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

May 28, 2021 updated by: Muzaffer Ağır, Bezmialem Vakif University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Bezmialem Vakif University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Time Frame: 12 months after injection
minimum score:0, maximum score:100, 100 is better function.
12 months after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant-Murley Shoulder Outcome Score (CMS)
Time Frame: 12 months after injection
minimum score:0, maximum score:100, 100 is better function.
12 months after injection
Visual analogue scale (VAS)
Time Frame: 12 months after injection
minimum score:0, maximum score:10, 0 is better function
12 months after injection
Subjective Shoulder Value (SSV)
Time Frame: 12 months after injection
minimum score:0, maximum score:100, 100 is better function.
12 months after injection
Range of Motion (ROM)
Time Frame: 12 months after injection
Active Shoulder Range of Motion Measurements
12 months after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

November 15, 2021

Study Completion (Anticipated)

September 15, 2022

Study Registration Dates

First Submitted

December 13, 2020

First Submitted That Met QC Criteria

December 20, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4350611

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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