Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 124
• Participant gender: Both

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: Uniformed Services University of the Health Sciences; Walter Reed National Military Medical Center
• Last Updated: 2016-08-29

Criteria

Inclusion Criteria:

1. Age > 18;

2. Low back pain principally below the L5 vertebra;

3. Three out of 6 positive SI joint provocative maneuvers;

4. Agreed to undergo SI joint injection for diagnostic/ therapeutic purposes;

5. Average pain score > 4/10 over the past week;

6. Pain duration > 6 weeks;

Exclusion Criteria:

1. Previous SI joint injection;

2. Leg pain > back pain or lower leg pain > upper leg pain

3. Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);

4. Untreated coagulopathy;

5. Allergy to contrast dye or bupivacaine;

6. Pain > 10 years in duration;

7. Poorly controlled psychiatric (e.g. PTSD) or medical (congestive heart failure) condition