Lumbosacral RadiculopathyNCT05711121
Caudal Versus S1 Transforaminal Epidural Steroid Injection for the Treatment of Unilateral S1 Radiculopathy
A study testing Transforaminal epidural steroid injection and Caudal epidural steroid injection in people with Lumbosacral Radiculopathy, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
To compare the efficacies of two different interventional techniques (Caudal epidural steroid injection and S1 transforaminal epidural steroid injection) for the treatment of unilateral S1 radiculopathy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- Transforaminal epidural steroid injection and Caudal epidural steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to Mar 2023
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral radicular pain resulting from a paracentral L5-S1 disc herniation causing S1 nerve root compression.
Who cannot join
- History of previous surgery, pregnancy, neurological disorders, bleeding diathesis, contrast medium allergy, spinal disorders, rheumatologic diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Medicine
Istanbul, Pendik, 34899
Savas Sencan, Assoc. Prof., +905370665713, savas-44@gmail.com
Rekib Sacaklidir, M.D., +905538044082, rekibsacakli@outlook.com
About this study
To compare the efficacies of two different interventional techniques (Caudal epidural steroid injection and S1 transforaminal epidural steroid injection) for the treatment of unilateral S1 radiculopathy.
Read the detailed description
Epidural steroid injections are commonly performed for the treatment of radicular pain resulting from a disc herniation. There are 3 different methods to deliver steroids to epidural area which are caudal, interlaminar and transforaminal routes. Lower lumbar and sacral radiculopathies can be managed with caudal epidural steroid injection which is generally quite easier to perform in comparison to transforaminal injection. Transforaminal epidural injection provides injectate to reach anterior epidural area and is the most target specific technique among others. In the present study investigators aim is to compare the success rates of these two different procedures regarding unilateral S1 radiculopathy. The patients referring to the pain medicine outpatient clinic of a university hospital for unilateral radicular pain and diagnosed S1 radiculopathy were planned to be randomized into these two different intervention groups.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- Transforaminal epidural steroid injection, Caudal epidural steroid injection
- Keywords
- epidural injection, radicular pain, disc herniation, lumbosacral radiculopathy, transforaminal injection, caudal injection
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal epidural steroid injectionProcedure or surgery
Fluoroscopy-guided transforaminal epidural injection for radicular pain resulting from a disc herniation.
Caudal epidural steroid injectionProcedure or surgery
Fluoroscopy-guided caudal epidural injection for radicular pain resulting from a disc herniation.
| Study group | Role | What they receive |
|---|---|---|
| S1 transforaminal | Active comparator | The group receiving S1 transforaminal epidural steroid injection Receives: Procedure: Transforaminal epidural steroid injection |
| Caudal | Active comparator | The group receiving caudal epidural steroid injection Receives: Procedure: Caudal epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
50 percent pain relief
Number of patients having at least 50 percent pain relief
Measured: 3 months
Secondary outcomes (3)
Oswestry Disability Index
Improvement in disability scores, 0 is the best, 100 is the worst score.
Measured: 3 months
Procedure time
The overall ease of application regarding procedure time.
Measured: during procedure
Radiation exposure
The exposed radiation dose during the procedures
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Jan 2022
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral 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
- Model description
- Patients having radicular pain were randomized to either caudal or transforaminal epidural injection group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
- Investigators
- Osman Hakan Gunduz, Prof., Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711121
- Sponsor's protocol ID
- 09.2020.719
- Status last verified
- Feb 2023
- First submitted
- 9 Jan 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient data, statistics and study protocol can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal Versus S1 Transforaminal Epidural Steroid Injection for the Treatment of Unilateral S1 Radiculopathy
- ClinicalTrials.gov ID
- NCT05711121
- Acronym / sponsor ID
- 09.2020.719
- Conditions
- Lumbosacral Radiculopathy
- Keywords
- epidural injection, radicular pain, disc herniation, lumbosacral radiculopathy, transforaminal injection, caudal injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 2 Feb 2023 (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.
To compare the efficacies of two different interventional techniques (Caudal epidural steroid injection and S1 transforaminal epidural steroid injection) for the treatment of unilateral S1 radiculopathy.
Detailed description
Epidural steroid injections are commonly performed for the treatment of radicular pain resulting from a disc herniation. There are 3 different methods to deliver steroids to epidural area which are caudal, interlaminar and transforaminal routes. Lower lumbar and sacral radiculopathies can be managed with caudal epidural steroid injection which is generally quite easier to perform in comparison to transforaminal injection. Transforaminal epidural injection provides injectate to reach anterior epidural area and is the most target specific technique among others. In the present study investigators aim is to compare the success rates of these two different procedures regarding unilateral S1 radiculopathy. The patients referring to the pain medicine outpatient clinic of a university hospital for unilateral radicular pain and diagnosed S1 radiculopathy were planned to be randomized into these two different intervention groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients having radicular pain were randomized to either caudal or transforaminal epidural injection group
| Arm | Type | Receives |
|---|---|---|
| S1 transforaminal | Active comparator | Procedure: Transforaminal epidural steroid injectionThe group receiving S1 transforaminal epidural steroid injection |
| Caudal | Active comparator | Procedure: Caudal epidural steroid injectionThe group receiving caudal epidural steroid injection |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Unilateral radicular pain resulting from a paracentral L5-S1 disc herniation causing S1 nerve root compression.
Key exclusion criteria (1 listed)
- History of previous surgery, pregnancy, neurological disorders, bleeding diathesis, contrast medium allergy, spinal disorders, rheumatologic diseases
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 |
|---|---|---|
| Transforaminal epidural steroid injectionFluoroscopy-guided transforaminal epidural injection for radicular pain resulting from a disc herniation. | Procedure or surgery | S1 transforaminal |
| Caudal epidural steroid injectionFluoroscopy-guided caudal epidural injection for radicular pain resulting from a disc herniation. | Procedure or surgery | Caudal |
Primary outcome
50 percent pain relief
Time frame: 3 months
Number of patients having at least 50 percent pain relief
3 secondary outcomes
Oswestry Disability Index
Time frame: 3 months
Procedure time
Time frame: during procedure
Radiation exposure
Time frame: during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Yes. Patient data, statistics and study protocol can be shared.
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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.
Osman Hakan Gunduz, Prof. study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transforaminal epidural steroid injection and Caudal epidural steroid injection in people with Lumbosacral Radiculopathy, run by Istanbul Medeniyet University 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 1 inclusion and 1 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 15 Feb 2023. 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 Ekim Can Ozturk, M.D. (+905448294239, ekimtrilogy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50 percent pain relief (time frame: 3 months). 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 15 Feb 2023.