Clinical trial NCT05145842: The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections
Official title: The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections on Procedure Time and Radiation Exposure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiculopathy
Lumbar Disc Herniation
Spinal Stenosis
Keywords: caudal injection
ultrasound
fluoroscopy
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to asses the effect of caudal epidural injection guided by a combination of ultrasound 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.

Secondary aims are to reveal the presence of structural variations that prevent injection by examining the morphology of the sacral hiatus by ultrasonography.

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. Before the procedure, all patients will be scanned with ultrasonography to examine the caudal region morphology.

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.

Eligibility criteria: Inclusion Criteria:

* Aged\> 18 years
* Participation in the study voluntarily
* Diagnosis of radiculopathy caused by spinal stenosis or disc herniation after physical examination and imaging (BT or MRI)

Exclusion Criteria:

* Cauda equina syndrome or rapidly progressing neurological deficit
* previous spine surgery
* local site infection
* history of allergy to local anesthetic and contrast agents
* acute or chronic unstable medical disease
* psychiatric illness
* anticoagulant therapy

Primary outcomes:
measure: Processing Time
timeFrame: during the intervention
Secondary outcomes:
measure: Fluoroscopy Time
timeFrame: immediately after the intervention
measure: Kerma-area Product (μGy)
timeFrame: immediately after the intervention
measure: Visual Analogue Scale
timeFrame: baseline, change from baseline VAS at 2 and 8 weeks after intervention
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: baseline, change from baseline VAS at 2 and 8 weeks after intervention
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
affiliation: SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Serdar Kesikburun, MD
role: STUDY_DIRECTOR
References: