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IRCT20230311057677N1 IRCT 2023-07-22 Ghoum University of Medical Sciences Simultaneous treatment of orthokine therapy and ozone therapy in knee arthrosis OOO Evaluation of the simultaneous effect of orthokine therapy and ozone therapy in the treatment of patients with knee osteoarthritis: A randomized controlled trails 2023-08-23 anticipated 120 Complete https://irct.ir/trial/69350 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 osteoarthritis. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Zahra Hajrezaei
Shahid Beheshti Hospital,Beheshti Blvd, Qom, Iran
Qom Iran (Islamic Republic of) 3713649373 +98 25 3285 2720 z.rezaei5054@gmail.com Ghoum University of Medical Sciences scientific Reza Aminnejad
Beheshti Hospital,Beheshti Blvd, Qom, Iran
Qom Iran (Islamic Republic of) 93456-37169 +98 25 3285 2720 r.aminnejad@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Patients with knee osteoarthritis with grades 2 and 3 in the Kellgren and Lawrence criteria no limit no limit Both The presence of coagulation disorders Taking anticoagulants Infection at the injection site M19.9 Arthrosis, unspecified Treatment - Drugs Treatment - Drugs 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. 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 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. Ghoum University of Medical Sciences Approved 2023-01-30 Ethics committee of Qom University of Medical Sciences Qom Univrsity for Medical Science, Saheli street Qom Ghoum Iran (Islamic Republic of)