- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07509580
Treatment Response to TFESI and DRG Pulsed RF in Lumbar Spinal Stenosis and Disc Herniation
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.
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Marmara University Faculty of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Absence of sufficient records in the hospital system
- Inaccessibility of radiological imaging
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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).
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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Baseline, 1 hour, and 3 weeks post-procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Radiological severity grading
Time Frame: Baseline (based on pre-procedural MRI)
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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).
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Baseline (based on pre-procedural MRI)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2026.26-0148
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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