Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：TI of the knee
|
This was done as a day case procedure under local anaesthetic. The medial patello-femoral approach was used. After full aseptic preparation, the skin and soft tissues were infiltrated with 5e10 ml of 1% lignocaine. The joint was then instilled with a further 10 ml of 1% lignocaine. After an initial puncture using a scalpel, a 3.2 mm diameter wrist arthroscope was advanced into the joint cavity. Up to 1 l of 0.9% normal saline was then irrigated through the joint: saline was run into the joint until fully distended and then allowed to flow out of the joint in a cyclical method until the aspirated fluid runs clear for at least three successive cycles. |
|
有源比较器：Intra-articular CSI
|
After full aseptic preparation, 40 mg triamcinolone acetonide and 2 ml 1% lignocaine were injected into the joint cavity using the medial patello-femoral approach via a 21-gauge needle.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
WOMAC pain (WP)score
大体时间：Weeks 0
|
Weeks 0
|
|
Visual Analogue Scale
大体时间：Weeks 0
|
Weeks 0
|
|
WOMAC pain (WP)score
大体时间：Weeks 2
|
Weeks 2
|
|
WOMAC pain (WP)score
大体时间：Weeks 4
|
Weeks 4
|
|
WOMAC pain (WP)score
大体时间：Weeks 12
|
Weeks 12
|
|
WOMAC pain (WP)score
大体时间：Weeks 26
|
Weeks 26
|
|
Visual Analogue Scale
大体时间：Weeks 2
|
Weeks 2
|
|
Visual Analogue Scale
大体时间：Weeks 4
|
Weeks 4
|
|
Visual Analogue Scale
大体时间：Weeks 12
|
Weeks 12
|
|
Visual Analogue Scale
大体时间：Weeks 26
|
Weeks 26
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
WOMAC physical function score (WF)
大体时间：Weeks 0,2,4,12,26
|
Weeks 0,2,4,12,26
|
|
Overall assessment of the impact of the procedure by the patient (five point scale) (PA)
大体时间：Weeks 0,2,4,12,26
|
Weeks 0,2,4,12,26
|
|
Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA)
大体时间：Weeks 0,2,4,12,26
|
Weeks 0,2,4,12,26
|
|
Time to walk fifty metre
大体时间：Weeks 0,2,4,12,26
|
Weeks 0,2,4,12,26
|
|
Analgesic intake
大体时间：Weeks 0,2,4,12,26
|
Weeks 0,2,4,12,26
|
|
Side effects of the procedure
大体时间：Weeks 0,2,4,12,26
|
Weeks 0,2,4,12,26
|
合作者和调查者
调查人员
- 首席研究员：Nigel K Arden、MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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