Comparison of functional improvement and quality of life in knee osteoarthritis after treatment of PRP (platelet rich plasma) and exercise: a randomized controlled trial
Goal: comparison of functional improvement and quality of life in knee osteoarthritis after treatment of PRP (platelet rich plasma) and exercise. Osteoarthritis (OA) is a highly prevalent, chronic, degenerative condition that generates a high expense. Alternative and co-adjuvant therapies to improve the quality of life and physical function of patients are currently being sought. Methods: A total of 66 patients with knee OA were treated with PRP (plasma rich in growth factors), and exercise in 2 groups (intervention and control) with OA of the knee (Outer bridge grades I–IV) and symptoms of >3 months duration met the inclusion criteria (age <75yr, history without of hematologic disorder and diabetes ...) and. 2 intra-articular injections of autologous PRP were administered at 4-week intervals in outpatient surgery and knee exercise is taught to both intervention and control groups. Participants were asked to fill out a questionnaire with personal data and the following assessment instruments: SF-36, WOMAC Index, before the injection of PRP and 6 months after injection or exercise.
General information
Acronym
PRP =platelet rich plasma
IRCT registration information
IRCT registration number:IRCT201110117770N1
Registration date:2013-01-18, 1391/10/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-18, 1391/10/29
Registrant information
Name
Marzieh Babaee
Name of organization / entity
Physical medicine and rehbilitation department, Shahid Beheshti university of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
marzieh.babaee@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of functional improvement and quality of life in knee osteoarthritis after treatment of PRP (platelet rich plasma) and exercise: a randomized controlled trial
Public title
Effectiveness of PRP in treatment of Knee degenerative disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of chronic (at least 3months) pain or swelling of the knee and imaging findings (X-ray or MRI) of degenerative changes of the joint according of American college of Rheumatology. Exclusion criteria: systemic disorders such as diabetes, rheumatoid arthritis, major axial deviation (varum 20 degree, valgum 20 degree), hematological diseases (coagulopathy), severe cardiovascular diseases, infections, immunodepression, patients in therapy with anticoagulants or antiaggregants, the use of NSAIDs in the 2 days before blood donation and patients with Hb values of 12 and platelet values of 150,000/mmc; Pregnancy; breast feeding; vasovagal shock; severe trauma; injection of corticosteroid in knee joint since 2 weeks ago.
Age
To 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Ethic committe of Shahid beheshti University of Medical siences
Street address
Shahid beheshti University of Medical siences,Velenjak
City
Tehran
Postal code
Approval date
2012-10-28, 1391/08/07
Ethics committee reference number
124
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
function
Timepoint
6 months
Method of measurement
WOMAC Questianir
2
Description
quality of life
Timepoint
6 months
Method of measurement
SF36 questinair
Secondary outcomes
empty
Intervention groups
1
Description
5 cc of PRP injection in 4 weeks interval and knee isometric exercise (4 types) 3 times in day, 10 times every exercise
Category
Treatment - Drugs
2
Description
knee isometric exercise (4 types) 3 times in day, 10 times every exercise
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Modares and Shohadaye Tajrish Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti university of Medical siences
Full name of responsible person
Vice chancellor for research, Dr. Rahmati Roodsari
Street address
Shahid Beheshti university of Medical siences , Kodakyar alley,Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti university of Medical siences
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
Physical medicine and Rehabilitation department of Shahid Beheshti university of medical siences
Full name of responsible person
Marzieh Babaee
Position
resident
Other areas of specialty/work
Street address
Physical medicine and Rehabilitation department,Shohadaye Tajrish Hospital,Tajrish
City
Tehran
Postal code
Phone
+98 21 2273 1112
Fax
Email
rambabaee@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Physical medicine and Rehabilitation department
Full name of responsible person
Marzieh Babaee
Position
resident
Other areas of specialty/work
Street address
Physical medicine and Rehabilitation department ,Shohadaye Tajrish Hospital, Tajrish
City
Tehran
Postal code
Phone
+98 21 2273 1112
Fax
Email
rambabaee@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)