Lumbar RadiculopathyNCT07509580
Treatment Response to TFESI and DRG Pulsed RF in Lumbar Spinal Stenosis and Disc Herniation
An observational study of Lumbar Radiculopathy and Lumbar Disc Herniation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Lumbar radiculopathy caused by conditions such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSS) can lead to chronic pain and reduced quality of life. In patients who do not respond to conservative treatments, minimally invasive procedures such as transforaminal epidural steroid injection (TFESI) and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Radiculopathy, Lumbar Disc Herniation, Lumbar Spinal Stenosis (LSS)
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18-75 years with lumbar radiculopathy secondary to lumbar disc herniation or lumbar spinal stenosis, who underwent transforaminal epidural corticosteroid injection and dorsal root ganglion pulsed radiofrequency at the Algology Clinic of Marmara University Pendik Training and Research Hospital between November 2024 and November 2025. Patients with a symptom duration of at least 3 months and with available clinical and radiological records are included in the analysis.
Who may be able to join
- Age between 18 and 75 years
- Presence of symptoms associated with lumbar spinal stenosis or lumbar disc herniation
- Symptom duration of at least 3 months
- Having undergone lumbar transforaminal epidural corticosteroid injection and dorsal root ganglion pulsed radiofrequency
Who cannot join
- Absence of sufficient records in the hospital system
- Inaccessibility of radiological imaging
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Medicine
Istanbul
About this study
Official title: Comparison of Treatment Response to Transforaminal Epidural Steroid Injection and Dorsal Root Ganglion Pulsed Radiofrequency in Patients With Lumbar Spinal Stenosis and Lumbar Disc Herniation
Lumbar radiculopathy caused by conditions such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSS) can lead to chronic pain and reduced quality of life. In patients who do not respond to conservative treatments, minimally invasive procedures such as transforaminal epidural steroid injection (TFESI) and pulsed radiofrequency (pRF) applied to the dorsal root ganglion (DRG) are commonly used.
This study aims to compare treatment responses between patients with lumbar disc herniation and those with lumbar spinal stenosis who have undergone TFESI combined with dorsal root ganglion pulsed radiofrequency. Pain levels and clinical outcomes will be evaluated to determine whether the underlying condition affects treatment effectiveness.
The results of this study may help guide clinicians in selecting the most appropriate treatment approach for patients with lumbar radiculopathy.
Read the detailed description
Lumbar radiculopathy is a common clinical condition associated with degenerative spine disorders such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSS), often resulting in chronic pain and functional limitation. In patients who do not respond adequately to conservative management, minimally invasive interventional procedures are frequently employed. Among these, transforaminal epidural steroid injection (TFESI) and pulsed radiofrequency (pRF) applied to the dorsal root ganglion (DRG) are widely used for pain control.
Pulsed radiofrequency (pRF) is thought to exert its analgesic effect through neuromodulatory mechanisms rather than neurodestruction, including modulation of nociceptive transmission and reduction of neuroinflammatory processes. When combined with transforaminal epidural steroid injection (TFESI), these interventions may provide enhanced clinical benefit.
Despite the increasing use of combined TFESI and dorsal root ganglion (DRG) pulsed radiofrequency (pRF), there is limited evidence comparing treatment responses across different etiological subgroups. The pathophysiological mechanisms underlying lumbar disc herniation (LDH) and lumbar spinal stenosis (LSS) differ, with LDH typically involving focal nerve root irritation and LSS characterized by chronic compression and ischemic changes. These differences may influence the effectiveness of interventional treatments.
This retrospective study aims to evaluate treatment outcomes in patients who underwent transforaminal epidural steroid injection (TFESI) combined with dorsal root ganglion (DRG) pulsed radiofrequency (pRF), by categorizing them into two groups based on underlying etiology: lumbar disc herniation and lumbar spinal stenosis. Changes in pain intensity and clinical outcomes will be compared between these groups. The findings are expected to contribute to a better understanding of patient selection and optimization of interventional pain management strategies.
- Keywords
- Lumbar radiculopathy, Transforaminal epidural steroid injection, TFESI, Dorsal root ganglion, Pulsed radiofrequency, DRG pulsed RF, Lumbar disc herniation, Lumbar spinal stenosis, Interventional pain management, Neuromodulation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Disc Herniation | Patients diagnosed with lumbar disc herniation (LDH) who underwent transforaminal epidural steroid injection (TFESI) and dorsal root ganglion (DRG) pulsed radiofrequency (pRF). | |
| Lumbar Spinal Stenosis | Patients diagnosed with lumbar spinal stenosis (LSS) who underwent transforaminal epidural steroid injection (TFESI) and dorsal root ganglion (DRG) pulsed radiofrequency (pRF). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of change in pain intensity (Numeric Rating Scale, NRS) between lumbar disc herniation and lumbar spinal stenosis
Pain intensity will be assessed using the Numeric Rating Scale (0-10), and changes from baseline at 1 hour and 3 weeks post-procedure will be compared between patients with lumbar disc herniation and lumbar spinal stenosis.
Measured: Baseline, 1 hour, and 3 weeks post-procedure
Secondary outcomes (1)
Radiological severity grading
Radiological findings will be evaluated using established classification systems, including the Pfirrmann grading system for lumbar disc degeneration, the Schizas classification for lumbar spinal stenosis (LSS), and the Michigan State University (MSU) classification for lumbar disc herniation (LDH).
Measured: Baseline (based on pre-procedural MRI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Nov 2024
- Primary completion30 Nov 2025
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haner Direskeneli, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509580
- Sponsor's protocol ID
- 09.2026.26-0148
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Response to Transforaminal Epidural Steroid Injection and Dorsal Root Ganglion Pulsed Radiofrequency in Patients With Lumbar Spinal Stenosis and Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT07509580
- Acronym / sponsor ID
- 09.2026.26-0148
- Keywords
- Lumbar radiculopathy, Transforaminal epidural steroid injection, TFESI, Dorsal root ganglion, Pulsed radiofrequency, DRG pulsed RF, Lumbar disc herniation, Lumbar spinal stenosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 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.
Lumbar radiculopathy caused by conditions such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSS) can lead to chronic pain and reduced quality of life. In patients who do not respond to conservative treatments, minimally invasive procedures such as transforaminal epidural steroid injection (TFESI) and pulsed radiofrequency (pRF) applied to the dorsal root ganglion (DRG) are commonly used.
This study aims to compare treatment responses between patients with lumbar disc herniation and those with lumbar spinal stenosis who have undergone TFESI combined with dorsal root ganglion pulsed radiofrequency. Pain levels and clinical outcomes will be evaluated to determine whether the underlying condition affects treatment effectiveness.
The results of this study may help guide clinicians in selecting the most appropriate treatment approach for patients with lumbar radiculopathy.
Detailed description
Lumbar radiculopathy is a common clinical condition associated with degenerative spine disorders such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSS), often resulting in chronic pain and functional limitation. In patients who do not respond adequately to conservative management, minimally invasive interventional procedures are frequently employed. Among these, transforaminal epidural steroid injection (TFESI) and pulsed radiofrequency (pRF) applied to the dorsal root ganglion (DRG) are widely used for pain control.
Pulsed radiofrequency (pRF) is thought to exert its analgesic effect through neuromodulatory mechanisms rather than neurodestruction, including modulation of nociceptive transmission and reduction of neuroinflammatory processes. When combined with transforaminal epidural steroid injection (TFESI), these interventions may provide enhanced clinical benefit.
Despite the increasing use of combined TFESI and dorsal root ganglion (DRG) pulsed radiofrequency (pRF), there is limited evidence comparing treatment responses across different etiological subgroups. The pathophysiological mechanisms underlying lumbar disc herniation (LDH) and lumbar spinal stenosis (LSS) differ, with LDH typically involving focal nerve root irritation and LSS characterized by chronic compression and ischemic changes. These differences may influence the effectiveness of interventional treatments.
This retrospective study aims to evaluate treatment outcomes in patients who underwent transforaminal epidural steroid injection (TFESI) combined with dorsal root ganglion (DRG) pulsed radiofrequency (pRF), by categorizing them into two groups based on underlying etiology: lumbar disc herniation and lumbar spinal stenosis. Changes in pain intensity and clinical outcomes will be compared between these groups. The findings are expected to contribute to a better understanding of patient selection and optimization of interventional pain management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar Disc Herniation | – | –Patients diagnosed with lumbar disc herniation (LDH) who underwent transforaminal epidural steroid injection (TFESI) and dorsal root ganglion (DRG) pulsed radiofrequency (pRF). |
| Lumbar Spinal Stenosis | – | –Patients diagnosed with lumbar spinal stenosis (LSS) who underwent transforaminal epidural steroid injection (TFESI) and dorsal root ganglion (DRG) pulsed radiofrequency (pRF). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18-75 years with lumbar radiculopathy secondary to lumbar disc herniation or lumbar spinal stenosis, who underwent transforaminal epidural corticosteroid injection and dorsal root ganglion pulsed radiofrequency at the Algology Clinic of Marmara University Pendik Training and Research Hospital between November 2024 and November 2025. Patients with a symptom duration of at least 3 months and with available clinical and radiological records are included in the analysis.
Key inclusion criteria (4 listed)
- Age between 18 and 75 years
- Presence of symptoms associated with lumbar spinal stenosis or lumbar disc herniation
- Symptom duration of at least 3 months
- Having undergone lumbar transforaminal epidural corticosteroid injection and dorsal root ganglion pulsed radiofrequency
Key exclusion criteria (2 listed)
- Absence of sufficient records in the hospital system
- Inaccessibility of radiological imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of change in pain intensity (Numeric Rating Scale, NRS) between lumbar disc herniation and lumbar spinal stenosis
Time frame: Baseline, 1 hour, and 3 weeks post-procedure
Pain intensity will be assessed using the Numeric Rating Scale (0-10), and changes from baseline at 1 hour and 3 weeks post-procedure will be compared between patients with lumbar disc herniation and lumbar spinal stenosis.
1 secondary outcome
Radiological severity grading
Time frame: Baseline (based on pre-procedural MRI)
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 22 Apr 2026.
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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?
An observational study of Lumbar Radiculopathy and Lumbar Disc Herniation, 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 2 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: under way, not looking for participants, as of the sponsor's last update on 22 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?
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?
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?
Comparison of change in pain intensity (Numeric Rating Scale, NRS) between lumbar disc herniation and lumbar spinal stenosis (time frame: Baseline, 1 hour, and 3 weeks post-procedure). 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 Apr 2026.