Inflammatory ResponseNCT07495566
Inflammatory Markers in Lumbar Radicular Pain Treated With PRF and TFESI
An observational study of Inflammatory Response and Radiculopathy, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inflammatory Response, Radiculopathy, Radiculopathy Lumbar
- What is being tested?
- Lumbar Dorsal Root Ganglion Pulsed Radiofrequency
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 264 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2025to 15 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Etlik, 06000
About this study
Official title: 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.
Read the 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.
- Being tested
- Lumbar Dorsal Root Ganglion Pulsed Radiofrequency
- Medical subject headings
- Radiculopathy, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Dorsal Root Ganglion Pulsed RadiofrequencyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Lumbar Dorsal Root Ganglion Pulsed Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start30 Dec 2025
- Primary completion15 Jan 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Turan, MD, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495566
- Sponsor's protocol ID
- PRF/TFESI and Hemogram Ratios
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Systemic Inflammatory Markers in Treatment Response in Lumbar Radicular Pain Treated With Pulsed Radiofrequency and Transforaminal Epidural Steroid Injection
- ClinicalTrials.gov ID
- NCT07495566
- Acronym / sponsor ID
- PRF/TFESI and Hemogram Ratios
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 27 Mar 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Succesful Group | – | Procedure: Lumbar Dorsal Root Ganglion Pulsed RadiofrequencyTreatment 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). |
| Failed Group | – | Procedure: Lumbar Dorsal Root Ganglion Pulsed RadiofrequencyPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Lumbar Dorsal Root Ganglion Pulsed RadiofrequencyIt 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. | Procedure or surgery | Failed Group, Succesful Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 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 Inflammatory Response and Radiculopathy, run by Ankara Etlik City Hospital 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 30 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Numerical Rating Scale (NRS) Score (time frame: Baseline and 4 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 30 Mar 2026.