- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07495566
Inflammatory Markers in Lumbar Radicular Pain Treated With PRF and TFESI
The Predictive Value of Systemic Inflammatory Markers in Treatment Response in Lumbar Radicular Pain Treated With Pulsed Radiofrequency and Transforaminal Epidural Steroid Injection
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Etlik
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Ankara, Etlik, Turkey (Türkiye), 06000
- Ankara Etlik City Hospital
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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 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
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.
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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.
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Baseline and 4 weeks post-procedure.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRF/TFESI and Hemogram Ratios
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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