Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- WOMAC pain (WP)score
研究概览
简要总结
Previous studies have indicated that patient expectations, beliefs and preferences may have an impact on treatment outcomes. The KIVIS study was primarily designed to compare two effective treatments for knee osteoarthritis (tidal irrigation (medical washout of the knee) or intra-articular corticosteroid injection). At study entry any preference expressed by the patient for each of the treatment interventions was recorded. This study assessed the effects of two treatments given at a single time-point and hence the effects of patient preference could be assessed independently of any compliance issues.
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 (Care Provider)
入排标准
- 年龄范围
- 40 Years 至 90 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 90 years old
排除标准
- •Symptomatic hip OA
- •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
- •Inability to provide informed consent
研究组 & 干预措施
TI of the knee
干预措施: TI of the knee (Procedure)
Intra-articular CSI
干预措施: Intra-articular CSI (Procedure)
结局指标
主要结局
WOMAC pain (WP)score
时间窗: Weeks 26
Visual Analogue Scale
时间窗: Weeks 26
Visual Analogue Scale
时间窗: Weeks 0
WOMAC pain (WP)score
时间窗: Weeks 2
WOMAC pain (WP)score
时间窗: Weeks 4
WOMAC pain (WP)score
时间窗: Weeks 12
WOMAC pain (WP)score
时间窗: Weeks 0
Visual Analogue Scale
时间窗: Weeks 2
Visual Analogue Scale
时间窗: Weeks 4
Visual Analogue Scale
时间窗: Weeks 12
次要结局
- Overall assessment of the impact of the procedure by the patient (five point scale) (PA)(Weeks 0,2,4,12,26)
- Analgesic intake(Weeks 0,2,4,12,26)
- Time to walk fifty metre(Weeks 0,2,4,12,26)
- Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA)(Weeks 0,2,4,12,26)
- WOMAC physical function score (WF)(Weeks 0,2,4,12,26)
- Side effects of the procedure(Weeks 0,2,4,12,26)