Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT01719081

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sacroiliac Joint Arthritis Causing Low Back Pain	Procedure: Sacroiliac Joint Injection	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Improvement of functional ability at 1 month [1 month from time of injection]
Oswestry Disability Index completed at 1 month to determine level of disability
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

Assessment of complications [Until 3 months after procedure]
Complications assessed at any point until 3 months after procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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