Guide-Free Sacroiliac Injection in Spondyloarthropathies
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Refractory inflammatory sacroiliac pain
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of guide-free sacroiliac joint (SIJ) injection in refractory sacroiliac pain due to spondyloarthropathies.
详细描述
A 20 weeks open-label clinical trial study of 35 patients, with different subtypes of spondyloarthropathies, is conducted In spondyloarthropathy's patients with refractory inflammatory buttock pain (fulfilling inclusion criteria), we performed outpatient guide-free sacroiliac injection of triamcinolone acetonide 40 mg in each joint. Patient (pain, stiffness, sleep disturbance) and Clinician assessments (sacroiliac tenderness, Finger to floor and Schober tests ) are recorded at baseline and every 4 weeks until the end of the study. MRI scoring of sacroiliac joint is recorded according to the Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) index for scoring inflammatory lesions in the sacroiliac joints, at baseline and in the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients had to fulfill the European Spondylarthropathy Study Group criteria for SpA.
- •The presence of inflammatory buttock pain for at least 4 months (typical night pain and morning stiffness) despite of receiving NSAIDs, corticosteroid and DMARDs (Disease Modifying Anti-Rheumatic Drugs) such as: methotrexate, sulfasalazin and azathioprine.
- •Tenderness over sacroiliac joint: pain over the sacroiliac sulcus with 4-5 kg/cm2 direct pressure.
排除标准
- •Spinal infections (such as Brucellosis).
- •Local infection in the site of injection.
- •Sacroiliac ankylosis based on pelvic X-Ray (sacroilitis grade IV).
- •Patients who had received anti TNF, corticosteroid pulse or an investigational drugs during 4 months before.
结局指标
主要结局
Refractory inflammatory sacroiliac pain
时间窗: 8 months
次要结局
- ESR, CRP(8 months)
- Patient's assessment of: pain, sleep disturbance, morning stiffness(8 months)
- Clinician assessment of: SIJ pain, change of finger to floor (cm) and Schober tests (mm)(8 months)
- MRI SIJ inflammatory scoring(8 months)