Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections
Randomized, Controlled, Double-blind, Comparative-effectiveness Study Comparing Fluoroscopically-guided and Landmark-guided Sacroiliac Joint Injections
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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San Diego、California、美国
- Naval Hospital-San Diego
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Maryland
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Baltimore、Maryland、美国、21205
- Johns Hopkins Hospital
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Rockville、Maryland、美国、20889
- Walter Reed National Military Medical Center
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Pennsylvania
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Hershey、Pennsylvania、美国、17033
- Penn State
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age > 18;
- 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;
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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
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Injection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance
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有源比较器:Landmark-guided SI joint injection
Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine at the point of maximal tenderness (3 ml)
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Injection of steroid into the joint area based on palpation.
The injection may be inside the joint (intra-articular) or outside the joint in the ligaments (extra-articular)
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Average Back Pain at 1 Month Measured Using the Numeric Pain Scale
大体时间:1 month from the start of treatment
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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.
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1 month from the start of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
使用 Oswestry 残疾指数在 1 个月时测量的与残疾相关的结果
大体时间:治疗开始后1个月
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使用 Oswestry 残疾指数测量的功能能力。
Oswestry 残疾指数的可能分数范围是 0-100。
0 等于没有残疾,100 是可能的最大残疾。
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治疗开始后1个月
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使用 Oswestry 残疾指数在 3 个月时测量的与残疾相关的结果
大体时间:治疗开始后 3 个月
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使用 Oswestry 残疾指数测量的功能能力。
Oswestry 残疾指数的可能分数范围是 0-100。
0 等于没有残疾,100 是可能的最大残疾。
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治疗开始后 3 个月
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Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale
大体时间:1 month from the start of treatment
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This outcome measure compares the worst back pain at baseline to the worst back pain at 1 months 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.
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1 month from the start of treatment
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Average Back Pain at 3 Months Measured Using the Numeric Pain Scale
大体时间:3 months from the start of treatment
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This outcome measure compares the average back pain at baseline to the average back pain at 3 months 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.
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3 months from the start of treatment
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Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale
大体时间:3 months after the start of treatment
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This outcome measure compares the worst back pain at baseline to the worst back pain at 3 months 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.
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3 months after the start of treatment
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Patient satisfaction of the procedure at 1 month measured using the Likert Scale
大体时间:1 month
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Patient satisfaction is measured at 1 month after the procedure using the Likert Scale.
The range of possible scores for the Likert Scale are 1-5.
I being very unsatisfied and 5 being very satisfied.
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1 month
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Patient satisfaction of the procedure at 3 months measured using the Likert Scale
大体时间:3 months
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Patient satisfaction is measured at 1 month after the procedure using the Likert Scale.
The range of possible scores for the Likert Scale are 1-5.
I being very unsatisfied and 5 being very satisfied.
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3 months
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Positive categorical outcome
大体时间:1 month
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Decrease in average back pain score at 1 month of greater or equal to 2 points coupled with a satisfaction score > 3 on a 1-5 scale
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1 month
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Positive categorical outcome
大体时间:3 months
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Decrease in average back pain score at 3 months of greater or equal to 2 points coupled with a satisfaction score > 3 on a 1-5 scale
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3 months
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Positive diagnostic blocks
大体时间:6 hours
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The percentage of participants who experience greater or equal to 50% pain relief based on their pain diary
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6 hours
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合作者和调查者
出版物和有用的链接
一般刊物
- Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148.
- Cohen SP, Bicket MC, Kurihara C, Griffith SR, Fowler IM, Jacobs MB, Liu R, Anderson White M, Verdun AJ, Hari SB, Fisher RL, Pasquina PF, Vorobeychik Y. Fluoroscopically Guided vs Landmark-Guided Sacroiliac Joint Injections: A Randomized Controlled Study. Mayo Clin Proc. 2019 Apr;94(4):628-642. doi: 10.1016/j.mayocp.2018.08.038. Epub 2019 Mar 8.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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