Comparison of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study

Study Overview
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Brief Summary
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There are many conservative treatment options available for partial rotator cuff tears. However, the superiority of a certain type of injection could not be demonstrated with the available data. Our aim is to compare the effectiveness of steroid, hyaluronic acid, prp and placebo (normal saline) injections in partial rotator cuff tears by applying the same physical therapy protocol after injection.

Official Title
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Clinical and Radiological Comparison of the Efficacy of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study

Conditions
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Partial Tear of Rotator Cuff, Rotator Cuff Tears

Intervention / Treatment
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* Combination Product: Subacromial Injection (hyaluronic acid) + Physical Therapy.
* Combination Product: Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.
* Combination Product: Subacromial Injection (methylprednisolone acetate) + Physical Therapy.
* Combination Product: Subacromial Injection (Serum Saline) + Physical Therapy.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: persistent continous pain at least 3 months partial thickness rotator cuff tear on MRI Exclusion Criteria: inflammatory disease pregnancy known malignancy bleeding disorder ( or <10 g/dl Hb level, <150.000 ul platelet) previous shoulder injection history of shoulder surgery full-thickness tear other shoulder problem (osteoarthritis, bony lesions, etc)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic Acid + Physical Therapy<br>4 ml hyaluronic acid (subacromial) | Combination Product: Subacromial Injection (hyaluronic acid) + Physical Therapy.<br>* arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.<br>|
| Experimental: Platelet-Rich-Plasma (PRP) + Physical Therapy<br>4 ml platelet-rich-plasma (subacromial) | Combination Product: Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.<br>* arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.<br>|
| Experimental: Steroid + Physical Therapy<br>methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) (subacromial) | Combination Product: Subacromial Injection (methylprednisolone acetate) + Physical Therapy.<br>* arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.<br>|
| Experimental: Placebo (serum saline) + Physical Therapy<br>4 ml serum saline (subacromial) | Combination Product: Subacromial Injection (Serum Saline) + Physical Therapy.<br>* arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) | minimum score:0, maximum score:100, 100 is better function. | 12 months after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-Murley Shoulder Outcome Score (CMS) | minimum score:0, maximum score:100, 100 is better function. | 12 months after injection | 
| Visual analogue scale (VAS) | minimum score:0, maximum score:10, 0 is better function | 12 months after injection | 
| Subjective Shoulder Value (SSV) | minimum score:0, maximum score:100, 100 is better function. | 12 months after injection | 
| Range of Motion (ROM) | Active Shoulder Range of Motion Measurements | 12 months after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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partial rotator cuff tear, subacromial injection, plateled-rich-plasma, physical therapy