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

Bezmialem Vakif University

Status: Unknown

Conditions: Partial Tear of Rotator Cuff; Rotator Cuff Tears

Treatments: Combination Product: Subacromial Injection (hyaluronic acid) + Physical Therapy.; Combination Product: Subacromial Injection (Serum Saline) + Physical Therapy.; Combination Product: Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.; Combination Product: Subacromial Injection (methylprednisolone acetate) + Physical Therapy.

Study type: Interventional

Funder types: Other

Identifiers

NCT04681937

4350611

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 4 patient groups

Hyaluronic Acid + Physical Therapy

Experimental group

Description:

4 ml hyaluronic acid (subacromial)

Treatment:

Combination Product: Subacromial Injection (hyaluronic acid) + Physical Therapy.

Platelet-Rich-Plasma (PRP) + Physical Therapy

Experimental group

Description:

4 ml platelet-rich-plasma (subacromial)

Treatment:

Combination Product: Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.

Steroid + Physical Therapy

Experimental group

Description:

methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) (subacromial)

Treatment:

Combination Product: Subacromial Injection (methylprednisolone acetate) + Physical Therapy.

Placebo (serum saline) + Physical Therapy

Experimental group

Description:

4 ml serum saline (subacromial)

Treatment:

Combination Product: Subacromial Injection (Serum Saline) + Physical Therapy.