Hip Denervation in Juvenile Idiopathic Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in visual analogue scale
研究概览
简要总结
Patients having juvenile idiopathic arthritis (according to ILAR criteria) with hip arthritis were divided into 3 groups. Group 1 received hip denervation and group 2 controlled and received a subcutaneous injection of saline, and group 3 received intra-articular triamcinolone. Outcome measures included pain, tenderness, range of motion, SOLAR, HARISS score. These outcomes were measured at baseline, 2 weeks, and 16 weeks
详细描述
The aim of the study is to test the effect of denervation of the active hip in JIA and compare it with a placebo without changing systemic treatment during the study. Outcome measures included pain, range of motion, SOLAR score, and Harris functional score.
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
- Double (Participant, Investigator)
盲法说明
double-blinded
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with JIA with unilateral hip arthritis
排除标准
- •hip involvement due to other causes including
- •septic arthritis
- •other connective tissue diseases
- •Avascular necrosis
研究组 & 干预措施
Hip denervation group
This group will receive Lidocaine 2% block of the femoral and obturator genicular branches.
干预措施: Lidocaine (Drug)
control group
this group will receive saline injection subcutaneously at the same places.
干预措施: Placebo (Drug)
Steroid
This group with receiving an intra-articular injection of 80mg triamcinolone
干预措施: Steroid (Drug)
结局指标
主要结局
Change in visual analogue scale
时间窗: Baseline, 2 weeks and 16 weeks
a scale from 0-100 will be used 0 means no pain 100 means the maximum pain
Change in range of motion
时间窗: Baseline, 2 weeks and 16 weeks
flexion, internal rotation, external rotation range will be calculated
Change in Harris functional score
时间窗: Baseline, 2 weeks and 16 weeks
100 means best results and 0 means worst results
semiquantitative tenderness score
时间窗: Baseline, 2 weeks and 16 weeks
0 means no tenderness and 3 means maximum tenderness
Change in SOLAR score
时间窗: Baseline, 2 weeks and 16 weeks
GSUS. 0 means the least synovitis and the maximum, PDUS, o means no PD and 3 the maximum
次要结局
未报告次要终点
研究者
Ahmed Mahrous
Associate professor
Sohag University