A comparative study on the effects of subacromial injections of platelet-rich plasma and methylprednisolone for improving range of motion, reducing pain, and enhancing function in patients with partial rotator cuff tears
Determination of the effect of platelet-rich plasma and methylprednisolone subacromial injection in improving rom⸲ reducing pain and improving function in patients with partial rotator cuff tear.
Design
This clinical trial consists of two parallel groups, each including 50 patients with partial rotator cuff tear. In one group, prednisolone is injected, and in the other group, Platelet-Rich Plasma (PRP) is injected. The study is single-blind, meaning the patient does not know which injection they have received. The study is randomized and is conducted on a total of 100 patients from May to August 2024. The ‘rand’ function of Excel software is used for randomization.
Settings and conduct
Patients with partial rotator cuff tear who visit the orthopedic clinic of Imam Khomeini Hospital are selected. One group is prepared for a subacromial injection of Platelet-Rich Plasma (PRP) and another group for a subacromial injection of methylprednisolone. To blind the patients, from the corticosteroid group, a blood sample is taken before injection and sent to the lab for CBC to preserve medical ethics. Also, during the injection, adhesive tape is used around the syringe.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients over 30 years old with shoulder pain and reduced rom due to partial rotator cuff tear.
Exclusion Criteria: Patients with history of previous shoulder surgery or other shoulder pathologies.
Intervention groups
100 patients with partial rotator cuff tears are selected. Patients are randomly divided into two experimental groups of 50 people each: one group receives PRP injections, and the other receives corticosteroid injections.
Main outcome variables
Simple shoulder tests, Oxford tests, and the improvement of ROM,
General information
Reason for update
Acronym
PRP
IRCT registration information
IRCT registration number:IRCT20230608058415N1
Registration date:2024-05-08, 1403/02/19
Registration timing:prospective
Last update:2024-05-08, 1403/02/19
Update count:0
Registration date
2024-05-08, 1403/02/19
Registrant information
Name
Mohammad Pourfarzaneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 5461
Email address
mpourfarzaneh50@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-29, 1403/03/09
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effects of subacromial injections of platelet-rich plasma and methylprednisolone for improving range of motion, reducing pain, and enhancing function in patients with partial rotator cuff tears
Public title
Effect of PRP and methylprednisolone injection in patients with partial rotator cuff tear
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with partial thickness rotator cuff tear and reduced shoulder range of motion
Patient does not have any contraindication for shoulder injection
Age more than 30
Exclusion criteria:
Patients with previous shoulder surgery and injection
Patients with frozen shoulder
Patients with shoulder fracture
Other pathologies induce shoulder pain (in examination and radiology)
Patients with full thickness rotator cuff tear
Age
From 30 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the block division of quadruple numbers that is done by Excel software.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the patients, the group receiving methylprednisolone injection also has a blood sample taken before the injection, and for the sake of medical ethics, the blood sample is sent to the laboratory for counting blood cells. Also, during the injection, adhesive tape is used around the syringe so that the patient does not realize the injected substance.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Imam khomeini Hospital Complex, Keshavarz Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.TUMS.IKHC.REC.1403.028
Health conditions studied
1
Description of health condition studied
Partial rotator cuff tear
ICD-10 code
S46.0
ICD-10 code description
Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder
Primary outcomes
1
Description
Shoulder function
Timepoint
Before injection, 3 & 6 months after injection
Method of measurement
Constant-Merely
Secondary outcomes
1
Description
Shoulder pain
Timepoint
Before injection, 3 & 6 months after injection
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: In the first intervention group, a subacromial injection of 40 milligrams of methylprednisolone is performed under sonography guidance. Then, simple shoulder tests, Oxford, and Constant-Murley tests are conducted before the injection and at three and six months after the injection in all patients.
Category
Treatment - Drugs
2
Description
Intervention Group: In the second intervention group, a subacromial injection of 6 cc of Platelet-Rich Plasma (PRP) derived from the patient’s blood is performed under sonography guidance. Then, simple shoulder tests, Oxford, and Constant-Murley tests are conducted before the injection and at three and six months after the injection in all patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital complex
Full name of responsible person
Mohammad Pourfarzaneh
Street address
Imam Khomeini Hospital Complex, Keshavarz Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Akbari Sari
Street address
Imam Khomeini hospital complex, Keshavarz Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Pourfarzaneh
Position
Orthopedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini Hospital Complex, Keshavarz Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
mpourfarzaneh50@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Pourfarzaneh
Position
Orthopedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini Hospital Complex, Keshavarz Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
mpourfarzaneh50@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Pourfarzaneh
Position
Orthopedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini Hospital Complex, Keshavarz Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
mpourfarzaneh50@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data collected from subjects throughout the study are publishable whilst keeping patients personal information confidential.
When the data will become available and for how long
6 months after publishing the findings.
To whom data/document is available
Academic researchers only.
Under which criteria data/document could be used
To be used by researchers with similar subjects of study.
From where data/document is obtainable
Dr. Mohammad Pour Farzaneh
Orthopedic surgery resident at Iman Khomeini Hospital Complex
mpourfarzaneh50@gmail.com
What processes are involved for a request to access data/document
An email to be sent to the above email address, entailing researcher's academic authentication as well as information of the proposed study.