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CompletedNCT06748469Updated Jan 8, 2026

Efficacy of Pulse Radiofrequency Durations in Lumbosacral Pain

An observational study in RADICULAR PAIN, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by Ankara City Hospital Bilkent · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • RADICULAR PAIN

Keywords

  • RADICULAR PAIN
  • DORSAL ROOT GANGLIA
  • PULSED RADIOFREQUENCY
03

In context

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients to undergo DRG PRF for lumbar radicular pain in bilkent city hospital algology clinic

Eligibility criteria

Inclusion Criteria:

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • patients with lumbosacral radicular pain

    patients with lumbosacral radicular pain resistant to conservative treatments

    Procedure: The duration of the intervention will be 240 seconds · Procedure: Dorsal Root Ganglion pulsed radiofrequency 480sec

Interventions

  • ProcedureThe duration of the intervention will be 240 seconds

    Dorsal Root Ganglion pulsed radiofrequency 240sec

  • ProcedureDorsal Root Ganglion pulsed radiofrequency 480sec

    The duration of the intervention will be 480 seconds

06

What researchers measure

Primary outcomes

  1. Numeric rating scale on pain severity (0 = no pain, 10 = unbearable pain))

    Change in pain severity

    Time frame: 1, 3, and 6 months

Secondary outcomes

  1. 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

    Time frame: 1, 3, and 6 months

  2. 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

    Time frame: 0, 1, 3, and 6 months

  3. Patient satisfaction

    Change in Patient satisfaction (5-point Likert scale, 0= very disappointed, 5=very satisfied) over time will be used

    Time frame: 1, 3, and 6 months

  4. Change in analgesic use

    Change in analgesic use over time (0=same, 1=decreased, 2=increased)

    Time frame: 1, 3, and 6 months

07

Study locations

1 site
  • Ankara Bilkent City Hospital Pain Medicine
    Ankara, Turkey (Türkiye)
08

References and documents

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 ↗

Related links

Individual participant data

Plan to share: No — ı don't want

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06748469
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Gülçin Babaoğlu (Medical doctor, Ankara City Hospital Bilkent) — Principal investigator
First posted
Dec 27, 2024
Start date
Feb 7, 2025
Primary completion
Sep 30, 2025
Completion
Dec 30, 2025
Last update
Jan 8, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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