Clinical trial NCT02420041: Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections
Official title: Comparison of the Efficacy of Two Techniques for Sacroiliac Joint Injection: Ultrasound Guidance Versus Fluoroscopic Guidance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliitis
Keywords: Sacroiliac Joint Injection
Fluoroscopy
Ultrasound
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: United States Naval Medical Center, Portsmouth
First posted: 2015-04-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy
timeFrame: difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes
measure: Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10
timeFrame: 30 minutes pre-procedure minus baseline
measure: Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS
timeFrame: 2 weeks post-procedure minus baseline
measure: Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS
timeFrame: 3 months post-procedure minus baseline
Secondary outcomes:
measure: Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale
timeFrame: 2 weeks post-procedure
measure: Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale
timeFrame: 3 months post-procedure
measure: Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS
timeFrame: during/just before sacroiliac (SI) injection and 2 weeks post-procedure
measure: Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS
timeFrame: during/just before sacroiliac (SI) injection and 3 months post-procedure
measure: Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5
timeFrame: 2 weeks post-procedure
measure: Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5
timeFrame: 3 months post-procedure
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pain Medicine Center, Department of Anesthesiology, Naval Medical Center, San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Steven R Hanling, MD
role: PRINCIPAL_INVESTIGATOR
References: