1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Comparison of the effect of knee injection of Dexamethasone and
Triamcinolone hexacetonide on knee pain in rheumatoid arthritis patients
Protocol summary
Summary
Comparison of knee pain between Dexamethasone and Triamcinolone hexacetonide in Knee Injection of
Rheumatoid Arthritis Patients will be done in the present study. 70 patients with rheumatoid arthritis based on ACR-EULAR criteria will recruit to the present study. All of the patients should have one or both knee swelling. We classified degree of knee swelling from grade 1 to taunt.
Knee circumference was measured from mid of patella.
Pain score will record with visual analog scale (0–100 mm). Patients that had knee swelling grade 2 or greater were selected and randomly allocated to the
Dexamethason (n =35) or Triamcinolon Hexaactenoid (n=35) groups. DAS 28 will be used to evaluation of disease activity. Blood samples for ESR, CRP and Anti- CCP will obtain from all patients. At first, joint aspiration will perform and if it reveal inflammatory pattern then involve joint will inject with 40 mg triamcinolon hexaastenid or 8mg deaxamethason sodium randomly.
Patients were unaware to the type of injection and will visit for knee swelling, circumference and pain at 1 and 3 weeks after joint injection by a rheumatologist that have not known about to drug was used for injection. Time of joint pain reduction will exam at 2, 4 and 6 months after inject for relapse of knee arthritis. Side effects of this procedure like as hot flash, skin pigmentation, fat atrophy, injection site reaction and infection will be evaluate in both groups.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT201008293812N4 Registration date: 2015-03-02, 1393/12/11 Registration timing: retrospective
Last update:
Update count: 0 Registration date
2015-03-02, 1393/12/11 Registrant information
Name
Amir Ghorbanihaghjo
Name of organization / entity
Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz 51664, Iran.
Country
Iran (Islamic Republic of) Phone
+98 41 1336 3234 Email address
[email protected] Recruitment status
Recruitment complete Funding source
Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences
Expected recruitment start date 2010-04-19, 1389/01/30
Expected recruitment end date 2011-04-19, 1390/01/30 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Comparison of the effect of knee injection of
Dexamethasone and Triamcinolone hexacetonide on knee pain in rheumatoid arthritis patients
Public title
Comparison of the effect of knee injection of
Dexamethasone and Triamcinolone hexacetonide on
2 knee pain in rheumatoid arthritis patients
Purpose Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Rheumatoid arthritis based on ACR- EULAR 2010 criteria; had one or both knee swelling Exclusion Criteria: joint or adjacent tissue infection; Non inflammatory arthritis on joint fluid analysis; Crystal related arthritis; Joint injection in previous 6 months;
patients that need to change their drugs Age
From 20 years old to 55 years old Gender
Both Phase
N/A
Groups that have been masked No information
Sample size
Target sample size: 70
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
Tabriz University of Medical Sciences Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, Iran
City Tabriz Postal code Approval date
2008-10-12, 1387/07/21
Ethics committee reference number 87/1-4/29
Health conditions studied
1
Description of health condition studied Systemic disorders of connective tissue ICD-10 code
M35.9
ICD-10 code description
Systemic involvement of connective tissue, unspecified
Primary outcomes
1
Description knee swelling Timepoint
Weeks 1 and 3
Method of measurement Observation
Secondary outcomes
1
Description
knee circumference Timepoint
Weeks 1 and 3
Method of measurement Physical examination
Intervention groups
1
Description
Intervention group 1: 40 mg triamcinolon hexaactenoid once injected into the knee joint
Category
Treatment - Drugs
2
Description
Intervention group 2: 8 mg dexamethason once injected into the knee joint
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Connective Tissue Diseases Research Center Full name of responsible person
Mehrzad Hajialilo Street address
Connective Tissue Diseases Research Center, Daneshgah Street, Tabriz University of Medical Sciences, Tabriz, Iran
City Tabriz
3
Sponsors / Funding sources
1
SponsorName of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences, Connective Tissue Diseases Full name of responsible person
Dr. Alireza Khabbazi Street address
Connective Tissue Diseases Research Center, Daneshgah Street, Tabriz University of Medical Sciences
City Tabriz 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 Tabriz University of Medical Sciences, Connective Tissue Diseases 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 Tabriz university of medical sciences Full name of responsible person
Amir ghorbanihaghjo Position
PhD, Biochemistry, Academic member of Biochemistry Department, Tbariz University of Medical Sciences
Other areas of specialty/work Street address
Drug Applied Research Center, Daneshgah street, Tabriz University of Medical Sciences, Tabriz, Iran City
Tabriz Postal code Phone
+98 413364666 Fax
[email protected] Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity Tabriz University of Medical Sciences Full name of responsible person
Mehrzad Hajialilo Position
Professor of Rheumatology Other areas of specialty/work Street address
Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
City Tabriz Postal code Phone
+98 413364666 Fax
[email protected] Web page address
Person responsible for updating data
Contact
Name of organization / entity
Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
Full name of responsible person Amir Ghorbanihaghjo
Position
Clinical Biochemistry, PhD Other areas of specialty/work Street address
Drug Applied Research Center, Daneshgah street, Tabriz University of Medical Sciences, Tabriz, Iran City
tabriz Postal code Phone
00 Fax Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
4 empty
