Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound

NCT01719081 | Completed DMC

• 1 other identifier: 11-0880-AE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliac Joint Arthritis Causing Low Back Pain

Keywords

Sacroiliac Joint; Ultrasound; Fluoroscopy; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Improvement of functional ability at 1 month

  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 Outcomes (1)

• Assessment of complications

  Until 3 months after procedure

Study Arms (2)

Ultrasound Guided SIJ Injection

EXPERIMENTAL

Needle placement will be performed under US guidance. Fluoroscopy will be used to confirm needle placement prior to medication injection.

Procedure: Sacroiliac Joint Injection

Xray Guided SIJ Injection

ACTIVE COMPARATOR

Needle placement will be performed under fluoroscopy.

Procedure: Sacroiliac Joint Injection

Interventions

Sacroiliac Joint Injection PROCEDURE

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

Ultrasound Guided SIJ Injection; Xray Guided SIJ Injection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anuj Bhatia, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 1, 2012
• Study Start: January 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 23, 2016

Record last verified: 2013-12

Locations

CA (1)