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CompletedNCT05516888Updated Sep 6, 2023

Comparison of the Radiofrequency Treatments for the Treatment of Trigeminal Neuralgia.

An interventional study of radiofrequency of gasserian ganglion and radiofrequency of the peripheral trigeminal branches in Trigeminal Neuralgia, sponsored by Diskapi Teaching and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by Diskapi Teaching and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to compare the efficacy of radiofrequency of the Gasserian ganglion versus peripheral branches of the trigeminal nerve for the treatment of trigeminal neuralgia.

Read the detailed description

Trigeminal neuralgia (TN) is defined as sudden, severe, short-term, stabbing and recurrent pain in the distribution of one or more branches of the trigeminal nerve. Many invasive treatments are available for patients who respond poorly to medical therapy. Among them, radiofrequency therapy is a viable option with a reliable initial and long-term clinical efficacy.

02

Conditions studied

  • Trigeminal Neuralgia
03

In context

Trigeminal Neuralgia

135 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.

This study's enrollment of 60 is above the median of 40 across 92 interventional studies indexed under Trigeminal Neuralgia.

Browse Trigeminal Neuralgia studies →

Lead sponsor

Diskapi Teaching and Research Hospital is the lead sponsor of 101 studies on the registry; 13 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

Inclusion criteria

  • Diagnosed with Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.
  • Suffering from severe trigeminal neuralgia that cannot be alleviated effectively with conservative therapy.
  • Agree to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Infection at the puncture site.
  • Coagulation disorder.
  • Abnormal blood test (hepatic or renal function)
  • History of receiving invasive treatment (glycerol rhizolysis, radiofrequency thermocoagulation, balloon compression, gamma knife treatment, microvascular decompression)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Radiofrequency of peripheral branches of the trigeminal nerve

    pulsed radiofrequency treatment of the peripheral branches of the trigeminal nerve

    Procedure: radiofrequency of the peripheral trigeminal branches

  • Active comparator
    Radiofrequency of gasserian ganglion

    radiofrequency ablation of the gasserian ganglion

    Procedure: radiofrequency of gasserian ganglion

Interventions

  • Procedureradiofrequency of gasserian ganglion

    radiofrequency ablation of the gasserian ganglion

  • Procedureradiofrequency of the peripheral trigeminal branches

    radiofrequency of the peripheral trigeminal branches ( maxillary, mandibular, supraorbital)

06

What researchers measure

Primary outcomes

  1. The modified Barrow Neurological Institute Pain Intensity Score

    The efficacy of the treatment will be assessed using the modified Barrow Neurological Institute Pain Intensity Score (I: No pain, off medications; II: Occasional pain, off medications; IIIa: No pain, continued use of medications; IIIb: Pain persists, but adequately controlled with medications; IV: Pain not adequately controlled with medications; V: No relief).

    Time frame: six months

Secondary outcomes

  1. Numeric rating scale

    Pain will evaluated by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).

    Time frame: baseline to six months

  2. Patient satisfaction

    Patient satisfaction scores on the 5-point Likert scale (1: poor, 2: fair, 3: good, 4: very good, 5: excellent)

    Time frame: six months

07

Study locations

1 site
  • Diskapi Yildirim Beyazit Training and Research Hospital
    Ankara, 06110, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05516888
Lead sponsor
Diskapi Teaching and Research Hospital
Responsible party
Selin Guven Kose (Principal Investigator, Diskapi Teaching and Research Hospital) — Principal investigator
First posted
Aug 26, 2022
Start date
Aug 25, 2022
Primary completion
Aug 1, 2023
Completion
Aug 25, 2023
Last update
Sep 6, 2023

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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