- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04681937
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
- 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.
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
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-
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Istanbul, Turkey, 34093
- Bezmialem Vakif University
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Contact:
- Vahdet Ucan, MD
- Phone Number: +905546586750
- Email: vahdetucan@hotmail.com
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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
16 years to 68 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)
|
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)
|
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)
|
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)
|
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
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
Additional Relevant MeSH Terms
- Wounds and Injuries
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Rotator Cuff Injuries
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Adjuvants, Immunologic
- Viscosupplements
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Hyaluronic Acid
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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