Clinical trial NCT06088706: Evaluation of the Effect of Different Doses of Ozone Therapy on Pain and Function of Patients With Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* Having primary knee osteoarthritis grade 2 and 3 according to the doctor's diagnosis and based on the Kellgren and Lawrence criteria (the presence of knee pain, morning dryness for less than 30 minutes, crypts during movement and radiological signs of osteoarthritis including joint space reduction, subchondral bone sclerosis and osteophyte formation in knee)
* Age 50-75 years
* Suffering from continuous knee pain for at least six months and with a severity of at least 4 based on the VAS criteria in physical activities such as going up and down the stairs, sitting for a long time and squatting
* Ability to walk independently for at least 30 meters
* Body mass index equal to or less than 35
* Complete consent of the patient to participate in the research
* Balanced mental state

Exclusion Criteria:

* History of intra-articular injections in the knee during the last six months
* Suffering from neuromuscular diseases
* Presence of acute traumatic injury in other ligaments and structures of the knee joint as confirmed by a specialist doctor
* History of previous surgery or injury in the knee and other joints of the lower limbs during the last year
* Presence of bone implants
* The presence of new fractures in the lower limbs during the last year
* Getting malignant tumors
* Participation in sports therapy and physiotherapy programs during the last three months

Primary outcomes:
measure: Questionnaire evaluations womac
timeFrame: before the intervention and two weeks later, one month and three months after the intervention
measure: Visual Analogue Scale
timeFrame: before the intervention and two weeks later, one month and three months after the intervention
Secondary outcomes:
measure: range of motion
timeFrame: before the intervention and two weeks later, one month and three months after the intervention
measure: Timed Up & Go functional test
timeFrame: before the intervention and two weeks later, one month and three months after the intervention
measure: Six-Minute Walk Functional Test
timeFrame: before the intervention and two weeks later, one month and three months after the intervention
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Department of Sports and Exercise Medicine, School of Medicine, Iran University of Medical Sciences
Study officials:
References: