SonoelastographyNCT06222281
Evaluation of Shoulder Strength and Deltoid Stiffness After Reverse Shoulder Arthroplasty (RSA)
An observational study of Sonoelastography and Isokinetic Test, run by Şensu Dinçer at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to test the strength of the shoulder joint and elasticity of the deltoid muscle of the patients who had a reverse shoulder arthroplasty. The main questions are: • Whether there is a difference between the operated and healthy shoulders in terms of strength and deltoid elasticity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sonoelastography, Isokinetic Test
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2025to 25 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were operated in the university hospital, department of orthopedics and traumatology
Who may be able to join
- Having undergone reverse shoulder arthroplasty surgery due to arthropathy because of unilateral rotator cuff tear
- Followed for at least 12 months after surgery.
- The other unoperated shoulder is healthy.
Who cannot join
- Patients with revision reverse shoulder arthroplasty
- Having inflammatory diseases
- Not having adequate range of motion to be able to perform isokinetic test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Shoulder Strength and Deltoid Stiffness After RSA
The goal of this observational study is to test the strength of the shoulder joint and elasticity of the deltoid muscle of the patients who had a reverse shoulder arthroplasty. The main questions are: • Whether there is a difference between the operated and healthy shoulders in terms of strength and deltoid elasticity of the patients. • Is there any correlation between the functional status, elasticity and strength of the operated shoulder? Participants will be asked to attend the isokinetic shoulder strength tests and shear wawe ultrasound elastography measurements. They will be also asked to fill the quick DASH and Constant score forms.
Read the detailed description
The ultrasound elastography is a measurement method that has become increasingly common recently and can measure some mechanical properties of tissue. Measurements can be made using two different techniques: strain and shear wave elastography (SWEUS). SWEUS provides objective and reproducible data collection about the elasticity of the tissue and is less affected by the user than the strain technique. The mechanical properties of the deltoid muscle are among the main factors affecting surgical results in patients undergoing reverse shoulder replacement surgery. Glenohumeral joint function is affected by the post-operative tension of the deltoid. Excessive tension in the deltoid muscle may cause restriction of movement and pain, as well as conditions such as instability and insufficient force production. Lack of elasticity of deltoid muscle may also lead to functional deficit of shoulder. Previous studies have found a linear correlation between muscle activity and muscle elasticity values measured by MR elastography (MRE). However, MRE is an expensive method that requires large equipment and space, and it is a more difficult method for patients, which may include various difficulties in patient positioning. Ultrasound elastography is a method that is highly investigated for clinical use because it is cheaper and easier to apply than MRE. Isokinetic dynamometer is one of the most objective methods used to measure muscle activity and strength.Thus, it is imperative to reveal the mechanical properties of deltoid muscle, which carries the most of the mechanical load in the shoulder region after the operation, as well as the relationship between them.
The medical history of patients who had undergone reverse prosthesis surgery in the Department of Orthopedics and Traumatology, and their postoperative files will be screened. Patients who meet the inclusion and exclusion criteria will be invited to the study.
Their demographic information will be recorded. The visual pain scale (VAS) and will be questioned to evaluate the pain status. Functional status of the patients, and the patients will be asked to complete the Constant score and the quick arm, shoulder and hand problems questionnaire (Q-DASH) under supervision. They will be asked to answer. Shear wave elastographic measurement and isokinetic tests of both shoulders will be carried out in the sports medicine department. Measurement outcomes of both shoulders will be compared.
- Conditions
- Sonoelastography, Isokinetic Test
- Keywords
- elastography, Deltoid, shoulder strength, reverse shoulder arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
shear wave elastography (SWE)
SWE provides an indirect measure of a tissue's mechanical properties by quantifying the speed at which sound waves propagate through soft tissue. Shear wave elastography will be carried out once for both shoulders before the isokinetic tests
Measured: Through study completion, an average of 8 weeks
shoulder adduction strength
adduction strength of both shoulders will be measured by the isokinetic test method. It will be carried out once for both shoulders for each patient. To measure the muscle strength, the average peak torque (nm) done with four repetitions at a velocity of 60 /sec was determined. It will be carried out once for both shoulders for each patient. Results will be presented in newton metre (nm) unit
Measured: Through study completion, an average of 8 weeks
shoulder adduction endurance
endurance strength of both shoulders will be measured by the isokinetic test method. It will be carried out once for both shoulders for each patient. To measure the muscle strength, the average peak torque (nm) done with four repetitions at a velocity of 180 /sec was determined. It will be carried out once for both shoulders for each patient. Results will be presented in newton metre (nm) unit.
Measured: Through study completion, an average of 8 weeks
modified Constant shoulder outcome score
Patients will fill the constant score questionnaire to evaluate the functional status of operated shoulder. The modified Constant score will be used to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).The higher the score, the higher the quality of the function
Measured: It will be carried out once for each patient, through study completion, an average of 8 weeks
American Shoulder Elbow Surgeons (ASES) orthopedic score
The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.
Measured: It will be carried out once for each patient, through study completion, an average of 8 weeks
Quick shoulder disabilities arm shoulder and hand questionnaire (QuickDASH)
Patients will fill the quick disabilities of the arm, shoulder, and hand outcome measure questionnaire (the quick-DASH) to evaluate the functional status of operated shoulder.his questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.t is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms.The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level.
Measured: It will be carried out once for each patient, through study completion, an average of 8 weeks
shoulder abduction endurance
to measure the shoulder abduction endurance, total work (nm) done with 15 repetitions at a velocity of 180/sec will be measured by an isokinetic dynamometer, results will be presented in newton metre (nm) unit
Measured: Through study completion, an average of 8 weeks
shoulder abduction strength
adduction strength of both shoulders will be measured by the isokinetic test method. It will be carried out once for both shoulders for each patient. To measure the muscle strength, the average peak torque (nm) done with four repetitions at a velocity of 60 /sec was determined. It will be carried out once for both shoulders for each patient. Results will be presented in newton metre (nm) unit
Measured: Through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start20 May 2025
- Primary completion15 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SonoelastographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Şensu Dinçer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Şensu Dinçer, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222281
- Sponsor's protocol ID
- Elastography RSA
- Status last verified
- Nov 2025
- First submitted
- 4 Jan 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Shoulder Strength and Deltoid Stiffness After RSA
- ClinicalTrials.gov ID
- NCT06222281
- Acronym / sponsor ID
- Elastography RSA
- Conditions
- Sonoelastography, Isokinetic Test
- Keywords
- elastography, Deltoid, shoulder strength, reverse shoulder arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Şensu DinçerUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to test the strength of the shoulder joint and elasticity of the deltoid muscle of the patients who had a reverse shoulder arthroplasty. The main questions are: • Whether there is a difference between the operated and healthy shoulders in terms of strength and deltoid elasticity of the patients. • Is there any correlation between the functional status, elasticity and strength of the operated shoulder? Participants will be asked to attend the isokinetic shoulder strength tests and shear wawe ultrasound elastography measurements. They will be also asked to fill the quick DASH and Constant score forms.
Detailed description
The ultrasound elastography is a measurement method that has become increasingly common recently and can measure some mechanical properties of tissue. Measurements can be made using two different techniques: strain and shear wave elastography (SWEUS). SWEUS provides objective and reproducible data collection about the elasticity of the tissue and is less affected by the user than the strain technique. The mechanical properties of the deltoid muscle are among the main factors affecting surgical results in patients undergoing reverse shoulder replacement surgery. Glenohumeral joint function is affected by the post-operative tension of the deltoid. Excessive tension in the deltoid muscle may cause restriction of movement and pain, as well as conditions such as instability and insufficient force production. Lack of elasticity of deltoid muscle may also lead to functional deficit of shoulder. Previous studies have found a linear correlation between muscle activity and muscle elasticity values measured by MR elastography (MRE). However, MRE is an expensive method that requires large equipment and space, and it is a more difficult method for patients, which may include various difficulties in patient positioning. Ultrasound elastography is a method that is highly investigated for clinical use because it is cheaper and easier to apply than MRE. Isokinetic dynamometer is one of the most objective methods used to measure muscle activity and strength.Thus, it is imperative to reveal the mechanical properties of deltoid muscle, which carries the most of the mechanical load in the shoulder region after the operation, as well as the relationship between them.
The medical history of patients who had undergone reverse prosthesis surgery in the Department of Orthopedics and Traumatology, and their postoperative files will be screened. Patients who meet the inclusion and exclusion criteria will be invited to the study.
Their demographic information will be recorded. The visual pain scale (VAS) and will be questioned to evaluate the pain status. Functional status of the patients, and the patients will be asked to complete the Constant score and the quick arm, shoulder and hand problems questionnaire (Q-DASH) under supervision. They will be asked to answer. Shear wave elastographic measurement and isokinetic tests of both shoulders will be carried out in the sports medicine department. Measurement outcomes of both shoulders will be compared.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were operated in the university hospital, department of orthopedics and traumatology
Key inclusion criteria (3 listed)
- Having undergone reverse shoulder arthroplasty surgery due to arthropathy because of unilateral rotator cuff tear
- Followed for at least 12 months after surgery.
- The other unoperated shoulder is healthy.
Key exclusion criteria (3 listed)
- Patients with revision reverse shoulder arthroplasty
- Having inflammatory diseases
- Not having adequate range of motion to be able to perform isokinetic test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
shear wave elastography (SWE)
Time frame: Through study completion, an average of 8 weeks
SWE provides an indirect measure of a tissue's mechanical properties by quantifying the speed at which sound waves propagate through soft tissue. Shear wave elastography will be carried out once for both shoulders before the isokinetic tests
shoulder adduction strength
Time frame: Through study completion, an average of 8 weeks
adduction strength of both shoulders will be measured by the isokinetic test method. It will be carried out once for both shoulders for each patient. To measure the muscle strength, the average peak torque (nm) done with four repetitions at a velocity of 60 /sec was determined. It will be carried out once for both shoulders for each patient. Results will be presented in newton metre (nm) unit
shoulder adduction endurance
Time frame: Through study completion, an average of 8 weeks
endurance strength of both shoulders will be measured by the isokinetic test method. It will be carried out once for both shoulders for each patient. To measure the muscle strength, the average peak torque (nm) done with four repetitions at a velocity of 180 /sec was determined. It will be carried out once for both shoulders for each patient. Results will be presented in newton metre (nm) unit.
modified Constant shoulder outcome score
Time frame: It will be carried out once for each patient, through study completion, an average of 8 weeks
Patients will fill the constant score questionnaire to evaluate the functional status of operated shoulder. The modified Constant score will be used to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).The higher the score, the higher the quality of the function
American Shoulder Elbow Surgeons (ASES) orthopedic score
Time frame: It will be carried out once for each patient, through study completion, an average of 8 weeks
The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.
Quick shoulder disabilities arm shoulder and hand questionnaire (QuickDASH)
Time frame: It will be carried out once for each patient, through study completion, an average of 8 weeks
Patients will fill the quick disabilities of the arm, shoulder, and hand outcome measure questionnaire (the quick-DASH) to evaluate the functional status of operated shoulder.his questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.t is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms.The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level.
shoulder abduction endurance
Time frame: Through study completion, an average of 8 weeks
to measure the shoulder abduction endurance, total work (nm) done with 15 repetitions at a velocity of 180/sec will be measured by an isokinetic dynamometer, results will be presented in newton metre (nm) unit
shoulder abduction strength
Time frame: Through study completion, an average of 8 weeks
adduction strength of both shoulders will be measured by the isokinetic test method. It will be carried out once for both shoulders for each patient. To measure the muscle strength, the average peak torque (nm) done with four repetitions at a velocity of 60 /sec was determined. It will be carried out once for both shoulders for each patient. Results will be presented in newton metre (nm) unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sonoelastography and Isokinetic Test, run by Şensu Dinçer at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shear wave elastography (SWE) (time frame: Through study completion, an average of 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.