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IRCT20210415050983N11 IRCT 2025-06-06 Shahid Beheshti University of Medical Sciences Comparison of Hyaluronic Acid injection with and without corticosteroids on the severity of pain and physical function in patients with knee Osteoarthritis grade 2 and 3 in Imam Hossein hospital Comparison of Hyaluronic Acid injection with and without corticosteroids on the severity of pain and physical function in patients with knee Osteoarthritis grade 2 and 3 2025-07-23 anticipated 88 Complete https://irct.ir/trial/83613 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted Randomized Blocks :In this method, 10 random blocks are generated by computer Software R. Each block includes 5 people in the intervention group and 5 people in the control group. The order of these people is randomly arranged by computer and people are assigned to groups in the same way. At the end of each block, a new block of 10 is produced and this process will continue until the final sample volume is reached, Blinding description: Forms with numbers 1 and 2 inside the packaged envelopes are used to group patients, which are given to patients randomly and the patients are not aware of the groupings. Before the injection begins, the envelope is opened by the anesthesiologist in charge of the patient and given to the patient based on the intervention or control group that was prepared in advance. The clinical caregiver, the evaluator and the results recorder, and the participant are not aware of the grouping. 1-2 Knee osteoarthritis. Intervention 1: Control group: Injection of 40 mg of hyaluronic acid alone (cross-linked hyaluronic acid) in the knee joint from the brand Rodiyax-C. Intervention 2: Intervention group: Injection of 44 mg of hyaluronic acid (cross-linked hyaluronic acid) and 9 mg of Triamcinolone Hexacetonide (corticosteroid) in the knee joint from the brand Rodiyax -T. 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 Restriction of some magazines to publish
public Amirhoosain solaimaki
South Kargar St. Kamali St. Special Loghman Hakim Hospital
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 amirhs92@gmail.com Shahid Beheshti University of Medical Sciences scientific Amihossain solaimani
South Kargar St. Kamali St. Special Loghman Hakim Hospital
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 amirhs92@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with grade 2 and 3 knee osteoarthritis are candidates for therapeutic interventions for pain control and refer to the pain clinic of Imam Hossein Hospital. 18 years no limit Both Patients with bone malignancies People addicted to opioid History of allergy to hyaluronic acid or the corticosteroid class of drugs patient dissatisfaction M15.9 Generalized osteoarthritis NOS Treatment - Drugs Treatment - Drugs Control group: Injection of 40 mg of hyaluronic acid alone (cross-linked hyaluronic acid) in the knee joint from the brand Rodiyax-C Intervention group: Injection of 44 mg of hyaluronic acid (cross-linked hyaluronic acid) and 9 mg of Triamcinolone Hexacetonide (corticosteroid) in the knee joint from the brand Rodiyax -T Examining changes in bone pain intensity. Timepoint: The total follow-up period is six months in 4 sessions. At time zero (time of study entry and before drug injection), one month, three months, and 6 months after injection. Method of measurement: VAS (Visual analog scale) pain rating tool. Assessing the extent of improvement in physical performance. Timepoint: The total follow-up period is six months in 4 sessions. At time zero (time of study entry and before drug injection), one month, three months, and 6 months after injection. Method of measurement: Based on WOMAC criteria. Shahid Beheshti University of Medical Sciences Approved 2025-05-10 Vice for Research and Technology, Shahid Beheshti University of Medical Sciences Velenjak, Yemen Street, Shahid Shahriari Square TEHRAN Tehran Iran (Islamic Republic of)