NCT01874574已完成4 期
Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee: A Prospective, Double-blind Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- WOMAC Score
研究概览
简要总结
Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients.
详细描述
Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients up to 6 months.
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)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of knee OA
- •Knee pain for most days of the prior month
- •Radiographic evidence consistent with knee OA
- •Aged between 40 and 80 years old
排除标准
- •Lumbar spondylosis
- •Gross deformity of the knee
- •Co-existent inflammatory or crystal arthritis
- •Prior knee surgery
- •Injury to the knee in the preceding 6 months
- •Any intra-articular injection in the preceding 3 months
- •Pregnant or Lactating
- •Current infection in the affected knee
- •Inability to provide informed consent
研究组 & 干预措施
Single shot Hylan G-F 20 (Synvisc)
Experimental
Intra-articular injection of the Single shot 6 mL of Hylan G-F 20 (Synvisc)
干预措施: Hylan G-F 20 (Drug)
Corticosteroid (Triamcinolone acetonide)
Active Comparator
Intra-articular injection of 1 mL of 40 mg Triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline injected at the knee by single shot
干预措施: Corticosteroid (Drug)
结局指标
主要结局
WOMAC Score
时间窗: 6 months
Change from Baseline in WOMAC score at 6 months
次要结局
- Visual Analogue Scale(VAS)(6 months)
研究者
Phonthakorn Panichkul
Dr. Phonthakorn Panichkul
Thammasat University
研究点 (1)
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