Clinical and Radiological Comparison of the Efficacy of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Bezmialem Vakif University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Hyaluronic Acid + Physical Therapy
4 ml hyaluronic acid (subacromial)
Intervention: Subacromial Injection (hyaluronic acid) + Physical Therapy. (Combination Product)
Platelet-Rich-Plasma (PRP) + Physical Therapy
4 ml platelet-rich-plasma (subacromial)
Intervention: Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy. (Combination Product)
Steroid + Physical Therapy
methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) (subacromial)
Intervention: Subacromial Injection (methylprednisolone acetate) + Physical Therapy. (Combination Product)
Placebo (serum saline) + Physical Therapy
4 ml serum saline (subacromial)
Intervention: Subacromial Injection (Serum Saline) + Physical Therapy. (Combination Product)
Outcomes
Primary Outcomes
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Time Frame: 12 months after injection
minimum score:0, maximum score:100, 100 is better function.
Secondary Outcomes
- Constant-Murley Shoulder Outcome Score (CMS)(12 months after injection)
- Subjective Shoulder Value (SSV)(12 months after injection)
- Visual analogue scale (VAS)(12 months after injection)
- Range of Motion (ROM)(12 months after injection)
Investigators
Muzaffer Ağır
MD
Bezmialem Vakif University