Randomized, Controlled, Double-blind, Comparative-effectiveness Study Comparing Fluoroscopically-guided and Landmark-guided Sacroiliac Joint Injections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 4
- 主要终点
- Average Back Pain at 1 Month Measured Using the Numeric Pain Scale
研究概览
简要总结
In this study, the investigators are attempting to determine whether intra- or extra-articular injections are more effective; the relative prevalence rate of intra-articular and extra-articular SI joint pain; and the accuracy of extra-articular injections using fluoroscopy as the reference standard. 124 consecutive patients with mechanical low back pain below L5, tenderness overlying the SI joint(s) and at least 3 positive provocative maneuvers will be randomized to receive SI joint injections by 2 different approaches.
Group 1 will receive fluoroscopically-guided injections into the joint. Group 2 will receive landmark-guided injections into the tender area around the joint. In order to determine whether the injection in group 2 was intra-articular or extra-articular, an x-ray will be done after the injection to ascertain the location of contrast spread. The primary outcome measure will be pain relief at 1-month. Patients who obtain benefit at 1-month will be followed at 3-months, while those who fail to obtain benefit will exit the study to receive alternative care.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low back pain principally below the L5 vertebra;
- •Three out of 6 positive SI joint provocative maneuvers;
- •Agreed to undergo SI joint injection for diagnostic/ therapeutic purposes;
- •Average pain score > 3/10 over the past week;
- •Pain duration > 6 weeks;
排除标准
- •Previous SI joint injection;
- •Leg pain > back pain or lower leg pain > upper leg pain
- •Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);
- •Untreated coagulopathy;
- •Allergy to contrast dye or bupivacaine;
- •Pain > 20 years in duration;
- •Poorly controlled psychiatric (e.g. PTSD) or medical (congestive heart failure) condition
研究组 & 干预措施
X-ray guided intra-articular injection
Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine into the SI (sacroiliac joint) cavity under fluoroscopic guidance
干预措施: X-ray SI joint steroid injection (Procedure)
Landmark-guided SI joint injection
Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine at the point of maximal tenderness (3 ml)
干预措施: Landmark-guided SI steroid injection (Procedure)
结局指标
主要结局
Average Back Pain at 1 Month Measured Using the Numeric Pain Scale
时间窗: 1 month from the start of treatment
This outcome measure compares the average back pain at baseline to the average back pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.
次要结局
- Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index(1 month after the start of treatment)
- Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale(1 month from the start of treatment)
- Average Back Pain at 3 Months Measured Using the Numeric Pain Scale(3 months from the start of treatment)
- Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale(3 months after the start of treatment)
- Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index(3 months after the start of treatment)
- Patient satisfaction of the procedure at 1 month measured using the Likert Scale(1 month)
- Patient satisfaction of the procedure at 3 months measured using the Likert Scale(3 months)
- Positive categorical outcome(3 months)
- Positive diagnostic blocks(6 hours)
- Positive categorical outcome(1 month)