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IRCT20100827004641N18 IRCT 2021-11-17 Physical Medicibe and Rehabilitaion Research Center of Tabriz Comparition the impact of Steroid and intraarticular ozon on improving the symptoms of osteoarthritis of knee Comparition the impact of intraarticular Steroid and intraarticular ozon on improving the symptoms of osteoarthritis of knee 2019-09-23 anticipated 40 Complete https://irct.ir/trial/59487 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be assigned to either the steroid or ozone injection groups using block randomization using random allocation software (RAS). The size of blocks is 4 including the equal numbers of each intervention of the study in each block and a 1:1 assignment ratio. Blocking will be performed by the non-involved person in data sampling and analysis. To conceal the assignment, the type of intervention will be written on a sheet of paper coding using the letters A and B and placed inside matted, consecutively numbered envelopes. The envelopes will be arranged according to the participants' entry to the intervention, and the type of group will be revealed, Blinding description: The study was single blind because it was not possible to blind patients due to the difference in the injection material and the volunteers will be aware of what treatment method was used in each group.The injections were performed by a physical medicine specialist.The researcher and the person conducting the follow up and data analysts and outcome assessors who are blinded and unaware of the intervention performed on each group of patients And only the final data in the form of the first and second groups and random numbers assigned to each patient will be available. 2-3 استئو آرتریت مزمن زانو. Intervention 1: Intervention group: In the ozone therapy group, 5 cc of ozone with a concentration of 30 micrograms per ml with 2 cc of 2% lidocaine will be injected into the joint. Ozone injections will be given to each patient once a week for 3 sessions. Consumable ozone is produced by Palaguar ozone generator, the exclusive representative of the German company Herrmann. Intervention 2: Intervention group: In the steroid therapy group, patients treated with a mixture of 40 mg triamcinolone and 1 mg lidocaine 2% will be given intra-articular once. Triamcinolone is consumed by Iran Hormone Company. 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 A decision will be made based on the test results.
public Dr. Bina Eftekharsadat
Imam Reza Hospital ,Golgasht street
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3337 6923 Binasadat@gmail.com Tabriz University of Medical Sciences scientific Dr. Bina Eftekharsadat
Physical Medicine and Rehabilitation Center, Imam reza hospital, The Golgasht street, Azadi avenue
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3337 6923 Binasadat@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Moderate Knee Osteoarthritis (grade two or three based Radiographic classification (Kellegren and Lawrence) Existence of symptoms in favor of Knee Osteoarthritis for at least 3 months Minimum score of 3 in the criterion (VAS) Absence of Inflammatory Rheumatic diseases 45 years old and older Satisfaction of patients participating in the study Failure to respond to Conservative drug treatments and physiotherapy lasted for 6 months 45 years no limit Both Severe Osteoarthritis (grade 4 candidates for joint replacement surgery) Rheumatic disease Clearly Visible deformity of the knee Ankylosis Contraindications to Ozone include: Hyperthyroidism , Thrombocytopenia ,Pregnancy , Recent heart attack history ,G6PD Deficiency Definitive and partial Contraindications to Steroid injection include: Bacteremia, Sepsis, Intra articular or pre uricular infection, History of post injection Allergy, Intra articular or Osteochondral fracture at the injection site, Severe Joint destruction in Injection site , Artificial joint , Uncontrolled Coagulation disorders Specific skin lesion at the injection site M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: In the ozone therapy group, 5 cc of ozone with a concentration of 30 micrograms per ml with 2 cc of 2% lidocaine will be injected into the joint. Ozone injections will be given to each patient once a week for 3 sessions. Consumable ozone is produced by Palaguar ozone generator, the exclusive representative of the German company Herrmann. Intervention group: In the steroid therapy group, patients treated with a mixture of 40 mg triamcinolone and 1 mg lidocaine 2% will be given intra-articular once. Triamcinolone is consumed by Iran Hormone Company. The amount af Reduce in pain after injection. Timepoint: Immediately before injection and 1 month after injection and 6 months after injection. Method of measurement: Western Ontario and McMaster Universities Arthritis Index (WOMAC)questionare. Improvement of function of Knee. Timepoint: Immediately before injection and one and six months after injection. Method of measurement: Western Ontario and McMaster Universities Arthritis Index (WOMAC)questionare. Physical Medicibe and Rehabilitaion Research Center of Tabriz Approved 2021-10-04 Ethic committee of tabriz university of medical sciences Golgasht avenue Tabriz East Azarbaijan Iran (Islamic Republic of)