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IRCT20190325043107N32 IRCT 2023-04-22 Shahid Beheshti University of Medical Sciences Comparison of hypertonic dextrose with corticosteroids on pain and motor status of chronic knee osteoarthritis Investigating the early effect of hypertonic dextrose on the pain level and movement status of patients with chronic osteoarthritis of the knee compared to corticosteroids 2023-05-19 anticipated 70 Complete https://irct.ir/trial/68803 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block random division method (blocks of 4) is used. One of the colleagues of the study, who was not blinded, names the dextrose treatment method with the letter A and the corticosteroid method with the letter B. Then, the researcher distributes packages A and B among the referring patients in order to participate in the study using a block random division method (of 4). Then, among the created blocks, so many blocks are randomly selected to reach the required sample size. To make a random sequence, we give numbers from 1 to 16 to the possible blocks (16 blocks). According to the sample size, any number of 4 blocks will be used. Block numbers will be selected from the table of random numbers and the sequence of blocks in each group will be determined based on these numbers. Finally, with the help of 16 blocks of four, random allocation will be done, Blinding description: The statistical consultant and the patient will be unaware of the type of grouping in this plan; The final results will be delivered to the statistical consultant. Since the statistical consultant and the patients will not be aware of the grouping of the participants; Therefore, they are blind during the study. 2-3 Pain. Intervention 1: Intervention group: 31 people will be randomly assigned to this group. Two cc of lidocaine 1% (Abdi Pharmacy) will be injected in the lateral part of the knee to numb the skin of the knee. Then, the 22G needle will be inserted under ultrasound guidance from the upper and outer lateral region of the knee, and after reaching the knee joint, 5 cc of 20% dextrose solution (Obeidi Pharmacy) will be injected. The intensity of pain will be measured before and after one month after the end of the intervention using the VAS tool. Intervention 2: Control group: 31 people will be randomly assigned to this group. Two cc of lidocaine 1% (Abdi Pharmacy) will be injected in the lateral part of the knee to numb the skin of the knee. Then, the 22G needle will be inserted under ultrasound guidance from the upper and outer lateral region of the knee, and after reaching the knee joint, 4 cc of triamcinolone solution (Obeidi Pharmacy) will be injected. The intensity of pain will be measured before and after one month after the end of the intervention using the VAS tool. 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 further information.
public Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981464863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences scientific Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Knee osteoarthritis Arthritis grade II Movement restriction Ages between 40 and 80 years 40 years 80 years Both Pregnancy Taking anticoagulants Infection at the injection site History of severe knee injury History of knee surgery Having diabetes mellitus G89.29 Other chronic pain Treatment - Drugs Treatment - Drugs Intervention group: 31 people will be randomly assigned to this group. Two cc of lidocaine 1% (Abdi Pharmacy) will be injected in the lateral part of the knee to numb the skin of the knee. Then, the 22G needle will be inserted under ultrasound guidance from the upper and outer lateral region of the knee, and after reaching the knee joint, 5 cc of 20% dextrose solution (Obeidi Pharmacy) will be injected. The intensity of pain will be measured before and after one month after the end of the intervention using the VAS tool. Control group: 31 people will be randomly assigned to this group. Two cc of lidocaine 1% (Abdi Pharmacy) will be injected in the lateral part of the knee to numb the skin of the knee. Then, the 22G needle will be inserted under ultrasound guidance from the upper and outer lateral region of the knee, and after reaching the knee joint, 4 cc of triamcinolone solution (Obeidi Pharmacy) will be injected. The intensity of pain will be measured before and after one month after the end of the intervention using the VAS tool. Pain. Timepoint: Before the intervention and one month after the end of the intervention. Method of measurement: Visual analog scale. Shahid Beheshti University of Medical Sciences Approved 2023-04-15 Researvh ethics committees of cice-chancellor in research affaris Shahid Beheshti University of Medi Tehran, Evin, Shahid Shahriari Square Tehran Tehran Iran (Islamic Republic of)