- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06903949
Radiofrequency for Chronic Radicular Lumbar Pain: Geriatric vs. Young Patients
Comparison of the Analgesic Efficacy of Radiofrequency Application to Lumbar Root Ganglia in Geriatric and Young Patients With Chronic Radicular Lumbar Pain
Study Overview
Status
Intervention / Treatment
Detailed Description
Chronic radicular lumbar pain is a significant health issue due to its increasing prevalence and impact on healthcare costs. Therefore, investigating and managing modifiable risk factors associated with chronic radicular lumbar pain play a crucial role in reducing the burden of this condition at both individual and societal levels. The most common causes of chronic radicular lumbar pain include intervertebral disc pathologies, facet joint degeneration, spinal canal stenosis, and mechanical or inflammatory involvement of neural structures. In cases resistant to medical and conservative treatment, interventional pain management techniques become the primary approach, making these patients the most frequently treated group in pain clinics.
Pulsed radiofrequency (PRF) therapy applied to the dorsal root ganglia (DRG) is a widely used minimally invasive interventional technique for radicular lumbar pain. In this procedure, fluoroscopy-guided insertion of specialized radiofrequency needles through the vertebral foramina allows the application of pulsed radiofrequency to the DRG. This technique modulates peripheral nociceptive signal transmission, contributing to pain relief.
Lumbar paraspinal muscles play a crucial role in maintaining spinal stability. Research on chronic low back pain suggests that fat infiltration in the paraspinal muscles is a significant factor in its pathophysiology. Lumbar magnetic resonance imaging (MRI) can be used to assess paraspinal muscle fat infiltration, which has been associated with higher pain intensity and poorer functional outcomes. The Goutallier classification is commonly used to grade fat infiltration. Previous studies suggest that in elderly patients with chronic low back pain, severe fat infiltration in the paraspinal muscles may be associated with a poor analgesic response to epidural steroid injections.
This study aims to evaluate the treatment response and lumbar MRI findings of patients who have undergone pulsed radiofrequency therapy for chronic radicular lumbar pain at the dorsal root ganglia. By comparing young (18-64 years) and geriatric (≥65 years) patient groups, the study seeks to assess the impact of age on treatment response and opioid consumption. Additionally, it aims to analyze the potential relationship between paraspinal muscle fat infiltration and treatment outcomes.
The medical records of patients who underwent pulsed radiofrequency therapy at the lumbar dorsal root ganglia will be reviewed retrospectively. Patients will be categorized into young (18-64 years) and geriatric (≥65 years) groups. Treatment efficacy will be assessed by retrospectively comparing Numeric Rating Scale (NRS) pain scores recorded before the procedure and at the 3rd month follow-up visit.
Since this is a retrospective study, the analysis will be conducted using existing clinical data without altering patient management or treatment plans. Additionally, pre-procedural lumbar MRI scans will be examined, and paraspinal muscle fat infiltration will be graded using the Goutallier classification. Demographic and clinical variables that may be associated with treatment response and paraspinal fat infiltration (including age, sex, body mass index (BMI), comorbidities, symptom duration, and opioid use) will be obtained from patient records.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ufuk Turan
- Phone Number: TR +905395594772
- Email: drufukturan@gmail.com
Study Locations
-
-
Etlik
-
Ankara, Etlik, Turkey, 06000
- Ankara Etlik City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age or older patients
- Patients that diagnosed with chronic radicular lumbar pain
- Have not received adequate response despite conservative treatments
- Have complete medical data available in the hospital data system
Exclusion Criteria:
- Missing data in the patient's follow-up records
- The patient has previously undergone interventional pain management
- The patient has previously had lumbar surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Young
Young group (18-64 years): These patients undergo Pulsed Radiofrequency therapy at the lumbar dorsal root ganglia, with treatment response and opioid consumption assessed post-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.
DRG is involved in transmitting sensory signals from the periphery (e.g., the limbs) to the central nervous system.
|
|
Geriatric
Geriatric group (≥65 years): These patients undergo Pulsed Radiofrequency therapy at the lumbar dorsal root ganglia, with treatment response and opioid consumption assessed post-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.
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 |
|---|---|---|
|
Numeric Rating Scale
Time Frame: Change from baseline to third month after treatment
|
Numeric Rating Scale is a scale that can be used measuring pain.
Scores range from 0 (no pain) to 10 (the worst pain)
|
Change from baseline to third month after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goutallier Classification
Time Frame: Pre-procedure grade
|
The Goutallier grading system is a scale used to assess the degree of fat infiltration in the paraspinal muscles, typically evaluated through magnetic resonance imaging (MRI).
Scores range from 0 (no fat infiltration, normal muscle) to 4 (complete fat infiltration, muscle entirely replaced by fat).
|
Pre-procedure grade
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Geriatric vs Young DRG
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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