Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Assessment of pain intensity using visual analog scale (VAS)
研究概览
简要总结
Comparison between ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis; a Randomized Double Blinded Controlled Study
详细描述
The sacroiliac joints (SIJ) are the largest axial joints in the human body. By aging, osteoarthritic degeneration occurs to SIJ. SIJ dysfunction typically results from abnormal motion and malalignment of the joint (1).
SIJ pain is one of the differential diagnoses of low back pain. Approximately, 10-25% of these patients will have SIJ dysfunction which should be considered clinically (1, 2). This pain affects physical, psychological and social aspects of the person reducing the work performance. It imposes a huge burden on nations globally (3, 4).
SIJ pain can be a difficult condition to treat and a multidisciplinary approach to treatment including multimodal medical, psychological, physical, and interventional approach is recommended (5).
Corticosteroids are a very magic therapy since their first use and they offer anti-inflammatory mechanisms to reduce low back pain and joint pain. SIJ steroid injections are typically performed for SIJ pain related to osteoarthritis, ligamentous sprain and sacroiliitis associated with inflammatory spondyloarthropathies (5, 6).
Intra-articular steroid injections have intermediate-term benefits, in which more than half of the patients had positive responses to treatment in a 6-month follow-up (7, 8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •One hundred and five patients, ASA physical status I - III, age 21 - 65 years, diagnosed with sacroiliitis.
排除标准
- •• Patient refusal
- •Psychological disturbance.
- •Local skin infection at the site of injection.
- •Ozone allergy
- •Coagulation disorders.
- •Chronic opioid use.
- •Sacroiliitis associated with disk pathology.
- •Severe ankylosing spondylitis.
- •History of corticosteroid injection within last three months.
- •Uncontrolled concomitant medical condition.
- •Severe arrhythmia, hypertensive crisis and other cardiovascular diseases.
- •Pregnant women.
- •Bowel inflammatory disease.
- •Psoriasis
研究组 & 干预措施
Group 1
40 mg methylprednisolone acetate and 1 mL lidocaine will be injected in sacroiliac joint in first week by ultrasound. While the second and third injections in the second and third weeks will be done by sham injection
干预措施: ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis (Procedure)
Group 1
40 mg methylprednisolone acetate and 1 mL lidocaine will be injected in sacroiliac joint in first week by ultrasound. While the second and third injections in the second and third weeks will be done by sham injection
干预措施: methylprednisolone acetate and lidocaine (Drug)
Group 2
3 mL PRP and 1 mL lidocaine will be injected in sacroiliac joint by ultrasound once/week for 3 weeks
干预措施: ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis (Procedure)
Group 2
3 mL PRP and 1 mL lidocaine will be injected in sacroiliac joint by ultrasound once/week for 3 weeks
干预措施: PRP and lidocaine (Drug)
Group 3
10 ml of medical ozone of 20 μg/ml will be injected in sacroiliac joint by ultrasound once/week for 3 weeks
干预措施: ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis (Procedure)
Group 3
10 ml of medical ozone of 20 μg/ml will be injected in sacroiliac joint by ultrasound once/week for 3 weeks
干预措施: medical ozone (Drug)
结局指标
主要结局
Assessment of pain intensity using visual analog scale (VAS)
时间窗: 2 years
Primary outcome
次要结局
未报告次要终点
研究者
Ahmed Abdelnaby Ibrahim
Ahmed elmaghrapy
Tanta University