N/A N=28 Randomized Treatment

Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections

Sacroiliitis

Bottom Line

View on ClinicalTrials.gov: NCT02420041 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy — 9.471; 9.552 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active comparator: Fluoroscopic Guided SIJ injection (Procedure); Ultrasound Guided Sacroiliac Joint Injection (Procedure); Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle (Device); SonoSite S-nerve (Device); iohexol (Device); triamcinolone/lidocaine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: United States Naval Medical Center, San Diego
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy	9.471; 9.552	—
PRIMARY Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10	-2.571; -2.571	—
PRIMARY Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS	-1; -1.643	—
PRIMARY Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS	-0.875; -1.556	—
SECONDARY Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale	2.385; 2.714	—
SECONDARY Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale	2.818; 2.222	—
SECONDARY Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS	4.846; 4.385	—
SECONDARY Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS	4; 4.333	—
SECONDARY Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5	3.364; 3.667	—
SECONDARY Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5	3.364; 3.667	—

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.

Eligibility Criteria

Inclusion Criteria

Diagnosis of SIJ dysfunction by history and physical exam
History: Either low back pain or buttock pain
Exam: Either tenderness to palpation over the SIJ or a positive provocative maneuver (i.e., Patrick's, Gaenslen's, and/or Yeoman's test)
Failed a trial of conservative therapy which may included medications, physical therapy, or both
Age > 18
Patient agrees to participate in study

Exclusion Criteria

Coagulopathy
Renal or Hepatic Failure
Current Pregnancy or actively pursuing pregnancy
Known allergy to local anesthetic or steroids
Infection at site of needle placement or SIJ infection
Patient unable to consent himself or herself
Patient refusal
Prior surgical procedures involving the SIJ
Body Mass Index > 35 kg/m2

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02420041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.