Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections

Summary

The purpose of this research project is to compare two different techniques for performing an injection of the sacroiliac joint. Although both techniques are safe and accurate, the goal of the study is to determine if one technique is better than the other with respect to improvement in a patient's pain, function, and his or her satisfaction. Additionally, the investigators want to determine if one technique is quicker and more efficient than the other.

Conditions

• Sacroiliitis

Interventions

PROCEDURE

Active comparator: Fluoroscopic Guided SIJ injection

* Needle entry point is in the lower one-third of the SIJ * Sterile preparation (with chlorhexidine) and draping and 3 mL of 1% lidocaine injected subcutaneously at site of needle entry * Under fluoroscopy guidance, Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle is inserted in a coaxial fashion into the SIJ * 1 mL of contrast (iohexol 300 mg/mL) is injected to outline the SIJ and to ensure no vascular uptake * Injection of 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine * Patient observed in recovery bay for 20 minutes and then discharged home

PROCEDURE

Ultrasound Guided Sacroiliac Joint Injection

* Sterile preparation (with chlorhexidine) and drape * Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer * 3 mL of 1% lidocaine is injected subcutaneously at site of needle entry * Under ultrasound guidance, a Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ. (0.5-2 mL of normal saline may be injected during needle insertion to locate tip of needle and to ensure solution does not "spill out" onto sacrum). * After using the Doppler function to identify any surrounding vessels (to avoid intravascular injection), 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine is injected. * Patient observed in recovery bay for 20 minutes and then discharged home

DEVICE

Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle

DEVICE

SonoSite S-nerve

DEVICE

iohexol

DRUG

triamcinolone/lidocaine

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth

  collaborator FED

• United States Naval Medical Center, San Diego

  lead FED

Principal Investigators

• Steven R Hanling, MD · United States Naval Medical Center, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• United States

Study Locations