Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound

Sacroiliac Joint Arthritis Causing Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719081
• Other study ID #: 11-0880-AE
• Status: Completed
• Phase: N/A
• First received: October 29, 2012
• Last updated: December 21, 2016
• Start date: January 2012
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Sacroiliac Joint Arthritis Causing Low Back Pain
• Sacroiliitis

Intervention

Procedure:
• Sacroiliac Joint Injection
Medication injected into the sacroiliac joint: Bupivicaine 3ml 0.25% with epinephrine 1/200,000 and Depo-Medrol 40mg.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of complications	Complications assessed at any point until 3 months after procedure	Until 3 months after procedure	Yes
Primary	Incidence of needle placement into SIJ		Assessed at time of injection	No
Primary	Pain - Numeric Rating Scale Score at 1 month		One month from time of injection	No
Secondary	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	No
Secondary	Patient Satisfaction		1 month from time of injection	No
Secondary	Average daily consumption of opioids at 1 month		1 month from injection	No
Secondary	Patient discomfort with procedure		Measured at time of procedure	No
Secondary	Number of needle readjustments		Measured at time of procedure	No