Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2026-01-26 @ 5:55 PM
Study NCT ID:
NCT05944861
Status:
UNKNOWN
Last Update Posted:
2023-07-13
First Post:
2023-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections
Sponsor:
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Organization:
Study Overview
Official Title:
Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections: Effect on Procedure Time and Radiation Exposure
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to investigate the effect of the application of sacroiliac joint injection guided by combination of ultrasonography and fluoroscopy on the duration of the procedure and the amount of radiation exposed during the procedure, compared to the application of only fluoroscopy-guided technique. Secondary objectives are to evaluate the effectiveness of the treatment with both methods and to record the adverse events that may be encountered during the procedure.
Detailed Description:
The study was designed as prospective, randomized, controlled trial. The patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio to fluoroscopy and ultrasound+fluoroscopy. Processing time will be recorded during injection. "Fluoroscopy time" (sec) and "kerma-area product" (μGy) automatically measured by the fluoroscopy device will be used to evaluate the radiation exposure. Pre-procedural visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) values were noted all the patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: