RADICULAR PAINNCT06748469
Efficacy of Pulse Radiofrequency Durations in Lumbosacral Pain
An observational study of RADICULAR PAIN, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary: This study aims to compare the efficacy of short-duration (240 sec) and long-duration (480 sec) pulsed radiofrequency (PRF) applications on pain, functionality, patient satisfaction, and side effect profiles in patients with lumbosacral radicular pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RADICULAR PAIN
- What is being tested?
- The duration of the intervention will be 240 seconds and Dorsal Root Ganglion pulsed radiofrequency 480sec
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2025to 30 Dec 2025
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients to undergo DRG PRF for lumbar radicular pain in bilkent city hospital algology clinic
Who may be able to join
- Age ≥ 18 years
- Pain severity NRS ≥ 4
- Pain duration > 12 weeks Refractory to conservative treatments (physical therapy, medical treatments) Exclusion Criteria Malignancy-related pain Diagnosis of diabetes mellitus or polyneuropathy Back pain more severe than leg pain Conditions that impair follow-up (e.g., psychiatric disorders, dementia) Patients refusing the procedure
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Pain Medicine
Ankara
About this study
Official title: Analgesic Efficacy of Different Pulse Radiofrequency Treatment Durations in the Management of Lumbosacral Radicular Pain
Brief Summary:
This study aims to compare the efficacy of short-duration (240 sec) and long-duration (480 sec) pulsed radiofrequency (PRF) applications on pain, functionality, patient satisfaction, and side effect profiles in patients with lumbosacral radicular pain. The PRF procedure will be applied to the dorsal root ganglion (DRG) under fluoroscopic guidance.
Read the detailed description
In this study, all procedures will be performed in the prone position under sterile conditions and guided by fluoroscopy. After identifying anatomical landmarks, the cannula will be positioned close to the dorsal root ganglion. The tip of the cannula will be placed in the dorsal-cranial quadrant of the intervertebral foramen in the lateral view, and between one-third and halfway along the pedicle column in the anteroposterior view. Once the RF cannula is properly positioned, an RF electrode will be inserted through the cannula and connected to the RF generator. The final position of the RF cannula will be confirmed by sensory stimulation (paresthesia) at less than 0.5 V and motor stimulation perceived at a level at least 1.5 times greater than the sensory stimulation threshold.
In the short-duration PRF group, a PRF cycle will be applied at 42°C for 240 seconds, while in the long-duration group, it will be applied at 42°C for 480 seconds. Following the PRF application, epidural spread will be confirmed using contrast dye, after which 4 mL of a solution containing 8 mg dexamethasone and 5 mg bupivacaine will be injected at each level.
- Conditions
- RADICULAR PAIN
- Being tested
- The duration of the intervention will be 240 seconds, Dorsal Root Ganglion pulsed radiofrequency 480sec
- Keywords
- RADICULAR PAIN, DORSAL ROOT GANGLIA, PULSED RADIOFREQUENCY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The duration of the intervention will be 240 secondsProcedure or surgery
Dorsal Root Ganglion pulsed radiofrequency 240sec
Dorsal Root Ganglion pulsed radiofrequency 480secProcedure or surgery
The duration of the intervention will be 480 seconds
| Study group | Role | What they receive |
|---|---|---|
| patients with lumbosacral radicular pain | patients with lumbosacral radicular pain resistant to conservative treatments Receives: Procedure: The duration of the intervention will be 240 seconds; Procedure: Dorsal Root Ganglion pulsed radiofrequency 480sec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale on pain severity (0 = no pain, 10 = unbearable pain))
Change in pain severity
Measured: 1, 3, and 6 months
Secondary outcomes (4)
Global perceived effect (GPE)
Change in GPE scores according to the 7-point Likert scale (1=worst, 7=best) over time will be used to assess patient satisfaction and improvement
Measured: 1, 3, and 6 months
Oswetry disability index (ODI)
Change in 10-item Oswestry disability index (ODI) questionnaire (range: 0-100; 0 = no disablility) over time will be used to assess physical function
Measured: 0, 1, 3, and 6 months
Patient satisfaction
Change in Patient satisfaction (5-point Likert scale, 0= very disappointed, 5=very satisfied) over time will be used
Measured: 1, 3, and 6 months
Change in analgesic use
Change in analgesic use over time (0=same, 1=decreased, 2=increased)
Measured: 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start7 Feb 2025
- Primary completion30 Sep 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RADICULAR PAINStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin Babaoğlu, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748469
- Sponsor's protocol ID
- TABED 1-24-764
- Status last verified
- Feb 2025
- First submitted
- 18 Dec 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ı don't want
Publications
Wan C, Dong DS, Song T. High-Voltage, Long-Duration Pulsed Radiofrequency on Gasserian Ganglion Improves Acute/Subacute Zoster-Related Trigeminal Neuralgia: A Randomized, Double-Blinded, Controlled Trial. Pain Physician. 2019 Jul;22(4):361-368.
PubMed 31337167
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Different Pulse Radiofrequency Treatment Durations in the Management of Lumbosacral Radicular Pain
- ClinicalTrials.gov ID
- NCT06748469
- Acronym / sponsor ID
- TABED 1-24-764
- Conditions
- RADICULAR PAIN
- Keywords
- RADICULAR PAIN, DORSAL ROOT GANGLIA, PULSED RADIOFREQUENCY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 27 Dec 2024 (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.
Brief Summary:
This study aims to compare the efficacy of short-duration (240 sec) and long-duration (480 sec) pulsed radiofrequency (PRF) applications on pain, functionality, patient satisfaction, and side effect profiles in patients with lumbosacral radicular pain. The PRF procedure will be applied to the dorsal root ganglion (DRG) under fluoroscopic guidance.
Detailed description
In this study, all procedures will be performed in the prone position under sterile conditions and guided by fluoroscopy. After identifying anatomical landmarks, the cannula will be positioned close to the dorsal root ganglion. The tip of the cannula will be placed in the dorsal-cranial quadrant of the intervertebral foramen in the lateral view, and between one-third and halfway along the pedicle column in the anteroposterior view. Once the RF cannula is properly positioned, an RF electrode will be inserted through the cannula and connected to the RF generator. The final position of the RF cannula will be confirmed by sensory stimulation (paresthesia) at less than 0.5 V and motor stimulation perceived at a level at least 1.5 times greater than the sensory stimulation threshold.
In the short-duration PRF group, a PRF cycle will be applied at 42°C for 240 seconds, while in the long-duration group, it will be applied at 42°C for 480 seconds. Following the PRF application, epidural spread will be confirmed using contrast dye, after which 4 mL of a solution containing 8 mg dexamethasone and 5 mg bupivacaine will be injected at each level.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with lumbosacral radicular pain | – | Procedure: The duration of the intervention will be 240 seconds, Procedure: Dorsal Root Ganglion pulsed radiofrequency 480secpatients with lumbosacral radicular pain resistant to conservative treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients to undergo DRG PRF for lumbar radicular pain in bilkent city hospital algology clinic
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Pain severity NRS ≥ 4
- Pain duration > 12 weeks Refractory to conservative treatments (physical therapy, medical treatments) Exclusion Criteria Malignancy-related pain Diagnosis of diabetes mellitus or polyneuropathy Back pain more severe than leg pain Conditions that impair follow-up (e.g., psychiatric disorders, dementia) Patients refusing the procedure
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| The duration of the intervention will be 240 secondsDorsal Root Ganglion pulsed radiofrequency 240sec | Procedure or surgery | patients with lumbosacral radicular pain |
| Dorsal Root Ganglion pulsed radiofrequency 480secThe duration of the intervention will be 480 seconds | Procedure or surgery | patients with lumbosacral radicular pain |
Primary outcome
Numeric rating scale on pain severity (0 = no pain, 10 = unbearable pain))
Time frame: 1, 3, and 6 months
Change in pain severity
4 secondary outcomes
Global perceived effect (GPE)
Time frame: 1, 3, and 6 months
Oswetry disability index (ODI)
Time frame: 0, 1, 3, and 6 months
Patient satisfaction
Time frame: 1, 3, and 6 months
Change in analgesic use
Time frame: 1, 3, and 6 months
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 8 Jan 2026.
- Results publication: PubMed 31337167Wan C, Dong DS, Song T. High-Voltage, Long-Duration Pulsed Radiofrequency on Gasserian Ganglion Improves Acute/Subacute Zoster-Related Trigeminal Neuralgia: A Randomized, Double-Blinded, Controlled Trial. Pain Physician. 2019 Jul;22(4):361-368.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. ı don't want
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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 RADICULAR PAIN, run by Ankara City Hospital Bilkent 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 3 inclusion and 0 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 8 Jan 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?
Numeric rating scale on pain severity (0 = no pain, 10 = unbearable pain)) (time frame: 1, 3, and 6 months). 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 NCT06748469, which also lists 1 linked publication.
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 8 Jan 2026.