An interventional study of Sacroiliac Joint Injection in Sacroiliac Joint Arthritis Causing Low Back Pain, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-12-23.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Needle placement will be performed under US guidance. Fluoroscopy will be used to confirm needle placement prior to medication injection.
Procedure: Sacroiliac Joint Injection
Needle placement will be performed under fluoroscopy.
Procedure: Sacroiliac Joint Injection
Medication injected into the sacroiliac joint: Bupivicaine 3ml 0.25% with epinephrine 1/200,000 and Depo-Medrol 40mg.
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
Improvement of functional ability at 1 month
Oswestry Disability Index completed at 1 month to determine level of disability
Time frame: 1 month from time of injection
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
Assessment of complications
Complications assessed at any point until 3 months after procedure
Time frame: Until 3 months after procedure
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto