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IRCT20151017024572N19 IRCT 2019-01-05 Iran University of Medical Sciences Effect of mesenchimal stem cell in knee osteoarthritis The effects of ultrasound-guided corticosteroid injection compared to mesenchimal stem cell injection in patients with knee osteoarthritis: a randomized controlled trial 2019-02-05 anticipated 30 Complete https://irct.ir/trial/34940 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Block randomization, Randomization description: Random assignment to intervention and control groups, Blinding description: Patients are randomly divided into two groups in closed packaging. 2-3 Primary knee osteoarthrosis, bilateral. Intervention 1: Intervention group: mesenchimal stem cell injection will be performed under the ultrasound guid in the knee joint which will be done by an experienced physical medicine and rehabilitation specialist; using supra patellar approach. Intervention 2: Control group: corticosteroid injection will be performed under the ultrasound guid in the knee joint which will be done by an experienced physical medicine and rehabilitation specialist; using supra patellar approach. No - There is not a plan to make this available Justification or reason for not sharing IPD is Prevention from scientific theft
public Khatereh Abdolmaleki
Valadi Ave.,Valie asr Ave.,Tehran
Tehran Iran (Islamic Republic of) 1593747812 +98 21 4128 9221 khatereh.abd@gmail.com Iran University of Medical Sciences scientific Dr.Arash Babaei
Valadi Ave.,Valie asr Ave.,Tehran
Tehran Iran (Islamic Republic of) 1593747811 +98 21 4128 9221 Babaei-ghazani.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients with mild to moderate OA of the knee (Kellgren Lawrence grade I, II and III) Knee pain for at least six months Age 18 to 75 years old The absence of any acute or chronic infection No pregnancy or lack of planning to get pregnant No history of any intra articular knee injection in three months ago The absence of inflammatory articular disease or secondary osteoarthritis No history of knee surgery No severe underlying disease such as uncontrolled diabetes,Use of anticoagulants Lack of daily use of opioid and non opioid analgesics 18 years 75 years Both The willingness of patients to exit from the study at any stage of the study M17.0 Primary knee osteoarthrosis, bilateral Treatment - Other Treatment - Other Intervention group: mesenchimal stem cell injection will be performed under the ultrasound guid in the knee joint which will be done by an experienced physical medicine and rehabilitation specialist; using supra patellar approach. Control group: corticosteroid injection will be performed under the ultrasound guid in the knee joint which will be done by an experienced physical medicine and rehabilitation specialist; using supra patellar approach. The severity of pain. Timepoint: Zero, two weeks, one and six months after. Method of measurement: Visual Analog Scale(VAS). The severity of symptoms and functional limitations. Timepoint: Zero, two weeks, one and six months after. Method of measurement: By using WOMAC questionnare. Range of motion. Timepoint: Zero, two weeks, one and six months after. Method of measurement: Goniometer. Side effects. Timepoint: two and four weeks after. Method of measurement: Physical examination. Iran University of Medical Sciences Approved 2018-08-26 committee of Iran University of Medical SciencesStreet address Iran University of Medical Sciences, Iran University of Medical Sciences, Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)