Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease

Study Overview
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Brief Summary
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This study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.

Detailed Description
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Rotator cuff disease in particular is a common cause of shoulder pain and weakness and comprises a significant proportion of the musculoskeletal complaints presenting to primary care doctors. Ultrasound is a readily available and cheap modality for looking more specifically at the rotator cuff and surrounding structures. More recently, ultrasound guidance has become a commonly employed method to perform diagnostic or therapeutic interventions. Despite the long history and the fact that this is a common diagnosis made in clinical practice, the exact cause and best treatment for this condition still are being explored. Although there are a few high-quality studies demonstrating the efficacy of sodium hyaluronate injection for rotator cuff disease, this study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.

Official Title
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Evaluating the Efficacy of Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in the Treatment of Rotator Cuff Disease

Conditions
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Subacromial Impingement Syndrome

Intervention / Treatment
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* Drug: Sodium Hyaluronate
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >= 18 years subacromial impingement syndrome without a complete tear of rotator cuff willingness to participate Exclusion Criteria: had any rheumatic disease, glenohumeral osteoarthritis, full-thickness rotator cuff tears, fractures, diabetes mellitus, infections, or tumors. had hypersensitivity to hyaluronate had participated in any other study within 6 months had received a subacromial injection within 8 weeks were pregnant or planned to become pregnant were at risk of complications of intra-articular injections such as patients who received anti-coagulant drugs.

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium hyaluronate<br>Ultrasound guided injection of sodium hyaluronate | Drug: Sodium Hyaluronate<br>* Ultrasound guided injection of sodium hyaluronate; Fermathron ™, 20 mg/2ml of Sodium Hyaluronate, 3 weekly injections.<br>|
| Placebo Comparator: Normal saline<br>Ultrasound guided injection of normal saline | Drug: Normal saline<br>* Ultrasound guided injection of 0.9% normal sodium hyaluronate line solution, at 2 mL/syringe, 3 weekly injections.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain severity after 3 weeks. | The pain score (100 mm Visual Analogue Score ) is evaluated before the first injection and one week after each injection up to 3rd week. | Up to 3 weeks |