Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Injection
1 other identifier
interventional
60
1 country
1
Brief Summary
The investigators aimed to evaluate the effectiveness of intra-articular sacroiliac joint injection under fluoroscopy versus ultrasound guidance
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2022
CompletedFirst Posted
Study publicly available on registry
February 11, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2022
CompletedNovember 1, 2022
October 1, 2022
6 months
February 2, 2022
October 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in pain
Pain assessment will be performed using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = the most severe pain felt).
Change from baseline pain score at 3 months
Secondary Outcomes (4)
Oswestry Disability Index (ODI)
Baseline to 3 months post-procedure
Patient satisfaction Questionnaire
baseline to 3 months post-procedure
Quantitative analgesic questionnaire
at 3 months post-procedure
Procedure time
Intraoperative
Study Arms (2)
Fluoroscopic-guided sacroiliac joint injection
EXPERIMENTALUltrasound-guided sacroiliac joint injection
ACTIVE COMPARATORInterventions
Using ultrasound the sacral hiatus in transverse position was identified. Then, sliding laterally and cephalad in transverse position, the posterior superior iliac spine and the posterior sacroiliac joint were identified. The needle was advanced toward the posterior joint space from medial to lateral, using an in-plane technique.
Using anterior posterior and contralateral oblique view the posterior joint line and inferior joint margin were identified and a needle was advanced at the point the posterior inferior joint line was most clearly seen.
Eligibility Criteria
You may qualify if:
- Low back and/or gluteal pain without radicular extension for more than 3 months
- Tenderness over the SI joint
- Pain score \> 3 by Visual Analogue Scale
You may not qualify if:
- Malignancy
- Generalized or local infection
- Coagulopathy
- Allergy to drugs to be injected
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 2, 2022
First Posted
February 11, 2022
Study Start
April 1, 2022
Primary Completion
October 1, 2022
Study Completion
October 15, 2022
Last Updated
November 1, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share