The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder

Study Overview
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Brief Summary
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The goal of this interventional study is to compare the outcomes of two different injection aprroaches in patients with frozen shoulder. The main questions it aims to answer are: Is hydrodilatation better than intraarticular corticosteroid injection? Is there any prognostic factors that will help clinicians guide their decision making when choosing between these two treatments? Participans will receive an injection(cortcosteroid and local anesthetics alone or with hydrodilatation-corticosteroid and local anesthetics plus sterile saline solution) and then they will follow a rehabilitation program.

Official Title
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The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder

Conditions
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Frozen Shoulder, Shoulder Capsulitis, Shoulder Pain

Intervention / Treatment
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* Other: Intra-articular corticosteroid injection
* Other: Ultrasound Guided Hydrodilatation with corticosteroid injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who fulfill the diagnostic criteria for frozen shoulder Agree to participate in the study Having the opportunity to follow up for at least 3 months Exclusion Criteria: Refusing to participate in the study History of shoulder injection in the last 3 months Having diabetes mellitus Presence of comorbidities that contraindicate injection therapy, such as bleeding diathesis Known history of allergy or anaphylaxis to drugs used in treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm study with one hydrodilatation group compared with the standart treatment group(cortisteroid injection)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Guided Hydrodilatation with corticosteroid injection<br>15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance Drugs: betamethasone dipropionate/ betamethasone sodium phosphate(diprospan) (5 mg+2mg/ml) (1 ml) prilocaine hydrochloride %2 (4 ml) Sodium chloride %0,9 (10 ml) | Other: Ultrasound Guided Hydrodilatation with corticosteroid injection<br>* 15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance<br>|
| Active Comparator: Blind intra-articular corticosteroid injection<br>5 ml intra-articular blind injection to shoulder via posterior approach Drugs: betamethasone dipropionate/ betamethasone sodium phosphate(diprospan) (5 mg+2mg/ml) (1 ml) prilocaine hydrochloride %2 (4 ml) | Other: Intra-articular corticosteroid injection<br>* 5 ml blind intra-articular corticosteroid injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline pain score on Visual Analog Scale(VAS) | Pain scored according to VAS; between 0(no pain) to 10(worst pain) | Baseline, 1 week, 1 month, 3 months | 
| Change in Shoulder Pain and Disability Index(SPADI) scores | Scored between 0-10 ; 0 means no pain and disability and 10 means the worst pain and disability | Baseline, 1 month, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Range of Movement(ROM) | Range of shoulder movements assessed with digital inclinometer in sittting and lying positions | Baseline, 1 week, 1 month, 3 months | 
| Ultrasound Parameters | Coracohumeral ligament(CHL) thickness, axillary pouch(AP) thickness, elastography of deltoid muscle(anterior, middle, and posterior) | Baseline, 1 month, 3 months | 
| Proprioception(Active position sense- joint position error) | Shoulder joint is positioned in 30 degree flexion and 15 degree internal and external rotation in lying position, patient is asked to position their joints and errors in degrees noted | Baseline, 3 months | 
| Shoulder Strength | Measured with cybex isokinetic dinamometer, shoulder flexion/extension and shoulder internal/external rotation | Baseline, 3 months | 
| Changes in Depression Score | measured by Beck's Depression Inventory(between 0 to 40), 0 means no depression and 40 means severe depression | Baseline, 1 months, 3 months | 
| Changes in Life Quality Score | Items from the SF-36 (Short Form 36) survey, between 0(worst) to 100(best) | Baseline, 1 month, 3 months | 
| Treatment Satisfaction | Global Improvement and Satisfaction Score, between 1 to 5, 1 very dissatisfied, and 5 very satisfied | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hydrodilatation, hydrodistension, ultrasound