The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections

Not Applicable

• Conditions: Lumbar Disc Herniation; Radiculopathy; Spinal Stenosis
• Interventions: Procedure: ultrasound+fluoroscopy; Procedure: floroscopy

• Registration Number: NCT05145842
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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.

Study Timeline

• Study Start: 2021-05-26
• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-23
• Status Verified: 2021-12
• Study First Posted: 2021-12-06
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-22
• Primary Completion: 2022-02-26
• Study Completion: 2022-05-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasound+fluoroscopy	ultrasound+fluoroscopy	28 patients who have previously been evaluated and planned for caudal epidural injections
floroscopy	floroscopy	28 patients who have previously been evaluated and planned for caudal epidural injections

Primary Outcome Measures

Name	Time	Method
Processing Time	during the intervention	The time will be measured by a researcher who will be present in the processing room, using a stopwatch. The chronometer will be started by the researcher with the contact of the needle tip with the skin, in which local anesthetic is used, and the time measurement will be terminated when the spinal treatment needle is withdrawn from the patient.

Secondary Outcome Measures

Name	Time	Method
Kerma-area Product (μGy)	immediately after the intervention	Kerma area product is a method of radiation dose monitoring used in radiographic and fluoroscopic studies. It provides an indication of the radiation dose received by a patient. It is measured automatically by the fluoroscopy device.
Visual Analogue Scale	baseline, change from baseline VAS at 2 and 8 weeks after intervention	Severity of pain was assessed using the standard 10 point VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end
Oswestry Low Back Pain Disability Questionnaire	baseline, change from baseline VAS at 2 and 8 weeks after intervention	Oswestry Low Back Pain Disability Questionnaire is a scale used to determine the degree of functional disability resulting from low back pain. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability
Fluoroscopy Time	immediately after the intervention	Fluoroscopy time will be used for the assessment of radiation exposure during the procedure. It is measured automatically by the fluoroscopy device.

Trial Locations

Locations (1)

SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital; 🇹🇷 Ankara, Turkey