The aim: compare the effect of ultrasound guided corticosteroid injection with ozone injection in patients with osteoarthritis of the knee.
Study design: non random sampling; convenience sampling and then patients will be assigned to two groups by block randomization. the study is double blind (patient and analyzer).
Population: patients with knee osteoarthritis referred to physical medicine clinics (Iran University of Medical Sciences).
The main inclusion criteria: patients with mild to moderate OA of the knee (Kellgren Lawrence grade I, II and III); the absence of any acute or chronic infection; no history of any intra articular injection of the knee in three months ago; the absence of inflammatory articular disease and absence of contraindications of ozone therapy.
The main exclusion criteria: the willingness of patients to exit from the study.
Sample size: 30.
Interventions: in initial time, 1 cc lidocaine 2% will be used for local anesthesia (skin) in both groups. then under sterile conditions, in one group 40 mg triamcinolone (1 cc) will be injected into the knee joint ( under ultrasound guided in suprapatellar Pouch). in another group under sterile conditions, 10 cc oxygen ozone (O2O3), (15 mg / ml) under ultrasound guided (in suprapatellar pouch), will be injected into the joint.
Outcomes: before injection , pain intensity (VAS) , WOMAC score, clinical assessment (range of motion), suprapatellar effusion (with ultrasound) in both groups will be determined and then this criteria evaluated at week, one month and three months post injection. the results will be compared before and after injection in each group and between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112724572N3
Registration date:2017-02-10, 1395/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Arash Babaei-Ghazani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2683
Email address
babaei-ghazani.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-10-23, 1395/08/02
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of ultrasound guided corticosteroid injection with ozone injection in patients with osteoarthritis of the knee.
Public title
Compare the effect of ozone injection with corticosteroid injection on osteoarthritis of the knee
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with mild to moderate OA of the knee (Kellgren Lawrence grade I, II and III); Knee pain for at least six months; Age 40 to 75 years; the absence of any acute or chronic infection; no pregnancy or lack of planning to get pregnant; no history of any intra articular knee injection in three months ago; The absence of inflammatory articular disease or secondary osteoarthritis; no history of knee surgery (3 months ago); no severe underlying disease such as uncontrolled diabetes; use of anticoagulants; lack of daily use of opioid and non opioid analgesics; absence of contraindications of ozone therapy (deficiency G6PD, uncontrolled hyperthyroidism, leukemia).
Exclusion criteria: the willingness of patients to exit from the study at any stage of the study; not coming patients for follow up and evaluation during the follow up period; daily use of any type of analgesic medication by patients during the follow up period; occurring a pathology in the knee, such as meniscus tear during the follow up period; occurring 4th and 7th inclusion criteria, during the study.
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
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
Not used
Assignment
Parallel
Other design features
Block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Postal code
1449614535
Approval date
2016-10-22, 1395/08/01
Ethics committee reference number
IR.IUMS.REC 1395.9411524007
Health conditions studied
1
Description of health condition studied
Primary gonarthrosis, bilatera
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
The severity of pain
Timepoint
Zero, one, four and twelve weeks after
Method of measurement
Visual Analog Scale(VAS)
2
Description
The severity of symptoms and functional limitations
Timepoint
Zero, one, four and twelve weeks after
Method of measurement
By using WOMAC questionnare
3
Description
Sonographic criteria (efusion)
Timepoint
Zero, one, four and twelve weeks after
Method of measurement
By using sonographic device
4
Description
Range of motion
Timepoint
Zero, one, four and twelve weeks after
Method of measurement
Goniometer
Secondary outcomes
1
Description
Side effects
Timepoint
One and four weeks after
Method of measurement
Physical examination
Intervention groups
1
Description
Intervent group: ozon injection will be performed under the ultrasound guid in the knee joint which will be done by an experienced physical medicine and rehabilitation specialist; using supra patellar approach.
Category
Treatment - Other
2
Description
Control group: corticosteroid injection will be performed under the ultrasound guid in the knee joint which will be done by an experienced physical medicine and rehabilitation specialist; using supra patellar approach.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firuzgar hospital
Full name of responsible person
Dr. saeideh najarzadeh mehdikhani
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research Iran University of Medical Sciences
Full name of responsible person
Dr Motovalian
Street address
5th floor, Headquarters, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr.Saeideh najarzadeh mehdikhani
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran.
City
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Fax
Email
snajjarzadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Arash Babaei
Position
Associate Professor of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran
City
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Fax
Email
babaei-ghazani.a@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. saeideh najarzadeh mehdikhani
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran.
City
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Fax
Email
snajjarzadeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)