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临床试验/NCT05219084
NCT05219084已完成3 期

Hip Denervation and Intra-articular Hydration in Damaged Hip in Axial Spondyloarthritis Patients

Sohag University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

hip denervation and intra-articular hydration were conducted together in this group

干预措施: Combined group (Drug)

placebo group

Placebo Comparator

5ml of normal; saline-injected subcutaneously

干预措施: Control group (Drug)

Hip denervatiopn

Active Comparator

Hip denervation with lidocaine 2% to each genicular branch, 2ml at each point

干预措施: hip denervation (Drug)

Inra-articular hydration

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mahrous

Associate professor

Sohag University

研究点 (1)

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