Comparison of intra-articular injection of platelet rich plasma (PRP) versus combined PRP/somatropin on pain and joint range of motion in patients with knee osteoarthritis
Objectives: Various methods have been proposed to treat the pain of osteoarthritis. The platelet-rich plasma (PRP) is a concentrate of autologous growth factors in the blood and due to increase in tissue regeneration is applicable in various fields of medicine.
Design: Block randomization, without placebo, single center, trial phase 2, including 54 patients with knee osteoarthritis.
Participants including major eligibility criteria: All patients with knee osteoarthritis.
Intervention: Intervention 1. Platelet-rich plasma, 8 ml, intra-articular injection
Intervention 2. Platelet-rich plasma in combination with 4 units of growth hormone, 8 ml, intra-articular injection
Main outcome measures: Pain, Joint movement.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070210599N4
Registration date:2016-01-17, 1394/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intra-articular injection of platelet rich plasma (PRP) versus combined PRP/somatropin on pain and joint range of motion in patients with knee osteoarthritis
Public title
Comparison of the effect of injection of platelet-rich plasma and growth hormone into the knee joint and their effect on knee pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age between 30-70 years; Knee osteoarthritis stage I-III according to American Rheumatologist society criteria or radiologic criteria I-III according to Kalgreen-Lawrence criteria. Exclusion criteria: Addiction to opioids or alcohol; history of rheumatoid arthritis or any rheumatologic disease; hemophilia.
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients were divided into two groups using block randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
Intervention 2. Platelet-rich plasma in combination with 4 units of growth hormone, made in Biosidus company, Argentina, 8 ml, intra-articular injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Dr Damoon Azad
Street address
Firoozgar hospital, Beh-afarin St, Karim Khan Av.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Seyed Mohsen Ziyaeifard
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
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, Vice Chancellor for Research
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
Iran University of Medical Sciences
Full name of responsible person
Dr Damoon Azad
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 2503
Fax
Email
damonazad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Damoon Azad
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 2503
Fax
Email
damonazad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Damoon Azad
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 2503
Fax
Email
damonazad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)