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

Primary Purpose

Partial Tear of Rotator Cuff, Rotator Cuff Tears

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Subacromial Injection (hyaluronic acid) + Physical Therapy.

Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.

Subacromial Injection (methylprednisolone acetate) + Physical Therapy.

Subacromial Injection (Serum Saline) + Physical Therapy.

About this trial

This is an interventional treatment trial for Partial Tear of Rotator Cuff focused on measuring partial rotator cuff tear, subacromial injection, plateled-rich-plasma, physical therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Bezmialem Vakif University
Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Hyaluronic Acid + Physical Therapy

Platelet-Rich-Plasma (PRP) + Physical Therapy

Steroid + Physical Therapy

Placebo (serum saline) + Physical Therapy

Arm Description

4 ml hyaluronic acid (subacromial)

4 ml platelet-rich-plasma (subacromial)

methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) (subacromial)

4 ml serum saline (subacromial)

Outcomes

Primary Outcome Measures

American Shoulder and Elbow Surgeons Shoulder Score (ASES)

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

Secondary Outcome Measures

Constant-Murley Shoulder Outcome Score (CMS)

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

Visual analogue scale (VAS)

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

Subjective Shoulder Value (SSV)

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

Range of Motion (ROM)

Active Shoulder Range of Motion Measurements

Full Information

NCT ID

NCT04681937

First Posted

December 13, 2020

Last Updated

May 28, 2021

Sponsor

Bezmialem Vakif University

1. Study Identification

Unique Protocol Identification Number

NCT04681937

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2021 (Anticipated)

Primary Completion Date

November 15, 2021 (Anticipated)

Study Completion Date

September 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Partial Tear of Rotator Cuff, Rotator Cuff Tears

Keywords

partial rotator cuff tear, subacromial injection, plateled-rich-plasma, physical therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hyaluronic Acid + Physical Therapy

Arm Type

Experimental

Arm Description

4 ml hyaluronic acid (subacromial)

Arm Title

Platelet-Rich-Plasma (PRP) + Physical Therapy

Arm Type

Experimental

Arm Description

4 ml platelet-rich-plasma (subacromial)

Arm Title

Steroid + Physical Therapy

Arm Type

Experimental

Arm Description

methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) (subacromial)

Arm Title

Placebo (serum saline) + Physical Therapy

Arm Type

Experimental

Arm Description

4 ml serum saline (subacromial)

Intervention Type

Combination Product

Intervention Name(s)

Subacromial Injection (hyaluronic acid) + Physical Therapy.

Intervention Description

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.

Intervention Type

Combination Product

Intervention Name(s)

Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.

Intervention Description

Intervention Type

Combination Product

Intervention Name(s)

Subacromial Injection (methylprednisolone acetate) + Physical Therapy.

Intervention Description

Intervention Type

Combination Product

Intervention Name(s)

Subacromial Injection (Serum Saline) + Physical Therapy.

Intervention Description

Primary Outcome Measure Information:

Title

American Shoulder and Elbow Surgeons Shoulder Score (ASES)

Description

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

Time Frame

12 months after injection

Secondary Outcome Measure Information:

Title

Constant-Murley Shoulder Outcome Score (CMS)

Description

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

Time Frame

12 months after injection

Title

Visual analogue scale (VAS)

Description

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

Time Frame

12 months after injection

Title

Subjective Shoulder Value (SSV)

Description

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

Time Frame

12 months after injection

Title

Range of Motion (ROM)

Description

Active Shoulder Range of Motion Measurements

Time Frame

12 months after injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Bezmialem Vakif University

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Bezmialem Vakif University

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vahdet Ucan, MD

Phone

+905546586750

vahdetucan@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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