Clinical Trial: Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound

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

Official Title: Ultrasound for Sacroiliac Joint Injection: Evaluation of the Efficacy of Two Image-Guided Techniques for Sacroiliac Joint Injection

Brief Summary: This project involves the assessment of the efficacy of two different image guided techniques in patients with low back pain due to arthritis of the sacroiliac joint (SIJ). Intra-articular injection of local anesthetics and steroids is performed to relieve pain originating from the SIJ. Fluoroscopy has been used traditionally for image guidance for this procedure but there is a growing interest in use of ultrasound (US) for this procedure. US avoids radiation exposure to the patient and the health care team (HCT) and is less expensive. We aim to compare procedural efficacy related outcomes for SIJ injections performed using these image-guided modalities.

Detailed Summary: The study is a prospective, randomized trial. Patients with low back pain which is diagnosed secondary to SIJ disease will be identified beforehand in clinic and offered a therapeutic joint injection. Informed consent will be obtained. Patients will be randomized for SIJ block with 3 mL of 0.25% bupivacaine with 1:200,000 epinephrine and 40 mg depomedrol using guidance with ultrasound or fluoroscopy. In both groups, confirmation of needle placement will be obtained using contrast injection imaging before the injection is performed. Record will be made of the number of times the needle is correctly placed into the articular space, as well as the number of attempts to do so. The final position of the needle will be recorded. Pain scores will be assessed before the procedure, as well as post-procedure at 24 and 72 hours, as well as 1 week, 1 month, and 3 months. Patients will keep a pain diary and will be followed up at 3 months time in clinic.
Sponsor: University Health Network, Toronto

Current Primary Outcome:

  • Incidence of needle placement into SIJ [ Time Frame: Assessed at time of injection ]
  • Pain - Numeric Rating Scale Score at 1 month [ Time Frame: One month from time of injection ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improvement of functional ability at 1 month [ Time Frame: 1 month from time of injection ]
    Oswestry Disability Index completed at 1 month to determine level of disability
  • Patient Satisfaction [ Time Frame: 1 month from time of injection ]
  • Average daily consumption of opioids at 1 month [ Time Frame: 1 month from injection ]
  • Patient discomfort with procedure [ Time Frame: Measured at time of procedure ]
  • Number of needle readjustments [ Time Frame: Measured at time of procedure ]


Original Secondary Outcome: Same as current

Information By: University Health Network, Toronto

Dates:
Date Received: October 29, 2012
Date Started: January 2012
Date Completion:
Last Updated: December 21, 2016
Last Verified: December 2013