Evaluation of the simultaneous effect of orthokine therapy and ozone therapy in the treatment of patients with knee osteoarthritis: A randomized controlled trails
Orthokine therapy and ozone therapy in knee osteoarthritis
Design
A clinical trial with parallel groups, double-blind, block randomization, phase 3 on 120 patients with knee arthritis, in one group orthokine will be injected with placebo and in the other group orthokine will be injected with ozone.
Settings and conduct
In this double-blind clinical trial study, 120 people with knee arthritis referred to the pain clinic of Shahid Beheshti Hospital, who were treated with orthokine therapy by random block method, will be divided into two groups of 60 people:
Group 1: including 60 people under orthokine therapy with ozone
Group 2: including 60 people under orthokine therapy with placebo
Treatment protocol of the first group: Ertokine including 4 injections of 2 ml of IL-1Ra on the first, seventh, fourteenth and twenty-first days of treatment, ozone including 3 injections of 10 ml of ozone (30 g/ml) + 5 ml of lidocaine % 1 to the knee joint on the first day of treatment, one month after the first injection and two months later. The treatment protocol of the second group will be orthokine therapy with placebo in three times.
Before the treatment and 1, 3 and 6 months after the treatment, the pain intensity of the patients will be measured using the WOMAC questionnaire.
Participants/Inclusion and exclusion criteria
All patients with knee osteoarthritis with grades 2 and 3
Intervention groups
1)orthokine including 4 injections of 2 ml of IL-1Ra on the first, seventh, fourteenth and twenty-first days of treatment, ozone including 3 injections of 10 ml of ozone (30 g/ml) + 5 ml of 1% lidocaine to the knee joint will be done on the first day of treatment, one month after the first injection and two months later. The treatment protocol of the second group will be 4 injections of orthokin, and receiving placebo on three times.
Main outcome variables
intensity of pain
General information
Reason for update
Acronym
OOO
IRCT registration information
IRCT registration number:IRCT20230311057677N1
Registration date:2023-07-22, 1402/04/31
Registration timing:prospective
Last update:2023-07-22, 1402/04/31
Update count:0
Registration date
2023-07-22, 1402/04/31
Registrant information
Name
Zahra Hajrezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3720 4173
Email address
z.rezaei5054@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the simultaneous effect of orthokine therapy and ozone therapy in the treatment of patients with knee osteoarthritis: A randomized controlled trails
Public title
Simultaneous treatment of orthokine therapy and ozone therapy in knee arthrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with knee osteoarthritis with grades 2 and 3 in the Kellgren and Lawrence criteria
Exclusion criteria:
The presence of coagulation disorders
Taking anticoagulants
Infection at the injection site
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using the balanced block randomization method with a block size of 6. The random sequence is generated by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com). Allocation concealment is also guaranteed due to the use of special codes generated by the website
Blinding (investigator's opinion)
Double blinded
Blinding description
It is explained to the patients that the injection is placed intra-articularly and the patient is lying supine and the injection is performed in the intrapatellar area, and the patients were unaware of the content of the injected substance. He will complete the pain assessment questionnaire.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Qom Univrsity for Medical Science, Saheli street
City
Qom
Province
Ghoum
Postal code
3719964797
Approval date
2023-01-30, 1401/11/10
Ethics committee reference number
IR.MUQ.REC.1401.157
Health conditions studied
1
Description of health condition studied
osteoarthritis
ICD-10 code
M19.9
ICD-10 code description
Arthrosis, unspecified
Primary outcomes
1
Description
Pain Intensity
Timepoint
Before intervention and 1-3 -6 months after the start of the intervention
Method of measurement
WOMAC (Western Ontario and McMaster University) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients receiving orthokine therapy with ozone. Artokine includes 4 injections of 2 ml of IL-1Ra on the first, seventh, fourteenth and twenty-first days of treatment, ozone includes 3 injections of 10 ml of ozone (30 g/ml) + 5 ml of 1% lidocaine to the knee joint in The first day of treatment will be done one month after the first injection and two months later.
Category
Treatment - Drugs
2
Description
The second intervention group: Ortokine including 4 injections of 2 ml of IL-1Ra on the first, seventh, fourteenth and twenty-first days of treatment and receiving placebo on three occasions
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Qom
Full name of responsible person
Dr Reza Aminnejad
Street address
Beheshti Hospital, Beheshti Blvd, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
r.aminnejad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Rahim Aali
Street address
No. 83, Shahid Lotfi Niaser Ave, Safashehr Blvd
City
Qom
Province
Ghoum
Postal code
93456-37169
Phone
+98 25 3285 2720
Email
research@mail.muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?