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Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01719081
Enrollment
40
Registered
2012-11-01
Start date
2012-01-31
Completion date
2013-08-31
Last updated
2016-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sacroiliac Joint Arthritis Causing Low Back Pain

Keywords

Sacroiliac Joint, Ultrasound, Fluoroscopy, Chronic Pain

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.

Interventions

Medication injected into the sacroiliac joint: Bupivicaine 3ml 0.25% with epinephrine 1/200,000 and Depo-Medrol 40mg.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frame
Pain - Numeric Rating Scale Score at 1 monthOne month from time of injection
Incidence of needle placement into SIJAssessed at time of injection

Secondary

MeasureTime frameDescription
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 injectionOswestry Disability Index completed at 1 month to determine level of disability
Number of needle readjustmentsMeasured at time of procedure
Patient Satisfaction1 month from time of injection

Other

MeasureTime frameDescription
Assessment of complicationsUntil 3 months after procedureComplications assessed at any point until 3 months after procedure

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026