CTRI/2020/07/026854尚未招募1 期
A comparative study between the clinical effect of Ultrasound versus Fluoroscopy guided Sacroiliac Joint injection in Spondyloarthropathy.
R G Kar Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年7月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- 1.Severity of sacroiliac joint pain - measured by NRS (Numeric Rating Scale) [0-10]
研究概览
简要总结
This study is a randomized, double blinded, parallel group, single centered interventional trial comparing the clinical effect of ultrasound and fluoroscopy guided injection ofcorticosteroid in sacroiliac joint in terms of pain reduction and improvement ofdisability arising from lower back pain in patients of spondyloarthropathy. This study will be conducted in only one center (in India). The primary outcome measurements are change of severity of pain measured by using the NRS score (0-10) and disability due to lower back pain by Oswestrydisability index in baseline (visit 0), at 1 week (visit 1), 4 weeks (visit 2), 12 weeks (visit3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed case of seronegative Spondyloarthropathy by ASAS criteria.
- •Pain primarily experienced between the upper level of the iliac crests and the gluteal fold.
- •Active sacroilitis clinically (positive finding of at least 3 of 6 following tests for SIJ pain) i.
- •Distraction or “Gapping†ii.
- •FABER/Patrick’s Test iii.
- •Thigh Thrust or Posterior Pelvic Pain Provocational Test iv.
- •Gaenslen’s Test v.
- •Sacroiliac Joint Compression Test vi.
- •Sacral Thrust or Yeoman’s Test.
- •Poorly controlled by conservative treatment for 1 month by means of both pharmacological and non-pharmacological therapy.
- •Age between 18-45 years.
- •Oswestry disability index > 40%
- •Reduction of pain intensity by > 75% following a diagnostic injection.
- •Unilateral sacroilitis.
排除标准
- •Severe peripheral arthritis with hip involvement.
- •Clinical findings and imaging studies suggest other obvious cause of the pain (e.g., central spinal stenosis with neurogenic claudication/myelopathy, foraminal stenosis or disc herniation with concordant radicular pain/radiculopathy, pyriformis syndrome, infection, tumour, fracture, pain related to spinal instrumentation).
- •Degenerative sacroiliac joint or complete ankylosis of sacroiliac joint (Grade IV).
- •Patient assume prone lying position to be difficult.
- •Allergy to lignocaine, contrast dye.
- •Presence of coagulation disorder or receiving anti-coagulant therapy.
- •With other systemic disorders or active infection or other contraindications for corticosteroid injection.
- •Unwilling patient.
- •Patient unable to come to hospital for subsequent visits for follow-up.
- •Has psychiatric disorder.
- •H/o prior injection in SIJ within 2 months.
结局指标
主要结局
1.Severity of sacroiliac joint pain - measured by NRS (Numeric Rating Scale) [0-10]
时间窗: Baseline | 1 Week | 4 Weeks | 12 Weeks
次要结局
- Disability due to low back pain - measured by Oswestry disability index(Baseline)
研究者
研究点 (1)
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