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Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound

Not Applicable
Completed
Conditions
Sacroiliac Joint Arthritis Causing Low Back Pain
Interventions
Procedure: Sacroiliac Joint Injection
Registration Number
NCT01719081
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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
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Exclusion Criteria
  • ongoing litigation issues related to the patient's pain
  • pregnancy
  • allergy to steroids or local anesthetics
  • multiple comorbidities
  • BMI > 35
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ultrasound Guided SIJ InjectionSacroiliac Joint InjectionNeedle placement will be performed under US guidance. Fluoroscopy will be used to confirm needle placement prior to medication injection.
Xray Guided SIJ InjectionSacroiliac Joint InjectionNeedle placement will be performed under fluoroscopy.
Primary Outcome Measures
NameTimeMethod
Incidence of needle placement into SIJAssessed at time of injection
Pain - Numeric Rating Scale Score at 1 monthOne month from time of injection
Secondary Outcome Measures
NameTimeMethod
Patient Satisfaction1 month from time of injection
Number of needle readjustmentsMeasured at time of procedure
Average daily consumption of opioids at 1 month1 month from injection
Patient discomfort with procedureMeasured at time of procedure
Improvement of functional ability at 1 month1 month from time of injection

Oswestry Disability Index completed at 1 month to determine level of disability

Trial Locations

Locations (1)

Toronto Western Hospital

🇨🇦

Toronto, Ontario, Canada

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