Inflammatory Markers in Lumbar Radicular Pain Treated With PRF and TFESI

March 25, 2026 updated by: Ufuk Turan, MD, Ankara Etlik City Hospital

The Predictive Value of Systemic Inflammatory Markers in Treatment Response in Lumbar Radicular Pain Treated With Pulsed Radiofrequency and Transforaminal Epidural Steroid Injection

This retrospective observational study aims to evaluate the predictive value of systemic inflammatory markers in determining treatment response in patients with lumbar radicular pain treated with a combination of pulsed radiofrequency (PRF) and transforaminal epidural steroid injection (TFESI). Hematologic indices derived from routine blood tests-including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), platelet-to-neutrophil ratio (PNR), neutrophil-to-monocyte ratio (NMR), systemic immune-inflammation index (SII), systemic inflammation response index (SIRI), mean platelet volume (MPV), red cell distribution width-standard deviation (RDW-SD), and red cell distribution width-coefficient of variation (RDW-CV) and pain scores assessed using the Numeric Rating Scale (NRS), will be analyzed in relation to treatment success (defined as ≥50% NRS reduction at 4 weeks). Receiver operating characteristic (ROC) analysis will be used to determine optimal cutoff values for significant markers. The study aims to contribute to personalized pain management strategies by identifying accessible biomarkers that may predict treatment outcomes.

Study Overview

Detailed Description

This retrospective, observational study aims to investigate whether systemic inflammatory markers can predict treatment response in patients with lumbar radicular pain who have undergone pulsed radiofrequency (PRF) therapy and transforaminal epidural steroid injection (TFESI) targeting the dorsal root ganglion (DRG).

Inflammatory parameters derived from the complete blood count-such as neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), platelet-to-neutrophil ratio (PNR), neutrophil-to-monocyte ratio (NMR), systemic immune-inflammation index (SII = Platelet × Neutrophil / Lymphocyte), systemic inflammation response index (SIRI = Neutrophil × Monocyte / Lymphocyte), mean platelet volume (MPV), red cell distribution width-standard deviation (RDW-SD), and red cell distribution width-coefficient of variation (RDW-CV) and pain severity scores on the Numeric Rating Scale (NRS) will be assessed.

Patients aged 18 to 85 with clinically and radiologically confirmed lumbar radiculopathy, who received both PRF and TFESI in the same session and have pre-intervention laboratory data and 4-week post-intervention NRS scores, will be included. Exclusion criteria involve prior lumbar surgery, systemic inflammatory or hematological diseases, malignancy, active infection, recent steroid or immunosuppressive use, or incomplete data.

The primary outcome is treatment success, defined as a ≥50% reduction in NRS score at 4 weeks after the intervention. Patients will be grouped as "successful" or "failed" based on this criterion. Between-group comparisons will identify which markers significantly differ. For parameters with statistically significant differences, ROC curve analysis will be performed to determine sensitivity, specificity, and optimal cutoff points using the Youden index.

This study will use anonymized, retrospective data and poses no physical or psychological risk to participants. It will be conducted in accordance with the Declaration of Helsinki. The anticipated sample size is approximately 200 patients over a one-year period. Statistical analyses will be performed using IBM SPSS Statistics version 25.0. Descriptive statistics will summarize the data. The normality of continuous variables will be assessed using the Kolmogorov-Smirnov test. Independent samples t-test or Mann-Whitney U test will be used based on distribution, and categorical comparisons will be made with chi-square or Fisher's exact test. A p-value of <0.05 will be considered statistically significant.

The findings are expected to enhance clinical decision-making by identifying practical and inexpensive hematologic markers that could help predict treatment response, allowing for more personalized approaches to pain management.

Study Type

Observational

Enrollment (Actual)

264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Etlik
      • Ankara, Etlik, Turkey (Türkiye), 06000
        • Ankara Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study includes adult patients aged 18 to 85 years with clinically and radiologically confirmed lumbar radiculopathy who underwent pulsed radiofrequency (PRF) and transforaminal epidural steroid injection (TFESI) targeting the same dorsal root ganglion (DRG) in a single session. All participants had available pre-intervention laboratory data and Numeric Rating Scale (NRS) scores at the baseline and 4 weeks post-intervention. Patients with prior lumbar surgery, systemic inflammatory or hematological conditions, malignancy, active infection, recent steroid or immunosuppressive use, or incomplete records were excluded.

Description

Inclusion Criteria:

  • Age between 18 and 85 years.
  • Clinically and radiologically confirmed diagnosis of lumbar radiculopathy.
  • Underwent pulsed radiofrequency (PRF) and transforaminal epidural steroid injection (TFESI) targeting the same dorsal root ganglion (DRG) in a single session.
  • Availability of pre-intervention laboratory data, including: Complete blood count (CBC)
  • Documented Numeric Rating Scale (NRS) scores before and 4 weeks after the intervention.
  • Medical records complete for demographic, clinical, and laboratory variables.

Exclusion Criteria:

  • History of prior lumbar spine surgery.
  • Presence of systemic inflammatory, autoimmune, or hematological diseases.
  • Diagnosis of malignancy.
  • Active infection at the time of procedure.
  • Use of systemic corticosteroids or immunosuppressive agents within the last 4 weeks.
  • Incomplete clinical or laboratory data.
  • Patients outside the age range (under 18 or over 85)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Succesful Group
Treatment success was defined as a ≥50% reduction in Numeric Rating Scale (NRS) score at 4 weeks following the intervention. These patients are considered to have responded positively to the combined pulsed radiofrequency (PRF) and transforaminal epidural steroid injection (TFESI) targeting the dorsal root ganglion (DRG).
It is an interventional pain management technique used to treat chronic radicular pain, often associated with conditions like lumbar disc herniation or degenerative disc disease. It involves the application of pulsed radiofrequency energy to the dorsal root ganglia (DRG), which are clusters of nerve cell bodies located just outside the spinal cord. The DRG is involved in transmitting sensory signals from the periphery (e.g., the limbs) to the central nervous system.
Failed Group
Patients who did not achieve treatment success were defined as having a <50% reduction in the NRS score at 4 weeks after the intervention. These individuals are considered non-responsive to the combined PRF and TFESI therapy.
It is an interventional pain management technique used to treat chronic radicular pain, often associated with conditions like lumbar disc herniation or degenerative disc disease. It involves the application of pulsed radiofrequency energy to the dorsal root ganglia (DRG), which are clusters of nerve cell bodies located just outside the spinal cord. The DRG is involved in transmitting sensory signals from the periphery (e.g., the limbs) to the central nervous system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Numerical Rating Scale (NRS) Score
Time Frame: Baseline and 4 weeks post-procedure.
The NRS is a segmented numerical version of the Visual Analog Scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. 0 represents 'no pain' and 10 represents the 'worst imaginable pain.' Treatment success is defined as a ≥50% reduction in the NRS score compared to the baseline.
Baseline and 4 weeks post-procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2025

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

February 15, 2026

Study Registration Dates

First Submitted

March 22, 2026

First Submitted That Met QC Criteria

March 22, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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