Lumbar Disc Herniation, Radiculopathy, Spinal Stenosis
Conditions
Keywords
caudal injection, ultrasound, fluoroscopy
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.
Interventions
PROCEDUREfloroscopy
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.
PROCEDUREultrasound+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.
Sponsors
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
Turkey (Türkiye)
Contacts
Primary ContactEsra Celik Karbancioglu, MD
Backup ContactSerdar Kesikburun, MD
Outcome results
None listed