Clinical Trial: Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of the Efficacy of Two Techniques for Sacroiliac Joint Injection: Ultrasound Guidance Versus Fluoroscopic Guidance

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 Summary: 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.
Sponsor: United States Naval Medical Center, San Diego

Current Primary Outcome:

  • Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Original Primary Outcome:

  • Difference in minutes between an sacroiliac joint injection done with Ultrasound vs fluoroscopy [ Time Frame: 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 from baseline in multi-dimensional pain score at 30 minutes pre-procedure using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 1-10 [ Time Frame: 30 minutes pre-procedure ]
  • Change from baseline in multi-dimensional pain score at 2 weeks post-procedure using the DoD/VA PRS [ Time Frame: 2 weeks post-procedure ]
  • Change from baseline in multi-dimensional pain score at 3 months post-procedure using the DoD/VA PRS [ Time Frame: 3 months post-procedure ]


Current Secondary Outcome:

  • Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months post-procedure ]
    "1= very dissatisfied" to "5=very satisfied".


Original Secondary Outcome:

  • Change from baseline in change in condition at 2 weeks post-procedure using the DoD/VA PRS [ Time Frame: 2 weeks post-procedure ]
  • Change from baseline in change in condition at 3 months post-procedure using the DoD/VA PRS [ Time Frame: 3 months post-procedure ]
  • Change from baseline since SI injection at 2 weeks post-procedure using the DoD/VA PRS [ Time Frame: 2 weeks post-procedure ]
  • Change from baseline since SI injection at 3 months post-procedure using the DoD/VA PRS [ Time Frame: 3 months post-procedure ]
  • Number of participants with satisfaction of procedure as a measure of safety and tolerability using a numerical scale 1-5 [ Time Frame: 2 weeks post-procedure ]
    "1= very dissatisfied" to "5=very satisfied"
  • Number of participants with satisfaction of procedure as a measure of safety and tolerability using a numerical scale 1-5 [ Time Frame: 3 months post-procedure ]
    "1= very dissatisfied" to "5=very satisfied"


Information By: United States Naval Medical Center, San Diego

Dates:
Date Received: September 30, 2014
Date Started: October 2012
Date Completion:
Last Updated: October 7, 2015
Last Verified: October 2015