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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound Guided Hydrodilatation with corticosteroid injection | Experimental | 15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance Drugs:
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| Blind intra-articular corticosteroid injection | Active Comparator | 5 ml intra-articular blind injection to shoulder via posterior approach Drugs:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-articular corticosteroid injection | Other | 5 ml blind intra-articular corticosteroid injection |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatmanur Yegin | Contact | 0905462729955 | fatmanur.yegin@istanbul.edu.tr |
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Two-arm study with one hydrodilatation group compared with the standart treatment group(cortisteroid injection)
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| Ultrasound Guided Hydrodilatation with corticosteroid injection | Other | 15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance |
|
| 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 |
| ID | Term |
|---|---|
| D002062 | Bursitis |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D018771 | Arthralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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