This randomized, double blind, parallel study was conducted with 140 knee OA patient to compare the Therapeutic effects of corticosteroids and hyaluronic acid. Patients will visit by a physician . after they signed informed consent they will choose. individuals randomly divided into two groups. Intensity of pain will assess by Visual analogue scale and Western Ontario McMaster University Osteoarthritis questionnaire. The treatment consisted of one IA injections of HA or one injections of CS and the follow-up visits were scheduled at 1 months, 2 months, and 3 months Qualified patients were men and women from 45 years to 80 years of age suffering from knee OA for more than 3 months, with radiographic. Main exclusion criteria was The use of NSAIDs in 2 days prior to injection. Patients and investigators were blinded in this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015031421460N1
Registration date:2015-08-01, 1394/05/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-01, 1394/05/10
Registrant information
Name
Tahereh Gholami
Name of organization / entity
Fasa University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 5335 7091
Email address
gholami@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Fasa University of Medical Sciences
Expected recruitment start date
2015-05-05, 1394/02/15
Expected recruitment end date
2015-06-05, 1394/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Hyaluronic Acid Compared with Corticosteroid Injections for the Treatment of Osteoarthritis of the knee
Public title
Hyaluronic Acid Compared with Corticosteroid Injections for the Treatment of Osteoarthritis of the knee
Purpose
Treatment
Inclusion/Exclusion criteria
Qualified patients were men and women from 45 years to 80 years of age suffering from knee OA for more than 3 months, with radiographic. Main exclusion criteria were a history or presence of trauma or surgery or cancer or malignant tumors, infections and sores on the target knee, History of vasovagal shock , The use of NSAIDs in 2 days prior to injection, Any receiving corticosteroids injection in the knee in the last 6 months , Pregnancy and lactation
Age
From 48 years old to 13 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Ethics Committee of Fasa University of Medical Sciences
Street address
Fasa University of Medical Sciences, Ebne Sina square, Fasa, Fars
City
Fasa
Postal code
Approval date
2014-12-02, 1393/09/11
Ethics committee reference number
e– 9306
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17- M18-
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
pain
Timepoint
before intervention- one- two- three months after intervention
Method of measurement
Visual analogue scale and questionnaire
Secondary outcomes
1
Description
Physical function
Timepoint
before and after intervention
Method of measurement
questionnaire and interview with patients
Intervention groups
1
Description
Patients participating in the study will be divided into two groups of 70 people. One group will take 40 mg Depomedrol corticosteroid injection in the space between the knee joint by an orthopedic physician. And second group will take hyaluronic acid (Hyalgan) in 2 ml vials to the space between the knee joint by an orthopedic physician.
Category
Treatment - Drugs
2
Description
intervention group: hyaluronic acid (Hyalgan) in 2 ml vials to the space between the knee joint by an orthopedic physician
Category
Treatment - Drugs
3
Description
control group: this group will take 40 mg Depomedrol corticosteroid injection in the space between the knee joint by an orthopedic physician
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamzeh hospital/ Fasa University of Medical Sciences
Full name of responsible person
Tahereh Gholami
Street address
Fasa University of Medical Sciences
City
Fasa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Fasa University of Medical Sciences
Full name of responsible person
Dr. Ehsan Bahramali
Street address
Fasa University of Medical Sciences, Ebne Sina square, Fasa, Fars
City
Fasa
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 of Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Dr. Alireza Askari
Position
Orthopedics/ Faculty
Other areas of specialty/work
Street address
Fasa University of Medical Sciences, Ebne Sina squar, Fasa, Fars
City
Fasa
Postal code
Phone
+98 71 5335 0994
Fax
Email
aaskari60@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Alireza Askari
Position
Orthopedics/ Faculty
Other areas of specialty/work
Street address
Fasa University of Medical Sciences, Ebne Sina square, Fasa, Fars
City
Fasa
Postal code
Phone
+98 71 5335 0994
Fax
Email
aaskari60@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Tahereh Gholami
Position
ergonomics- faculty
Other areas of specialty/work
Street address
Fasa University of Medical Sciences,Ebne Sina square, Fasa, Fars
City
Fasa
Postal code
Phone
+98 71 5335 0994
Fax
+98 53357091
Email
gholami@fums.as.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)