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临床试验/NCT02576249
NCT02576249已完成4 期

Does Anesthetic Contribute to Symptomatic Relief in Corticosteroid Injections for Knee Osteoarthritis? A Double-Blind Randomized Trial Comparing Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Ropivacaine and Methylprednisolone

Active Comparator

0.2% ropivacaine and methylprednisolone knee joint injection

干预措施: Ropivacaine (Drug)

Ropivacaine and Methylprednisolone

Active Comparator

0.2% ropivacaine and methylprednisolone knee joint injection

干预措施: Methylprednisolone (Drug)

Saline and Methylprednisolone

Experimental

0.9% normal saline and methylprednisolone knee joint injection

干预措施: Normal saline (Drug)

Saline and Methylprednisolone

Experimental

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob L. Sellon, M.D.

Assistant Professor of Physical Medicine and Rehabilitation

Mayo Clinic

研究点 (1)

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