RadiculopathyNCT05145842
The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections
A study testing floroscopy and ultrasound+fluoroscopy in people with Radiculopathy and Lumbar Disc Herniation, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiculopathy, Lumbar Disc Herniation, Spinal Stenosis
- What is being tested?
- floroscopy and ultrasound+fluoroscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 May 2021to 26 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara
Esra Celik Karbancioglu, +905058236020
About this study
Official title: The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections on Procedure Time and Radiation Exposure
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.
Read the 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.
- Conditions
- Radiculopathy, Lumbar Disc Herniation, Spinal Stenosis
- Being tested
- floroscopy, ultrasound+fluoroscopy
- Keywords
- caudal injection, ultrasound, fluoroscopy
- Medical subject headings
- Radiculopathy, Intervertebral Disc Displacement, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
floroscopyProcedure or surgery
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+fluoroscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| floroscopy | Active comparator | 28 patients who have previously been evaluated and planned for caudal epidural injections Receives: Procedure: floroscopy |
| ultrasound+fluoroscopy | Experimental | 28 patients who have previously been evaluated and planned for caudal epidural injections Receives: Procedure: ultrasound+fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the intervention
Secondary outcomes (4)
Fluoroscopy Time
Fluoroscopy time will be used for the assessment of radiation exposure during the procedure. It is measured automatically by the fluoroscopy device.
Measured: immediately after the intervention
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.
Measured: immediately after the intervention
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
Measured: baseline, change from baseline VAS at 2 and 8 weeks after intervention
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
Measured: baseline, change from baseline VAS at 2 and 8 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start26 May 2021
- Primary completion26 Feb 2022 (estimated)
- Study completion26 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Serdar Kesikburun, MD, Study director, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145842
- Sponsor's protocol ID
- 24
- Status last verified
- Dec 2021
- First submitted
- 11 Nov 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections on Procedure Time and Radiation Exposure
- ClinicalTrials.gov ID
- NCT05145842
- Acronym / sponsor ID
- 24
- Conditions
- Radiculopathy, Lumbar Disc Herniation, Spinal Stenosis
- Keywords
- caudal injection, ultrasound, fluoroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 26 Feb 2022 (estimated)
- Study completion
- 26 May 2022 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| floroscopy | Active comparator | Procedure: floroscopy28 patients who have previously been evaluated and planned for caudal epidural injections |
| ultrasound+fluoroscopy | Experimental | Procedure: ultrasound+fluoroscopy28 patients who have previously been evaluated and planned for caudal epidural injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| floroscopyAfter 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. | Procedure or surgery | floroscopy |
| ultrasound+fluoroscopyAfter 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. | Procedure or surgery | ultrasound+fluoroscopy |
Primary outcome
Processing Time
Time frame: 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.
4 secondary outcomes
Fluoroscopy Time
Time frame: immediately after the intervention
Kerma-area Product (μGy)
Time frame: immediately after the intervention
Visual Analogue Scale
Time frame: baseline, change from baseline VAS at 2 and 8 weeks after intervention
Oswestry Low Back Pain Disability Questionnaire
Time frame: baseline, change from baseline VAS at 2 and 8 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serdar Kesikburun, MD study director
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing floroscopy and ultrasound+fluoroscopy in people with Radiculopathy and Lumbar Disc Herniation, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra Celik Karbancioglu, MD (+905058236020, esracelikdr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Processing Time (time frame: during the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.