The Effectiveness of Ultrasound Guided Intraarticular and Periarticular Ozone (O2-O3) Injection in the Treatment of Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- PAIN - Numerical Rating Scale (NRS)
研究概览
简要总结
Knee ostheoarthritis (KOA) is a common disabling and degenerative disease leading to painful joints, articular stiffness, and decreased function. The mechanism of the ozone of relieving the pain and improving the knee function is through inhibiting the inflammation reaction in the KOA directly. Actually, the ozone intra-articular injection had been used to relieve the pain caused by KOA.
The aim of this study is to evaluate the effect of intra-articular injection of medical ozone given into the knee of the osteoarthritis patients, and to compare it with intra-articular steroid injection and to investigate the effectiveness of ozone and steroid the job to determine the superiority of the injections to each other.
详细描述
The study was designed as prospective, randomized, controlled trial. 96 people who met the inclusion criteria were randomized into two groups of people. The first group will be designated as Ozone group will be applied to these patients. Patients in the second group will be designated as the steroid group, and injections will be applied in accordance with protocol. Participants were evaluated with Visual Analogue Scale (VAS), The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The presence of suprapatellar effusion of the participants whose evaluations are completed will be evaluated by ultrasonography and the findings will be recorded. Initial evaluations of the participants will be made before the first injection. Patients in the ozone (O2-O3) injection group will be given intraarticular and per-articular knee injections 3 times as the first dose of 10 μg / ml, the second dose is 15 μg / ml, and the third dose is 20 μg / ml, each session in a volume of 10 ml. In the steroid injection group, 1 ml of betamethasone (6 mg / ml) will be injected once intraarticular knee injection. Patients will be evaluated according to the study criteria at the beginning, 4 and 12 weeks later by a blinded investigator.
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female / male aged> 45 years
- •Diagnosis of knee ostheoarthritis after physical examination and imaging (direct radiography)
- •Those whose symptoms persist> 6 months
- •Radiological staging of osteoarthritis according to the Kellgren-Lawrence scale Grade 2 and 3
- •Participation in the study voluntarily and regularly
排除标准
- •History of previous knee surgery
- •Patients with inflammatory arthritis (Rheumatoid arthritis, psoriatic arthritis, gouty arthritis as)
- •Patients with neuropathic pain
- •Those with pain reflected from the waist or hip
- •History of tumor, infectious, psychiatric illness, bleeding diathesis
- •Trauma history within the last 6 months
- •Hyaluronic acid or steroid injection in the last 3 months
- •Those with systemic diseases such as diabetes, rheumatoid arthritis, hepatitis, coagulopathy
- •Those with malignant hypertension
- •Those with G6PDH (Glucose 6-Phosphate Dehydrogenase) deficiency
- •Those with Graves' disease
- •Those with cerebrovascular event disease in which bleeding continues actively
结局指标
主要结局
PAIN - Numerical Rating Scale (NRS)
时间窗: up to 12 weeks
Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Severity of pain was assessed NRS using the standard 10 cm (at rest, at motion and at night) with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end.
次要结局
- PAIN, PHYSICAL FUNCTION -Western Ontario and McMaster Universities Arthritis Index (WOMAC)(initial, 4th week 12th week pain change)
- Quality of life - Short Form-36 (SF-36)(initial, 4th week 12th week pain change)
研究者
Sefa Gümrük Aslan
Physical Medicine and Rehabilitation Specialist
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital