Transforaminal Epidural Steroid InjectionNCT07538765
Efficacy of TFESI in Lumbar Radicular Pain
An observational study of Transforaminal Epidural Steroid Injection and Radicular Low Back Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The goal of this retrospective study is to evaluate the effectiveness of transforaminal epidural steroid injections (TFESI) in patients with radicular low back pain caused by lumbar disc herniation who did not improve with conservative treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Transforaminal Epidural Steroid Injection, Radicular Low Back Pain
- What is being tested?
- transforaminal epidural steroid injections (TFESI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 221 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 20 Dec 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We included 252 patients admitted to unilateral or bilateral radiating pain in the lower extremity associated with Low Back Pain.
Who may be able to join
- Between 18 and 90 years,
- Presence of Low Back Pain with unilateral or bilateral pain radiating to the lower extremity,
- Duration of symptoms for at least three months and unresponsive to conservative management,
- Evidence of lumbar intervertebral disc herniation confirmed by MRI within the last six months
Who cannot join
- Prior lumbar ESI within 3 months,
- History of polyneuropathy or entrapment neuropathy,
- Presence of bleeding diathesis,
- Systemic or local infections,
- Having systemic and rheumatic diseases associated with peripheral nerve involvement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Transforaminal Epidural Steroid Injections in Lumbar Radicular Pain
The goal of this retrospective study is to evaluate the effectiveness of transforaminal epidural steroid injections (TFESI) in patients with radicular low back pain caused by lumbar disc herniation who did not improve with conservative treatment.
The main questions it aims to answer are:
Read more
How effective is TFESI in reducing pain and improving physical function over a three-month period?
Can this procedure serve as a viable alternative to surgery for patients with persistent radiculopathy?
Participants aged 18 to 90 underwent image-guided injections and were monitored for three months. Researchers tracked changes in their pain levels (using the Visual Analog Scale) and their ability to perform daily activities (using the Oswestry Disability Index) to determine the treatment's success.
- Being tested
- transforaminal epidural steroid injections (TFESI)
- Keywords
- Lumbar radicular pain, transforaminal epidural steroid injection, interventional pain management.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transforaminal epidural steroid injections (TFESI)Procedure or surgery
TFESI procedure was performed under sterile conditions, and the injection area was sterilized with povidone-iodine and a sterile drape was laid. To visualize the foramen, the fluoroscopy unit was rotated cranially and obliquely at an angle between 5 and 20 degrees, and 1% lidocaine was injected subcutaneously as a local anesthetic. A Quincke 90mm 22 gauge spinal needle was inserted under the intermittent guidance of fluoroscopy. The needle was advanced into the subpedicular space, proceeding along the path corresponding to the 6 o'clock position. Needle placement was confirmed with a lateral fluoroscopic image.
| Study group | Role | What they receive |
|---|---|---|
| patients with radicular low back pain caused by lumbar disc herniation | Not described Receives: Procedure: transforaminal epidural steroid injections (TFESI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
(VAS: 0-10)
Measured: baseline, the 2nd weeks, and the 3rd months
Secondary outcomes (1)
functional status,
Oswestry Disability Index (ODI)
Measured: baseline, the 2nd weeks, and the 3rd months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Sep 2024
- Primary completion15 Aug 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transforaminal Epidural Steroid InjectionStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 221 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Esra Bilir, Ankara City Hospital Bilkent
- Investigators
- Bilir, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538765
- Sponsor's protocol ID
- TABED 1-25-1862
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roy C, Chatterjee N, Patro SN, Chakraborty A, Vijay Kumar GR, Sengupta R. The efficacy of transforaminal epidural steroid injections in lumbosacral radiculopathy. Neurol India. 2011 Sep-Oct;59(5):685-9. doi: 10.4103/0028-3886.86541.
PubMed 22019651Koc Z, Ozcakir S, Sivrioglu K, Gurbet A, Kucukoglu S. Effectiveness of physical therapy and epidural steroid injections in lumbar spinal stenosis. Spine (Phila Pa 1976). 2009 May 1;34(10):985-9. doi: 10.1097/BRS.0b013e31819c0a6b.
PubMed 19404172Bilir EE, Ata AM, Ozlemis B, Adiguzel E. Efficacy Of Transforaminal Epidural Steroid Injections in Lumbar Radicular Pain. J Pain Res. 2026 Jun 30;19:618013. doi: 10.2147/JPR.S618013. eCollection 2026.
PubMed 42404685
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transforaminal Epidural Steroid Injections in Lumbar Radicular Pain
- ClinicalTrials.gov ID
- NCT07538765
- Acronym / sponsor ID
- TABED 1-25-1862
- Keywords
- Lumbar radicular pain, transforaminal epidural steroid injection, interventional pain management.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 20 Apr 2026 (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 goal of this retrospective study is to evaluate the effectiveness of transforaminal epidural steroid injections (TFESI) in patients with radicular low back pain caused by lumbar disc herniation who did not improve with conservative treatment.
The main questions it aims to answer are:
How effective is TFESI in reducing pain and improving physical function over a three-month period?
Can this procedure serve as a viable alternative to surgery for patients with persistent radiculopathy?
Participants aged 18 to 90 underwent image-guided injections and were monitored for three months. Researchers tracked changes in their pain levels (using the Visual Analog Scale) and their ability to perform daily activities (using the Oswestry Disability Index) to determine the treatment's success.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with radicular low back pain caused by lumbar disc herniation | – | Procedure: transforaminal epidural steroid injections (TFESI) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We included 252 patients admitted to unilateral or bilateral radiating pain in the lower extremity associated with Low Back Pain.
Key inclusion criteria (4 listed)
- Between 18 and 90 years,
- Presence of Low Back Pain with unilateral or bilateral pain radiating to the lower extremity,
- Duration of symptoms for at least three months and unresponsive to conservative management,
- Evidence of lumbar intervertebral disc herniation confirmed by MRI within the last six months
Key exclusion criteria (5 listed)
- Prior lumbar ESI within 3 months,
- History of polyneuropathy or entrapment neuropathy,
- Presence of bleeding diathesis,
- Systemic or local infections,
- Having systemic and rheumatic diseases associated with peripheral nerve involvement.
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 injections (TFESI)TFESI procedure was performed under sterile conditions, and the injection area was sterilized with povidone-iodine and a sterile drape was laid. To visualize the foramen, the fluoroscopy unit was rotated cranially and obliquely at an angle between 5 and 20 degrees, and 1% lidocaine was injected subcutaneously as a local anesthetic. A Quincke 90mm 22 gauge spinal needle was inserted under the intermittent guidance of fluoroscopy. The needle was advanced into the subpedicular space, proceeding along the path corresponding to the 6 o'clock position. Needle placement was confirmed with a lateral fluoroscopic image. | Procedure or surgery | patients with radicular low back pain caused by lumbar disc herniation |
Primary outcome
Visual analog scale
Time frame: baseline, the 2nd weeks, and the 3rd months
(VAS: 0-10)
1 secondary outcome
functional status,
Time frame: baseline, the 2nd weeks, and the 3rd 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 20 Apr 2026.
- Results publication: PubMed 22019651Roy C, Chatterjee N, Patro SN, Chakraborty A, Vijay Kumar GR, Sengupta R. The efficacy of transforaminal epidural steroid injections in lumbosacral radiculopathy. Neurol India. 2011 Sep-Oct;59(5):685-9. doi: 10.4103/0028-3886.86541.
- Results publication: PubMed 19404172Koc Z, Ozcakir S, Sivrioglu K, Gurbet A, Kucukoglu S. Effectiveness of physical therapy and epidural steroid injections in lumbar spinal stenosis. Spine (Phila Pa 1976). 2009 May 1;34(10):985-9. doi: 10.1097/BRS.0b013e31819c0a6b.
- Derived from this study: PubMed 42404685Bilir EE, Ata AM, Ozlemis B, Adiguzel E. Efficacy Of Transforaminal Epidural Steroid Injections in Lumbar Radicular Pain. J Pain Res. 2026 Jun 30;19:618013. doi: 10.2147/JPR.S618013. eCollection 2026.
- 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.
Bilir principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transforaminal Epidural Steroid Injection and Radicular Low Back Pain, run by Ankara City Hospital Bilkent 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 4 inclusion and 5 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 20 Apr 2026. 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?
Visual analog scale (time frame: baseline, the 2nd weeks, and the 3rd months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07538765, which also lists 3 linked publications.
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 20 Apr 2026.