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IRCT20190810044500N22 IRCT 2022-02-26 Yazd University of Medical Sciences The effect of topical ketorolac on knee osteoarthritis Comparison of therapeutic effects of topical ketorolac versus topical diclofenac in the treatment of knee osteoarthritis pain: a clinical trial 2022-05-22 anticipated 40 Complete https://irct.ir/trial/59939 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned to two groups of 20 controls or interventions by the permutation block method. Ten blocks of 4 are considered. Generation of random codes using Permuted Block Randomization method will be done with the help of Random allocation software (version 1). The first person who is eligible to enter the study is given number one and likewise, the last eligible person is given number 40. By using the software-generated table, patients receive each intervention A or B (Each of the letters A and B will be installed on similar containers of the interventions). In order to consider blinding in random allocation, the list is given to another person outside the study and using short message service (SMS) before assigning the type of treatment according to the number of eligible people is asked and thus people enter the study, Blinding description: After the products have been prepared, the first Executor, the treating physician, and the researcher monitoring the patients will not be aware of any of the groupings performed. In this way, after preparing the products, which all look the same, are placed in similar boxes. Then we ask another person to identify them with the codes A or B. 2 Knee osteoarthritis. Intervention 1: Intervention group: Patients will use the topical gel of ketorolac 2% (prepared in the Pharmaceutics Laboratory of Yazd School of Pharmacy) three times daily for 2 weeks. Patients will be evaluated for joint function, pain, and inflammation in the first and second weeks. Acetaminophen 500 mg tablets (Jalinus) will also be prescribed in patients' prescriptions so that if the pain is not controlled with these topical products, the patient will use a maximum of four acetaminophen 500 mg daily, provided that all acetaminophen blisters are used during this period. Has been kept until the end of 14 days. During treatment, patients will be monitored for side effects. For patients, a health assessment questionnaire, WOMAC pain assessment questionnaire, and VAS questionnaire will be evaluated for side effects. Intervention 2: Control group: Patients use the topical gel of diclofenac 1% (Iran Najo) three times daily for 2 weeks. Patients will be evaluated for joint function, pain, and inflammation in the first and second weeks. Acetaminophen 500 mg tablets (Jalinus) will also be prescribed in patients' prescriptions so that if the pain is not controlled with these topical products, the patient will use a maximum of four acetaminophen 500 mg daily, provided that all acetaminophen blisters are used during this period. Has been kept until the end of 14 days. 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 rostami
Shahid Sadoughi University of Medical Sciences, Shohaday Gomnam Boulevard, Alam Square, Yazd
yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 mehdirostami2025@gmail.com Yazd University of Medical Sciences scientific Fatemeh Saghafi
Yazd, Alam Square, Anonymous Martyrs Boulevard, Shahid Sadoughi University of Medical Sciences, Yazd
yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 saghafi.fa@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Age over 40 Primary osteoarthritis Pain in more than half of the days of the previous month during one of the following activities: walking, going up and down stairs, standing or lying on a bed or mattress during Night Radiographic evidence of tibiofemoral or patellofemoral osteoarthritis baseline score of 40 on the WOMAC scale no intra-articular injection of hyaluronic acid / glucocorticoid during the last six months no positive pregnancy test or pregnancy program during the study 40 years no limit Both Not taking the right medicine Serious medical condition in which the patient is unable to return for regular visits History of liver disease Inability to walk without a cane Secondary osteoarthritis for example following trauma M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: Patients will use the topical gel of ketorolac 2% (prepared in the Pharmaceutics Laboratory of Yazd School of Pharmacy) three times daily for 2 weeks. Patients will be evaluated for joint function, pain, and inflammation in the first and second weeks. Acetaminophen 500 mg tablets (Jalinus) will also be prescribed in patients' prescriptions so that if the pain is not controlled with these topical products, the patient will use a maximum of four acetaminophen 500 mg daily, provided that all acetaminophen blisters are used during this period. Has been kept until the end of 14 days. During treatment, patients will be monitored for side effects. For patients, a health assessment questionnaire, WOMAC pain assessment questionnaire, and VAS questionnaire will be evaluated for side effects. Control group: Patients use the topical gel of diclofenac 1% (Iran Najo) three times daily for 2 weeks. Patients will be evaluated for joint function, pain, and inflammation in the first and second weeks. Acetaminophen 500 mg tablets (Jalinus) will also be prescribed in patients' prescriptions so that if the pain is not controlled with these topical products, the patient will use a maximum of four acetaminophen 500 mg daily, provided that all acetaminophen blisters are used during this period. Has been kept until the end of 14 days. Joint range of motion. Timepoint: At the beginning of the study and 7 and 14 days after starting topical ketorolac and topical diclofenac. Method of measurement: Western ontario and mc master universities osteoarthritis index and Knee Injury and Osteoarthritis Outcome Score. Pain. Timepoint: At the beginning of the study and 7 and 14 days after starting ketorolac topical and diclofenac. Method of measurement: Western Ontario and mc master universities osteoarthritis index and Visual Analogue Scale and Knee Injury and Osteoarthritis Outcome Score. Inflammation. Timepoint: At the beginning of the study and 7 and 14 days after starting ketorolac topical and diclofenac. Method of measurement: Western ontario and mc master universities osteoarthritis index and Visual Analogue Scale and Knee Injury and Osteoarthritis Outcome Score. Yazd University of Medical Sciences Approved 2022-01-12 Ethics Committee of Medical School - Shahid Sadoughi University of Medical Sciences, Yazd Anonymous Martyrs Boulevard - Shahid Sadoughi University of Medical Sciences, Yazd Yazd Yazd Iran (Islamic Republic of)