Ultrasound for Sacroiliac Joint Injection: Evaluation of the Efficacy of Two Image-Guided Techniques for Sacroiliac Joint Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of needle placement into SIJ
研究概览
简要总结
This project involves the assessment of the efficacy of two different image guided techniques in patients with low back pain due to arthritis of the sacroiliac joint (SIJ). Intra-articular injection of local anesthetics and steroids is performed to relieve pain originating from the SIJ. Fluoroscopy has been used traditionally for image guidance for this procedure but there is a growing interest in use of ultrasound (US) for this procedure. US avoids radiation exposure to the patient and the health care team (HCT) and is less expensive. We aim to compare procedural efficacy related outcomes for SIJ injections performed using these image-guided modalities.
详细描述
The study is a prospective, randomized trial. Patients with low back pain which is diagnosed secondary to SIJ disease will be identified beforehand in clinic and offered a therapeutic joint injection. Informed consent will be obtained. Patients will be randomized for SIJ block with 3 mL of 0.25% bupivacaine with 1:200,000 epinephrine and 40 mg depomedrol using guidance with ultrasound or fluoroscopy. In both groups, confirmation of needle placement will be obtained using contrast injection imaging before the injection is performed. Record will be made of the number of times the needle is correctly placed into the articular space, as well as the number of attempts to do so. The final position of the needle will be recorded. Pain scores will be assessed before the procedure, as well as post-procedure at 24 and 72 hours, as well as 1 week, 1 month, and 3 months. Patients will keep a pain diary and will be followed up at 3 months time in clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspicion of SIJ disease on history: pain below the lumbo-sacral junction; pain with full weight-bearing on one leg; pain worse going down hills or inclines; very low back pain associated with groin pain and absence of lumbar symptoms
- •Two positive responses to the following maneuver: FABER (flexion abduction and external rotation of hip), POSH (posterior shear test), REAB (resisted abduction)
- •Baseline NRS pain score > or = to 4
- •Refractory to oral analgesic therapy
排除标准
- •ongoing litigation issues related to the patient's pain
- •pregnancy
- •allergy to steroids or local anesthetics
- •multiple comorbidities
- •BMI > 35
研究组 & 干预措施
Ultrasound Guided SIJ Injection
Needle placement will be performed under US guidance. Fluoroscopy will be used to confirm needle placement prior to medication injection.
干预措施: Sacroiliac Joint Injection (Procedure)
Xray Guided SIJ Injection
Needle placement will be performed under fluoroscopy.
干预措施: Sacroiliac Joint Injection (Procedure)
结局指标
主要结局
Incidence of needle placement into SIJ
时间窗: Assessed at time of injection
Pain - Numeric Rating Scale Score at 1 month
时间窗: One month from time of injection
次要结局
- Patient Satisfaction(1 month from time of injection)
- Number of needle readjustments(Measured at time of procedure)
- Average daily consumption of opioids at 1 month(1 month from injection)
- Patient discomfort with procedure(Measured at time of procedure)
- Improvement of functional ability at 1 month(1 month from time of injection)