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Completed

NCT Number: NCT01719081

Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sacroiliac joint injection

Procedure

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

Primary outcomes

  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 outcomes

  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 outcomes

  1. Assessment of complications

    Time frame: Until 3 months after procedure

    Complications assessed at any point until 3 months after procedure

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 1, 2012
Registry last updated
Dec 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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