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IRCT20100827004641N19 IRCT 2022-01-27 Physical Medicine and Rehabilitation Research Center of Tabriz Comparıson between clınıcal effects of ıntra-artıcular ozone and intra-articular steroıd injection ın the treatment of chronic ankle osteoarthrıtıs Comparıson between clınıcal effects of ıntra-artıcular ozone and intra-articular steroıd injection ın the treatment of chronic ankle osteoarthrıtıs 2019-09-23 anticipated 40 Complete https://irct.ir/trial/59489 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation was performed using block randomization using software (RAS). The size of the blocks is 4, which includes an equal number of each intervention with a 1: 1 allocation ratio. Blocking is done by a person not involved in sampling and data analysis. To hide the allocation, the type of intervention was written on a piece of paper using the letters A and B and placed in matte and numbered envelopes. The envelopes were given to the participants in the order of the participants, Blinding description: It was not possible to blind patients due to the difference in the injection material, so the volunteers were aware of what treatment method was used in each group. The injections were performed by a physical medicine specialist. Data researchers, data analyzers, and outcome evaluators were blind. They were not aware of the intervention performed on each group of patients. Only the final data in the form of the first and second groups and random numbers assigned to each patient was available. 2-3 Chronic Osteoartritis of Ankle. Intervention 1: Intervention group: corticosteroid injection: mixture of 40 mg of triamcinolone and 1 mg of lidocaine 2% was injected . Mortis join was the dite of injection. On the inter-maleular line, we entered the ankle joint space in 2 inches medial to the lateral maleus. With Needle 23 in the steroid therapy group before the start of the study, one month after the methylprednisolone injection and 6 months after the injection, the following items were recorded for each patient: Pain by the theoretical analog standard (VAS) 2) FADI Foot And Ankle Disability Index ). Intervention 2: Intervention group: ozone injection: 5 cc ozone with a concentration of 30 micrograms per ml with half a cc of 2% lidocaine was injected into the joint. Ozone injections were given to each patient once a week for 3 sessions. Mortis joint was injection site. Patient was in the supine position and the ankle was in the neutral position .in the sterile condition through the dorsal depression of the ankle on the intermalleular line in 2 inches medial to the lateral maleus entered the joint space. With Needle 23 in the ozone therapy group before the start of the study, at the end of the third session, one month later and 6 months after the end of the ozone therapy sessions, the following items are recorded for each patient: Pain by Theoretical Analogue Criterion (VAS) 2) FADI) Foot And Ankle Disability Index). 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 Decision will be made based on the result of the research.
public Bina Eftekharsadat
Physical Medicine and Rehabilitation Research Center of Tabriz, imam reza hospital, Golgasht st.
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 1336 4672 binasadat@gmail.com Tabriz University of Medical Sciences scientific Dr Bina Eftekhar Sadat
Physical Medicine and Rehabilitation Center, Imam reza hospital, The Golgasht street, Azadi avenue
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 1385 7765 binasadat@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Existence of symptoms of ankle osteoarthritis for at least 3 months Minimum score of 3 in the criterion (VAS) Absence of inflammatory rheumatic diseases Failure to respond to conservative drug and physiotherapy treatments during the past 6 months Satisfaction of patients participating in the study rug and physiotherapy treatments during the past 6 months Aged 45 years and older 45 years no limit Both Severe osteoarthritis (Grade 4 candidates for joint replacement surgery) Rumatic disease Clearly visible deformity of the ankle Ankylosis Ozone contraindications include: -Hyperthyroidism -Thrombocytopenia -Pregnancy Recent history of heart attack G-6PD deficiency Definitive and relative contraindications to steroid injections include: Bacteremia, sepsis, intra-articular or pre-uricular infection, history of post-injection allergies Specific skin lesion at the injection site M19.079 Primary osteoarthritis, unspecified ankle and foot Treatment - Other Treatment - Other Intervention group: corticosteroid injection: mixture of 40 mg of triamcinolone and 1 mg of lidocaine 2% was injected . Mortis join was the dite of injection. On the inter-maleular line, we entered the ankle joint space in 2 inches medial to the lateral maleus. With Needle 23 in the steroid therapy group before the start of the study, one month after the methylprednisolone injection and 6 months after the injection, the following items were recorded for each patient: Pain by the theoretical analog standard (VAS) 2) FADI Foot And Ankle Disability Index ) Intervention group: ozone injection: 5 cc ozone with a concentration of 30 micrograms per ml with half a cc of 2% lidocaine was injected into the joint. Ozone injections were given to each patient once a week for 3 sessions. Mortis joint was injection site. Patient was in the supine position and the ankle was in the neutral position .in the sterile condition through the dorsal depression of the ankle on the intermalleular line in 2 inches medial to the lateral maleus entered the joint space. With Needle 23 in the ozone therapy group before the start of the study, at the end of the third session, one month later and 6 months after the end of the ozone therapy sessions, the following items are recorded for each patient: Pain by Theoretical Analogue Criterion (VAS) 2) FADI) Foot And Ankle Disability Index) The amount af Reduce in pain after injection. Timepoint: 1 month after injection and 6 months after injection. Method of measurement: FADI questionnaire. Improvement of function and reduce in pain of ankle. Timepoint: Before,1 month an 6 months after injection. Method of measurement: FADI questionnaire. Physical Medicine and Rehabilitation Research Center of Tabriz Approved 2021-10-12 Ethic committee of Tabriz university of medical sciences Golgasht Avenue Tabriz East Azarbaijan Iran (Islamic Republic of)