Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections
Completed · Not applicable
Conditions studied: Sacroiliac Joint Pain
In brief
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.
Key facts
- Study ID
- NCT02096653
- Run by
- Johns Hopkins University
- People needed
- 125
- Starts
- 2014-05-01
- Expected to finish
- 2017-11-01
- Last updated by the study team
- 2018-02-07
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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
Where it is running
- Naval Hospital-San Diego — San Diego, California, United States
- Johns Hopkins Hospital — Baltimore, Maryland, United States
- Walter Reed National Military Medical Center — Rockville, Maryland, United States
- Penn State — Hershey, Pennsylvania, United States
Full record on ClinicalTrials.gov
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