Does Anesthetic Contribute to Symptomatic Relief in Corticosteroid Injections for Knee Osteoarthritis? A Double-Blind Randomized Trial Comparing Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale
研究概览
简要总结
Corticosteroid injections are commonly used for the symptomatic treatment of knee osteoarthritis. Common practice is to inject the joint with a combination of corticosteroid and local anesthetic, with the rationale of providing longer duration pain relief with the corticosteroid and immediate, though short duration relief with the anesthetic. However, multiple in vitro and animal studies have shown that local anesthetic may be harmful to chondrocytes. Despite this data, use of intra-articular anesthetic remains widespread. Many clinicians believe incorporating the anesthetic is important because it can provide immediate pain relief and facilitate patient confidence in the treatment program. However, there is no published data to validate this reasoning. Therefore, the anesthetic has unknown clinical benefit and may have adverse effects on articular cartilage. In light of this, the investigators question the routine use of anesthetics in joint injections. The purpose of this study is to compare the effects of knee joint injections using: 1) corticosteroid with local anesthetic versus 2) corticosteroid with normal saline.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ropivacaine and Methylprednisolone
0.2% ropivacaine and methylprednisolone knee joint injection
干预措施: Ropivacaine (Drug)
Ropivacaine and Methylprednisolone
0.2% ropivacaine and methylprednisolone knee joint injection
干预措施: Methylprednisolone (Drug)
Saline and Methylprednisolone
0.9% normal saline and methylprednisolone knee joint injection
干预措施: Normal saline (Drug)
Saline and Methylprednisolone
0.9% normal saline and methylprednisolone knee joint injection
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale
时间窗: 3 months after the injection
The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
次要结局
- Pain Scale Score(Pre-injection, immediately post-injection, 2 weeks, 3 months)
- Tegner Activity Level Scale(baseline (pre-injection), 2 weeks, 3 months)
研究者
Jacob L. Sellon, M.D.
Assistant Professor of Physical Medicine and Rehabilitation
Mayo Clinic
