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IRCT20220526054993N1 IRCT 2022-06-29 Alborz University of Medical Science Evaluation of the effect of intra-articular injection of dexamethasone and vitamin D compared to injection of dexamethasone alone on signs of knee osteoarthritis The Effects of Intra-articular injection of dexamethasone and vitamin D compared to injection of just dexamethasone on signs of knee osteoarthritis with grade 2 and 3_ a randomized double-blind clinical trial 2022-08-21 anticipated 154 Complete https://irct.ir/trial/63833 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of patients to case and control groups is done using "permuted balance block randomization technique" with a ratio of (1: 1). The blocks considered in this study include 4 patients, Blinding description: For the two-sided blindness of the study, after randomly assigning the patient to one of the two groups, one of the colleagues fills the syringe from one of the two types of vial that both have the same color. (Vitamin D and dexamethasone or dexamethasone alone). Both the physician and the patient are not informed of the contents of the syringe. 3 Knee osteoarthritis with grade 2 and 3. Intervention 1: Intervention group: After randomization , 4 mg of dexamethasone plus one hundred and fifty thousand international units (IU) of vitamin D3 will be injected into the intra-articular space of the patient's knees separately (right and left knee). The pharmacological form of vitamin D3 which we use is Cholecalciferol from AburaihanCo.Iran . Intervention 2: Control group: After randomization, 4 mg of dexamethasone is injected separately into the intra-articular space of the knees of control patients separately (right knee and left knee). To double-blinding, the drug is injected in the same condition as the intervention group. Yes - There is a plan to make this available What will be shared: All data will be available after deidentification When: Upon rational request To whom: To the researchers Conditions: For research purposes, such as meta analysis or systematic reviews Where to obtain: From corresponding author How to obtain: To be an verified researcher in the field Comments:
public Arvin Najafi
Shahid Madani Square, Mahan Boulevard, Taleghani intersection, Kara
Karaj Iran (Islamic Republic of) 3143744693 +98 26 3442 7001 parsmedicine@gmail.com Alborz University of Medical Science scientific Arvin Najafi
Shahid Madani Square, Mahan Boulevard, Taleghani intersection, Kara
Karaj Iran (Islamic Republic of) 3143744693 +98 26 3442 7001 parsmedicine@gmail.com Alborz University of Medical Science Iran (Islamic Republic of) Age between 40 to 65 Bilateral knee osteoarthritis Having score 2 and 3 of KL system radiography Completion of informed consent form to enter the study 40 years 65 years Both Presence of secondary cause for knee osteoarthritis Allergic history to dexamethasone or vitamin D History of diabetes or coagulopathy History or manifestation of joint infection or deformity M16.30 Treatment - Drugs Treatment - Drugs Intervention group: After randomization , 4 mg of dexamethasone plus one hundred and fifty thousand international units (IU) of vitamin D3 will be injected into the intra-articular space of the patient's knees separately (right and left knee). The pharmacological form of vitamin D3 which we use is Cholecalciferol from AburaihanCo.Iran . Control group: After randomization, 4 mg of dexamethasone is injected separately into the intra-articular space of the knees of control patients separately (right knee and left knee). To double-blinding, the drug is injected in the same condition as the intervention group. The score obtained in the WOMAC knee score to evaluate the degree of osteoarthritis. Timepoint: Before intervention and 1, 3, and 6 month after intervention. Method of measurement: WOMAC knee score. The amount of analgesic consumption. Timepoint: Before intervention and 1, 3, and 6 mouths after intervention. Method of measurement: Questionnaire to assess the number of analgesics consumed per week. Range of motion of the knee. Timepoint: Before intervention and 1, 3, and 6 mouths after intervention. Method of measurement: Clinical examination. Joint pain. Timepoint: Before intervention and 1, 3, and 6 mouths after intervention. Method of measurement: The size of joint pain in millimeters on the scaled ruler. Alborz University of Medical Science Approved 2022-04-16 Research Ethics committee of Alborz University of Medical Science N.528 - 120 street - Eram boulvard - Mehrshahr - Karaj Karaj Alborz Iran (Islamic Republic of)