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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
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).
详细描述
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:
- Control group - intra-articular injection of oxygen without ozone
- Intervention group 1- Intra-articular injection of ozone with a dose of 20 micrograms
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Visual Analogue Scale
时间窗: before the intervention and two weeks later, one month and three months after the intervention
Feeling pain in the knee with vas criteria
Questionnaire evaluations womac
时间窗: before the intervention and two weeks later, one month and three months after the intervention
Western Ontario and McMaster Universities Osteoarthritis Index questionnaire or WOMAC for short: This questionnaire has 24 items which are arranged in three sections. 1. The first part examines pain with five items in different positions of walking, climbing stairs, while resting in bed, while sitting or sleeping, and standing. 2. The second part examines morning dryness and joint stiffness at the end of the day with two items. 3. The third section examines the patient's functional activities in different situations with seventeen items. 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.
次要结局
- range of motion(before the intervention and two weeks later, one month and three months after the intervention)
- Timed Up & Go functional test(before the intervention and two weeks later, one month and three months after the intervention)
- Six-Minute Walk Functional Test(before the intervention and two weeks later, one month and three months after the intervention)
研究者
Ahmad Nazari
Assistant Professor
Iran University of Medical Sciences