Radiculopathy LumbarNCT06903949
Radiofrequency for Chronic Radicular Lumbar Pain: Geriatric vs. Young Patients
An observational study of Radiculopathy Lumbar and Radiculopathy, Lumbosacral Region, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the treatment response and lumbar magnetic resonance imaging (MRI) findings of patients who have undergone pulsed radiofrequency therapy for chronic radicular lumbar pain at the dorsal root ganglia. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Radiculopathy Lumbar, Radiculopathy, Lumbosacral Region, Chronic Pain
- What is being tested?
- Lumbar Dorsal Root Ganglia Pulsed Radiofrequency
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 15 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients who underwent pulsed radiofrequency (PRF) therapy at the lumbar dorsal root ganglia for chronic radicular lumbar pain. Participants are divided into two age groups: young group (18-64 years) and geriatric group (65 years and older). Only patients who have not responded well to medical and conservative treatments for their chronic radicular lumbar pain and have not undergone prior surgery will be included.
Who may be able to join
- 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
Who cannot join
- Missing data in the patient's follow-up records
- The patient has previously undergone interventional pain management
- The patient has previously had lumbar surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Etlik, 06000
About this study
Official title: Comparison of the Analgesic Efficacy of Radiofrequency Application to Lumbar Root Ganglia in Geriatric and Young Patients With Chronic Radicular Lumbar Pain
This study aims to evaluate the treatment response and lumbar magnetic resonance imaging (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.
Read the 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.
- Being tested
- Lumbar Dorsal Root Ganglia Pulsed Radiofrequency
- Keywords
- Radiculopathy Lumbar, Radiculopathy, Lumbosacral Region, Chronic Pain
- 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 Ganglia 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. 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 |
|---|---|---|
| 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. Receives: Procedure: Lumbar Dorsal Root Ganglia Pulsed Radiofrequency | |
| 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. Receives: Procedure: Lumbar Dorsal Root Ganglia Pulsed Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
Numeric Rating Scale is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
Measured: Change from baseline to third month after treatment
Secondary outcomes (1)
Goutallier Classification
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).
Measured: Pre-procedure grade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start15 May 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiculopathy LumbarStudies 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
- 130 participants (estimated)
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
- NCT06903949
- Sponsor's protocol ID
- Geriatric vs Young DRG
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 1 Apr 2025
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Efficacy of Radiofrequency Application to Lumbar Root Ganglia in Geriatric and Young Patients With Chronic Radicular Lumbar Pain
- ClinicalTrials.gov ID
- NCT06903949
- Acronym / sponsor ID
- Geriatric vs Young DRG
- Keywords
- Radiculopathy Lumbar, Radiculopathy, Lumbosacral Region, Chronic Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 1 Apr 2025 (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 study aims to evaluate the treatment response and lumbar magnetic resonance imaging (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young | – | Procedure: Lumbar Dorsal Root Ganglia Pulsed RadiofrequencyYoung 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. |
| Geriatric | – | Procedure: Lumbar Dorsal Root Ganglia Pulsed RadiofrequencyGeriatric group (≥65 years): These patients undergo Pulsed Radiofrequency therapy at the lumbar dorsal root ganglia, with treatment response and opioid consumption assessed post-procedure. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients who underwent pulsed radiofrequency (PRF) therapy at the lumbar dorsal root ganglia for chronic radicular lumbar pain. Participants are divided into two age groups: young group (18-64 years) and geriatric group (65 years and older). Only patients who have not responded well to medical and conservative treatments for their chronic radicular lumbar pain and have not undergone prior surgery will be included.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Missing data in the patient's follow-up records
- The patient has previously undergone interventional pain management
- The patient has previously had lumbar surgery
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 Ganglia 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. DRG is involved in transmitting sensory signals from the periphery (e.g., the limbs) to the central nervous system. | Procedure or surgery | Geriatric, Young |
Primary outcome
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)
1 secondary outcome
Goutallier Classification
Time frame: Pre-procedure grade
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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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.
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 Radiculopathy Lumbar and Radiculopathy, Lumbosacral Region, 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 1 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ufuk Turan (+905395594772 ext. TR, drufukturan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (time frame: Change from baseline to third month after treatment). 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 1 Apr 2025.