Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections

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.

• Active comparator: Fluoroscopic Guided SIJ injection (Procedure): * 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 Injection (Procedure): * 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
• Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle (Device)
• SonoSite S-nerve (Device)
• iohexol (Device)
• triamcinolone/lidocaine (Drug)

Primary outcomes

• Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy [difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes]: during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin
• Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10 [30 minutes pre-procedure minus baseline]: 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.
• Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS [2 weeks post-procedure minus baseline]: 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.
• Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS [3 months post-procedure minus baseline]: 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.

Secondary outcomes

• Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale [2 weeks post-procedure]: 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.
• Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale [3 months post-procedure]: 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.
• Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS [during/just before sacroiliac (SI) injection and 2 weeks post-procedure]: 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. Score reported is reporting a difference/change between two time points.
• Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS [during/just before sacroiliac (SI) injection and 3 months post-procedure]: 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.Score reported is reporting a difference/change between two time points.
• Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5 [2 weeks post-procedure]: "1= very dissatisfied" to "5=very satisfied".
• Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5 [3 months post-procedure]: "1= very dissatisfied" to "5=very satisfied".

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy (Primary), Mean, minutes: Fluoroscopic Guidance 9.471 (6.92 to 15); Ultrasound Guidance 9.552 (3 to 30)
• Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10 (Primary), Mean, units on a scale: Fluoroscopic Guidance -2.571 (-5 to 0); Ultrasound Guidance -2.571 (-7 to 0)
• Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS (Primary), Mean, units on a scale: Fluoroscopic Guidance -1 (-3 to 0); Ultrasound Guidance -1.643 (-6 to 0)
• Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS (Primary), Mean, units on a scale: Fluoroscopic Guidance -0.875 (-2 to .5); Ultrasound Guidance -1.556 (-5 to 0)
• Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale (Secondary), Mean, units on a scale: Fluoroscopic Guidance 2.385 (0 to 5); Ultrasound Guidance 2.714 (0 to 5)
• Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale (Secondary), Mean, units on a scale: Fluoroscopic Guidance 2.818 (0 to 5); Ultrasound Guidance 2.222 (0 to 5)
• Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS (Secondary), Mean, units on a scale: Fluoroscopic Guidance 4.846 (0 to 8); Ultrasound Guidance 4.385 (2 to 9)
• Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS (Secondary), Mean, units on a scale: Fluoroscopic Guidance 4 (1 to 7); Ultrasound Guidance 4.333 (3 to 8)
• Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5 (Secondary), Mean, units on a scale of satisfaction: Fluoroscopic Guidance 3.615 (1 to 5); Ultrasound Guidance 3.857 (2 to 5)
• Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5 (Secondary), Mean, units on a scale of satisfaction: Fluoroscopic Guidance 3.364 (2 to 4); Ultrasound Guidance 3.667 (3 to 4)

Adverse events

Other adverse events by term

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