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NCT04681937 Clinical Trial

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

Rotator Cuff Tears Clinical Trial

Official title:
Clinical and Radiological Comparison of the Efficacy of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04681937
Other study ID # 4350611
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date September 15, 2022

Study information
Verified date May 2021
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date September 15, 2022
Est. primary completion date November 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Combination Product:
• 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.

Locations
Country Name City State
Turkey Bezmialem Vakif University Istanbul
Turkey Bezmialem Vakif University Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary American Shoulder and Elbow Surgeons Shoulder Score (ASES) minimum score:0, maximum score:100, 100 is better function. 12 months after injection
Secondary Constant-Murley Shoulder Outcome Score (CMS) minimum score:0, maximum score:100, 100 is better function. 12 months after injection
Secondary Visual analogue scale (VAS) minimum score:0, maximum score:10, 0 is better function 12 months after injection
Secondary Subjective Shoulder Value (SSV) minimum score:0, maximum score:100, 100 is better function. 12 months after injection
Secondary Range of Motion (ROM) Active Shoulder Range of Motion Measurements 12 months after injection
See also
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