Clinical trial NCT01719081: Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound
Official title: Ultrasound for Sacroiliac Joint Injection: Evaluation of the Efficacy of Two Image-Guided Techniques for Sacroiliac Joint Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Joint Arthritis Causing Low Back Pain
Keywords: Sacroiliac Joint
Ultrasound
Fluoroscopy
Chronic Pain
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incidence of needle placement into SIJ
timeFrame: Assessed at time of injection
measure: Pain - Numeric Rating Scale Score at 1 month
timeFrame: One month from time of injection
Secondary outcomes:
measure: Improvement of functional ability at 1 month
timeFrame: 1 month from time of injection
measure: Patient Satisfaction
timeFrame: 1 month from time of injection
measure: Average daily consumption of opioids at 1 month
timeFrame: 1 month from injection
measure: Patient discomfort with procedure
timeFrame: Measured at time of procedure
measure: Number of needle readjustments
timeFrame: Measured at time of procedure
Other outcomes:
measure: Assessment of complications
timeFrame: Until 3 months after procedure
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Anuj Bhatia, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: