Intra-Articular 0.5 % Lidocaine Injection Under Ultrasound Guidance in Chronic Knee Pain Due To Osteoarthritis
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
- 是
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
intra-articular 7 mL 0.5% lidocaine injection for 3 times with one week intervals
干预措施: Lidocaine (Drug)
intra-articular saline
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
H. Evren Eker
Ass Prof
Baskent University
