Comparative study of corticosteroid injections and platelet rich plasma in the treatment of patients with shoulder tendinopathy compare sonographic findings
In Rheumatology clinic, patients with shoulder pain would be assessed clinically and paraclinically in order to confirm the rotator cuff or biceps tendinopathy. The patients would be referred to the sports medicine clinic and would be divided in two groups randomly; Platelet rich Plasma and corticosteroid injection groups.
The platelet rich plasma group is injected twice within a month. In this group, 20 ml of venous blood was taken by centrifuges Selex protocol RCF, blood samples from the men with the 1800 and 2000 cycles and women with 1600 and 2000 cycle. Plasma rich platelets are separated after adding calcium gluconate 10% cc platelet concentrate obtained under ultrasound Guide, in collaboration with a radiologist and a sports medicine specialist in the area of sub-45 degree lateral Acromion is injected (based on Sonographic Guide).
The injection for corticosteroid group, however, is applied once or twice within a month based on the Rheumatologist decision.
At the baseline, after four weeks and also eight weeks after intervention, all the studies including pain, range of motion, function, and Sonographic findings changes are evaluated and compared with the data which is recorded before intervention.
Assessment of clinical sing such as pain (based on VAS measurement), shoulder range of motion and its function is occurred. Moreover, musculoskeletal sonography is applied by two clinician experts. These (findings are) recorded and compared.
Considering the significant level 20 SD = 05/0 and test in 8/0, a sample of 32 patients per group is needed. Due to the possible data missing, 35 patients in each group are considered for this study.
General information
Acronym
PRP
IRCT registration information
IRCT registration number:IRCT201302174251N9
Registration date:2013-05-03, 1392/02/13
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2013-05-03, 1392/02/13
Registrant information
Name
Haleh Dadgostar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 4050
Email address
dadgostar.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of corticosteroid injections and platelet rich plasma in the treatment of patients with shoulder tendinopathy compare sonographic findings
Public title
Comparing the effect of corticosteroid injections and platelet rich plasma on the treatment of shoulder tendinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Shoulder pain that lasts for more than 3 months; limited shoulder range of motion;Absence of radicular pain,Inflammatory disorders such as rheumatoid arthritis,fibromyalgia, lack of complete rotator cuff tear, the ligament laxity, non-corticosteroid injections in the past three months.
Exclusion criteria:Unwillingness of the patient to continue treatment;shoulder joint surgery; the presence of other disorders that limit joint motion such as frozen shoulder
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Ghods street Keshavars Blv
City
Tehran
Postal code
Approval date
2012-07-20, 1391/04/30
Ethics committee reference number
19910-91-4-30
Health conditions studied
1
Description of health condition studied
Shoulder Tendinopathy
ICD-10 code
M75.1
ICD-10 code description
rotator cuff syndrome rotator cuff or supraspinatous tear or rupture (complete ) ( incomplete ) not specified as traumatic
Primary outcomes
1
Description
Pain
Timepoint
every 2 weeks up to 8 weeks
Method of measurement
VAS scale
2
Description
range of motion
Timepoint
every 2 weeks up to 8 weeks
Method of measurement
Goniameter
3
Description
Sonographic finding
Timepoint
at base line and 8 weeks later
Method of measurement
Sonographic prob
Secondary outcomes
empty
Intervention groups
1
Description
The platelet rich plasma group is injected twice within a month. In this group, 20 ml of venous blood was taken by centrifuges Selex protocol RCF, blood samples from the men with the 1800 and 2000 cycles and women with 1600 and 2000 cycle. Plasma rich platelets are separated after adding calcium gluconate 10% cc platelet concentrate obtained. Under ultrasound Guide, in collaboration with a radiologist and a sports medicine specialist in the area of sub-45 degree lateral Acromion is injected (based on Sonographic Guide). Assessment of clinical sing such as pain (based on VAS measurement), shoulder range of motion and its function is occurred. Moreover, musculoskeletal sonography is applied by two clinician experts. These (findings are) recorded and compared
Category
Treatment - Drugs
2
Description
The injection for corticosteroid group, however, is applied MethylPrednisolone 40 mg once or twice within a month based on the Rheumatologist decision.
At the baseline, after four weeks and also eight weeks after intervention, all the studies including pain, range of motion, function, and Sonographic findings changes are evaluated and compared with the data which is recorded before intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Haleh Dadgostar MD
Street address
Shahr ara street Sattar khan street
City
Tehran
2
Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Shafieh Movaseghi MD
Street address
End of Keshavars Blv
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi MD
Street address
Tehran University of Medical Sciences, Keshavarz Boulvard, Ghods st
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Sports Medicine Research Center.Tehran University of Medical Sciences . Tehran. Iran
Full name of responsible person
Haleh Dadgostar MD
Position
Assistance Professor
Other areas of specialty/work
Street address
Shahr Ara street Sattar khan street
City
Tehran
Postal code
Phone
+98 21 6435 2446
Fax
Email
hldadgostar@gmail.comhdadgostar@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sports Medicine Research Center Tehran University of Medical Sciences Tehran Iran
Full name of responsible person
Haleh Dadgostar MD
Position
Assistance Professor
Other areas of specialty/work
Street address
Shahr Ara street Sattar khan street
City
Tehran
Postal code
Phone
+98 21 6435 2446
Fax
Email
hldadgostar@gmail.comhdadgostar@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sports Medicine Research center Tehran University of Medical University Tehran Iran
Full name of responsible person
Haleh Ddagostar MD
Position
Assistance Professor
Other areas of specialty/work
Street address
Shahr Ara street sattar khan street
City
Tehran
Postal code
Phone
+98 21 6435 2446
Fax
Email
hldadgostar@gmail.comhdadgostar@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)