Comparing The Efficacy Of Intra-Articular Ozone Injection Vs Intra-Articular Corticosteroid Injection In Knee Synovitis In Rheumatoid Arthritis.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare the improvement in pain in the intervened knee (measured by VAS 100mm scale)
研究概览
简要总结
This study is a randomized double blinded control trial to compare the efficacy and advantage of offering intra articular ozone injection instead of intra articular corticosteroid injection in improving pain and knee synovitis in patients with rheumatoid arthritis The primary outcome will be the decrease in pain (as VAS 100 score) at 2, 6 and 12 weeks post final injection. The secondary outcomes will be improvement in quality of life via EuroQOL and CIFKAS and RAPS scale and decrease in synovial hypertrophy as per EULAR-OMERACT criteria.m
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients age greater than 18 years, fulfilling the clinical criteria of rheumatoid arthritis defined by ACR EULAR diagnostic criteria greater or equal to 6/10
- •Increased knee pain and stiffness for at last 3 months.
- •Pain intensity on Visual Analog Scale greater than or equal to 4 out of 10 at knee joint.
- •RA diagnosed and patient has taken DMARDs for more than 6 months, with no alteration in dosage for the last 3 months.
排除标准
- •Diabetes mellitus
- •Pregnancy
- •Previous arthroplasty
- •Intra articular or peri articular injection in the past three months
- •Body mass index more than
- •Any disease flare in the last 3 months
- •Any local lesion in the injection site.
- •Coagulation disorder, Allergic reaction to local anesthetic, ozone, and steroid in the past
- •Switch to any other treatment modality during the 12 weeks of follow up in the post injection period.
- •Any patient on systemic Biological DMARDs.
结局指标
主要结局
To compare the improvement in pain in the intervened knee (measured by VAS 100mm scale)
时间窗: at 2, 6 and 12 weeks post intervention
following intra-articular injection of ozone therapy against intra-articular injection of
时间窗: at 2, 6 and 12 weeks post intervention
corticosteroid in rheumatoid arthritis patients with synovitis of knee
时间窗: at 2, 6 and 12 weeks post intervention
次要结局
- Improvement in quality of life and functional improvement(at 2, 6 and 12 weeks post intervention)
- measure decrease in synovial hypertrophy in injected knee(at 2, 6 and 12 weeks post intervention)
研究者
Dr Deshik Nekkalapudi
AIIMS Bhubaneswar