Herniated Disk LumbarNCT05088954
Effect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Chronic Lumbar Radiculopathy
A study testing transforaminal epidural steroid injection in people with Herniated Disk Lumbar and Metabolic Syndrome, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Transforaminal epidural steroid injection (TFESI) has been increasingly preferred in patients who can not benefit from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar disc herniation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herniated Disk Lumbar, Metabolic Syndrome
- What is being tested?
- transforaminal 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
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Sep 2025
- 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
- lumbar radiculopathy due to lumbar disc herniation, unresponsive to conservative treatments, duration of pain is at least 3 months, Patients aged 18 and above
Who cannot join
- the cases when fluoroscopy or epidural injection is contraindicated (coagulation disorders, pregnancy etc...), to have a history of lumbar spinal surgery, inflammatory diseases (rheumatoid arthritis, spondyloarthropathy), spinal infection or malignancy, systemic infection, Spondylolisthesis or spinal stenoz at the involved or adjacent segments, allergies to local anesthetics, contrast dyes or steroids, Refusal of a patient, History of prior lumbar spine surgery, presence of hip pathology (avascular necrosis, congenital hip dislocation etc...
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Patients With Chronic Lumbar Radiculopathy
Transforaminal epidural steroid injection (TFESI) has been increasingly preferred in patients who can not benefit from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar disc herniation. The aim of our study is to evaluate the effect of metabolic syndrome on the treatment results of transforaminal epidural steroid injection in patients with chronic radicular low back pain due to lumbar disc herniation.
- Conditions
- Herniated Disk Lumbar, Metabolic Syndrome
- Being tested
- transforaminal epidural steroid injection
- Medical subject headings
- Metabolic Syndrome
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
In the transforaminal approach, a small amount of drug is injected into the epidural space, and in previous studies, reduction in pain and improvement in functionality were found in patients with lumbar radicular pain in the short and medium term.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with metabolic syndrome | Active comparator | Not described Receives: Procedure: transforaminal epidural steroid injection |
| Patients without a diagnosis with metabolic syndrome | Active comparator | Not described Receives: Procedure: transforaminal epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Successful Response
The primary outcome measure of our study is successful response (>50% reduction in NRS)
Measured: 6 months
Secondary outcomes (3)
Numerical Rating Scale
The patient is asked to give a score between 1 and 10 to explain the pain level. The change in NRS compared to the baseline was measured at the outpatient visit.
Measured: 6 months
Istanbul Low Back Pain Disability Index (ILBPDI)
Istanbul Low Back Pain Disability Index (ILBPDI) is a scale developed to evaluate functional disability in patients with chronic low back pain, scoring 18 subjects. The change in ILBPDI compared to the baseline was measured at the outpatient visit.
Measured: 6 months
Short Form 12 (SF-12)
Short Form 12 (SF-12) is a quality of life assessment scale consisting of 8 sub-dimensions and 12 items. The change in SF-12 compared to baseline is measured at the outpatient visit.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 May 2024
- Primary completion1 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniated Disk LumbarStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- transforaminal epidural steroid injection
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088954
- Sponsor's protocol ID
- 09.2021.1040
- Status last verified
- Nov 2025
- First submitted
- 21 Oct 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Patients With Chronic Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT05088954
- Acronym / sponsor ID
- 09.2021.1040
- Conditions
- Herniated Disk Lumbar, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 22 Oct 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.
Transforaminal epidural steroid injection (TFESI) has been increasingly preferred in patients who can not benefit from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar disc herniation. The aim of our study is to evaluate the effect of metabolic syndrome on the treatment results of transforaminal epidural steroid injection in patients with chronic radicular low back pain due to lumbar disc herniation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- transforaminal epidural steroid injection
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with metabolic syndrome | Active comparator | Procedure: transforaminal epidural steroid injection |
| Patients without a diagnosis with metabolic syndrome | Active comparator | Procedure: transforaminal epidural steroid injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- lumbar radiculopathy due to lumbar disc herniation, unresponsive to conservative treatments, duration of pain is at least 3 months, Patients aged 18 and above
Key exclusion criteria (1 listed)
- the cases when fluoroscopy or epidural injection is contraindicated (coagulation disorders, pregnancy etc...), to have a history of lumbar spinal surgery, inflammatory diseases (rheumatoid arthritis, spondyloarthropathy), spinal infection or malignancy, systemic infection, Spondylolisthesis or spinal stenoz at the involved or adjacent segments, allergies to local anesthetics, contrast dyes or steroids, Refusal of a patient, History of prior lumbar spine surgery, presence of hip pathology (avascular necrosis, congenital hip dislocation etc...
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 injectionIn the transforaminal approach, a small amount of drug is injected into the epidural space, and in previous studies, reduction in pain and improvement in functionality were found in patients with lumbar radicular pain in the short and medium term. | Procedure or surgery | Patients diagnosed with metabolic syndrome, Patients without a diagnosis with metabolic syndrome |
Primary outcome
Rate of Successful Response
Time frame: 6 months
The primary outcome measure of our study is successful response (>50% reduction in NRS)
3 secondary outcomes
Numerical Rating Scale
Time frame: 6 months
Istanbul Low Back Pain Disability Index (ILBPDI)
Time frame: 6 months
Short Form 12 (SF-12)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Herniated Disk Lumbar and Metabolic Syndrome, run by Marmara 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: finished, as of the sponsor's last update on 4 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Successful Response (time frame: 6 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 4 Dec 2025.