The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections
Primary Purpose
Radiculopathy, Lumbar Disc Herniation, Spinal Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
floroscopy
ultrasound+fluoroscopy
Sponsored by
About this trial
This is an interventional treatment trial for Radiculopathy focused on measuring caudal injection, ultrasound, fluoroscopy
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
Sites / Locations
- SBU,Gaziler Physical Medicine and Rehabilitation Education and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
floroscopy
ultrasound+fluoroscopy
Arm Description
28 patients who have previously been evaluated and planned for caudal epidural injections
28 patients who have previously been evaluated and planned for caudal epidural injections
Outcomes
Primary Outcome Measures
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in which local anesthetic is used, and the time measurement will be terminated when the spinal treatment needle is withdrawn from the patient.
Secondary Outcome Measures
Fluoroscopy Time
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)
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
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
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
Full Information
NCT ID
NCT05145842
First Posted
November 11, 2021
Last Updated
December 7, 2021
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05145842
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
February 26, 2022 (Anticipated)
Study Completion Date
May 26, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy, Lumbar Disc Herniation, Spinal Stenosis
Keywords
caudal injection, ultrasound, fluoroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
floroscopy
Arm Type
Active Comparator
Arm Description
28 patients who have previously been evaluated and planned for caudal epidural injections
Arm Title
ultrasound+fluoroscopy
Arm Type
Experimental
Arm Description
28 patients who have previously been evaluated and planned for caudal epidural injections
Intervention Type
Procedure
Intervention Name(s)
floroscopy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ultrasound+fluoroscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Processing Time
Description
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.
Time Frame
during the intervention
Secondary Outcome Measure Information:
Title
Fluoroscopy Time
Description
Fluoroscopy time will be used for the assessment of radiation exposure during the procedure. It is measured automatically by the fluoroscopy device.
Time Frame
immediately after the intervention
Title
Kerma-area Product (μGy)
Description
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.
Time Frame
immediately after the intervention
Title
Visual Analogue Scale
Description
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
Time Frame
baseline, change from baseline VAS at 2 and 8 weeks after intervention
Title
Oswestry Low Back Pain Disability Questionnaire
Description
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
Time Frame
baseline, change from baseline VAS at 2 and 8 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Celik Karbancioglu, MD
Phone
+905058236020
Email
esracelikdr@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Serdar Kesikburun, MD
Phone
+903122911402
Email
serdarkb@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serdar Kesikburun, MD
Organizational Affiliation
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esra Celik Karbancioglu
Phone
+905058236020
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections
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