Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-05-31
2021-04-07
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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Group 1
conventional 2-D fluoroscopy guidance as the first choice of guidance
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).
Group 2
3-D CT guidance as the first choice of guidance
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Philips Medical Systems
INDUSTRY
University of Washington
OTHER
Responsible Party
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Jiang Wu
Clinic Assistant Professor
Principal Investigators
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Jiang Wu, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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UW Center for Pain Relief
Seattle, Washington, United States
Countries
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References
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Leschka SC, Babic D, El Shikh S, Wossmann C, Schumacher M, Taschner CA. C-arm cone beam computed tomography needle path overlay for image-guided procedures of the spine and pelvis. Neuroradiology. 2012 Mar;54(3):215-23. doi: 10.1007/s00234-011-0866-y. Epub 2011 Apr 8.
Orth RC, Wallace MJ, Kuo MD; Technology Assessment Committee of the Society of Interventional Radiology. C-arm cone-beam CT: general principles and technical considerations for use in interventional radiology. J Vasc Interv Radiol. 2009 Jul;20(7 Suppl):S538-44. doi: 10.1016/j.jvir.2009.04.026.
Scarfe WC, Farman AG. What is cone-beam CT and how does it work? Dent Clin North Am. 2008 Oct;52(4):707-30, v. doi: 10.1016/j.cden.2008.05.005.
Wagner AL. CT fluoroscopic-guided cervical nerve root blocks. AJNR Am J Neuroradiol. 2005 Jan;26(1):43-4.
Thakor AS, Patel PA, Gu R, Rea V, Amaral J, Connolly BL. MR cone-beam CT fusion image overlay for fluoroscopically guided percutaneous biopsies in pediatric patients. Pediatr Radiol. 2016 Mar;46(3):407-12. doi: 10.1007/s00247-015-3479-5. Epub 2015 Nov 13.
Simopoulos TT, Manchikanti L, Singh V, Gupta S, Hameed H, Diwan S, Cohen SP. A systematic evaluation of prevalence and diagnostic accuracy of sacroiliac joint interventions. Pain Physician. 2012 May-Jun;15(3):E305-44.
Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148.
King W, Ahmed SU, Baisden J, Patel N, Kennedy DJ, Duszynski B, MacVicar J. Diagnosis and treatment of posterior sacroiliac complex pain: a systematic review with comprehensive analysis of the published data. Pain Med. 2015 Feb;16(2):257-65. doi: 10.1111/pme.12630.
Kennedy DJ, Engel A, Kreiner DS, Nampiaparampil D, Duszynski B, MacVicar J. Fluoroscopically Guided Diagnostic and Therapeutic Intra-Articular Sacroiliac Joint Injections: A Systematic Review. Pain Med. 2015 Aug;16(8):1500-18. doi: 10.1111/pme.12833. Epub 2015 Jul 14.
Kasliwal PJ, Kasliwal S. Fluoroscopy-Guided Sacroiliac Joint Injection: Description of a Modified Technique. Pain Physician. 2016 Feb;19(2):E329-38.
Hawkins CM, Kukreja K, Singewald T, Minevich E, Johnson ND, Reddy P, Racadio JM. Use of cone-beam CT and live 3-D needle guidance to facilitate percutaneous nephrostomy and nephrolithotripsy access in children and adolescents. Pediatr Radiol. 2016 Apr;46(4):570-4. doi: 10.1007/s00247-015-3499-1. Epub 2015 Dec 4.
Other Identifiers
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STUDY00006861
Identifier Type: -
Identifier Source: org_study_id
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