Frame: 3 week
|
Test will be applied to assess the endurance of the core muscles.
Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion.
The evaluator fixes the feet on the ground by supporting them from the toes.
When the 60º trunk flexion is broken, the test will be terminated.
How long the patient was able to perform the test was recorded in seconds.
|
3 week
|
|
Trunk flexors endurance test
Time Frame: 6 week
|
Test will be applied to assess the endurance of the core muscles.
Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion.
The evaluator fixes the feet on the ground by supporting them from the toes.
When the 60º trunk flexion is broken, the test will be terminated.
How long the patient was able to perform the test was recorded in seconds.
|
6 week
|
|
Trunk flexors endurance test
Time Frame: 12 week
|
Test will be applied to assess the endurance of the core muscles.
Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion.
The evaluator fixes the feet on the ground by supporting them from the toes.
When the 60º trunk flexion is broken, the test will be terminated.
How long the patient was able to perform the test was recorded in seconds.
|
12 week
|
|
Lateral bridge test
Time Frame: Baseline
|
Test will be applied to assess the endurance of the core muscles.
The subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position(both sides).
How long the patient was able to perform the test was recorded in seconds.
|
Baseline
|
|
Lateral bridge test
Time Frame: 3 week
|
Test will be applied to assess the endurance of the core muscles.
The subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position(both sides).
How long the patient was able to perform the test was recorded in seconds.
|
3 week
|
|
Lateral bridge test
Time Frame: 6 week
|
Test will be applied to assess the endurance of the core muscles.
The subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position(both sides).
How long the patient was able to perform the test was recorded in seconds.
|
6 week
|
|
Lateral bridge test
Time Frame: 12 week
|
Test will be applied to assess the endurance of the core muscles.
The subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position(both sides).
How long the patient was able to perform the test was recorded in seconds.
|
12 week
|
|
Prone bridge test
Time Frame: Baseline
|
Test will be applied to assess the endurance of the core muscles.
The subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight.
The tests end when the subjects break the test positions.
How long the patient was able to perform the test was recorded in seconds.
|
Baseline
|
|
Prone bridge test
Time Frame: 3 week
|
Test will be applied to assess the endurance of the core muscles.
The subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight.
The tests end when the subjects break the test positions.
How long the patient was able to perform the test was recorded in seconds.
|
3 week
|
|
Prone bridge test
Time Frame: 6 week
|
Test will be applied to assess the endurance of the core muscles.
The subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight.
The tests end when the subjects break the test positions.
How long the patient was able to perform the test was recorded in seconds.
|
6 week
|
|
Prone bridge test
Time Frame: 12 week
|
Test will be applied to assess the endurance of the core muscles.
The subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight.
The tests end when the subjects break the test positions.
How long the patient was able to perform the test was recorded in seconds.
|
12 week
|
|
Modified "Push-ups" test
Time Frame: Baseline
|
Test will be applied to assess the strength of the core muscles.
The subjects are positioned in the prone position with their hands shoulder-width apart and elbows and knees flexed.
The subjects were asked to raise their body up by extending their elbows.
The number of times the patient repeats the movement in 30 seconds is recorded.
|
Baseline
|
|
Modified "Push-ups" test
Time Frame: 3 week
|
Test will be applied to assess the strength of the core muscles.
The subjects are positioned in the prone position with their hands shoulder-width apart and elbows and knees flexed.
The subjects were asked to raise their body up by extending their elbows.
The number of times the patient repeats the movement in 30 seconds is recorded.
|
3 week
|
|
Modified "Push-ups" test
Time Frame: 6 week
|
Test will be applied to assess the strength of the core muscles.
The subjects are positioned in the prone position with their hands shoulder-width apart and elbows and knees flexed.
The subjects were asked to raise their body up by extending their elbows.
The number of times the patient repeats the movement in 30 seconds is recorded.
|
6 week
|
|
Modified "Push-ups" test
Time Frame: 12 week
|
Test will be applied to assess the strength of the core muscles.
The subjects are positioned in the prone position with their hands shoulder-width apart and elbows and knees flexed.
The subjects were asked to raise their body up by extending their elbows.
The number of times the patient repeats the movement in 30 seconds is recorded.
|
12 week
|
|
Sit-ups test
Time Frame: Baseline
|
Test will be applied to assess the strength of the core muscles.
The subjects are asked to flex the trunk while the knees are flexed in the supine position.
During the test, the feet of subjects are stabilized.
The number of times the patient repeats the movement in 30 seconds is recorded.
|
Baseline
|
|
Sit-ups test
Time Frame: 3 week
|
Test will be applied to assess the strength of the core muscles.
The subjects are asked to flex the trunk while the knees are flexed in the supine position.
During the test, the feet of subjects are stabilized.
The number of times the patient repeats the movement in 30 seconds is recorded.
|
3 week
|
|
Sit-ups test
Time Frame: 6 week
|
Test will be applied to assess the strength of the core muscles.
The subjects are asked to flex the trunk while the knees are flexed in the supine position.
During the test, the feet of subjects are stabilized.
The number of times the patient repeats the movement in 30 seconds is recorded.
|
6 week
|
|
Sit-ups test
Time Frame: 12 week
|
Test will be applied to assess the strength of the core muscles.
The subjects are asked to flex the trunk while the knees are flexed in the supine position.
During the test, the feet of subjects are stabilized.
The number of times the patient repeats the movement in 30 seconds is recorded.
|
12 week
|
|
Stabilizer pressure biofeedback device
Time Frame: Baseline
|
This device will be used to measure deep cervical flexor muscles endurance.
|
Baseline
|
|
Stabilizer pressure biofeedback device
Time Frame: 3 week
|
This device will be used to measure deep cervical flexor muscles endurance.
|
3 week
|
|
Stabilizer pressure biofeedback device
Time Frame: 6 week
|
This device will be used to measure deep cervical flexor muscles endurance.
|
6 week
|
|
Stabilizer pressure biofeedback device
Time Frame: 12 week
|
This device will be used to measure deep cervical flexor muscles endurance.
|
12 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2023
Primary Completion (Actual)
August 1, 2024
Study Completion (Actual)
August 1, 2024
Study Registration Dates
First Submitted
July 13, 2023
First Submitted That Met QC Criteria
July 27, 2023
First Posted (Actual)
July 28, 2023
Study Record Updates
Last Update Posted (Estimated)
August 27, 2025
Last Update Submitted That Met QC Criteria
August 21, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-29
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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