To assess the effectiveness of Ultrasound guided genicular nerve block using 0.5% Bupivacaine in comparison with Ultrasound guided intra articular injection of 40mg Depo-Medrol in the management of chronic osteoarthritis knee pain-Double blinded randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean change in knee pain assessed by Visual Analog Scale
研究概览
简要总结
Osteoarthritis is an activedegenerative process involving cartilage destruction, subchondral remodellingand formation of osteophytes. The most common symptom in patients with OA kneeis mechanical knee pain. Exercise programme and jointprotection techniques are recommended in all guidelines to manageosteoarthritis knee. Pain very often results in poor compliance for exercises.GNB for pain relief can improve compliance to exercise programme.
The objective of this study is toassess the mean change in knee joint pain as measured by VAS score (0-100mm) onreceiving genicular nerve block with 2ml of 0.5% bupivacaine tosuperomedial(SMGN), superolateral(SLGN) and inferomedial genicularnerves(IMGN), when compared to intra articular injection of 40mg of Depo-Medrolin those with chronic osteoarthritis knee pain. Patients with more than 3months of pain will be recruited in this study. Participants will be randomized by blockmethod. Opaque envelopes will be used to conceal allocation of patients to thecontrol and interventional group. Intervention group will receive genicular nerveblock with 2 ml of 0.5%bupivacaine to SMGN, SLGN, IMGN along with standardizedexercise programme and control group will receive intra articular injectionwith 40mg of Depo-Medrol in knee joint along with standardized exerciseprogramme. Pre and post procedure VAS and LFI will be documented in 1stweek and then at 4 weeks and 12 weeks by telephonic assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Chronic osteoarthritis knee with more than 3 months of pain with pain scored by visual analog scale more than or equal to 40mm Radiological osteoarthritis grade greater than Kellegren Lawrence grade 2 Refractory knee osteoarthritis pain not alleviated with first line of treatment Well controlled diabetes No signs of active infection at injection site.
排除标准
- •Patients who underwent prior knee surgery or surgery scheduled in the next 3 months Patients with severe knee joint instability Patients with serious neurological or psychiatric illness Those received steroid or hyaluronic acid injection therapy in last 3 months Those who on anticoagulant medication use and those with severe bleeding diathesis Patients with hypersensitivity to local anaesthetics or steroids.
结局指标
主要结局
Mean change in knee pain assessed by Visual Analog Scale
时间窗: At 1,4 and 12 weeks
次要结局
- Mean change in Lequesne Functional Index(Incidence of adverse events)