NCT03047096Unknown1 期
Intra-Articular, Single-shot Injection of Hyaluronic Acid and Corticosteroids in Knee Osteoarthritis
Zhongda Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- VAS
研究概览
简要总结
The aim of present study is to to investigate whether the combined injection of HA and CS was superior than HA alone in the treatment of knee OA.
详细描述
Intra-articular injection of hyaluronic acid (HA) or corticosteroids (CS) has been widely used with debate on its efficacy in osteoarthritis (OA). The aim of present study is to to investigate whether the combined injection of HA and CS is superior than HA alone in the treatment of knee OA.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to radiographic findings, patients who are suffering from knee OA for over 3 months have to be stage II-IV according to the Kellgren-Lawrence (KL) grade by a senior radiologist. The diagnosis of symptomatic knee OA is based on American Rheumatism Association classification criteria for knee osteoarthritis.
排除标准
- •Exclusion criteria are the diagnosis of rheumatoid arthritis or other inflammatory OA, presence of trauma or pain-causing diseases, treatment with oral medications in recent 3 days, physiotherapy and intra-articular injection of HA or CS in the past 6 months. Participants who are allergic to any of the medications used in this study or diagnosed with current systemic infection are also excluded.
研究组 & 干预措施
HA & CS group
Experimental
hyaluronic acid and corticosteroids
干预措施: hyaluronic acid and corticosteroids (Drug)
HA group
Experimental
hyaluronic acid
干预措施: hyaluronic acid (Drug)
结局指标
主要结局
VAS
时间窗: 6 months
Visual analog scale
次要结局
- Knee flexion motion(6 months)
- WOMAC(6 months)
研究者
Dr. Shan-zheng Wang
Assitant secretory of Orthopaedics department
Zhongda Hospital
研究点 (1)
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