Partial Tear of Rotator Cuff, Rotator Cuff Tears
Conditions
Keywords
partial rotator cuff tear, subacromial injection, plateled-rich-plasma, physical therapy
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.
Interventions
COMBINATION_PRODUCTSubacromial 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.
COMBINATION_PRODUCTSubacromial 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.
COMBINATION_PRODUCTSubacromial 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.
COMBINATION_PRODUCTSubacromial 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.
Sponsors
Bezmialem Vakif University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) | 12 months after injection | minimum score:0, maximum score:100, 100 is better function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant-Murley Shoulder Outcome Score (CMS) | 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 |
| Subjective Shoulder Value (SSV) | 12 months after injection | minimum score:0, maximum score:100, 100 is better function. |
| Range of Motion (ROM) | 12 months after injection | Active Shoulder Range of Motion Measurements |
Countries
Turkey (Türkiye)
Outcome results
None listed