Comparison between ultrasound-guided injection of triamcinolone in sacroiliac joints and oral Etoricoxib in patients with axial spondyloarthritis: a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Decrease of spinal pain score (VAS 0-10 scale) at 12 weeks
研究概览
简要总结
Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as first-line treatment, followed by biologic disease-modifying antirheumatic drugs (bDMARDs). However, in some patients NSAID is contraindicated, e.g., patients with renal or hepatic dysfunction. Furthermore, some patients may not tolerate NSAID. For such patients ultrasound guided steroid injections in the sacroiliac (S.I) joints may give pain relief and abate inflammation. However, there is paucity of good quality data on efficacy of steroid injection in S.I. joint.
In this open label randomised trial we would like to investigate the comparative efficacy and safety between ultrasound guided Triamcenolone acetonide injection in S.I. joint and oral etoricoxib in axial spondyloarthritis patients.
Patients with Active axial spondylosrthritis defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4 or ASDAS ≥ 2.1, will be randomized in 1:1 ratio, using an online random number generator, in two arms. In the first arm, patients will receive ultrasound guided Triamcenolone acetonide injection in S.I. joints (single intervention) and in the other arm patients will receive oral etoricoxib for 12 weeks and they will be followed up to 12 weeks.
Primary outcome of this study is decrease of spinal pain score (VAS 0-10 scale) at 12 weeks, and the secondary outcomes areASDAS (Ankylosing Spondylitis Disease Activity Score) improvement, Bath ankylosing spondylitis disease activity index (BASDAI) 50 response, reduction in CRP levels in blood, NSAID index and adverse effects at 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients ≥ 18 years of age ii.
- •Fulfilling the ASAS classification criteria of Axial Spondyloarthritis
- •Active disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4, or ASDAS ≥ 2.1.
排除标准
- •Bony ankylosis of sacroiliac joint.
- •Grade 4 sacroilitis according to the modified New York criteria
- •Patients with only peripheral spondyloarthropathy
- •Predominantly Psoriatic arthritis
- •Predominantly Enteropathic arthritis
- •Patients on biologics and JAK inhibitors
- •Allergy to etoricoxib
- •Contraindication to NSAIDs
- •Pregnancy or lactation at the time of study entry
- •Infective sacroiliitis
- •History of corticosteroid injection in the sacroiliac joint within six months before study entry
- •Malignancy.
结局指标
主要结局
Decrease of spinal pain score (VAS 0-10 scale) at 12 weeks
时间窗: 12 weeks
次要结局
- ASDAS (Ankylosing Spondylitis Disease Activity Score) improvement(12 weeks)
- Bath ankylosing spondylitis disease activity index (BASDAI) 50 response(12 weeks)
- Reduction in CRP levels in blood at 12 weeks(12 weeks)
- NSAID index at 12 weeks(12 weeks)
- Any adverse effect in both the arms(12 weeks)
研究者
Dr. Shyamashis Das
Institute of Neurosciences Kolkata