Clinical trial NCT03992053: Imaging for SIJ Injection Therapy
Official title: The Clinic Application of CBCT XperGuide in Interventional Sacroiliac Joint Pain Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sacroiliitis
Sacroiliac Joint Pain
Keywords: 2-dimensional (2-D) fluoroscopy
3-dimensional (3-D) Computed Tomography (CT) guidance
sacroiliac joint injection
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Philips Medical Systems
First posted: 2019-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 and older
2. Clinically diagnosed with sacroiliac joint pain
3. 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)
4. Financial pre-authorization of SIJ injection approved by insurance
5. English speaking
6. Scheduled for SIJ injection on the Allura machine

Exclusion Criteria:

1. Patient refusal or inability to study informed consent

Primary outcomes:
measure: The success rate of sacroiliac joint injection
timeFrame: during the procedure periods
measure: The crossover rate from the first choice guidance to back-up guidance
timeFrame: during the procedure periods
Secondary outcomes:
measure: Procedure Radiation Dose
timeFrame: during the procedure periods
measure: Procedure Contrast Dose
timeFrame: during the procedure periods
measure: Procedure Duration
timeFrame: during the procedure periods
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: during the procedure periods
measure: Procedure Pain
timeFrame: during the procedure periods
measure: Patient Satisfaction Score
timeFrame: during the procedure periods
measure: Needle placement attempts
timeFrame: during the procedure periods
Other outcomes:
Locations:
city: Seattle
country: United States
facility: UW Center for Pain Relief
state: Washington
Study officials:
affiliation: University of Washington
name: Jiang Wu, MD
role: PRINCIPAL_INVESTIGATOR
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