Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound

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

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.

Study Overview

• Status: Completed
• Conditions: Sacroiliac Joint Arthritis Causing Low Back Pain
• Intervention / Treatment: Procedure: Sacroiliac Joint Injection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Suspicion of SIJ disease on history: pain below the lumbo-sacral junction; pain with full weight-bearing on one leg; pain worse going down hills or inclines; very low back pain associated with groin pain and absence of lumbar symptoms
• Two positive responses to the following maneuver: FABER (flexion abduction and external rotation of hip), POSH (posterior shear test), REAB (resisted abduction)
• Baseline NRS pain score > or = to 4
• Refractory to oral analgesic therapy

Exclusion Criteria:

• ongoing litigation issues related to the patient's pain
• pregnancy
• allergy to steroids or local anesthetics
• multiple comorbidities
• BMI > 35

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound Guided SIJ Injection; Needle placement will be performed under US guidance. Fluoroscopy will be used to confirm needle placement prior to medication injection.	Procedure: Sacroiliac Joint Injection; Medication injected into the sacroiliac joint: Bupivicaine 3ml 0.25% with epinephrine 1/200,000 and Depo-Medrol 40mg.
Active Comparator: Xray Guided SIJ 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of needle placement into SIJ	Assessed at time of injection
Pain - Numeric Rating Scale Score at 1 month	One month from time of injection

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of complications	Complications assessed at any point until 3 months after procedure	Until 3 months after procedure

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Anuj Bhatia, MD, FRCPC, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Estimate): December 23, 2016
• Last Update Submitted That Met QC Criteria: December 21, 2016
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Ultrasound; Chronic Pain; Sacroiliac Joint; Fluoroscopy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthritis; Back Pain; Low Back Pain; Sacroiliitis
• Other Study ID Numbers: 11-0880-AE