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

Spinal Stenosis Clinical Trial

Official title:

The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections on Procedure Time and Radiation Exposure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05145842
• Other study ID #: 24
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2021
• Est. completion date: May 26, 2022

Study information

• Verified date: December 2021
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: Esra Celik Karbancioglu, MD
• Phone: +905058236020
• Email: esracelikdr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: May 26, 2022
• Est. primary completion date: February 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Disc Herniation
• Radiculopathy
• Spinal Stenosis

Intervention

Procedure:
• floroscopy
After proper antiseptic dressing and draping, sacral hiatus was identified. the position of the needle was confirmed by lateral and anteroposterior fluoroscopic images. The needle was introduced up to S3 level for proper spread of the drug.
• ultrasound+fluoroscopy
After proper antiseptic dressing and draping, the caudal region will be shown in the longitudinal section using sterile probe cover and gel. Under ultrasonographic imaging, the sacrococcygeal ligament will be crossed and the needle will not be advanced any further once the sacral canal is entered. The fluoroscopy phase of the combined imaging will be started and the needle position will be checked by taking an anteroposterior view. The needle tip will be positioned at the sacral 3 level. The needle will be repositioned until the proper position is achieved. The research will be terminated at this point and the time to this stage and the radiation exposure dose will be obtained.

Locations

Country	Name	City	State
Turkey	SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Processing Time	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.	during the intervention
Secondary	Fluoroscopy Time	Fluoroscopy time will be used for the assessment of radiation exposure during the procedure. It is measured automatically by the fluoroscopy device.	immediately after the intervention
Secondary	Kerma-area Product (µGy)	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.	immediately after the intervention
Secondary	Visual Analogue Scale	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	baseline, change from baseline VAS at 2 and 8 weeks after intervention
Secondary	Oswestry Low Back Pain Disability Questionnaire	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	baseline, change from baseline VAS at 2 and 8 weeks after intervention