Comparison of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study
NCT ID: NCT04681937
Last Updated: 2021-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2021-06-01
2022-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Hyaluronic Acid + Physical Therapy
4 ml hyaluronic acid (subacromial)
Subacromial Injection (hyaluronic acid) + Physical Therapy.
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.
Platelet-Rich-Plasma (PRP) + Physical Therapy
4 ml platelet-rich-plasma (subacromial)
Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.
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.
Steroid + Physical Therapy
methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) (subacromial)
Subacromial Injection (methylprednisolone acetate) + Physical Therapy.
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.
Placebo (serum saline) + Physical Therapy
4 ml serum saline (subacromial)
Subacromial Injection (Serum Saline) + Physical Therapy.
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.
Interventions
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Subacromial Injection (hyaluronic acid) + Physical Therapy.
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.
Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.
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.
Subacromial Injection (methylprednisolone acetate) + Physical Therapy.
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.
Subacromial Injection (Serum Saline) + Physical Therapy.
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.
Eligibility Criteria
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Inclusion Criteria
* partial thickness rotator cuff tear on MRI
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
No
Sponsors
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Bezmialem Vakif University
OTHER
Responsible Party
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Muzaffer Ağır
MD
Locations
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Bezmialem Vakif University
Istanbul, , Turkey (Türkiye)
Bezmialem Vakif University
Istanbul, , Turkey (Türkiye)
Countries
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Facility Contacts
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Other Identifiers
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4350611
Identifier Type: -
Identifier Source: org_study_id
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