Imaging for SIJ Injection Therapy

NCT03992053 | Withdrawn DMC

• 1 other identifier: STUDY00006861
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliitis; Sacroiliac Joint Pain

Keywords

2-dimensional (2-D) fluoroscopy; 3-dimensional (3-D) Computed Tomography (CT) guidance; sacroiliac joint injection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Procedure Radiation Dose

  during the procedure periods

• Procedure Contrast Dose

  during the procedure periods

• Procedure Duration

  during the procedure periods

• Incidence of Treatment-Emergent Adverse Events

  during the procedure periods

• Procedure Pain

  during the procedure periods

Study Arms (2)

Group 1

ACTIVE COMPARATOR

conventional 2-D fluoroscopy guidance as the first choice of guidance

Other: sacroiliac joint injection

Group 2

ACTIVE COMPARATOR

3-D CT guidance as the first choice of guidance

Other: sacroiliac joint injection

Interventions

sacroiliac joint injection OTHER

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 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. Patient refusal or inability to study informed consent

Sponsors & Collaborators

• University of Washington: lead
• Philips Medical Systems: collaborator

Study Sites (1)

UW Center for Pain Relief

Seattle, Washington, 98105, United States

Location

Related Publications (11)

• 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.

  PMID: 21476020 BACKGROUND

• 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.

  PMID: 19560038 BACKGROUND

• 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.

  PMID: 18805225 BACKGROUND

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

  PMID: 15661697 BACKGROUND

• 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.

  PMID: 26563298 BACKGROUND

• 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.

  PMID: 22622915 BACKGROUND

• 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.

  PMID: 23253394 BACKGROUND

• 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.

  PMID: 25677327 BACKGROUND

• 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.

  PMID: 26178855 BACKGROUND

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

  PMID: 26815260 BACKGROUND

• 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.

  PMID: 26637320 BACKGROUND

MeSH Terms

Conditions

Sacroiliitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Jiang Wu, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic Assistant Professor

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 19, 2019
• Study Start: May 31, 2019
• Primary Completion: April 7, 2021
• Study Completion: April 7, 2021
• Last Updated: May 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)