Imaging for SIJ Injection Therapy

Sacroiliitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03992053
• Other study ID #: STUDY00006861
• Status: Withdrawn
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: April 7, 2021

Study information

• Verified date: April 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 7, 2021
• Est. primary completion date: April 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Sacroiliac Joint Pain
• Sacroiliitis

Intervention

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).

Locations

Country	Name	City	State
United States	UW Center for Pain Relief	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Philips Medical Systems

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. Review. — View Citation

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. Review. — View Citation

Kasliwal PJ, Kasliwal S. Fluoroscopy-Guided Sacroiliac Joint Injection: Description of a Modified Technique. Pain Physician. 2016 Feb;19(2):E329-38. — View Citation

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. Review. — View Citation

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. Review. Erratum in: Pain Med. 2015 Nov;16(11):2216. Duszynski, Belinda [added]. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Wagner AL. CT fluoroscopic-guided cervical nerve root blocks. AJNR Am J Neuroradiol. 2005 Jan;26(1):43-4. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Procedure Radiation Dose	Measurement of radiation dose in Rads during procedure.	during the procedure periods
Secondary	Procedure Contrast Dose	Measurement of contrast dose in mL during procedure.	during the procedure periods
Secondary	Procedure Duration	Length of time for procedure measured in minutes.	during the procedure periods
Secondary	Incidence of Treatment-Emergent Adverse Events	Tachycardia, hypertension, vasovagal reaction, procedural abortion, etc.	during the procedure periods
Secondary	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
Secondary	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
Secondary	Needle placement attempts	Number of attempts to place needle for procedure.	during the procedure periods