The effect of intra articular injection of triamcinolone in comparison with ketorolac on pain and function of patients with knee osteoarthritis, single blind clinical trial
This study is designed to compare the effect of intraarticular injection of triamcinolone and ketorolac in function and activity of daily living (ADL) in patients with knee osteoarthritis. Knee osteoarthritis is the most common joint disease, but despite a variety of non-surgical procedures, so far there is no general consensus on the priority of treatment. This study is a single-blind randomized controlled clinical trial on 40 patients with mild to moderate osteoarthritis who come to Mahdieh Hospital. Patients with pain or joint swelling and radiologic findings of joint destruction since 3 months ago based on knee osteoarthritis criteria of The ACR (grade 2, 3 of Kellgren-Lawrence scale ) will be recruited. Exclusion criteria are patients with history of any intera-articular injection, knee surgery or physiotherapy in last 3 months. One injection of triamcinolone will be received in one group and ketorolac will be injected in the other one. Exercise will be prescribed for both groups. Pain, function, maximum distance walking and ADL will be measured through WOMAC and Lequesne questionnaires before intervention, 1 months and 3 months after injection
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041633000N2
Registration date:2017-04-26, 1396/02/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-26, 1396/02/06
Registrant information
Name
Masume Bayat
Name of organization / entity
Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
bayat.masyme@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intra articular injection of triamcinolone in comparison with ketorolac on pain and function of patients with knee osteoarthritis, single blind clinical trial
Public title
Comparison of triamcinolone and ketorolac in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: arthralgia since the past 3 months; radiologic evidence of articular damage (grade 2,3 of Kellgren-Lawrence scale) based on knee OA criteria of ACR and age between 45-75 years.
Exclusion criteria: systemic diseases such as rheumatoid arthritis (RA), any history of intera articular injection, knee surgery or physiotherapy in the last 3 months.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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, Tehran, Iran
City
TEHRAN
Postal code
Approval date
2016-11-22, 1395/09/02
Ethics committee reference number
IR.SBMU.MSP.REC.1395.354
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis (Gonarthrosis)
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
knee pain
Timepoint
before intervention,1 months & 3 months after intervention
Method of measurement
WOMAC questionnaire
2
Description
Joint Stiffness
Timepoint
before intervention, 1 months & 3 months after intervention
Method of measurement
WOMAC questionnaire
3
Description
function
Timepoint
before intervention,1 months & 3 months after intervention
Method of measurement
WOMAC questionnaire
4
Description
The maximum distance of walking
Timepoint
before intervention, 1 months & 3 months after intervention
Method of measurement
Lequesne Index
5
Description
Activity of daily living
Timepoint
before intervention, 1 months & 3 months after intervention
Method of measurement
Lequesne Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: triamcinolone, knee intraarticular injection, 40 mg 1 time
Category
Treatment - Drugs
2
Description
Intervention group 2: ketorolac, knee intraarticuar injection, 30mg, 1 times
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Masumeh Bayat
Street address
Mahdieh Hospital, Rajab Nia Street,Shisheh gar Aley, Fadaian Inslam Street, Shosh Squar, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physical Medicine and Rehabilitation Department of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masumeh Bayat
Street address
Mahdieh Hospital, Rajab nia Street, shisheh gar alley, Fadaian Inslam Street, Shosh Squar, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicine and Rehabilitation Department of Shahid Beheshti 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
Shahid Beheshti Univeraity of Medical Sciences
Full name of responsible person
Mahsa Adili
Position
Resident in Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Mahdieh Hospital, Tehran
City
Tehran
Postal code
Phone
+98 21 6606 6490
Fax
Email
mahsaadili@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Univeraity of Medical Sciences
Full name of responsible person
Masumeh Bayat
Position
Assistant Professor
Other areas of specialty/work
Street address
Mahdieh Hospital, Tehran
City
tehran
Postal code
Phone
+98 21 5506 2628
Fax
Email
bayat.masyme@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti Univeraity of Medical Sciences
Full name of responsible person
Mahsa Adili
Position
Resident in Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Shahid Modarres Hospital, Saadat Abad street, Tehran
City
Tehran
Postal code
Phone
+98 216606490
Fax
Email
mahsaadili@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)