Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections

N/ACompletedNCT02420041

United States Naval Medical Center, San Diego28 enrolled

Overview

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.

Sacroiliac joint dysfunction is a source of low back pain that causes significant pain and disability. Injection of the sacroiliac joint with a local anesthetic/corticosteroid mixture has shown efficacy in treating this condition, when conservative therapy fails. The use of fluoroscopic guidance and anatomic landmarks are traditional methods for performing this injection; however, ultrasound imaging has recently been utilized for performing this procedure. Although studies exist that describe and validate the ultrasound technique, no studies exist that compare the techniques with respect to short-term and long-term outcomes. In this study, the primary objective is to determine if a difference exists between a fluoroscopic-guided technique and ultrasound-guided technique with respect to pain and function. A secondary objective is to compare the two techniques with respect to procedural characteristics.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sacroiliitis

Interventions

Active comparator: Fluoroscopic Guided SIJ injectionPROCEDURE

* 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

Ultrasound Guided Sacroiliac Joint InjectionPROCEDURE

* 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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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) 2. Failed a trial of conservative therapy which may included medications, physical therapy, or both 3. Age \> 18 4. Patient agrees to participate in study Exclusion Criteria: 1. Coagulopathy 2. Renal or Hepatic Failure 3. Current Pregnancy or actively pursuing pregnancy 4. Known allergy to local anesthetic or steroids 5. Infection at site of needle placement or SIJ infection 6. Patient unable to consent himself or herself 7. Patient refusal 8. Prior surgical procedures involving the SIJ 9. Body Mass Index \> 35 kg/m2

Locations (1)

Pain Medicine Center, Department of Anesthesiology, Naval Medical Center, San Diego

San Diego, California, United States

Outcomes

Primary Outcomes

Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy

during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin

Time frame: difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes

Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10

Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.

Time frame: 30 minutes pre-procedure minus baseline

Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS

Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.

Time frame: 2 weeks post-procedure minus baseline

Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS

Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.

Time frame: 3 months post-procedure minus baseline

Secondary Outcomes

Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale

Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.

Time frame: 2 weeks post-procedure

Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale

Data from ClinicalTrials.gov

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