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IRCT20151017024572N18 IRCT 2018-09-01 Iran University of Medical Sciences Comparison of ozone effect on knee osteoarthritis Comparison the therapeutic effect of one-time with three-times ozone injection under ultrasound guidance in patients with knee osteoarthritis 2018-09-11 anticipated 40 Complete https://irct.ir/trial/30193 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 Primery gonrthrosis,bilatral. Intervention 1: Intervent group: three times ozon injectione with a one-week interval by a physician and rhabilition spesialist under the ultrasound guide in the knee joint through a supra patellar approach. Intervention 2: Control group: ozon injection will be performed under the ultrasound guid in the knee joint which will be done by an experienced physical medicine and rehabilitation specialis.using supra patellar approach. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Dr. Vajihe Alishahi
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran.
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1229 vajihe.alishahi@yahoo.com Iran University of Medical Sciences scientific Dr. Arash Babaei
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran.
Tehan Iran (Islamic Republic of) 1593747811 +98 21 8214 1229 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 40 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 (3 months ago) No severe underlying disease such as uncontrolled diabetes Use of anticoagulants Lack of daily use of opioid and non opioid analgesics Absence of contraindications of ozone therapy (deficiency G6PD, uncontrolled hyperthyroidism, leukemia). 40 years 75 years Both The willingness of patients to exit from the study at any stage of the study Not coming patients for follow up and evaluation during the follow up period Daily use of any type of analgesic medication by patients during the follow up period Occurring a pathology in the knee, such as meniscus tear during the follow up period Occurring 4th and 7th inclusion criteria, during the study. M17.0 Bilateral primary osteoarthritis of knee Treatment - Other Treatment - Other Intervent group: three times ozon injectione with a one-week interval by a physician and rhabilition spesialist under the ultrasound guide in the knee joint through a supra patellar approach Control group: ozon injection will be performed under the ultrasound guid in the knee joint which will be done by an experienced physical medicine and rehabilitation specialis.using supra patellar approach The severity of pain. Timepoint: Zero, one, four and twelve weeks after. Method of measurement: Visual Analog Scale(VAS). The severity of symptoms and functional limitations. Timepoint: Zero, one, four and twelve weeks after. Method of measurement: By using WOMAC questioner. Sonographic criteria (efusion). Timepoint: Zero, one, four and twelve weeks after. Method of measurement: By using sonographic device. Range of motion. Timepoint: Zero, one, four and twelve weeks after. Method of measurement: Goniometer. Side effects. Timepoint: one, four weeks after. Method of measurement: Physical examination. Iran University of Medical Sciences Approved 2018-07-23 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway, Tehran. Tehran Tehran Iran (Islamic Republic of)