Evaluation of Shoulder Strength and Deltoid Stiffness After Reverse Shoulder Arthroplasty (RSA)

Sonoelastography Clinical Trial

Official title:

Evaluation of Shoulder Strength and Deltoid Stiffness After RSA

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06222281
• Other study ID #: Elastography RSA
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: August 30, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sonoelastography

Locations

Country	Name	City	State
Turkey	Sensu Dinçer	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sensu Dinçer

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion, an average of 8 weeks
Primary	shoulder abduction strength	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
Primary	shoulder forward flexion strength	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
Primary	shoulder internal rotation strength	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
Primary	shoulder external rotation strength	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
Primary	Constant-Murley shoulder outcome score	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	It will be carried out once for each patient, through study completion, an average of 8 weeks
Primary	quick DASH	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.	It will be carried out once for each patient, through study completion, an average of 8 weeks
Primary	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 dynomemeter, results will be presented in newton metre (nm) unit	Through study completion, an average of 8 weeks
Primary	shoulder forward flexion 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 dynomemeter, results will be presented in newton metre (nm) unit	Through study completion, an average of 8 weeks
Primary	shoulder internal rotation 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 dynomemeter, results will be presented in newton metre (nm) unit	Through study completion, an average of 8 weeks
Primary	shoulder external rotation 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 dynomemeter, results will be presented in newton metre (nm) unit	Through study completion, an average of 8 weeks