CTRI/2018/09/015662招募中4 期
A Randomized Controlled Trial to Compare the Effect of Intra -Articular Adalimumab Versus Intra - Articular Hyaluronic Acid in Primary Osteoarthritis of the Knee
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- To Compare the Effect of a Single Ultrasound - Guided Intra - Articular Injection of Adalirec) mumab with a Single Ultrasound Guided Intra -Articular Injection of Hyaluronic Acid on Pain using VAS
研究概览
简要总结
Although an Intra - Articular Injection of Hyaluronic Acid is commonly used for the treatment of Osteoarthritis of the knee, Adalimumab owing to its ability to downregulate the expression of pro - inflammatory cytokines and rate of synthesis of metalloproteinases has shown good results in inflammatory conditions. However, few attempts have been made to improve the treatment of patients with Knee OA by Intra -Articular Adalimumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of Knee OA as per 2016 ACR Revised Criteria for Early Diagnosis of Knee OA
- •Unilateral Primary OA of Grade 2 or Grade 3 on Kellgren Lawrence Scale
- •Pain Score >4 on VAS( Visual Analogue Scale) within the past one month
- •Lack of efficacy of previous treatment with Diclofenac at a dose of 75mg/day.
排除标准
- •Previous treatment with TNF inhibitors
- •Previous Intra.
- •Articular treatment within 3 months 3.Previous Knee Surgery
- •History of tumor or serious Infection
- •Cognitive Impairment
- •Previous history of trauma to the knee.
结局指标
主要结局
To Compare the Effect of a Single Ultrasound - Guided Intra - Articular Injection of Adalirec) mumab with a Single Ultrasound Guided Intra -Articular Injection of Hyaluronic Acid on Pain using VAS
时间窗: 4 weeks and 12 weeks post injection
次要结局
- To Compare the Effect of a Single Ultrasound - Guided Intra - Articular Injection of Adalimumab with a Single Ultrasound Guided Intra -Articular Injection of Hyaluronic Acid on Pain, other Symptoms, Function in Daily Living(ADL), Function in Sport and Recreation(Sport/Rec) using KOOS Scale(4 weeks and 12 weeks post injection)
研究者
研究点 (1)
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