NCT06088706

Evaluation of the Effect of Different Doses of Ozone Therapy on Pain and Function of Patients With Knee Osteoarthritis

Evaluation of the Effect of Different Doses of Ozone Therapy on Pain and Function of Patients With Knee Osteoarthritis Referred to the Sports Medicine Clinic of Hazrat Rasool Akram Hospital

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ahmad Nazari · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as a randomized clinical trial that will be conducted in Hazrat Rasool Akram Hospital in Tehran. Patients with knee osteoarthritis were selected based on the study entry criteria and written consent was obtained from them. Then, by random assignment, patients will be divided into three treatment groups: control group (under oxygen gas injection), intervention group 1 (intra-articular injection of ozone with a dose of 20 micrograms) and intervention group 2 (intra-articular injection of ozone with a dose of 40 micrograms).

Detailed description

This research is a type of randomized clinical trial (RCT) in which the studied samples will be selected from the patients with knee osteoarthritis referring to Hazrat Rasool Akram hospital by available sampling method. All the stages of this research will be done with the approval of the ethics committee of the Research Vice-Chancellor of Iran University of Medical Sciences, and written consent will be obtained from all the participants in this research. The population studied in this research will be made up of knee osteoarthritis sufferers who, according to the announcements that will be posted at the hospitals of Iran University of Medical Sciences in Tehran, will come from all urban areas to participate in this study to Hazrat Rasool Akram Hospital.) will be called and after meeting the conditions for entering the research, they will be randomly placed in one of the proposed treatment groups. The intervention groups in this research are: 1. Control group - intra-articular injection of oxygen without ozone 2. Intervention group 1- Intra-articular injection of ozone with a dose of 20 micrograms 3. Intervention group 2- Intra-articular injection of ozone with a dose of 40 micrograms In the next step, a summary of the evaluation and treatment plans for the participants will be stated in simple language, and after that, the results of the research on the studied patients will be evaluated and the results will be recorded. Then, according to their groups, the patients will be subjected to exercise therapy interventions under supervision in the clinic or based on the Internet for six weeks. Before and in the second week, the first month and the third month after the intervention, patients will be evaluated with VAS, knee range of motion, WOMAC questionnaires and functional tests (6MWT and Timed Up and Go Test).

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
PROCEDURE	Intra-articular injection of ozone	the patient is lying on the bed with his knee flexed at about 45 degrees. Then The syringe containing ozone is prepared by a sports medicine assistant and covered with a label so that the clinician is not aware of the injected ozone dose. Lateral Approach will be used for intra-articular injection. after preparation and drape of the desired position and aspiration, the ozone composition will be injected into the joint. In order to inject for this group, a 10 cc needle and a predetermined concentration of 20 and 40 micrograms ozone are used under sterile conditions. The duration of the injection will be 15-20 seconds. The number of sessions considered for injection will be three sessions, once a week for three weeks. The second and third injection will be done under the same conditions as the first session. In this study, Ozonette Sedecal device ( Spain) will be used. And the exercise therapy protocol is performed.

Timeline

• Start date: 2023-11-20
• Primary completion: 2024-04-10
• Completion: 2024-05-01
• First posted: 2023-10-18
• Last updated: 2024-07-16

Locations

1 site across 1 country: Iran