NCT02096653

Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections

Randomized, Controlled, Double-blind, Comparative-effectiveness Study Comparing Fluoroscopically-guided and Landmark-guided Sacroiliac Joint Injections

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sacroiliac Joint Pain

Interventions

Type	Name	Description
PROCEDURE	X-ray SI joint steroid injection	Injection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance
PROCEDURE	Landmark-guided SI steroid injection	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)

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2014-03-26
• Last updated: 2018-02-07

Locations

4 sites across 1 country: United States