A Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks

Study Overview
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Brief Summary
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Sacral lateral branch blocks are used for the diagnosis and treatment of sacroiliac joint pain. This study will compare ultrasound and fluoroscopy guidance for sacral lateral branch blocks. Outcomes examined will include performance times and success rates.

Official Title
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A Prospective Randomized Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks

Conditions
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Back Pain

Intervention / Treatment
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* Device: Ultrasound guided
* Device: Fluoroscopy guided


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any consenting patient over 18 years of age, undergoing a diagnostic sacral lateral branch block for suspected sacroiliac joint related pain. Exclusion Criteria: Inability to consent, iodine or lidocaine allergy, pregnancy, coagulopathy (as defined by an international normalized ratio over 1.4, platelets under 100,000, or a documented bleeding disorder) and inability to visualize the target areas necessary for sensory testing (posterior superior iliac spine, dorsal aspect of SIJ) under ultrasound guidance.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound guided<br>Ultrasound guided sacral lateral branch block | Device: Ultrasound guided<br>* This group will be treated using an ultrasound imaging device<br>* Other names: Ultrasound guided sacral lateral branch block;|
| Active Comparator: Fluoroscopy guided<br>Fluoroscopically guided sacral lateral branch block | Device: Fluoroscopy guided<br>* This group will be treated using a fluoroscopy imaging device<br>* Other names: Fluoroscopically guided sacral lateral branch block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance time | Block performance time will be measured from the time the first image is acquired, until the last injection is completed. Typical performance time are expected to be less than 20 minutes for both groups. | Duration of procedure (less than 20 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain numerical rating score from baseline | The extent of anesthesia provided by the blocks will be assessed by probing structures known to be innervated by the lateral branches and L5 posterior root. Two pain measurements will be undertaken, before and 20 minutes after the injections. Pain reports will be quantified by using a numerical rating score. | Baseline and 20 minutes after procedure |