Ultrasound Guided Epidural Block in Axial SPA Patient With Limited Spine Mobility: a Prospective Pilot Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- change in pain
研究概览
简要总结
Study Design: A randomized, prospective, pilot, controlled trial. Setting: Rheumatology and rehabilitation department Minia University and Sohag University Objectives: To evaluate the effectiveness of caudal epidural injections with triamcinolone and lidocaine in managing limited spine mobility in axial SPA.
Methods: Patients were randomly assigned to one of 2 groups, Group I patients received caudal epidural injections with 1% lidocaine hydrochloride (xylocaine AstraZeneca) 9 mL mixed with 1 mL of triamcinolone 40 milligrams (Kenacort Bristol Myers Squip), whereas Group II patients did not receive. Both groups were age and sex matched and both were under treatment with anti TNF and NSAIDs with or without sDMARDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •all participants fulfilled the ASAS criteria for axial SPA
- •all participants under treatment including bDMARDS and sDMARDs beside NSAIDs
排除标准
- •Naive patients not under treatment
- •limitation of spine flexion due to non inflammatory causes
研究组 & 干预措施
Epidural block
Group I patients received caudal epidural injections with 1% lidocaine hydrochloride (xylocaine Astra Zeneca) 9 mL mixed with 1 mL of triamcinolone 40 milligrams (Kenacort Bristol Myers Squip)
干预措施: Epidural block with lidocaine and triamcinilone (Drug)
结局指标
主要结局
change in pain
时间窗: Baseline, after 2 weeks and after 8 weeks
visual analogue scale for pain minimum score 0 maximum score 10
Change in functional ability of the patient
时间窗: Baseline, after 2 weeks and after 8 weeks
Bath Ankylosing Spondylitis Functional Index (BASFI) minimum score 0 maximum 100, Oswestry Disability Index (ODI) minimum 0 no disability, maximum 100 means complete disability
Change in spinal mobility
时间窗: Baseline, after 2 weeks and after 8 weeks
Bath AS Metrology Index (BASMI) minimum score 0 maximum 50, modified Schober test less than 5 cm yield means limited mobility, Lateral lumbar flexion more than 55 cm yield means limited lateral flexion
Change in ASDAS- CRP score
时间窗: Baseline, after 2 weeks and after 8 weeks
≥ 1.1 reduction in the initial score, less than 1.3 inactive disease, between 1.3 and 2.1 moderate, between 2.1-3.5 high disease activity, \> 3.5 very high disease activty
次要结局
未报告次要终点
研究者
Ahmed Mahrous
Associate professor
Sohag University