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IRCT20131124015515N5 IRCT 2019-03-14 Shahid Beheshti University of Medical Sciences The effect of ozone injection with two different injection methods to control knee pain Comparative effect of intra-articular Ozone injections with suprapatellar lateral and inferomedial approaches for pain control in patients with knee osteoarthritis 2019-03-10 anticipated 60 Complete https://irct.ir/trial/38023 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization based on random numbers table, Blinding description: Participant and clinical outcomes evaluator are not aware of the code assigned to each of the groups. 2-3 Knee Osteoartritis. Intervention 1: Intervention group: suprapatellar lateral approach، the patient is placed in a supine position, Insert the needle one centimeter high and one cm in the lateral portion of the super pellet margin with an angle of 45 ° in the direction of the cephalo lateral to the quadomedial, landmark of the injection area is determined. Intervention 2: Control group: Inferomedial approach، the patient is placed in a supine position, It is characterized by knee flexion of about 45 to 30 degrees on the lateral side of the knee, landmark of the injection area is determined. Yes - There is a plan to make this available What will be shared: The whole data can be shared after unidentifiable people. When: Start the access period 12 months after printing the results To whom: Only available to scholars working in academic and academic institutions Conditions: Employed in research centers Where to obtain: Person responsible for scientific inquiries How to obtain: Send email to person responsible for scientific inquiries Comments:

public Seyed Masoud Hashemi MD

Akhtar Hospital, Sharifi Manesh st

Tehran Iran (Islamic Republic of) 1964714953 +98 21 2261 2252 dr.hashemi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Seyed Masoud Hashemi MD

Akhtar Hospital, Sharifi Manesh st.

Tehran Iran (Islamic Republic of) 1964714953 +98 21 2261 2252 dr.hashemi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients older than 40 years The pain of knee osteoarthritis for more than three months Radiological findings confirming knee osteoarthritis based on the American College of Rheumatology Osteoarthritis with Grade II-III based on Kellgren-Lawrence radiology grading No effusion Signed written informed consent to participate in the study 40 years no limit Both Patients with history of knee surgery Deformity and lower limb contraction Lower limb neovascular disease Acute lumbosacral pathology Injection of steroid drugs over the past two months History of inflammatory rheumatoid arthritis Infection Diabetes Pregnancy Breast feeding Body Mass Index >35 kg/m2 Patients undergoing knee surgery Knee deviation (verrucous or valgus more than 5 degrees) confirmed by three joint view Radicular pain Knee pain Anticoagulant therapy Post-traumatic arthritis History of intraArticular or ozone therapy during 12 Last month Systemic or psychiatric illness Severe osteoarthritis with Grade over III M17.10 Unilateral primary osteoarthritis, unspecified knee Treatment - Other Treatment - Other Intervention group: suprapatellar lateral approach، the patient is placed in a supine position, Insert the needle one centimeter high and one cm in the lateral portion of the super pellet margin with an angle of 45 ° in the direction of the cephalo lateral to the quadomedial, landmark of the injection area is determined. Control group: Inferomedial approach، the patient is placed in a supine position, It is characterized by knee flexion of about 45 to 30 degrees on the lateral side of the knee, landmark of the injection area is determined. Pain Level by visual analog scale. Timepoint: In the portal area during the first, second, third and fourth injections and knee pain before treatment, one month and three months after the last injection. Method of measurement: Visual analog scale (VAS) (0 None; 1-3 Mild; 4-7 Moderate; 8-10 Severe). Disability Level by Oswestry Low Back Disability Questionnaire. Timepoint: Before starting treatment and three months after the last injection. Method of measurement: Oswestry Low Back Disability Questionnaire that disability is measured with 10 items. Each item is scored from 5-0, which indicates a higher score for the disability. Shahid Beheshti University of Medical Sciences Approved 2018-06-29 Ethics committee of Shahid Beheshti University of Medical Sciences and Health Services Tabnak St.,Tehran, Tehran, Iran, Islamic Republic Of Tehran Tehran Iran (Islamic Republic of)