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

Not Applicable

• Conditions: Partial Tear of Rotator Cuff; Rotator Cuff Tears
• Interventions: Combination Product: Subacromial Injection (Serum Saline) + Physical Therapy.; Combination Product: Subacromial Injection (hyaluronic acid) + Physical Therapy.; Combination Product: Subacromial Injection (methylprednisolone acetate) + Physical Therapy.; Combination Product: Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.

• Registration Number: NCT04681937
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2020-12-20
• Study First Posted: 2020-12-23
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-28
• Study Start: 2021-06-01
• Last Update Posted: 2021-06-01
• Primary Completion: 2021-11-15
• Study Completion: 2022-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (serum saline) + Physical Therapy	Subacromial Injection (Serum Saline) + Physical Therapy.	4 ml serum saline (subacromial)
Hyaluronic Acid + Physical Therapy	Subacromial Injection (hyaluronic acid) + Physical Therapy.	4 ml hyaluronic acid (subacromial)
Steroid + Physical Therapy	Subacromial Injection (methylprednisolone acetate) + Physical Therapy.	methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) (subacromial)
Platelet-Rich-Plasma (PRP) + Physical Therapy	Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.	4 ml platelet-rich-plasma (subacromial)

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons Shoulder Score (ASES)	12 months after injection	minimum score:0, maximum score:100, 100 is better function.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey