- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06222281
Evaluation of Shoulder Strength and Deltoid Stiffness After Reverse Shoulder Arthroplasty (RSA)
Evaluation of Shoulder Strength and Deltoid Stiffness After RSA
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34093
- Şensu Dinçer
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with revision reverse shoulder arthroplasty
- Having inflammatory diseases
- Not having adequate range of motion to be able to perform isokinetic test
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Through study completion, an average of 8 weeks
|
shoulder abduction strength
Time Frame: Through study completion, an average of 8 weeks
|
abduction 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
|
Through study completion, an average of 8 weeks
|
shoulder forward flexion strength
Time Frame: Through study completion, an average of 8 weeks
|
forward flexion, 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.
|
Through study completion, an average of 8 weeks
|
shoulder internal rotation strength
Time Frame: Through study completion, an average of 8 weeks
|
internal rotation 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.
|
Through study completion, an average of 8 weeks
|
shoulder external rotation strength
Time Frame: Through study completion, an average of 8 weeks
|
External rotation 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.
|
Through study completion, an average of 8 weeks
|
Constant-Murley 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 Constant-Murley 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
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It will be carried out once for each patient, through study completion, an average of 8 weeks
|
quick DASH
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.
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It will be carried out once for each patient, through study completion, an average of 8 weeks
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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 dynomemeter, results will be presented in newton metre (nm) unit
|
Through study completion, an average of 8 weeks
|
shoulder forward flexion 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 dynomemeter, results will be presented in newton metre (nm) unit
|
Through study completion, an average of 8 weeks
|
shoulder internal rotation 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 dynomemeter, results will be presented in newton metre (nm) unit
|
Through study completion, an average of 8 weeks
|
shoulder external rotation 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 dynomemeter, results will be presented in newton metre (nm) unit
|
Through study completion, an average of 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Elastography RSA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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