Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01719081
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : December 23, 2016
Information provided by (Responsible Party):
University Health Network, Toronto

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 Not Applicable

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  (Clinical Trial)
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 : January 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound X-Rays
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Incidence of needle placement into SIJ [ Time Frame: Assessed at time of injection ]
  2. Pain - Numeric Rating Scale Score at 1 month [ Time Frame: One month from time of injection ]

Secondary Outcome Measures :
  1. Improvement of functional ability at 1 month [ Time Frame: 1 month from time of injection ]
    Oswestry Disability Index completed at 1 month to determine level of disability

  2. Patient Satisfaction [ Time Frame: 1 month from time of injection ]
  3. Average daily consumption of opioids at 1 month [ Time Frame: 1 month from injection ]
  4. Patient discomfort with procedure [ Time Frame: Measured at time of procedure ]
  5. Number of needle readjustments [ Time Frame: Measured at time of procedure ]

Other Outcome Measures:
  1. Assessment of complications [ Time Frame: Until 3 months after procedure ]
    Complications assessed at any point until 3 months after procedure

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01719081

Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Anuj Bhatia, MD, FRCPC University Health Network, Toronto

Responsible Party: University Health Network, Toronto Identifier: NCT01719081     History of Changes
Other Study ID Numbers: 11-0880-AE
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2013

Keywords provided by University Health Network, Toronto:
Sacroiliac Joint
Chronic Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases