Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06088706
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2023-09-28
Brief Title:
Evaluation of the Effect of Different Doses of Ozone Therapy on Pain and Function of Patients With Knee Osteoarthritis
Sponsor:
Ahmad Nazari
Organization:
Iran University of Medical Sciences
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None