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IRCT20210725051977N3 IRCT 2023-01-15 Islamic Azad University Comparison of the intra-articular injection versus quadruple injection at the joint surface in the treatment of sacroiliac joint pain Comparison of the intra-articular injection versus quadruple injection at the joint surface in the treatment of sacroiliac joint pain 2023-02-20 anticipated 40 Complete https://irct.ir/trial/67859 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample size of the study is 40 patients. The first patient who admitted to the office and meets the inclusion criteria will be No. 1 and the 40th patient will be No. 40. In advance, using the https://www.random.org, from the "List Randomizer" section of the website, the numbers 1 to 40 is randomly divided into two groups of 20 (the first twenty patients for the intra-articular injection group and the second 20 patients for the periarticular injection group). Example: Number 5 is in the intra-articular injection group in randomization of numbers 1 to 40, therefore, the fifth patient who meets the inclusion criteria will be in the intra-articular injection group, Blinding description: The researcher and the patient are unaware of the grouping and what type of injection method (intra-joint or peri-joint) was performed. in such a way that the specialist doctor randomly selects each patient's group and Using the random numbers obtained from the List Randomizer website https://www.random.org, before referring to the operating room, he determines and performs the injection in the operating room without the presence of the researcher.Then 40 patients are given to the researcher to evaluate the severity of pain and complications after the injection. 2 sacroiliac joint pain. Intervention 1: Intervention group: Intra-articular injection Triamcinolone mixture of Hexal brand in the amount of 40 mgPlusMarcaine (bupivacaine) of Myungmoon brand is 0-25% with a volume of 8cc. Intervention 2: Intervention group: Intraoperative injection around the joint (4 specific points around the joint) Triamcinolone mixture of Hexal brand in the amount of 40 mgPlusMarcaine (bupivacaine) of Myungmoon brand is 0-25% with a volume of 8cc. 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 more information
public Dr Masoud Khoshbin
Yazd, Shahid Sadoughi Boulevard, in front of Sepah, 40th dead end
Yazd Iran (Islamic Republic of) 8917694784 +98 35 3138 0155 masoudkhoshbin@iauyazd.ac.ir Islamic Azad University scientific Dr Masoud Khoshbin
Yazd - Shahid Sadoughi Boulevard, in front of Sepah, 40th dead end
Yazd Iran (Islamic Republic of) 8917694784 +98 35 3138 0155 masoudkhoshbin@iauyazd.ac.ir Islamic Azad University Iran (Islamic Republic of) ASA (American Society of Anesthesiologists) patients in class I and II, 18 years old and above, referred to Yazd city pain clinic, who came with complaints of back pain and during clinical examinations, they had a clinical diagnosis of SIJ joint pain. 18 years no limit Both History of any uncontrolled medical illness History of rheumatological or infectious diseases (RA, brucellosis) S33.6 Sprain of sacroiliac joint Treatment - Drugs Treatment - Drugs Intervention group: Intra-articular injection Triamcinolone mixture of Hexal brand in the amount of 40 mgPlusMarcaine (bupivacaine) of Myungmoon brand is 0-25% with a volume of 8cc. Intervention group: Intraoperative injection around the joint (4 specific points around the joint) Triamcinolone mixture of Hexal brand in the amount of 40 mgPlusMarcaine (bupivacaine) of Myungmoon brand is 0-25% with a volume of 8cc. Pain intensity. Timepoint: Pain intensity of the patient at the beginning of the study (before the start of the intervention), one hour after the injection and 4 weeks after the injection. Method of measurement: Visual Analogue Scale (VAS). Frequency of side effects in each group. Timepoint: one hour after the injection and 4 weeks after the injection. Method of measurement: check list including possible adverse (including injection site infection, pain aggravation, etc.). Islamic Azad University Approved 2022-12-14 Ethics Committee of Yazd Islamic Azad University Medical School Safaieh, Alam Square, Boulevard of the Shohadaie Gomnam, Ali Ibn Abitaleb Medical School Yazd Yazd Iran (Islamic Republic of)