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

NCT ID: NCT04681937

Last Updated: 2021-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Partial Tear of Rotator Cuff Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Hyaluronic Acid + Physical Therapy

4 ml hyaluronic acid (subacromial)

Group Type EXPERIMENTAL

Subacromial Injection (hyaluronic acid) + Physical Therapy.

Intervention Type COMBINATION_PRODUCT

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.

Platelet-Rich-Plasma (PRP) + Physical Therapy

4 ml platelet-rich-plasma (subacromial)

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

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.

Steroid + Physical Therapy

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

Group Type EXPERIMENTAL

Subacromial Injection (methylprednisolone acetate) + Physical Therapy.

Intervention Type COMBINATION_PRODUCT

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.

Placebo (serum saline) + Physical Therapy

4 ml serum saline (subacromial)

Group Type EXPERIMENTAL

Subacromial Injection (Serum Saline) + Physical Therapy.

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Muzaffer Ağır

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Site Status

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Facility Contacts

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Vahdet Ucan, MD

Role: primary

+905546586750

Other Identifiers

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4350611

Identifier Type: -

Identifier Source: org_study_id

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