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

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

This study will be a randomized clinical trial (blocks of four) and double-blind (patient and data analyst), phase 2-3, with parallel groups and with the participation of 62 patients with knee osteoarthritis. Patients will be divided into two groups.

This randomized and double-blind clinical trial study (patients and data analysts) will be conducted with the participation of patients with symptoms of knee arthritis who will refer to Imam Hossein Hospital. Under ultrasound guidance, a 22G needle is inserted from the lateral part of the outer part of the knee, and triamcinolone (40 mg) or dextrose 20% (5 cc) drugs will be injected into the knee joint, and the pain intensity after one month of the intervention between two The group will be compared.

The inclusion criteria for this study include: suffering from knee osteoarthritis, ages between 40 and 80 years, Grade II arthrosis and mobility limitation, and the exclusion criteria for this study include: pregnancy, use of anticoagulants, infection at the injection site, history of severe knee trauma, history of knee surgery and diabetes mellitus.

In this randomized and double-blind clinical trial study, 62 patients will be randomly assigned to two groups of dextrose or corticosteroid injections in the knee joint, and their pain intensity will be measured after the completion of the intervention (three months).

Pain

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.

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.