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Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound

This study is currently recruiting participants.
Verified October 2012 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01719081
First received: October 29, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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 Intervention
Sacroiliac Joint Arthritis Causing Low Back Pain.
 Procedure: Sacroiliac Joint Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ultrasound for Sacroiliac Joint Injection: Evaluation of the Efficacy of Two Image-Guided Techniques for Sacroiliac Joint Injection

Resource links provided by NLM:

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

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Incidence of needle placement into SIJ [ Time Frame: Assessed at time of injection ] [ Designated as safety issue: No ]
  • Pain - Numeric Rating Scale Score at 1 month [ Time Frame: One month from time of injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of functional ability at 1 month [ Time Frame: 1 month from time of injection ] [ Designated as safety issue: No ]
    Oswestry Disability Index completed at 1 month to determine level of disability

  • Patient Satisfaction [ Time Frame: 1 month from time of injection ] [ Designated as safety issue: No ]
  • Average daily consumption of opioids at 1 month [ Time Frame: 1 month from injection ] [ Designated as safety issue: No ]
  • Patient discomfort with procedure [ Time Frame: Measured at time of procedure ] [ Designated as safety issue: No ]
  • Number of needle readjustments [ Time Frame: Measured at time of procedure ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Assessment of complications [ Time Frame: Until 3 months after procedure ] [ Designated as safety issue: Yes ]
    Complications assessed at any point until 3 months after procedure


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719081

Contacts
Contact: Anuj Bhatia, MD, FRCPC 647-801-5143 anuj.bhatia@uhn.ca
Contact: Neilesh Soneji, MD, FRCPC 647-262-3466 neilesh.soneji@uhn.ca

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Anuj Bhatia, MD, FRCPC     647-801-5143     anuj.bhatia@uhn.ca    
Contact: Neilesh Soneji, MD, FRCPC     647-262-3466     neilesh.soneji@uhn.ca    
Principal Investigator: Anuj Bhatia, MD, FRCPC            
Sub-Investigator: Neilesh Soneji, MD, FRCPC            
Sub-Investigator: Philip Peng, MBBS, FRCPC            
Sub-Investigator: Paul Tumber, MD, FRCPC            
Sub-Investigator: Rachael Seib, MD, FRCPC            
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Anuj Bhatia, MD, FRCPC Toronto Western Hospital, University Health Network
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01719081     History of Changes
Other Study ID Numbers: 11-0880-AE
Study First Received: October 29, 2012
Last Updated: October 29, 2012
Health Authority: Canada: Canadian Institutes of Health Research

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

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

ClinicalTrials.gov processed this record on May 16, 2013