1. Home
  2. Approved trials
  3. » فارسی

Effect of the Platelet-Rich Plasma (PRP) injection in primary manifestations of knee osteoarthritis in patients who refer to rheumatology clinic of Kowsar hospital, Semnan

Protocol summary

Summary
Purpose: Assessment the intra-articular injection effect of platelet-rich plasma (PRP) on symptoms of primary osteoarthritis. Study design: This study is a randomized, double-blind, placebo controlled, uni- center, 2-3 phase of clinical trials. Study population: patients with primary osteoarthritis of the knee who will refer to Kowsar hospital that are randomly selected. Main inclusion criteria: age 40-60 years, history of chronic knee pain for at least 12 months and a Kellgren-Lawrence radiological criterion. Main exclusion criteria: thrombocytopenia, antiplatelet drugs, corticosteroids, liver or kidney systemic disease, leukemia and lymphoma, congestive heart failure, myocardial infarction and arrhythmias, septic arthritis, intra-articular injection of steroids or hyaluronic acid during the last 6 months, smoking . Sample Size: 60 patients, 30 in the intervention group and 30 patients as control group Interventions: The intervention group patients received autologous PRP injections 3 CC in both knee and patients in control group received placebo injections (empty syring). Time of interventions: The patients will be assessed at initiation, 3 and 6 months after the intervention, using the IKDC, EQ VAS and Tegner criteria. Primary outcome: improving of IKDC, EQ-VAS and Tegner criteria in 3 and 6 months after injection of PRP in compare to before injection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015010112823N2
Registration date: 2015-01-19, 1393/10/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-19, 1393/10/29
Registrant information
Name
Jamileh Moghimi
Name of organization / entity
Semnan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 23 1332 8017
Email address
moghimi_jam@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the Platelet-Rich Plasma (PRP) injection in primary manifestations of knee osteoarthritis in patients who refer to rheumatology clinic of Kowsar hospital, Semnan
Public title
Effect of the Platelet-Rich Plasma(PRP) injection in primary manifestations of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- age 40-60 years, 2- a history of chronic knee pain for at least 12 months, 3-Kellgren-Lawrence radiological criteria for having developing osteoarthritis of the knee (grade 1 and 2). Exclusion criteria: 1. Thrombocytopenia, 2- taking anticoagulant agents during the past 2 weeks 3- taking immunosuppressive drugs, NSAIDs and corticosteroids, 4- liver or renal disease, 5- leukemia and lymphoma, 6- a history of malignancy, active malignant disease, 7- severe cardiovascular disease including congestive heart failure, myocardial infarction and cardiac arrhythmia, 8- bacterial arthritis at least during last 6 months, 9- intra-articular injection of steroid or hyaluronic acid during the last 6 months, 10- use of cigarettes and tobacco 11- fever and systemic infections and local infection in injection site.
Age
From 40 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee, Semnan university of Medical Sciences
Street address
Basidj Boulevard
City
Semnan
Postal code
3519899951
Approval date
2015-01-13, 1393/10/23
Ethics committee reference number
93/551664

Health conditions studied

1

Description of health condition studied
primary manifestations of osteoarthritis
ICD-10 code
Gonarthros
ICD-10 code description
M17

Primary outcomes

1

Description
Pain
Timepoint
Befor and 3 and 6 months after intervention
Method of measurement
IKDC, EQ-VAS and Tegner criteria

Secondary outcomes

1

Description
Physical Activities
Timepoint
6 months after intervantion
Method of measurement
IKDC، EQ-VAS and Tegner criteria

Intervention groups

1

Description
In the first group (N=30) 3 CC autologous PRP by a syringe which covered in aluminum foil will be intraarticularly injected. The patient is not aware of the contents of the syringe (real injections).
Category
Treatment - Drugs

2

Description
For patients in the control group (n=30) an empty syringe which covered by aluminum foil prepared and its needle enter up to 5 mm into skin and fat tissue without entering into the joint space (Pseudo injection).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Dr. Jamileh Moghimi
Street address
Amin Ave., Alghadir square
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Asgari
Street address
Basidj Boulevard
City
Semnan
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 and Technology, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Jamileh Moghimi
Position
Rheumatologist/ Associate Professor
Other areas of specialty/work
Street address
Basidj Boulevard
City
Semnan
Postal code
Phone
+98 23 3345 1336
Fax
Email
moghimi_jam@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Jamileh Moghimi
Position
Rheumatologist/ Associate Professor
Other areas of specialty/work
Street address
Basidj Boulevard
City
Semnan
Postal code
Phone
+98 23 3345 1336
Fax
Email
moghimi_jam@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of MEdical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research Expert
Other areas of specialty/work
Street address
Kowsar Hospital, Amin Ave., Alghadir square
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7838
Fax
+98 23 3343 7838
Email
mehrdadzahmatkesh@semums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...