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临床试验/NCT02632565
NCT02632565已完成4 期

Intra-Articular 0.5 % Lidocaine Injection Under Ultrasound Guidance in Chronic Knee Pain Due To Osteoarthritis

H. Evren Eker0 个研究点目标入组 52 人开始时间: 2009年12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
入组人数
52
主要终点
Pain scores according to visual analog scale

研究概览

简要总结

In this study, investigators compared the efficacy of intra-articular 0.5% lidocaine and saline injection on pain, stiffness and physical function in patients with osteoarthritis.

详细描述

Patients with osteoarthritis were randomly allocated into two groups. Group I (n=26) received intra-articular injection of 7 mL 0.5% lidocaine and Group II (n=26) received 7 mL saline into painful knee for 3 times with one week intervals under USG guidance. VAS and WOMAC scale including pain, stiffness and physical function was used for the assessment of patients with osteoarthritis. Analgesic requirements were also recorded.

The primary outcome parameter of this study was the pain scores. The sample size for the primary variable was calculated based on a standard deviation of 20 mm estimated from a previous study. A power analysis with a type II error of 20% at a two-sided 5% significance level estimated 22 patients per group to be included. Investigators included 26 patients per groups for possible missing date. χ2 test for categorical data and independent samples t-test for the comparison of VAS and WOMAC scores between groups were used for statistical analysis.

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
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • knee pain for more than 25 of the past 30 days, morning stiffness or less than 30 minutes, crepitation in the knee
  • pain for more than 25 of the past 30 days and osteophytes on x-ray examination of the knees indicating knee OA

排除标准

  • the knees with a history of mechanical derangement, fibromyalgia, skin lesions and other risk factors of infection, therapy with anticoagulants and trauma/surgery

研究组 & 干预措施

intra-articular 0.5% lidocaine

Active Comparator

intra-articular 7 mL 0.5% lidocaine injection for 3 times with one week intervals

干预措施: Lidocaine (Drug)

intra-articular saline

Active Comparator

intra-articular 7 mL saline injection for 3 times with one week intervals

干预措施: Saline (Drug)

结局指标

主要结局

Pain scores according to visual analog scale

时间窗: 3 months after the treatment

次要结局

未报告次要终点

研究者

发起方
H. Evren Eker
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

H. Evren Eker

Ass Prof

Baskent University

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