Lumbar Disc HerniationNCT07367191
The Role of Temporal Changes in Pain Response After Transforaminal Epidural Steroid Injection on Treatment Success
An observational study of Lumbar Disc Herniation and Lumbar Radiculopathy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Transforaminal epidural steroid injection (TFESI) is a commonly used minimally invasive procedure for the treatment of lumbar radicular pain secondary to disc herniation. Although TFESI has been shown to provide significant pain relief in a substantial proportion of patients, the onset, duration, and temporal pattern… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Radiculopathy, Radicular Low Back Pain
- What is being tested?
- Transforaminal epidural steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 15 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 to 65 years with lumbar disc herniation-related radiculopathy who are undergoing fluoroscopy-guided transforaminal epidural steroid injection as part of routine clinical care. All participants have clinically significant radicular pain with a pre-procedural Numeric Rating Scale (NRS) score of 4 or higher and lumbar disc herniation confirmed by magnetic resonance imaging (MRI) at a segmental level consistent with clinical findings. Patients included in the study are those who have not achieved adequate symptom relief with conservative treatment modalities and are therefore referred for transforaminal epidural steroid injection by the algology clinic. Participants are prospectively followed after the procedure to evaluate temporal changes in pain intensity and their association with clinical treatment success.
Who may be able to join
- Age between 18 and 65 years
- Pre-procedural Numeric Rating Scale (NRS) pain score of 4 or higher
- Presence of segmental lumbar disc herniation demonstrated on magnetic resonance imaging (MRI) consistent with clinical findings
- Undergoing fluoroscopy-guided transforaminal epidural steroid injection due to insufficient response to conservative treatments, as determined by the algology clinic
Who cannot join
- Presence of spondylolisthesis, scoliosis, or lumbar spinal stenosis accompanying lumbar disc herniation
- Presence of malignancy
- History of lumbar spine surgery for disc herniation
- Transforaminal epidural steroid injection within the previous 6 months
- Requirement for repeat epidural steroid injection during the data collection or follow-up period
- Inability to be contacted for follow-up assessments by telephone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Savas Sencan contact
Turkey (Türkiye)1 site
Marmara Üniversitesi Tıp Fakültesi, Istanbul, Maltepe 34854
Istanbul
Secretary General Secretary, +90 2166254545, kasimogluoguzhan@gmail.com
About this study
Transforaminal epidural steroid injection (TFESI) is a commonly used minimally invasive procedure for the treatment of lumbar radicular pain secondary to disc herniation. Although TFESI has been shown to provide significant pain relief in a substantial proportion of patients, the onset, duration, and temporal pattern of pain relief after the procedure vary considerably among individuals. The relationship between early pain response patterns and long-term treatment success remains poorly understood.
This prospective observational study aims to evaluate whether temporal changes in pain intensity following TFESI, particularly during the early post-procedural period, are associated with clinical treatment success at mid- and long-term follow-up. Pain intensity will be assessed using the Numeric Rating Scale (NRS) at predefined time points following the procedure, and treatment success will be defined as a ≥50% reduction in NRS score compared with baseline.
Read the detailed description
Transforaminal epidural steroid injection (TFESI) is widely utilized in patients with lumbar disc herniation-related radiculopathy who do not respond adequately to conservative treatment and are not immediate candidates for surgery. While previous studies have demonstrated the overall effectiveness of TFESI, there is limited evidence regarding the temporal characteristics of pain relief following the procedure and how these patterns influence long-term outcomes.
In routine clinical practice, patients may exhibit heterogeneous pain trajectories after TFESI, including early responders, delayed responders, transient responders, or those with minimal or no response. Identifying early pain response patterns that predict treatment success may help clinicians optimize patient counseling, follow-up strategies, and decisions regarding repeat interventions.
In this prospective observational cohort study, adult patients undergoing fluoroscopy-guided TFESI as part of routine clinical care will be followed longitudinally. Pain intensity will be assessed using the Numeric Rating Scale (NRS) before the procedure; at 1 hour post-procedure; every 72 hours during the first 21 days; and at 1, 3, and 6 months. Demographic data, clinical characteristics, and radiological findings from lumbar magnetic resonance imaging will be recorded.
The primary objective is to determine whether early temporal changes in pain intensity following TFESI are associated with treatment success at 3 months. Secondary objectives include evaluating treatment success at 6 months and identifying early pain response thresholds that predict favorable outcomes.
- Being tested
- Transforaminal epidural steroid injection
- Keywords
- TFESI, Temporal Pain Response, Numeric Rating Scale, NRS, Transforaminal Epidural Steroid Injection, Treatment Success
- Medical subject headings
- Intervertebral Disc Displacement, Radiculopathy, Sciatica
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 steroid injection performed as part of routine clinical care. After confirmation of correct needle placement with contrast medium and exclusion of intravascular uptake, a mixture of betamethasone, bupivacaine, and normal saline is injected slowly into the epidural space. This procedure is not assigned by the study and is performed according to standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving Treatment for Lumbar Disc Herniation-Related Radiculopathy | Adult patients with lumbar disc herniation-related radiculopathy undergoing routine fluoroscopy-guided transforaminal epidural steroid injection as part of standard clinical care, followed prospectively for pain outcomes. Receives: Procedure: Transforaminal epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of Early Temporal Changes in Pain Response on Treatment Success
Association between temporal changes in pain response following transforaminal epidural steroid injection and clinical treatment success.
Pain intensity will be assessed using the Numeric Rating Scale (NRS) at baseline (pre-procedure), at 1 hour post-procedure via face-to-face assessment, every 72 hours during the first 21 days, and at 1, 3, and 6 months via telephone follow-up. Temporal patterns of pain response over these time points will be analyzed in relation to clinical treatment success, defined as a ≥50% reduction in NRS score at 3 months compared with baseline.Clinical treatment success is defined as a ≥50% reduction in NRS score at 3 months compared with baseline.
Measured: Baseline to 6 months after transforaminal epidural steroid injection
Secondary outcomes (4)
Clinical Treatment Success at 3 Months
Proportion of participants achieving a ≥50% reduction in Numeric Rating Scale (NRS) pain score at 3 months compared with baseline (pre-procedure).
Measured: 3 months after transforaminal epidural steroid injection
Clinical Treatment Success at 6 Months
Proportion of participants achieving a ≥50% reduction in Numeric Rating Scale (NRS) pain score at 6 months compared with baseline.
Measured: 6 months after transforaminal epidural steroid injection
Time to Maximum Pain Relief
Time (in days) from transforaminal epidural steroid injection to the lowest recorded Numeric Rating Scale (NRS) pain score during follow-up.
Measured: Up to 6 months after the procedure
Association Between Radiological Findings and Pain Response
Relationship between lumbar magnetic resonance imaging characteristics (disc herniation level, location, size, and nerve root compression) and temporal pain response patterns following transforaminal epidural steroid injection.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start15 Feb 2026 (estimated)
- Primary completion16 Aug 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367191
- Sponsor's protocol ID
- MarmaraU-FTR-OK-3
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 26 Jan 2026
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Temporal Changes in Pain Response After Transforaminal Epidural Steroid Injection on Treatment Success
- ClinicalTrials.gov ID
- NCT07367191
- Acronym / sponsor ID
- MarmaraU-FTR-OK-3
- Keywords
- TFESI, Temporal Pain Response, Numeric Rating Scale, NRS, Transforaminal Epidural Steroid Injection, Treatment Success
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 16 Aug 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 26 Jan 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.
Transforaminal epidural steroid injection (TFESI) is a commonly used minimally invasive procedure for the treatment of lumbar radicular pain secondary to disc herniation. Although TFESI has been shown to provide significant pain relief in a substantial proportion of patients, the onset, duration, and temporal pattern of pain relief after the procedure vary considerably among individuals. The relationship between early pain response patterns and long-term treatment success remains poorly understood.
This prospective observational study aims to evaluate whether temporal changes in pain intensity following TFESI, particularly during the early post-procedural period, are associated with clinical treatment success at mid- and long-term follow-up. Pain intensity will be assessed using the Numeric Rating Scale (NRS) at predefined time points following the procedure, and treatment success will be defined as a ≥50% reduction in NRS score compared with baseline.
Detailed description
Transforaminal epidural steroid injection (TFESI) is widely utilized in patients with lumbar disc herniation-related radiculopathy who do not respond adequately to conservative treatment and are not immediate candidates for surgery. While previous studies have demonstrated the overall effectiveness of TFESI, there is limited evidence regarding the temporal characteristics of pain relief following the procedure and how these patterns influence long-term outcomes.
In routine clinical practice, patients may exhibit heterogeneous pain trajectories after TFESI, including early responders, delayed responders, transient responders, or those with minimal or no response. Identifying early pain response patterns that predict treatment success may help clinicians optimize patient counseling, follow-up strategies, and decisions regarding repeat interventions.
In this prospective observational cohort study, adult patients undergoing fluoroscopy-guided TFESI as part of routine clinical care will be followed longitudinally. Pain intensity will be assessed using the Numeric Rating Scale (NRS) before the procedure; at 1 hour post-procedure; every 72 hours during the first 21 days; and at 1, 3, and 6 months. Demographic data, clinical characteristics, and radiological findings from lumbar magnetic resonance imaging will be recorded.
The primary objective is to determine whether early temporal changes in pain intensity following TFESI are associated with treatment success at 3 months. Secondary objectives include evaluating treatment success at 6 months and identifying early pain response thresholds that predict favorable outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving Treatment for Lumbar Disc Herniation-Related Radiculopathy | – | Procedure: Transforaminal epidural steroid injectionAdult patients with lumbar disc herniation-related radiculopathy undergoing routine fluoroscopy-guided transforaminal epidural steroid injection as part of standard clinical care, followed prospectively for pain outcomes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 to 65 years with lumbar disc herniation-related radiculopathy who are undergoing fluoroscopy-guided transforaminal epidural steroid injection as part of routine clinical care. All participants have clinically significant radicular pain with a pre-procedural Numeric Rating Scale (NRS) score of 4 or higher and lumbar disc herniation confirmed by magnetic resonance imaging (MRI) at a segmental level consistent with clinical findings. Patients included in the study are those who have not achieved adequate symptom relief with conservative treatment modalities and are therefore referred for transforaminal epidural steroid injection by the algology clinic. Participants are prospectively followed after the procedure to evaluate temporal changes in pain intensity and their association with clinical treatment success.
Key inclusion criteria (4 listed)
- Age between 18 and 65 years
- Pre-procedural Numeric Rating Scale (NRS) pain score of 4 or higher
- Presence of segmental lumbar disc herniation demonstrated on magnetic resonance imaging (MRI) consistent with clinical findings
- Undergoing fluoroscopy-guided transforaminal epidural steroid injection due to insufficient response to conservative treatments, as determined by the algology clinic
Key exclusion criteria (6 listed)
- Presence of spondylolisthesis, scoliosis, or lumbar spinal stenosis accompanying lumbar disc herniation
- Presence of malignancy
- History of lumbar spine surgery for disc herniation
- Transforaminal epidural steroid injection within the previous 6 months
- Requirement for repeat epidural steroid injection during the data collection or follow-up period
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 steroid injection performed as part of routine clinical care. After confirmation of correct needle placement with contrast medium and exclusion of intravascular uptake, a mixture of betamethasone, bupivacaine, and normal saline is injected slowly into the epidural space. This procedure is not assigned by the study and is performed according to standard clinical practice. | Procedure or surgery | Patients Receiving Treatment for Lumbar Disc Herniation-Related Radiculopathy |
Primary outcome
Role of Early Temporal Changes in Pain Response on Treatment Success
Time frame: Baseline to 6 months after transforaminal epidural steroid injection
Association between temporal changes in pain response following transforaminal epidural steroid injection and clinical treatment success. Pain intensity will be assessed using the Numeric Rating Scale (NRS) at baseline (pre-procedure), at 1 hour post-procedure via face-to-face assessment, every 72 hours during the first 21 days, and at 1, 3, and 6 months via telephone follow-up. Temporal patterns of pain response over these time points will be analyzed in relation to clinical treatment success, defined as a ≥50% reduction in NRS score at 3 months compared with baseline.Clinical treatment success is defined as a ≥50% reduction in NRS score at 3 months compared with baseline.
4 secondary outcomes
Clinical Treatment Success at 3 Months
Time frame: 3 months after transforaminal epidural steroid injection
Clinical Treatment Success at 6 Months
Time frame: 6 months after transforaminal epidural steroid injection
Time to Maximum Pain Relief
Time frame: Up to 6 months after the procedure
Association Between Radiological Findings and Pain Response
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 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.
Savas Sencan contact
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 Lumbar Disc Herniation and Lumbar Radiculopathy, 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 26 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oguzhan Kasimoglu (+90 5448911835, kasimogluoguzhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of Early Temporal Changes in Pain Response on Treatment Success (time frame: Baseline to 6 months after transforaminal epidural steroid injection). 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 26 Jan 2026.