An interventional study of sacroiliac joint injection in Sacroiliitis and Sacroiliac Joint Pain, sponsored by University of Washington. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-05.
Sponsored by University of Washington · Not applicable, Interventional, and Diagnostic
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.
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.
Exclusion Criteria:
conventional 2-D fluoroscopy guidance as the first choice of guidance
Other: sacroiliac joint injection
3-D CT guidance as the first choice of guidance
Other: sacroiliac joint injection
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).
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
Time frame: 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
Time frame: during the procedure periods
Procedure Radiation Dose
Measurement of radiation dose in Rads during procedure.
Time frame: during the procedure periods
Procedure Contrast Dose
Measurement of contrast dose in mL during procedure.
Time frame: during the procedure periods
Procedure Duration
Length of time for procedure measured in minutes.
Time frame: during the procedure periods
Incidence of Treatment-Emergent Adverse Events
Tachycardia, hypertension, vasovagal reaction, procedural abortion, etc.
Time frame: 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.
Time frame: 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.
Time frame: during the procedure periods
Needle placement attempts
Number of attempts to place needle for procedure.
Time frame: during the procedure periods
Plan to share: No — Patient's IPD is confidential information and well protected under HIPPA law, and reinforced by the Institute IRB policy
This study is withdrawn, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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