Ultra Sound Guided Injection of Platelet Rich Plasma Versus Steroid for Sacroiliac Joint Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- visual analog score
研究概览
简要总结
Comparison between the effect of steroids and platelet-rich plasma on low back pain after ultrasound-guided sacroiliac injection to determine any is more effective and of long duration
详细描述
A prospective randomized controlled study was conducted at the department of anesthesiology Mansoura University Hospital during the period from December 2017 to January 2019 on fifty ASA I-III adult patients, of both sex after approval of IRB (Institutional Review Board) ID number MS17.10.03 & IRB date 12-11-2017. The patients were randomly allocated into two groups each of 25 patients according to computer-generated random number codes that were placed in sealed envelopes, double blinded, with parallel-group comparison.
Steroid Group (S) (n. 25):- Patients were injected by 4 ml of sterile water containing the methylprednisolone Acetate (Depo-Medrol) per-kg calculated dose (0.5mg/kg up to a lean muscle body weight of 80kg in the painful sacroiliac joint).
Platelet rich plasma Group (P) (n. 25):-Patients received fixed volume of 4 ml platelet-rich plasma in the inflamed painful sacroiliac joint.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex.
- •ASA I&III.
- •Age between 18 - 70 years.
- •Chronic lower back pain of sacroiliac origin.
- •Anatomy of the joint can identified by the ultrasonography. Exclusion criteria
- •Patients with contraindications to sacroiliac injection.
- •Patients known to be allergic to platelet rich plasma or local anesthetics.
- •History of immune suppression or immune compromised diseases
- •Patient below age of 18 as the joint will undergo normal physiological changes.
- •Patient over 70 years.
- •Sacroiliac pain of multiple sources.
- •Preoperative shivering or fever (>38oc).
- •Hepatic, renal and heart failure patients.
- •Patients on; anticoagulants, antiplatelet, and with INR≥1.
- •Exclude corticosteroid injection in the sacroiliac joint at the last three months.
- •Patient refusal.
排除标准
- 未提供
结局指标
主要结局
visual analog score
时间窗: Basal and after 6 months
To evaluate the changes in visual analogue score over a 6-month follow-up period after intra-articular injection and compare these changes among the studied groups.
次要结局
未报告次要终点