Short-term efficacy of intra-articular injection, PRP(platelet rich plasma) compared with placebo in patients with osteoarthritis of the knee in Zanjan province
This study will be conducted in Vali-Asr Hospital Rheumatology Clinic of men and women in the age range 30-70 years with osteoarthritis of the America College of Rheumatology classification criteria (ACR) shall be verified and if both diseases with a severely infected knee and the severity of patients in radiology 3-2 (moderately severe) will be examined. There is pain in patients with osteoarthritis of the knees and feel Krypytasyvn detailed mechanical examinations and x-rays are symptoms. PRP injections will be as follows: 48 hours ago PRP injection is not taking any painkiller. The amount of 4 cc of PRP produced in absolutely sterile syringes prepared in the knee by a rheumatologist PT Supra respected. From anesthetic injection will not be used. The patient's knee under sterile conditions and given normal saline Khvahdshd.dr baseline VAS and WOMAC questionnaire six weeks after PRP injections for patients by residents will be filled, and every knee will be examined separately. It also is repeated after 6 weeks of preliminary tests to check for possible side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030626922N1
Registration date:2016-04-08, 1395/01/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Tayebe Lakzaei
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3302 3231
Email address
dr.lakzaei55@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
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
Short-term efficacy of intra-articular injection, PRP(platelet rich plasma) compared with placebo in patients with osteoarthritis of the knee in Zanjan province
Public title
Short-term efficacy of intra-articular injection, PRP(platelet rich plasma) compared with placebo in patients with osteoarthritis of the knee
Purpose
Treatment
Inclusion/Exclusion criteria
This study will be conducted in Vali-Asr Hospital Rheumatology Clinic of men and women in the age range 30-70 years with osteoarthritis of the America College of Rheumatology classification criteria (ACR) shall be verified and if both diseases with a severely infected knee and the severity of patients in radiology 3-2 (moderately severe) will be examined. There is pain in patients with osteoarthritis of the knees and feel Krypytasyvn detailed mechanical examinations and x-rays are symptoms. Exclusion criteria included osteoarthritis secondary to inflammatory diseases - osteoarthritis generalized - osteoarthritis with grade 1 and 4 - metabolic bone - back pain - patients during the last 3 months any intra-articular injection have or arthroscopy during the past year have had. Any severe deformity of the knee - the knee varus and valgus knee more than 5 degrees more than 5 degrees - associated diseases such as septic knee - tumor - Crystal arthropathy or stiff joint effusion - anticoagulant treatment of patients with Hb less than 10 - dysfunction platelets or blood platelet count less than 150,000 liters in Mbkrv is also pregnancy- older than 70 years of sustainable use of NSAIDS in the past 48 hours, systemic disease, such as ischemic heart disease - diabetes and hepatitis
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
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
Zanjan university of medical sciences
Street address
zanjan-Azadi sq.
City
zanjan
Postal code
4515776978
Approval date
2015-02-12, 1393/11/23
Ethics committee reference number
ZUMS.REC.1393.272
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
(M15-M19)
ICD-10 code description
osteoarthritis
Primary outcomes
1
Description
The severity of joint pain
Timepoint
4-6week
Method of measurement
Patient interview questionnaire WOMAC + VAS
2
Description
The severity of stiffness
Timepoint
4-6 week
Method of measurement
Patient interview questionnaire WOMAC + VAS
3
Description
Severity of joint dysfunction
Timepoint
4-6 week
Method of measurement
Patient interview questionnaire WOMAC + VAS
Secondary outcomes
empty
Intervention groups
1
Description
injection
A:PRP B:normal salin
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
zanjan-Vali-e-asr hospital
Full name of responsible person
dr.A. sadeghi
Street address
zanjan-Vali-e-asr Sq.
City
zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan university of medical sciences
Full name of responsible person
dr.A. sadeghi
Street address
zanjan- Azadi Sq.
City
zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan university of medical sciences
Full name of responsible person
tayebe lakzaei
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Zanjan
City
Zanjan
Postal code
4515776978
Phone
+243 30 23236
Fax
Email
Dr.lakzaei55@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan university of medical sciences
Full name of responsible person
dr.A. sadeghi
Position
Rheumatologist
Other areas of specialty/work
Street address
Zanjan university of medical sciences
City
Zanjan
Postal code
Phone
+243 30 23236
Fax
Email
Sadeghialireza@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan university of medical sciences
Full name of responsible person
tayebe lakzaei
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Zanjan university of medical sciences- Vali-e-asr hospital
City
Zanjan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)