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The effects of intraarticular injection of Platelet Rich Plasma(PRP) and corticosteroid on knee osteoarthritis: a randomized clinical trial

Protocol summary

Summary
The goal of this study is the comparison of the effect of PRP and corticosteroid on the treatment of knee osteoarthritis. 40 people, 50 to 75 years old, with pain more than 60mm based on VAS who are referred to Physical Medicine and Rehabilitation clinic, enter to PRP or corticosteroid (Depomedrol) group accidentally.People with coagulopathies, poor controlled diabetes melitus, active infection or malignancy, knee surgery during 3 months ago, any knee injection during 6 months ago, NSAID or ASA intake during 5 days before injection exclude from the study.25 cc and 5 cc venous blood will taken from patients of PRP and corticosteroid group respectively. In PRP group the blood will centrifuge 2 times, PRP will prepared. After local anesthesia with Lidocain, PRP or corticosteroid will be injected intraarticularely by resident of Physical Medicine and Rehabilitation. Patients would be under evaluation before injection, 3m, 2m, 6m after treatment with VAS, KOOS questionnaire and 20 meters walk test by trained occupationalist who is unaware of grouping and kind of injection of patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013041413012N1
Registration date: 2013-06-09, 1392/03/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-06-09, 1392/03/19
Registrant information
Name
Elaheh Mianehsaz
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+992 166009109
Email address
e_mianehsaz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-03-10, 1391/12/20
Expected recruitment end date
2013-09-11, 1392/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of intraarticular injection of Platelet Rich Plasma(PRP) and corticosteroid on knee osteoarthritis: a randomized clinical trial
Public title
Comparison between Platelet Rich Plasma(PRP) and corticosteroid in the treatment of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: knee osteoarthritis; VAS more than 60; use of at least two other methods of treatment previously. Exclusion: breast feeding; pregnancy; RA; severe cardiac disease; immunosuppresion; warfarin intake; coagulopathies; take NSAID or ASA during 5 days ago; radiculopathy; knee surgery during 3 months ago; active infection or malignancy; substance abuse; poor controlled diabetes mellitus; any knee injection during 6 months ago; doing physiotherapy or acupuncture during 6 months after injection
Age
From 50 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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
Central building of Tehran University of Medical Sciences, Ghods street, Keshavarz blv, Tehran
City
Tehran
Postal code
Approval date
2013-02-16, 1391/11/28
Ethics committee reference number
91/d//130/2980

Health conditions studied

1

Description of health condition studied
Gonarthrosis [arthrosis of knee]
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral

Primary outcomes

1

Description
pain severity
Timepoint
before injection, 3 weeks, 2 and 6 months after injection
Method of measurement
VAS

2

Description
time of 20 meters traverse
Timepoint
before injection, 3 weeks, 2 and 6 months after injection
Method of measurement
20 meteres walk test

3

Description
pain, symptomes and function of patient
Timepoint
before injection, 2 and 6 months after injection
Method of measurement
KOOS questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
first group: Injection of 5 cc PRP (tubex, super PRP tube system) in the knee intraarticularly.
Category
Treatment - Drugs

2

Description
second group: injection of 40 mg corticosteroid (Depomedrol) in the knee intraarticularly.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitation ward, Firouzgar hospital
Full name of responsible person
Elaheh Mianehsaz
Street address
Physical Medicine and Rehabilitation ward, Firouzgar hospital, Behafarin st, Valiasr sq, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Vice Chancellor forresearch, Tehran University of Medical Sciences, Poursina st, Tehran
City
Tehran
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
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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Bijan Forogh
Position
Associate Professor of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation ward, Firouzgar hospital, Behafarin st, Valiasr sq, Teharn.
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
bijanfr@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medcal Sciences
Full name of responsible person
Dr. Bijan Forogh
Position
Associate Professor of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation ward, Firouzgar hospital, Behafarin st, Valiasr sq, Tehran.
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
bijanfr@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Elaheh Mianehsaz
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation ward, Firouzgar hospital, Behafarin st, Valiasr sq, Tehran.
City
Tehran
Postal code
Phone
+98 21 6600 9109
Fax
Email
elaheh.mianehsaz@gmail.com
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
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