Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections

Johns Hopkins University

Status: Completed

Conditions: Sacroiliac Joint Pain

Treatments: Procedure: X-ray SI joint steroid injection; Procedure: Landmark-guided SI steroid injection

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02096653

NA_00092414

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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 > 3/10 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 > 20 years in duration;
7. Poorly controlled psychiatric (e.g. PTSD) or medical (congestive heart failure) condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 2 patient groups

X-ray guided intra-articular injection

Experimental group

Description:

Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine into the SI (sacroiliac joint) cavity under fluoroscopic guidance

Treatment:

Procedure: X-ray SI joint steroid injection

Landmark-guided SI joint injection

Active Comparator group

Description:

Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine at the point of maximal tenderness (3 ml)

Treatment:

Procedure: Landmark-guided SI steroid injection