The comparison of the effectiveness of high leukocyte PRP, low leukocyte PRP & placebo in treatment of the patients having rotator cuff tendinopathy or partial tear
Assessment and comparison of the effect of the high leukocyte and low leukocyte plasma rich platelet in the rotator cuff injuries
Design
In this double blinded randomized control group study, a total of 75 patients who have the inclusion criteria will be randomized into the three groups via random numbers table. 25 patients in the high leukocyte platelet rich plasma, 25 patients in the low leukocyte platelet rich plasma and 25 patients in the group subjected to placebo injection will be followed in parallel groups. The patients in the three groups will be subjected to the same therapeutic exercise protocol following the injection. Range of shoulder motion and the strength of the rotator cuff muscles and also pain and disability will be assessed before the treatment and then at 1,3 and 6 months after starting the treatment. Data is entered in the SPSS version 22 software and statistically measured by the use of t-student & Mann-Whitney u tests.
Settings and conduct
Patients with shoulder pain more than 6 weeks are referred to the sports medicine clinic of Rasoul-e-Akram Hospital, they are examined by the sports medical specialist and if tendinopathy or incomplete tear of their Rotator Cuff would be diagnosed by physical exams & confirmed by MRI findings, and If they do not have exclusion conditions, they will be included in the study
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Shoulder pain more than six weeks
Tendinopathy or partial tear of rotator cuff tendons
Exclusion criteria
Total tear of rotator cuff
The history of shoulder surgery
Intervention groups
Intervention group 1: Platelet rich plasma with high leukocyte; Intervention group 2: Platelet rich plasma with low leukocyte; Control group 3: Placebo injection
Main outcome variables
Patients' pain and function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100718004409N12
Registration date:2019-09-28, 1398/07/06
Registration timing:retrospective
Last update:2019-09-28, 1398/07/06
Update count:0
Registration date
2019-09-28, 1398/07/06
Registrant information
Name
Parisa Nejati
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4480 0361
Email address
parisanejati@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of high leukocyte PRP, low leukocyte PRP & placebo in treatment of the patients having rotator cuff tendinopathy or partial tear
Public title
The comparison of effectiveness of high leukocyte and low leukocyte PRP in tendinopathy and partial tear of rotator cuff
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Shoulder pain lasted more than 6 weeks
At least 3 positive specific shoulder tests
MRI findings implying tendinopathy or partial tear of rotator cuff
Exclusion criteria:
Shoulder pain that lasted less than six weeks
The presence of sensory or motor disturbances caused by the cervical radiculer pain
Evidence from other pathologies that can lead to shoulder pain. For example, the presence of calcified tendonitis or adhesive capsulitis and ...
History of shoulder surgery in the last 6 months
The presence of inflammatory rhomatologic diseases such as rheumatoid arthritis, fibromyalgia, poly mialia rheumatica and ...
Complete rupture of rotator cuff tendons based on MRI findings
The presence of ligamentous laxity or shoulder instability based on physical examination
History of corticosteroid, analgesic or hyaluronic acid injection in the shoulder joint over the past 3 months
History of exercise therapy and physiotherapy modalities over the past 6 weeks
The history of treatment with PRP in the last 6 months
Use of other therapies during the intervention period
Patients request for discontinuing the treatment
Contraindications for performing MRI or PRP in patients
Any non-rheumatologic inflammatory disease and severe acute infection in patients
Thrombocytopenia in patients
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
The included patients will be randomized in a simple randomization method. The random number tables found in the most statistical text books will be used for the random numbers. The numbers between 0-24 are considered for the first group, 25-49 for the second group and 50 -75 for the third group. The 3 groups are 1- high leukocyte-PRP, 2- low leukocyte PRP & 3- the placebo group. concealment is performed in sequentially numbered, sealed & opaque envelopes, and will be kept by the department secretory.
Blinding (investigator's opinion)
Double blinded
Blinding description
After randomization the patients of the each group will be introduced to the researcher 2 by the researcher 1 for evaluation of the outcomes. The researcher 2 only evaluates the outcomes and records the findings without being informed of the intervention and its effects. The analyzer receives the data at the end of the study and is not informed of the intervention groups at all. The patients are not informed about the injected syringe. Blood of the patients in the three groups will be centrifuged then the plasma in the groups 1 and 2 and the normal saline of the control group will be pulled in a covered syringe injected will be covered.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Iran university of medical sciences
Street address
Iran University of Medical Sciences, Near the Milad Tower,Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-05-22, 1398/03/01
Ethics committee reference number
IR.IUMS.FMD.REC.1398.073
Health conditions studied
1
Description of health condition studied
rotator cuff tendinopathy, partial tear of rotator cuff
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff tear or rupture, not specified as traumatic
2
Description of health condition studied
Shoulder impingement
ICD-10 code
M75.40
ICD-10 code description
Impingement syndrome of unspecified shoulder
Primary outcomes
1
Description
pain amount
Timepoint
Before intervention, 1 ,3 ,6 months after intervention
Method of measurement
Visual Analog Scale
2
Description
Function of the patients
Timepoint
Before intervention, 1 ,3 ,6 months after intervention
Method of measurement
WORC & DASH questionnaires
Secondary outcomes
1
Description
Shoulder range of motion
Timepoint
Before the intervention, 1,3,6 months after intervention
Method of measurement
Goniometry
2
Description
Rotator cuff strength
Timepoint
Before the intervention, 1,3,6 months after intervention
Method of measurement
Muscle Manual Test
Intervention groups
1
Description
Intervention group 1: Platelet rich plasma with high leukocyte 20 cc blood will be centrifuged in two 10- minute steps by Rooyagen kit then the 2 cc of the plasma will be drained
Category
Treatment - Other
2
Description
Intervention group: Platelet rich plasma with low leukocyte in this group the 2 cc of plasma will not be drained
Category
Treatment - Other
3
Description
Intervention group 3 or control group: placebo injection 0.5 cc normal saline will be injected in the shoulder
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran university of medical sciences, Rasool hospital,sports medicine clinic
Full name of responsible person
Parisa Nejati
Street address
Sattarkhan, Niayesh st.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2446
Email
parisanejati2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Iran University of Medical Sciences, Near the Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2243
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Parisa Nejati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Rasool hospital, Niayesh st.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
parisanejati2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Nejati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Rasool hospital, Niayesh street, Sattarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
parisanejati@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Nejati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Near the Milad Tower, Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 982164352446
Email
parisanejati2@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD