Inflammatory Markers in Lumbar Radicular Pain Treated With PRF and TFESI

NCT07495566 | Completed

• 1 other identifier: PRF/TFESI and Hemogram Ratios
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Response; Radiculopathy; Radiculopathy Lumbar; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Numerical Rating Scale (NRS) Score

  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.

Study Arms (2)

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).

Procedure: Lumbar Dorsal Root Ganglion Pulsed Radiofrequency

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.

Procedure: Lumbar Dorsal Root Ganglion Pulsed Radiofrequency

Interventions

Lumbar Dorsal Root Ganglion Pulsed Radiofrequency PROCEDURE

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; Succesful Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Etlik, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Radiculopathy; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: December 30, 2025
• Primary Completion: January 15, 2026
• Study Completion: February 15, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

TU (1)