SacroiliitisNCT03992053
Imaging for SIJ Injection Therapy
A study testing sacroiliac joint injection in people with Sacroiliitis and Sacroiliac Joint Pain, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliitis, Sacroiliac Joint Pain
- What is being tested?
- sacroiliac joint injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2019to 7 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Patient refusal or inability to study informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Center for Pain Relief
Seattle, Washington, 98105
About this study
Official title: The Clinic Application of CBCT XperGuide in Interventional Sacroiliac Joint Pain Therapy
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.
Read the 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.
- Conditions
- Sacroiliitis, Sacroiliac Joint Pain
- Being tested
- sacroiliac joint injection
- Keywords
- 2-dimensional (2-D) fluoroscopy, 3-dimensional (3-D) Computed Tomography (CT) guidance, sacroiliac joint injection
- Medical subject headings
- Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacroiliac joint injectionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | conventional 2-D fluoroscopy guidance as the first choice of guidance Receives: Other: sacroiliac joint injection |
| Group 2 | Active comparator | 3-D CT guidance as the first choice of guidance Receives: Other: sacroiliac joint injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: during the procedure periods
Secondary outcomes (7)
Procedure Radiation Dose
Measurement of radiation dose in Rads during procedure.
Measured: during the procedure periods
Procedure Contrast Dose
Measurement of contrast dose in mL during procedure.
Measured: during the procedure periods
Procedure Duration
Length of time for procedure measured in minutes.
Measured: during the procedure periods
Incidence of Treatment-Emergent Adverse Events
Tachycardia, hypertension, vasovagal reaction, procedural abortion, etc.
Measured: 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.
Measured: 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.
Measured: during the procedure periods
Needle placement attempts
Number of attempts to place needle for procedure.
Measured: during the procedure periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start31 May 2019
- Primary completion7 Apr 2021
- Study completion7 Apr 2021
Why it stopped: No subjects were recruited because of the COVID-19 pandemic. The study is now closed as sponsor milestones (not related to subjects) are completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for SacroiliitisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Medical Systems
- Responsible party
- Principal investigator, Jiang Wu, University of Washington
- Investigators
- Jiang Wu, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992053
- Sponsor's protocol ID
- STUDY00006861
- Status last verified
- Apr 2021
- First submitted
- 7 Jun 2019
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient's IPD is confidential information and well protected under HIPPA law, and reinforced by the Institute IRB policy
Publications
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.
PubMed 21476020Orth 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.
PubMed 19560038Scarfe 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.
PubMed 18805225Wagner AL. CT fluoroscopic-guided cervical nerve root blocks. AJNR Am J Neuroradiol. 2005 Jan;26(1):43-4.
PubMed 15661697Thakor 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.
PubMed 26563298Simopoulos 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.
PubMed 22622915Cohen 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.
PubMed 23253394King 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.
PubMed 25677327Kennedy 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.
PubMed 26178855Kasliwal PJ, Kasliwal S. Fluoroscopy-Guided Sacroiliac Joint Injection: Description of a Modified Technique. Pain Physician. 2016 Feb;19(2):E329-38.
PubMed 26815260Hawkins 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.
PubMed 26637320
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinic Application of CBCT XperGuide in Interventional Sacroiliac Joint Pain Therapy
- ClinicalTrials.gov ID
- NCT03992053
- Acronym / sponsor ID
- STUDY00006861
- Conditions
- Sacroiliitis, Sacroiliac Joint Pain
- Keywords
- 2-dimensional (2-D) fluoroscopy, 3-dimensional (3-D) Computed Tomography (CT) guidance, sacroiliac joint injection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects were recruited because of the COVID-19 pandemic. The study is now closed as sponsor milestones (not related to subjects) are completed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Philips Medical Systems
- Study start
- 31 May 2019 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: sacroiliac joint injectionconventional 2-D fluoroscopy guidance as the first choice of guidance |
| Group 2 | Active comparator | Other: sacroiliac joint injection3-D CT guidance as the first choice of guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Patient refusal or inability to study informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacroiliac joint injectionImage-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). | Other | Group 1, Group 2 |
Primary outcome
The success rate of sacroiliac joint injection
Time frame: during the procedure periods
the difference between the success rate of Sacroiliac Joint injection under 3-D CBCT and that of 2-D fluoroscopy guidance
The crossover rate from the first choice guidance to back-up guidance
Time frame: during the procedure periods
The crossover rate from the first choice guidance to back-up guidance after three best attempts
7 secondary outcomes
Procedure Radiation Dose
Time frame: during the procedure periods
Procedure Contrast Dose
Time frame: during the procedure periods
Procedure Duration
Time frame: during the procedure periods
Incidence of Treatment-Emergent Adverse Events
Time frame: during the procedure periods
Procedure Pain
Time frame: during the procedure periods
Patient Satisfaction Score
Time frame: during the procedure periods
Needle placement attempts
Time frame: during the procedure periods
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Background: PubMed 21476020Leschka 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.
- Background: PubMed 19560038Orth 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.
- Background: PubMed 18805225Scarfe 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.
- Background: PubMed 15661697Wagner AL. CT fluoroscopic-guided cervical nerve root blocks. AJNR Am J Neuroradiol. 2005 Jan;26(1):43-4.
- Background: PubMed 26563298Thakor 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.
- Background: PubMed 22622915Simopoulos 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.
- Background: PubMed 23253394Cohen 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.
- Background: PubMed 25677327King 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.
- Background: PubMed 26178855Kennedy 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.
- Background: PubMed 26815260Kasliwal PJ, Kasliwal S. Fluoroscopy-Guided Sacroiliac Joint Injection: Description of a Modified Technique. Pain Physician. 2016 Feb;19(2):E329-38.
- Background: PubMed 26637320Hawkins 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.
- Individual participant dataSharing planned: No. Patient's IPD is confidential information and well protected under HIPPA law, and reinforced by the Institute IRB policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang Wu, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sacroiliac joint injection in people with Sacroiliitis and Sacroiliac Joint Pain, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of sacroiliac joint injection (time frame: during the procedure periods). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03992053, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.