Dorsal Root GanglionNCT06756893
The Effect of Sensory Stimulation Threshold on the Efficacy of Pulsed Radiofrequency Applied to the Dorsal Root Ganglion in Patients with Chronic Lumbar Radicular Pain
An observational study of Dorsal Root Ganglion and Pulsed Radiofrequency, run by Ankara University.
Trial summary
Lomber dorsal root ganglion pRF is an interventional treatment options in the treatment of lumbar radicular pain. The goal of this study is to investigate the effect of sensory threshold outcomes on pain severity during dorsal root ganglion pulsed radiofrequency (DRG-pRF). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dorsal Root Ganglion, Pulsed Radiofrequency, Chronic Pain
- What is being tested?
- Dorsal Root Ganglion Pulsed Radiofrequency
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Oct 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Candidates who visited algology clinic of Ankara University Medicine Faculty Hospitals to DRG-pRF prodecure for chronic LRP.
Who may be able to join
- Pain lasting ≥3 months NRS score ≥4 Unilateral pain Diagnosis of spinal stenosis or lumbar disc herniation causing root compression, confirmed by magnetic resonance imaging (MRI) according to appropriate diagnostic criteria and classification Failure of conservative treatment
Who cannot join
- Unwillingness to participate in the study Epidural steroid injection within the past month Uncontrolled psychiatric disorders despite medical treatment Systemic or localized infection signs at the procedure site Severe spinal stenosis Allergy to steroids or contrast agents History of cancer Coagulopathy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Sensory Stimulation Thresholds on the Efficacy of Pulsed Radiofrequency Applied to the Dorsal Root Ganglion in Patients with Chronic Lumbar Radicular Pain
Lomber dorsal root ganglion pRF is an interventional treatment options in the treatment of lumbar radicular pain. The goal of this study is to investigate the effect of sensory threshold outcomes on pain severity during dorsal root ganglion pulsed radiofrequency (DRG-pRF). It will also learn effects about disability due to chronic LRP. The main questions it aims to answer are:
Does lower sensory threshold result in lower pain scores and chronic LRP related disability?
Participants will:
Take DRG-pRF procedure for 4 minutes. Visit the clinic at 1. and 3. month for questionnaries.
Read the detailed description
Lumbar radicular pain is characterized by sharp, stabbing, or throbbing pain radiating to one or more dermatomes. It is a common and challenging condition for clinicians to manage in pain practice. Conservative treatments such as physical therapy, non-steroidal anti-inflammatory drugs, rest, and exercise may fail, leading to chronic pain. In such cases, minimally invasive methods such as epidural steroid injection (ESI) or pulsed radiofrequency (pRF) of the dorsal root ganglion (DRG) may be preferred.
Unlike conventional radiofrequency, pRF does not cause ablation. Due to the intermittent delivery of energy generated by the electric current, the target tissue temperature does not exceed 42°C. This creates a magnetic field that modulates pain without causing neuronal damage.
The DRG, highly sensitive to mechanical compression, is a critical target in radicular pain. There is evidence supporting the efficacy of DRG pRF in chronic lumbar radicular pain. Studies comparing pRF alone or in combination with ESI versus ESI alone have found it effective in providing long-term pain relief. However, despite the increasing body of evidence, studies are lacking on the impact of the proximity of pRF to the target neuronal tissue on clinical outcomes.
The primary aim of this study is to investigate the relationship between the sensory stimulation threshold, indicating the proximity to the target tissue during DRG pRF, and the reduction in Numeric Rating Scale (NRS) scores at the 3-month follow-up. Secondary objectives include examining the relationship between Oswestry Disability Index (ODI) and NRS scores at various assessment time points.
The DRG, highly sensitive to mechanical compression, is a critical target in radicular pain (5,6). There is evidence supporting the efficacy of DRG pRF in chronic lumbar radicular pain. Studies comparing pRF alone or in combination with ESI versus ESI alone have found it effective in providing long-term pain relief (7). However, despite the increasing body of evidence, studies are lacking on the impact of the proximity of pRF to the target neuronal tissue on clinical outcomes.
The primary aim of this study is to investigate the relationship between the sensory stimulation threshold, indicating the proximity to the target tissue during DRG pRF, and the reduction in Numeric Rating Scale (NRS) scores at the 3-month follow-up. Secondary objectives include examining the relationship between Oswestry Disability Index (ODI) and NRS scores at various assessment time points.
- Conditions
- Dorsal Root Ganglion, Pulsed Radiofrequency, Chronic Pain, Lumbar Radiculopathy, Lumbar Spinal Stenosis
- Being tested
- Dorsal Root Ganglion Pulsed Radiofrequency
- Keywords
- dorsal root ganglion, pulsed radiofrequency, lumbar radiculopathy, pain related disability
- Medical subject headings
- Chronic Pain, Radiculopathy, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsal Root Ganglion Pulsed RadiofrequencyProcedure or surgery
Using C-arm fluoroscopy, a 22G, 10 cm RF needle with a 5 mm active tip will be directed from lateral to medial towards the vertebral foramen. Once the needle reaches the lateral edge of the pedicle shadow, the C-arm will be adjusted to a lateral view to confirm that the needle is located at the craniodorsal portion of the intervertebral foramen. Sensory stimulation will be delivered through the RF generator at 50 Hz, and paresthesia will be sought in the corresponding dermatome at values between 0.4-0.8 mA.
After achieving paresthesia, motor stimulation at 2 Hz will be applied, and the location near the DRG will be confirmed if motor stimulation is not elicited at values less than 1.5 times the sensory threshold. Pulsed RF will then be applied for 4 minutes at a setting of 45 V, 20 ms pulse width, and 2 Hz frequency. Following the application, needle will be directed slightly anterior and after appropriate contrast flow, dexamethasone will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Dorsal Root Ganglion Pulsed Radiofrequency | Not described Receives: Procedure: Dorsal Root Ganglion Pulsed Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprocedure pain severity at 3th month
Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 3 months after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.
Measured: From procedure to 3 months after prodecure
Secondary outcomes (4)
Postprocedure pain severity at 30. min
Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 30. min after interventions at bedside. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.
Measured: From procedure to 30 minustes after procedure
Postprocedure first month pain severity
Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 1 month after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.
Measured: From procedure to 1 month after procedure
Postprocedure first month OSWESTRY scores
Disability will be assessed with OSWESTRY Diasability Index at 1 month. OSWESTRY measures pain related lumbar disability. It has 0 minimum and 100 maximum value. Lower scores represent better outcomes.
Measured: From procedure to 1 month after procedure
Postprocedure 3th month OSWESTRY scores
Disability will be assessed with OSWESTRY Diasability Index at 3 month. OSWESTRY measures pain related lumbar disability. It has 0 minimum and 100 maximum value. Lower scores represent better outcomes.
Measured: From procedure to 3 month after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dorsal Root GanglionStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanzade Aybuke Unal, Ankara University
- Investigators
- Güngör Enver Özgencil, MD, Study director, Ankara University Medicine Faculty Anesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756893
- Sponsor's protocol ID
- 2024/766
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data can be shared except personal data.
Publications
Cohen SP, Strassels SA, Kurihara C, Lesnick IK, Hanling SR, Griffith SR, Buckenmaier CC 3rd, Nguyen C. Does sensory stimulation threshold affect lumbar facet radiofrequency denervation outcomes? A prospective clinical correlational study. Anesth Analg. 2011 Nov;113(5):1233-41. doi: 10.1213/ANE.0b013e31822dd379. Epub 2011 Sep 14.
PubMed 21918166Park S, Park JH, Jang JN, Choi SI, Song Y, Kim YU, Park S. Pulsed radiofrequency of lumbar dorsal root ganglion for lumbar radicular pain: A systematic review and meta-analysis. Pain Pract. 2024 Jun;24(5):772-785. doi: 10.1111/papr.13351. Epub 2024 Jan 31.
PubMed 38294072
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sensory Stimulation Thresholds on the Efficacy of Pulsed Radiofrequency Applied to the Dorsal Root Ganglion in Patients with Chronic Lumbar Radicular Pain
- ClinicalTrials.gov ID
- NCT06756893
- Acronym / sponsor ID
- 2024/766
- Conditions
- Dorsal Root Ganglion, Pulsed Radiofrequency, Chronic Pain, Lumbar Radiculopathy, Lumbar Spinal Stenosis
- Keywords
- dorsal root ganglion, pulsed radiofrequency, lumbar radiculopathy, pain related disability
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 3 Jan 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.
Lomber dorsal root ganglion pRF is an interventional treatment options in the treatment of lumbar radicular pain. The goal of this study is to investigate the effect of sensory threshold outcomes on pain severity during dorsal root ganglion pulsed radiofrequency (DRG-pRF). It will also learn effects about disability due to chronic LRP. The main questions it aims to answer are:
Does lower sensory threshold result in lower pain scores and chronic LRP related disability?
Participants will:
Take DRG-pRF procedure for 4 minutes. Visit the clinic at 1. and 3. month for questionnaries.
Detailed description
Lumbar radicular pain is characterized by sharp, stabbing, or throbbing pain radiating to one or more dermatomes. It is a common and challenging condition for clinicians to manage in pain practice. Conservative treatments such as physical therapy, non-steroidal anti-inflammatory drugs, rest, and exercise may fail, leading to chronic pain. In such cases, minimally invasive methods such as epidural steroid injection (ESI) or pulsed radiofrequency (pRF) of the dorsal root ganglion (DRG) may be preferred.
Unlike conventional radiofrequency, pRF does not cause ablation. Due to the intermittent delivery of energy generated by the electric current, the target tissue temperature does not exceed 42°C. This creates a magnetic field that modulates pain without causing neuronal damage.
The DRG, highly sensitive to mechanical compression, is a critical target in radicular pain. There is evidence supporting the efficacy of DRG pRF in chronic lumbar radicular pain. Studies comparing pRF alone or in combination with ESI versus ESI alone have found it effective in providing long-term pain relief. However, despite the increasing body of evidence, studies are lacking on the impact of the proximity of pRF to the target neuronal tissue on clinical outcomes.
The primary aim of this study is to investigate the relationship between the sensory stimulation threshold, indicating the proximity to the target tissue during DRG pRF, and the reduction in Numeric Rating Scale (NRS) scores at the 3-month follow-up. Secondary objectives include examining the relationship between Oswestry Disability Index (ODI) and NRS scores at various assessment time points.
The DRG, highly sensitive to mechanical compression, is a critical target in radicular pain (5,6). There is evidence supporting the efficacy of DRG pRF in chronic lumbar radicular pain. Studies comparing pRF alone or in combination with ESI versus ESI alone have found it effective in providing long-term pain relief (7). However, despite the increasing body of evidence, studies are lacking on the impact of the proximity of pRF to the target neuronal tissue on clinical outcomes.
The primary aim of this study is to investigate the relationship between the sensory stimulation threshold, indicating the proximity to the target tissue during DRG pRF, and the reduction in Numeric Rating Scale (NRS) scores at the 3-month follow-up. Secondary objectives include examining the relationship between Oswestry Disability Index (ODI) and NRS scores at various assessment time points.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dorsal Root Ganglion Pulsed Radiofrequency | – | Procedure: Dorsal Root Ganglion Pulsed Radiofrequency |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Candidates who visited algology clinic of Ankara University Medicine Faculty Hospitals to DRG-pRF prodecure for chronic LRP.
Key inclusion criteria (1 listed)
- Pain lasting ≥3 months NRS score ≥4 Unilateral pain Diagnosis of spinal stenosis or lumbar disc herniation causing root compression, confirmed by magnetic resonance imaging (MRI) according to appropriate diagnostic criteria and classification Failure of conservative treatment
Key exclusion criteria (1 listed)
- Unwillingness to participate in the study Epidural steroid injection within the past month Uncontrolled psychiatric disorders despite medical treatment Systemic or localized infection signs at the procedure site Severe spinal stenosis Allergy to steroids or contrast agents History of cancer Coagulopathy
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 |
|---|---|---|
| Dorsal Root Ganglion Pulsed RadiofrequencyUsing C-arm fluoroscopy, a 22G, 10 cm RF needle with a 5 mm active tip will be directed from lateral to medial towards the vertebral foramen. Once the needle reaches the lateral edge of the pedicle shadow, the C-arm will be adjusted to a lateral view to confirm that the needle is located at the craniodorsal portion of the intervertebral foramen. Sensory stimulation will be delivered through the RF generator at 50 Hz, and paresthesia will be sought in the corresponding dermatome at values between 0.4-0.8 mA. After achieving paresthesia, motor stimulation at 2 Hz will be applied, and the location near the DRG will be confirmed if motor stimulation is not elicited at values less than 1.5 times the sensory threshold. Pulsed RF will then be applied for 4 minutes at a setting of 45 V, 20 ms pulse width, and 2 Hz frequency. Following the application, needle will be directed slightly anterior and after appropriate contrast flow, dexamethasone will be injected. | Procedure or surgery | Dorsal Root Ganglion Pulsed Radiofrequency |
Primary outcome
Postprocedure pain severity at 3th month
Time frame: From procedure to 3 months after prodecure
Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 3 months after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.
4 secondary outcomes
Postprocedure pain severity at 30. min
Time frame: From procedure to 30 minustes after procedure
Postprocedure first month pain severity
Time frame: From procedure to 1 month after procedure
Postprocedure first month OSWESTRY scores
Time frame: From procedure to 1 month after procedure
Postprocedure 3th month OSWESTRY scores
Time frame: From procedure to 3 month after procedure
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 3 Jan 2025.
- Background: PubMed 21918166Cohen SP, Strassels SA, Kurihara C, Lesnick IK, Hanling SR, Griffith SR, Buckenmaier CC 3rd, Nguyen C. Does sensory stimulation threshold affect lumbar facet radiofrequency denervation outcomes? A prospective clinical correlational study. Anesth Analg. 2011 Nov;113(5):1233-41. doi: 10.1213/ANE.0b013e31822dd379. Epub 2011 Sep 14.
- Background: PubMed 38294072Park S, Park JH, Jang JN, Choi SI, Song Y, Kim YU, Park S. Pulsed radiofrequency of lumbar dorsal root ganglion for lumbar radicular pain: A systematic review and meta-analysis. Pain Pract. 2024 Jun;24(5):772-785. doi: 10.1111/papr.13351. Epub 2024 Jan 31.
- Individual participant dataSharing planned: Yes. All data can be shared except personal data.
Related trials for Dorsal Root Ganglion
Not yet recruiting
Dorsal Root Ganglion Stimulation After Lower Motor Neuron Damage
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Active, not recruitingObservational study
Electrophysiological Predictors of Cervical DRG Pulsed Radiofrequency Outcomes
Chronic Cervical Radicular Pain
Recruiting
45 V vs 60 V Pulsed Radiofrequency of the Cervical Dorsal Root Ganglion for Cervical Radicular Pain
Cervical Radicular Pain
Active, not recruitingObservational study
Treatment Response to TFESI and DRG Pulsed RF in Lumbar Spinal Stenosis and Disc Herniation
Lumbar Radiculopathy, Lumbar Disc Herniation
Active, not recruiting
The Effect of Adding a Local Anesthetic to Transforaminal Epidural Injection in Cervical Disc Herniation.
Transforaminal Epidural Injection, Dorsal Root Ganglion Stimulation
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.
Güngör Enver Özgencil, MD study director
Ankara University Medicine Faculty Anesthesiology and Reanimation Department
Questions about this trial
What is this clinical trial studying?
An observational study of Dorsal Root Ganglion and Pulsed Radiofrequency, run by Ankara University.
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 1 inclusion and 1 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 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Hanzade Aybuke Unal, MD (+905057179039, hanzadeunal@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprocedure pain severity at 3th month (time frame: From procedure to 3 months after prodecure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06756893, which also lists 2 linked publications.
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 3 Jan 2025.