Genicular Nerve Block in Rheumatoid Arthritis: a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- SOLAR score for inflammation changes by ultrasound
研究概览
简要总结
N=64 RA patients either early or established disease diagnosed after ACR/EULAR criteria 2010 with unilateral persistent knee arthritis. They were randomly assigned into two groups; group 1 received genicular nerve block, group 2 intra-articular triamcinolone. Both groups were examined by SOLAR scoring system, Visual analogue scale (VAS) and Lysholm score at 0, 2 and 12 weeks. A semi-quantitative score was used to assess tenderness and swelling at the same intervals.
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)
盲法说明
The participants does not know the nature of the injected material. Syringe was colored to cover it
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
- •RA patients
- •Age > 18
- •unilateral persistent knee arthritis
排除标准
- •Participants with severe knee osteoarthritis
- •peripheral neuropathy
- •psoriatic arthritis
- •skin infection
- •or those who have allergy for Bupivacaine
研究组 & 干预措施
Nerve block group
3 point genicular nerve block under ultrasound guidance. half ml of Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) was injected in each point.
干预措施: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) (Drug)
Nerve block group
3 point genicular nerve block under ultrasound guidance. half ml of Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) was injected in each point.
干预措施: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) (Drug)
intra-articular steroid injection
1 mL of triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) was injected intraarticular.
干预措施: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) (Drug)
intra-articular steroid injection
1 mL of triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) was injected intraarticular.
干预措施: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) (Drug)
结局指标
主要结局
SOLAR score for inflammation changes by ultrasound
时间窗: at 0 time after 2 weeks and after 12 weeks
0 means normal and 27 means the worst possible inflammation
Pain changes by VAS
时间窗: at 0 time after 2 weeks and after 12 weeks
0 means no pain and 10 means the most severe pain
Lysholm score for change in knee function
时间窗: at 0 time after 2 weeks and after 12 weeks
100 means the best performance and 0 means complete loss of function
次要结局
未报告次要终点
研究者
Ahmed Mahrous
Associate professor
Sohag University