The effect of intra-articular injection of ozone on pain and function in patients with mild to moderate osteoarthritis.
Design
Clinical trials with a control group, parallel groups, double-blind, randomized, sample size 60
Settings and conduct
Emam Khomeini hospital
Participants/Inclusion and exclusion criteria
Patients with mild to moderate knee osteoarthritis and aged between 45 and 75 with body mass index less than 30 were included. If they started drugs they were excluded.
Intervention groups
Intervention group: 6 knee intraarticular injections per week, including 10 cc of 20 micrograms of Ozone were received, for 6 weeks.
Control group: 6 placebo injections with an insulin syringe per week were received for 6 weeks.
Main outcome variables
Pain; function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111025007903N13
Registration date:2023-05-11, 1402/02/21
Registration timing:retrospective
Last update:2023-05-11, 1402/02/21
Update count:0
Registration date
2023-05-11, 1402/02/21
Registrant information
Name
Zahra Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2282
Email address
z_alizadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-15, 1398/10/25
Expected recruitment end date
2021-01-14, 1399/10/25
Actual recruitment start date
2020-04-08, 1399/01/20
Actual recruitment end date
2021-04-19, 1400/01/30
Trial completion date
2021-04-19, 1400/01/30
Scientific title
Effect of intra-articular Ozone injection on pain and function in patients with mild to moderate knee osteoarthritis
Public title
Effect of Ozone injection on knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate knee osteoarthritis
Body mass index less than 30
Pain exacerbation with walking
Age between 45 and 75 years
Exclusion criteria:
History of knee trauma or surgery, metabolic or autoimmune diseases
Knee effusion
Pregnancy or lactation
Usage of anti-coagulant drugs
Age
From 45 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were entered into the study using randomized block tables. We prepared 10 blocks, and six patients were considered for each block. Patient one entered block 1, patient two/block 2, patient 3/block 3… patient 10/ block 10. Then the rotation repeated again, patient 11/block 1…until patient 60/block 10, respectively. After that, the third person who he did not aware of the patients’ groups, selected 5 blocks as the control group and 5 blocks as the injection group, according to a random sequence. This method not only caused randomization to be equal in both groups but also at each stage of the study, patients were equally assigned to the groups. These small blocks kept the balance between the two groups and made the number of people in each group the same.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were blinded with a shield on the knee
The investigator and the outcome assessor were blinded about the type of injection
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
Dr. Gharib street, Tohid square
City
TEHRAN
Province
Tehran
Postal code
1419733141
Approval date
2019-12-28, 1398/10/07
Ethics committee reference number
IR.TUMS.IKHC.REC.1398.211
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
knee pain
Timepoint
before intervention, 6 weeks and, 6 months after injection
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Function
Timepoint
before intervention, 6 weeks and, 6 months after injection
Method of measurement
6minute walking test
Intervention groups
1
Description
Intervention group: For knee injection, a 22-gauge syringe was used by the classic anterolateral approach in a supine position and at an angle of 90 degrees to the knee. In the intervention group, 10 ml of 20 μg of ozone solution was used intra-articular. A total of six intra-articular injections of ozone were given to each patient for six consecutive weeks (one injection per week). After the injection, an ice pack was used at the injection site to prevent hematoma. The patients were advised to rest for up to 48 hours and continue the exercise programs afterwards. Participants were received stretching and strengthening exercise during the trial.Exercise program in the form of isometric multi-joint exercises of the muscles around the knee was defined, including the quadriceps, abductors and adductors of the thigh, holding for 10 seconds, ten repetitions three times a day. In addition, stretching exercises include stretching the hamstrings, gastrocnemius and soleus muscles, holding for 20 seconds in a state of painless stretching with a feeling of discomfort caused by stretching, which was done 1 set of 5 repetitions a day. After one month, concentric exercises of the thigh muscles (quadriceps, then abductors and adductors) with one set of 10 repetitions were started, then the number of repeats was increased to 12 repetitions. In the next step, the number of sets was increased to 3 sets per day, and finally, the weight was added by controlling patients' pain and symptoms. The mentioned program was monitored and re-educated by a sports medicine specialist in each injection session.
Category
Treatment - Other
2
Description
Control group: In the control group, an insulin syringe was used at the injection point without any injection, only for the feeling of the needle by patients. In addition, the patients were blinded during the injection. A total of six needling with an insulin syringe were given to each patient for six consecutive weeks (one injection per week). The exercise program was similar to the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Zahra Alizadeh
Street address
Dr. Gharib street, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6111 2282
Email
za_al10@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hajar Moamaee
Street address
4th Floor, The Center of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3617
Email
z_alizadeh@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizade
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Research Center, No7, Opposite of Shariati Hospital, Ale-Ahmad Highway
City
Teanhr
Province
Tehran
Postal code
1411734143
Phone
+98 21 6119 2282
Fax
+98 21 8800 3539
Email
z_alizadeh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Associate Professor of Sports Medicine
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No7, Ale-Ahmad Highway, Opposite of Shariati Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
14395578
Phone
+98 21886302278
Fax
Email
z_alizadeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizade
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Research Center, No7, Opposite of Shariati Hospital, Ale-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411734143
Phone
+98 21 6119 2282
Fax
+98 21 8800 3539
Email
z_alizadeh@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Primary and secondary outcomes, and others according to researchers' request
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
Please contact with this e-mail: z_alizadeh@tums.ac.ir
Under which criteria data/document could be used
Please contact with this e-mail: z_alizadeh@tums.ac.ir
From where data/document is obtainable
Please contact with this e-mail: z_alizadeh@tums.ac.ir
What processes are involved for a request to access data/document
Please contact with this e-mail: z_alizadeh@tums.ac.ir