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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group 1 (O3 20mg) | Experimental | 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 micrograms is injected 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. |
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| Intervention group 2 (O3 40mg) | Active Comparator | Just like intervention group 1, in this group, a predetermined concentration of 40 micrograms ozone is injected under sterile conditions.According to the standard treatment guidelines of the American College of Rheumatology, 1gram of acetaminophen in two doses of 500 mg is allowed up to two weeks after daily injections, which is applicable to all three groups. |
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| Control group | Placebo Comparator | Just like intervention group 1, in this group, a syringe containing oxygen without ozone is injected under sterile conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-articular injection of ozone | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire evaluations womac | Western Ontario and McMaster Universities Osteoarthritis Index questionnaire or WOMAC for short: This questionnaire has 24 items which are arranged in three sections.
It is worth mentioning that the translation, localization and validation of WOMAC questionnaire in Iran was done in 2014 by Dr. Ebrahimzadeh and his colleagues. | before the intervention and two weeks later, one month and three months after the intervention |
| Visual Analogue Scale | Feeling pain in the knee with vas criteria | before the intervention and two weeks later, one month and three months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| range of motion | In this research, the active range of motion of the knee is measured with a goniometer and recorded in degrees | before the intervention and two weeks later, one month and three months after the intervention |
| Timed Up & Go functional test |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Sports and Exercise Medicine, School of Medicine, Iran University of Medical Sciences | Tehran | 14496-14535 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40050950 | Derived | Arjmanddoust Z, Nazari A, Moezy A. Efficacy of two doses of intra-articular ozone therapy for pain and functional mobility in knee osteoarthritis: a double-blind randomized trial. Adv Rheumatol. 2025 Mar 6;65(1):11. doi: 10.1186/s42358-025-00443-w. |
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In the randomized clinical trial study, Convenience Sampling will be done among the patients with knee osteoarthritis called to the sports medicine assessment clinic, at Hazrat Rasool Akram hospital.
Allocation of patients in treatment groups will be done randomly using blocks with blocks of six in one of the treatment groups as follows:
A: Control (CL) B: O3 20mg C: O3 40mg
The block randomization method is used to assign people to the three study groups. For this purpose, the length of the block will be equal to 6 houses (two houses for each treatment).
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Clinician: injection interventions are performed under the supervision of a sports medicine specialist who does not know the dose of the injections and only injects the solution prepared by another assistant.
Assessor Clinician: Assessments before and after interventions will be done by a sports medicine resident who is not involved in running the trial.
Statistical analyzer: The analysis of the research data will be done by a statistical consultant who is not aware of the patient groups.
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n this evaluation, the patient will be asked to get up from a standard chair and walk along a line drawn on the floor in front of a three-meter long chair in a completely comfortable and safe manner, then go around and walk again. Return to the side of the chair and sit on it. The time to perform this test will be measured with a stopwatch and recorded in seconds. |
| before the intervention and two weeks later, one month and three months after the intervention |
| Six-Minute Walk Functional Test | In this evaluation, the patient will be asked to walk the maximum distance he can within 6 minutes. The distance traveled by the patient during the test will be measured with a tape measure and recorded with a meter unit. Each of these functional evaluations is repeated three times and the best result for the patient will be recorded | before the intervention and two weeks later, one month and three months after the intervention |