Comparison of the effect of platelet rich plasma injection with the combination of platelet rich plasma and vitamin C on partial thickness rotator cuff tears
1) Determining and comparing the average pain intensity in the two groups of platelet-rich plasma (PRP) and normal saline injection with PRP and vitamin C injection before, 1 month after and 3 months after the intervention.
2) Determining and comparing the average range of motion angle in the two groups of PRP and normal saline injection with PRP and vitamin C injection before, 1 month after, and 3 months after the intervention.
3) Determining and comparing the average pain intensity and range of motion angle in two groups of PRP and normal saline injection with PRP and vitamin C injection adjusted according to demographic characteristics before, 1 month after and 3 months after intervention
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 110 patients. Simple random tables created by computer were used for randomization.
Settings and conduct
The ultrasound-guided injection will be performed in the subacromial space during two periods with an interval of 3 weeks. The first group will be treated with 1.5 ml of normal saline + 1.5 ml of PRP and the second group will be treated with 2.5 ml of PRP and 0.5 ml of vitamin C. The process of blinding for the patients and the doctor and the person evaluating the treatment result will be done during the study.
Participants/Inclusion and exclusion criteria
Entry conditions:
Patients who, according to the clinical examination of an orthopedic specialist doctor and MRI results, according to Elman's classification system, have partial rotator cuff tears of the 1st and 2nd stage located in supraspinatus.
Non-entry conditions:
Rotator cuff tears secondary to fracture
Prior surgical repair or revision arthroscopy
Intervention groups
Patients will be randomly assigned to one of two groups: normal saline + PRP or vitamin C + PRP.
Main outcome variables
pain intensity score; Range of motion angle score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230821059205N1
Registration date:2023-08-26, 1402/06/04
Registration timing:prospective
Last update:2023-08-26, 1402/06/04
Update count:1
Registration date
2023-08-26, 1402/06/04
Registrant information
Name
Fatemeh Mohammadi Vahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3251 0435
Email address
fatemehmohammadi.v98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of platelet rich plasma injection with the combination of platelet rich plasma and vitamin C on partial thickness rotator cuff tears
Public title
The effect of platelet rich plasma and vitamin C on rotator cuff tears
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women between 18 and 70 years of age
Within 6 months of initial diagnosis
Patients who, according to the clinical examination of an orthopedic specialist doctor and MRI results, according to Elman's classification system, have partial rotator cuff tears of the 1st and 2nd stage located in supraspinatus (with a size of less than 6 mm and a tendon tear less than 50 percent).
Exclusion criteria:
Elderly patients over 70 years old
Rotator cuff tears secondary to fracture
Prior surgical repair or revision arthroscopy
Prior platelet-rich plasma or other drug intervention
Pregnant patients
History of mental disorders, cardio-cerebrovascular disease
shoulder pain induced by non- rotator cuff tear
Patients treated with drugs that interfere with vitamin C
Active infection
Hemoglobin <7.0 g٫dl or platelets < 150,000٫µL
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
People will be randomly assigned to two groups of normal saline + platelet-rich plasma and vitamin C + platelet-rich plasma by simple random method and based on simple random tables created by computer.
Blinding (investigator's opinion)
Double blinded
Blinding description
Despite obtaining informed consent from the participants in the study, these people are unaware of which treatment intervention group they will be placed in.
The preparation of platelet-rich plasma (PRP) is performed by a hematologist at the Comprehensive Center for Stem Cells and Regenerative Medicine. He combines the PRP prepared from the patients with normal saline or vitamin C and by writing the names of the patients, he is aware of what type of treatment intervention will be done for each person. In addition, the syringe containing any type of therapeutic combination (normal saline + PRP and vitamin C + PRP) will be labeled as A or B by convention, and the mentioned hematologist is aware of how to mark according to the type of therapeutic intervention.
The orthopedic specialist who is responsible for injecting the therapeutic combination is unaware of the type of therapeutic combination and is generally kept blind in the study process.
The researcher, who is actually the person who evaluates the treatment outcomes and patients' questionnaires, is also kept blind in the study process.
The statistical consultant of the research who is in charge of data analysis is also kept blind in the study process.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Public Health - Shahid Sadoughi University of Medical Scienc
Street address
Alam Square, Shohday Gomnam Blvd., Campus of Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Faculty of Health
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Approval date
2023-07-29, 1402/05/07
Ethics committee reference number
IR.SSU.SPH.REC.1402.045
Health conditions studied
1
Description of health condition studied
Partial rotator cuff tear
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff tear or rupture, not specified as traumatic
Primary outcomes
1
Description
Pain intensity score of patients on visual analog scale
Timepoint
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
Method of measurement
Visual analog scale, American shoulder and elbow surgeons questionnaire
2
Description
Range of motion angle score in the standardized evaluation questionnaire of American shoulder and elbow surgeons
Timepoint
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
Method of measurement
American shoulder and elbow surgeons questionnaire,
3
Description
Range of motion angle score in the Constant Shoulder Score questionnaire
Timepoint
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
Method of measurement
Constant Shoulder Score
Secondary outcomes
1
Description
Pain intensity score
Timepoint
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
Method of measurement
Visual analog scale, American shoulder and elbow surgeons questionnaire
2
Description
Range of motion angle score
Timepoint
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
Method of measurement
American shoulder and elbow surgeons questionnaire, Constant Shoulder Score
Intervention groups
1
Description
Intervention group: Injection of 0.5 ml of vitamin C and 2.5 ml of platelet-rich plasma will be performed under ultrasound guidance in the subacromial space during two periods with an interval of 3 weeks.
Category
Treatment - Drugs
2
Description
Control group: Injection of 1.5 ml of normal saline and 1.5 ml of platelet-rich plasma will be performed under ultrasound guidance in the subacromial space during two periods with an interval of 3 weeks. The preparation method of PRP is similar to the procedure mentioned in the intervention group, with the difference that for the control group, after preparation, PRP mixed with normal saline is used for injection to the patients of the control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic specialist office
Full name of responsible person
Dr. Amirreza Sadeghifar
Street address
Jahad Boulevard, Baran doctors building, 4th floor, Unit 409
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5280
Email
drsadeghifar2000@gmail.com
2
Recruitment center
Name of recruitment center
Stem Cells and Regenerative Medicine Innovation Center
Full name of responsible person
Dr. Alireza Farsinejad
Street address
Islamic Republic Blvd., Shafa Intersection, Stem Cells and Regenerative Medicine Innovation Center
City
Kerman
Province
Kerman
Postal code
7618747653
Phone
+98 34 3121 5683
Fax
+98 34 3121 5682
Email
info.SIC@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargoui
Street address
Imam Hossein Square, Daneshjoo Blvd., Imam Reza (a.s.) educational and research complex, vice president of research and technology, Shahid Sadougi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۸۸۶۳۷
Phone
+98 35 3628 8114
Email
dvc.research@ssu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi Vahedi
Position
Master Science Student of Surgical Technology, Yazd University of Medical Sciences, Yazd, Iran
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 25, The Alley No. 10, North Sheikh Ahmed Kafi Avenue., Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7617759585
Phone
+98 34 3251 0435
Email
fatemehmohammadi.v98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amirreza Sadeghifar
Position
Associate Professor of Orthopaedics
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Unit 409, 4th floor, Baran Doctors Complex, Jahad Boulevard, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619817189
Phone
+98 34 3223 5280
Email
drsadeghifar2000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi Vahedi
Position
Master Science Student of Surgical Technology, Yazd University of Medical Sciences, Yazd, Iran
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 25, The Alley No. 10, North Sheikh Ahmed Kafi Avenue., Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7617759585
Phone
+98 34 3251 0435
Email
fatemehmohammadi.v98@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available