Efficacy of Pulse Radiofrequency Durations in Lumbosacral Pain

NCT ID: NCT06748469

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-07

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

RADICULAR PAIN

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients with lumbosacral radicular pain

patients with lumbosacral radicular pain resistant to conservative treatments

The duration of the intervention will be 240 seconds

Intervention Type PROCEDURE

Dorsal Root Ganglion pulsed radiofrequency 240sec

Dorsal Root Ganglion pulsed radiofrequency 480sec

Intervention Type PROCEDURE

The duration of the intervention will be 480 seconds

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The duration of the intervention will be 240 seconds

Dorsal Root Ganglion pulsed radiofrequency 240sec

Intervention Type PROCEDURE

Dorsal Root Ganglion pulsed radiofrequency 480sec

The duration of the intervention will be 480 seconds

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Age ≥ 18 years

* Pain severity NRS ≥ 4
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gülçin Babaoğlu

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ankara Bilkent City Hospital Pain Medicine

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 31337167 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TABED 1-24-764

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Blind Needling Accuracy in Lumbar Muscles
NCT07074249 NOT_YET_RECRUITING NA