Comparison of therapeutic effects of intraarticular Hyaluronic acid injections with and without ultrasound guidance in patients with moderate knee osteoarthritis
Objectives: Our aim in this study is to evaluate the role of ultrasound in increasing the range of motion and reducing pain in patients with moderate knee osteoarthritis.(2) design: In this study, 40 patients with moderate knee osteoarthritis referring to physical medicine and rehabilitation clinic, Imam Reza Hospital, Tabriz will be included in the study after qualifying the inclusion and exclusion criteria and obtaining the informed consent. (3) Setting and conduct: Patients will be randomly divided to groups of 20. For randomization, we will use computerized randomization with Excel software. Inclusion criteria are age between 50 and 80 years old, grade 2 or 3 knee osteoarthritis based on Kellgren and Lawrence grading scale, not having any rheumatologic diseases and not responding to conservative medical therapies. Exclusion criterion is receiving corticosteroids. (4) Intervention: Patients will be divided into two groups of intraarticular Hyaluronic acid injection with ultrasound guidance and without ultrasound guidance. In intervention group, the route will be first defined and confirmed by using ultrasound. In the other group injection will be performed in superior lateral part without using other instruments. Three injections will be performed for each patients with a two week interval between injections. (5) Main outcome measures: Pain severity at rest, Pain severity while moving, knee range of motion, evaluation time and timed up and go test will be evaluated before study, after the last injection and two months after the last injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401043217N8
Registration date:2014-01-31, 1392/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-31, 1392/11/11
Registrant information
Name
Fariba Eslamian
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3967
Email address
eslamiyanf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of intraarticular Hyaluronic acid injections with and without ultrasound guidance in patients with moderate knee osteoarthritis
Public title
Evaluating the effects of using an ancillary method for performing intraarticular injections in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 50 and 80 years old; grade 2 or 3 knee osteoarthritis based on Kellgren and Lawrence grading scale; not having any rheumatologic diseases; not responding to conservative medical therapies. Exclusion criteria: Receiving corticosteroids.
Age
From 50 years old to 80 years old
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For randomization, we used computerized randomization with Excel software.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethics committee, Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
Approval date
2012-08-10, 1391/05/20
Ethics committee reference number
91165
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M15.9
ICD-10 code description
Generalized osteoarthritis NOS
Primary outcomes
1
Description
Pain severity at rest
Timepoint
Before starting the study and two months after the third injection
Method of measurement
Using visual analogue scale
2
Description
Knee's range of motion
Timepoint
Before starting the study and two months after the third injection
Method of measurement
By using goniometry
3
Description
Pain severity while moving
Timepoint
Before starting the study and two months after the third injection
Method of measurement
Using visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, the route will be first defined and confirmed by using ultrasound and the the injection will be performed.
Category
Treatment - Drugs
2
Description
In the control group injection will be performed in superior lateral part without using other instruments.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Roja Javadi
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Street address
Vice Chancellor for research, Tabriz University of Medical Sciences, Daneshgah square, Tabriz
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
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
Dr. Roja Javadi
Position
Physical Medicine and rehabilitation resident
Other areas of specialty/work
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1337 3967
Fax
Email
roja.javadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Fariba Eslamiyan
Position
Associate professor of Physical Medicine & rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1337 3967
Fax
Email
eslamiyanf@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Roja Javadi
Position
Physical Medicine and rehabilitation resident
Other areas of specialty/work
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1337 3967
Fax
Email
roja.javadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)