Hip Denervation and Intra-articular Hydration in Damaged Hip in Axial Spondyloarthritis Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Harris functional hip score
研究概览
简要总结
Background: The hip joint is frequently affected in axial spondyloarthritis (SpA) of adults with destructive effects in untreated patients. About 35% of axial SpA patients had either unilateral or bilateral hip arthritis. Destruction is more common with early-onset, active disease, or enthesitis.
Objectives: The aim of this study is to evaluate the effect of hip denervation (HD) and intra-articular hydration (IAH) on pain, function score, hip mobility scores in a cohort of axial SpA patients with grade 3 and 4 hip BASRI scores.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or more
- •Axial; SpA fulfilled ASA criteria
- •BASRI score grade 3 or 4 for one hip at least
排除标准
- •patients younger than 18
- •Axial; SpA with normal hip or hip involvement less than 3 on BASRI score
研究组 & 干预措施
compined group
hip denervation and intra-articular hydration were conducted together in this group
干预措施: Combined group (Drug)
placebo group
5ml of normal; saline-injected subcutaneously
干预措施: Control group (Drug)
Hip denervatiopn
Hip denervation with lidocaine 2% to each genicular branch, 2ml at each point
干预措施: hip denervation (Drug)
Inra-articular hydration
10 ml of normal saline injected inside the hip under ultrasound guidance
干预措施: intra-articular hydration (Drug)
结局指标
主要结局
Change in Harris functional hip score
时间窗: Baseline, after 4 weeks and after 12 weeks
Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction. A total score of \<70 is considered a poor result; 70-80 is considered fair, 80-90 is good, and 90-100 is an excellent result
Change in range of motion of the hip
时间窗: Baseline, after 4 weeks and after 12 weeks
hip flexion, extension , internal; rotation , external; rotation , abduction , and adduction all were recopreded
Change in semiquantitative tenderness score
时间窗: Baseline, after 4 weeks and after 12 weeks
a score from 0-3, 90 means no tenderness and 3 means maximum tenderness
Change in visual analogue scale
时间窗: Baseline , after 4 weeks and after 12 weeks
0 means no pain, 100 means the highest degree of pain
次要结局
未报告次要终点
研究者
Ahmed Mahrous
Associate professor
Sohag University