Genicular Nerve Block in Juvenile Idiopathic Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in visual analogue scale over time
研究概览
简要总结
N=104 juvenile idiopathic arthritis patients diagnosed after ILAR criteria with unilateral persistent knee arthritis. They will be randomly assigned into two groups; group 1 will receive genicular nerve block, group 2 intra-articular triamcinolone. Both groups will be examined by SOLAR ultrasound scoring system, Visual analogue scale and Lysholm score at 0, 2 and 12 weeks. A semi-quantitative score will be 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)
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •juvenile idiopathic arthritis with persistent knee arthritis
- •age below 16
排除标准
- •severe knee osteoarthritis
- •peripheral neuropathy,
- •psoriatic arthritis,
- •those under anticoagulant therapy, skin infection,
- •prior knee injection in the last 3 months3
- •those who have an allergy to Bupivacaine
研究组 & 干预措施
Active genicular nerve block group
group 1 will receive genicular nerve block. The injection and US examination will be done by two experienced sonographers. They were blinded to clinical data. Patients will also be blinded for the injected substance. Each point will be injected with 2 ml of Lidocaine hydrochloride 2 % (Xylocaine, Astrazeneca). The injection will be done using the 3 point technique (superior medial, superior lateral, and inferior medial genicular nerves).
干预措施: genicular nerve block (Drug)
intra-articular steroid injection group
while group 2 received intra-articular triamcinolone under ultrasound guidance and through injecting the supra-patellar bursa.
干预措施: intra-articular steroid injection (Drug)
结局指标
主要结局
Change in visual analogue scale over time
时间窗: Baseline, 2 weeks and 12 weeks
a graded score for pain evaluation filled by the patient graded from 0 to 10
Change in Lysholm score over time
时间窗: Baseline, 2 weeks and 12 weeks
a score to assess knee function. This questionnaire has 8 domains. A score between 95 and 100 means excellent functional performance, good 84-94, fair 65-83 and poor \<64
Change in semiquantitative score for swelling and tenderness over time
时间窗: Baseline, 2 weeks and 12 weeks
A score graded from 0 to 3; score 0 means no swelling nor tenderness and 3 means maximum swelling and tenderness
Change in SOLAR score over time
时间窗: Baseline, 2 weeks and 12 weeks
score to assess ultrasound parameters of the knee including power doppler and grey scale measures
次要结局
未报告次要终点
研究者
Ahmed Mahrous
Associate professor
Sohag University