Comparison the Therapeutic Effect of One-Time Injection with Three Ozone Under Sonography on Patients with Knee Strengthening
Design
Patients are randomly and evenly divided into two groups: group A or ozonotherapy group in one session; group B or ozone therapy group in three sessions. Before injection of one cc of lidocaine 2% for local skin anesthetic and the underlying tissues are used in both groups. Then, under sterile conditions, in a group of patients, a dose of 15g / ml (5 cubic cubic meters) of ozone-oxygen is injected into the knee joint (in one session) by ultrasound.
Settings and conduct
Patients are randomly divided into two groups: group A or ozone therapy group in one session and group B or ozone therapy group in three sessions
Participants/Inclusion and exclusion criteria
Knee osteoarthritis based on the CRC of the American College of Rheumatology in Grades 1, 2 and 3, consistent with the Lowrence-Kellergan Criteria; knee pain for at least six months; age 18 to 75 years old; the absence of any acute or chronic infection; no tend to become pregnant or not to decide on pregnancy; to tending to perform any intra-articular injection of the knee during the last three months; absence of joint inflammatory diseases or secondary osteoarthritis; no history of knee surgery; lack of severe underlying disease such as uncontrolled diabetes, anti-coagulant use, and no daily intake of opioid and non-opioid analgesics.
Intervention groups
Group A or ozone therapy group in a session-group B or ozone therapy group in three sessions.
Main outcome variables
Severity of pain; knee range of motion; individual performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151017024572N18
Registration date:2018-09-01, 1397/06/10
Registration timing:registered_while_recruiting
Last update:2018-09-01, 1397/06/10
Update count:1
Registration date
2018-09-01, 1397/06/10
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
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the therapeutic effect of one-time with three-times ozone injection under ultrasound guidance in patients with knee osteoarthritis
Public title
Comparison of ozone effect on knee osteoarthritis
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 old
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
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are randomly divided into two groups in closed packaging
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
Province
Tehran
Postal code
1449614535
Approval date
2018-07-23, 1397/05/01
Ethics committee reference number
IR.IUMS.REC.1397.120
Health conditions studied
1
Description of health condition studied
Primery gonrthrosis,bilatral
ICD-10 code
M17.0
ICD-10 code description
Bilateral primary osteoarthritis of knee
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 questioner
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
5
Description
Side effects
Timepoint
one, four weeks after
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervent group: three times ozon injectione with a one-week interval by a physician and rhabilition spesialist under the ultrasound guide in the knee joint through a supra patellar approach
Category
Treatment - Other
2
Description
Control 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 specialis.using supra patellar approach
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firuzgar hospital
Full name of responsible person
Dr. vajihe alishahi
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
vajihe.alishahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
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
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
vajihe.alishahi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Vajihe Alishahi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
vajihe.alishahi@yahoo.com
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
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran.
City
Tehan
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
babaei-ghazani.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Vajihe Alishahi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
vajihe.alishahi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD