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

• Sponsor: Bezmialem Vakif University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04681937
• Collaborator: (none)
• Enrollment: 80
• Locations: 2
• Arms: 4
• Anticipated Duration (Months): 15.5
• Patients Per Site: 40
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Partial Tear of Rotator Cuff; Rotator Cuff Tears	Combination Product: Subacromial Injection (hyaluronic acid) + Physical Therapy.; Combination Product: Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.; Combination Product: Subacromial Injection (methylprednisolone acetate) + Physical Therapy.; Combination Product: Subacromial Injection (Serum Saline) + Physical Therapy.	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Nov 15, 2021
• Anticipated Study Completion Date: Sep 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hyaluronic Acid + Physical Therapy 4 ml hyaluronic acid (subacromial)	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.
Experimental: Platelet-Rich-Plasma (PRP) + Physical Therapy 4 ml platelet-rich-plasma (subacromial)	Combination Product: 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.
Experimental: Steroid + Physical Therapy methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) (subacromial)	Combination Product: 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.
Experimental: Placebo (serum saline) + Physical Therapy 4 ml serum saline (subacromial)	Combination Product: 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Constant-Murley Shoulder Outcome Score (CMS) [12 months after injection]

   minimum score:0, maximum score:100, 100 is better function.

2. Visual analogue scale (VAS) [12 months after injection]

   minimum score:0, maximum score:10, 0 is better function

3. Subjective Shoulder Value (SSV) [12 months after injection]

   minimum score:0, maximum score:100, 100 is better function.

4. Range of Motion (ROM) [12 months after injection]

   Active Shoulder Range of Motion Measurements

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bezmialem Vakif University	Istanbul		Turkey	34093
2	Bezmialem Vakif University	Istanbul		Turkey	34093

Sponsors and Collaborators

• Bezmialem Vakif University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Muzaffer Ağır, MD, Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT04681937
• Other Study ID Numbers: 4350611
• First Posted: Dec 23, 2020
• Last Update Posted: Jun 1, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Muzaffer Ağır, MD, Bezmialem Vakif University: partial rotator cuff tear; subacromial injection; plateled-rich-plasma; physical therapy
• Additional relevant MeSH terms: Rotator Cuff Injuries; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Hyaluronic Acid

Study Results

No Results Posted as of Jun 1, 2021