Imaging for SIJ Injection Therapy

Study Overview
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Brief Summary
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The Research question: Among two standard image guidance techniques [2-dimension (2-D) conventional Fluoroscopy Versus 3-dimension (3-D) Cone-Beam Computed Tomography (CBCT)], which is the better guidance for Sacroiliac Joint Injection therapy and should be used first? The specific aims: To detect the difference of the first-time success rate, the cross-over rate, the procedural time, the radiation exposure, the incidence of adverse events/complications, and overall satisfaction score between the 2-D Fluoroscopy versus 3-D CBCT guidance for SIJ injection.

Detailed Description
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There are no published research studies comparing the injection success rates, procedure duration, radiation exposure, and patient comfort between the two standard imaging systems. The investigators hypothesize that the newer 3-D Cone-beam Based Computer Tomography (CBCT) image system will result in higher success rates, shorter procedure times, fewer image snapshots during the procedure, and less patient discomfort than conventional 2-D fluoroscopy imaging. Although the radiation exposure from one-time low-dose 3-D CT reconstruction with CBCT image system at the beginning of the procedure is higher, the number of later snapshots with the 3-D system is likely to be significantly lower. Therefore the 3-D system may result in overall equivalent radiation exposure to the 2-D system. A statistical power analysis was conducted and determined that a sample size of 100 (50 per group) will give 80% power for detecting a difference if the true rates are 65% (2-D Fluoroscopy guidance) and 90% (3-D CBCT guidance). For this study, patients undergoing SIJ injection will be randomized to either Fluoroscopy guidance or CBCT guidance. The primary outcome measure is injection success within 3 attempts of needle placement. Statistical analysis will use the Chi-square test to test whether the rate of injection success differs between the two methods of guidance. In order to provide appropriate clinical care, whenever success is not achieved with the initial guidance method then injection using the other guidance method will be attempted. However, the analysis will only consider whether or not injection success was achieved with the initial guidance method to which the subject was randomized. Whether or not injection success was achieved after crossing over to the other guidance method is not relevant to the primary analysis. In summary, the investigators would like to formally analyze the differences in these two standard image guidance options in SIJ injection therapy. The investigators propose to randomly select the first imaging system that will be utilized during standard medical care in patients scheduled to undergo an SIJ injection. Presumed that there is a difference in success rate between these two standard images, the imaging procedures are considered to be a part of the research.

Official Title
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The Clinic Application of CBCT XperGuide in Interventional Sacroiliac Joint Pain Therapy

Conditions
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Sacroiliitis, Sacroiliac Joint Pain

Intervention / Treatment
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* Other: sacroiliac joint injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and older Clinically diagnosed with sacroiliac joint pain Medically indicated for sacroiliac joint injection (SIJ) therapy (with chronic sacroiliac joint pain, debilitating with pain score > 4 and not responsive to conservative medical management) Financial pre-authorization of SIJ injection approved by insurance English speaking Scheduled for SIJ injection on the Allura machine Exclusion Criteria: 1. Patient refusal or inability to study informed consent

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>conventional 2-D fluoroscopy guidance as the first choice of guidance | Other: sacroiliac joint injection<br>* Image-guided sacroiliac joint injection under fluoroscopy or CT guidance and the success of intraarticular access was demonstrated by inter-articular contrast spread (the standard of care, not part of study intervention).<br>|
| Active Comparator: Group 2<br>3-D CT guidance as the first choice of guidance | Other: sacroiliac joint injection<br>* Image-guided sacroiliac joint injection under fluoroscopy or CT guidance and the success of intraarticular access was demonstrated by inter-articular contrast spread (the standard of care, not part of study intervention).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of sacroiliac joint injection | the difference between the success rate of Sacroiliac Joint injection under 3-D CBCT and that of 2-D fluoroscopy guidance | during the procedure periods | 
| The crossover rate from the first choice guidance to back-up guidance | The crossover rate from the first choice guidance to back-up guidance after three best attempts | during the procedure periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Radiation Dose | Measurement of radiation dose in Rads during procedure. | during the procedure periods | 
| Procedure Contrast Dose | Measurement of contrast dose in mL during procedure. | during the procedure periods | 
| Procedure Duration | Length of time for procedure measured in minutes. | during the procedure periods | 
| Incidence of Treatment-Emergent Adverse Events | Tachycardia, hypertension, vasovagal reaction, procedural abortion, etc. | during the procedure periods | 
| Procedure Pain | Pre-procedure typical baseline pain and post-procedure typical pain measured on a 0-10 Visual Analog Scale. This scale measures the pain intensity and percentage of pain relief. The left zero end represents no pain and right 10 end represents worst pain imaginable. | during the procedure periods | 
| Patient Satisfaction Score | Procedure Satisfaction Score measured on a 0-10 Visual Analog Scale. The left zero end represents not satisfied at all and the right 10 end represents 100% satisfaction. | during the procedure periods | 
| Needle placement attempts | Number of attempts to place needle for procedure. | during the procedure periods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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2-dimensional (2-D) fluoroscopy, 3-dimensional (3-D) Computed Tomography (CT) guidance, sacroiliac joint injection