]>
IRCT20180518039700N3 IRCT 2021-09-12 Tabriz University of Medical Sciences Comparison of radiofrequency with ozone in improving the symptoms of knee osteoarthritis Comparison of the Radioferequency and intraarticular ozone on improving the osteoarthritis symptoms of knee joint 2021-07-23 anticipated 70 Complete https://irct.ir/trial/54590 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using GraphPad online randomization software (https://www.graphpad.com/quickcalcs/randomize1), 70 patients will be randomly allocated into two groups (n=35) A (ozone group) and B (radio-frequency group). According to this list, the patients referred to the study will be considered as group A or B, respectively. In the ozone group, intra-articular injection of ozone and in the radio-frequency group, radio frequency therapy will be applied intra-articularly, Blinding description: This study is single blinded study and in this trial 70 patients with study inclusion criteria, first examined by one of coworkers due to knee pain and functional limitation, and the results are recorded. The patients are referred to the principle investigator and they randomly assigned to one of the two groups; Radioferequency or ozone (n=35). At the end of the treatment, the patients will be examined again by the same coworker, who will be kept blind to the treatment, and the result is recorded. At the end of the study, the two groups will be compared due to their pain and functional status. 2 knee osteoarthritis. Intervention 1: Intervention group:Ozone group: 15 cc of ozone 35 micro-grams per millilitre will be injected. After injection, flexion and extension movements will be performed for better distribution of gas in the knee.When finished, the place is bandaged and it is transferred to the recovery and stays in the recovery for 30 minutes, then it is transferred to the ward and will be released after 4 hours.This action will be done twice a week for a total of 4 sessions. Intervention 2: Intervention group: Radiofrequency group: Radiofrequency needle with 100 mm length and 10 mm active tip is inserted into the joint, then PRF with a temperature of 42 ° C and a pulse width of 20 milliseconds, 2 Hz is applied for 15 minutes. This action is done twice. It is done in 2 weeks (once a week). Yes - There is a plan to make this available What will be shared: All potential data can be shared after making peoples unrecognizable When: Starting 6 months after publication. To whom: Documents will be available for people working in academic institutions and also people working in businesses. Conditions: There will be no specific limitations to the utilization of the data Where to obtain: Dr .Solmaz Fakhari , Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , solmaz_fakhari@yahoo.com How to obtain: Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week. Comments:
public Solmaz Fakhari
Imam Reza Hospital, Golgasht St., Azadi Blvd
Tabriz Iran (Islamic Republic of) 5138947979 +98 41 3334 1994 solmaz_fakhari@yahoo.com Tabriz University of Medical Sciences scientific Solmaz Fakhari
Imam Reza Hospital, Golgasht St., Azadi Blvd.
Tabriz Iran (Islamic Republic of) 5138947979 +98 41 3334 1994 solmaz_fakhari@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Median knee osteoarthritis (Grade 2 or 3 based on Kellegren and Lawrence knee radiography) Patients over 45 years old Satisfaction of patients participating in the study Failure to respond to conservative and physiotherapy treatments over the past 6 months 45 years no limit Both Severe osteoarthritis (Grade 4 candidates for joint replacement surgery) Rheumatic disease Received previous corticosteroids 3 months ago Clearly visible deformity of the varus or valgus of the knee Severe knee flexion contraction Ankylosis Psychological disorders Drug dependence Hyperthyroidism Thrombocytopenia Pregnancy M15.0 Primary generalized (osteo)arthritis Treatment - Drugs Treatment - Drugs Intervention group:Ozone group: 15 cc of ozone 35 micro-grams per millilitre will be injected. After injection, flexion and extension movements will be performed for better distribution of gas in the knee.When finished, the place is bandaged and it is transferred to the recovery and stays in the recovery for 30 minutes, then it is transferred to the ward and will be released after 4 hours.This action will be done twice a week for a total of 4 sessions. Intervention group: Radiofrequency group: Radiofrequency needle with 100 mm length and 10 mm active tip is inserted into the joint, then PRF with a temperature of 42 ° C and a pulse width of 20 milliseconds, 2 Hz is applied for 15 minutes. This action is done twice. It is done in 2 weeks (once a week). Physical performance. Timepoint: At the beginning of the study, in 4th session of ozone therapy and 2nd session of radio frequency (at the end of sessions of both methods) and one month after the end of sessions. Method of measurement: WOMAC questionnaire(Western Ontario and McMaster Universities Osteoarthritis Index questionnaire). Intensity of pain. Timepoint: At the beginning of the study, in 4th session of ozone therapy and 2nd session of radio frequency (at the end of sessions of both methods) and one month after the end of sessions. Method of measurement: VAS (Visual Analog Scale) will be measured at rest and after 6 meters of walking. Patient satisfaction. Timepoint: At the beginning of the study, in 4th session of ozone therapy and 2nd session of radio frequency (at the end of sessions of both methods) and one month after the end of sessions. Method of measurement: Question from the patient (excellent, good, acceptable and unsatisfactory). Tabriz University of Medical Sciences Approved 2021-01-25 Ethic Committee of Tabriz University of Medical Sciences Vice chancellor for research, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)