Trigeminal Ganglion RFT vs Maxillary/Mandibular PRF in the Treatment of Trigeminal Neuralgia

April 10, 2024 updated by: Damla Yürük, Diskapi Teaching and Research Hospital

Comparison of the Efficacy of Trigeminal Ganglion Radiofrequency Thermocoagulation and Ultrasound-guided Maxillary-mandibular Pulsed Radiofrequency in the Treatment of Trigeminal Neuralgia

Trigeminal ganglion (TG) radiofrequency thermocoagulation (RFT) and ultrasound (US)-guided maxillary or mandibular (max/mand) pulsed radiofrequency (PRF) are two interventional procedures for the treatment of trigeminal neuralgia (TN). The aim of this study was to compare the efficacy and safety of these two procedures. For this evaluation, the numeric rating scale (NRS) was used to assess pain relief and the Medication Quantification Scale III (MQS III) was used to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Trigeminal neuralgia (TN) is a very severe, unilateral, short, lightning-like pain that starts and ends suddenly and is limited to the areas related to the branches of the trigeminal nerve. The pain can be triggered by stimuli such as washing face, shaving, smoking, talking and/or brushing teeth (trigger factors) and usually occurs spontaneously.

Treatment of TN is complex despite the use of multiple medications and may be resistant. Interventional procedures are an option in cases that do not respond to medical treatments or if there are side effects. Interventional procedures include trigeminal ganglion RFT and maxillary-mandibular (max/mand) nerve PRF. PRF delivers short bursts of high-voltage electrical current to the target nerve, creating a non-thermal effect that modulates the transmission of pain signals. RFT delivers a continuous current that heats the target tissue, causing coagulation necrosis on nerves.

Although trigeminal ganglion RFT is a frequently performed method in the treatment of idiopathic TN, there is limited literature data on ultrasonography (US)-guided max/mand nerve PRF.

The primary aim of this study was to compare the efficacy of trigeminal ganglion RFT and max/mand nerve PRF for TN. Secondary aims were to determine the effects of interventions on drug consumption and interventional safety based on adverse events. A total of at least 44 patients, 22 patients in each group, will be enrolled for comparison. NRS, and MQS III scores before treatments, 1 month, and 6 months after treatments will be compared both within and between groups.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Diskapi Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with idiopathic TN according to the international headache society
  • Pain for at least 6 months and numeric rating scale (NRS) score greater than 6 despite medical treatment (despite the maximum tolerated dose of carbamazepine, gabapentinoid or tramadol)

Exclusion Criteria:

  • Vascular compression of the trigeminal nerve by MRI and MRI angiography and the presence of secondary causes such as multiple sclerosis
  • Dental or temporomandibular joint pathologies
  • Previous interventional procedures or surgery for TN
  • Coagulopathy or use of antiaggregants and anticoagulants
  • Cardiac pacemaker
  • Renal-hepatic insufficiency
  • Diagnosis of psychiatric illness
  • Malignancy and
  • Injection site or systemic infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: radiofrequency thermocoagulation group
Trigeminal ganglion radiofrequency thermocoagulation for trigeminal neuralgia
Procedure: Radiofrequency thermocoagulation of the trigeminal ganglion
The patient is placed in the supine position and the foramen ovale is identified medial to the coronoid process of the mandible by giving the head a submental oblique position under fluoroscopic guidance. A 20-gauge, 5 mm active type, and 100 mm radiofrequency cannula is inserted 2 cm lateral to the commissura labialis and advanced towards the foramen. After entering the foramen ovale with a lateral fluoroscopic image, the radiofrequency cannula is connected to the radiofrequency generator and sensory and motor stimulations are performed to confirm the target maxillary and mandibular nerves. The radiofrequency lesion is applied at 60°C, 65°C and 70°C for 60-seconds periods. The patient is observed for side effects for 1 hour after the procedure.
Active Comparator: pulsed radiofrequency group
Maxillary mandibular nerve pulsed radiofrequency for trigeminal neuralgia
Procedure: Maxillary/Mandibular nerve pulsed radiofrequency
The patient is placed in the lateral decubitus position with the affected side up. A 5-12 MHz linear ultrasound probe is placed in the infrazygomatic area above the maxilla at a 45° inclination in both the frontal and horizontal planes. The probe position allows visualization of the pterygopalatine fossa, which is limited to the maxilla anteriorly and the greater wing of the sphenoid posteriorly. Real-time ultrasound guidance allows direct localization of the internal maxillary artery and identification of the needle tip. The radiofrequency cannula was connected to the radiofrequency generator and PRF was applied at 42°C for 240 seconds after confirming the localization of the maxillary and mandibular nerve by obtaining appropriate responses to sensory and motor stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical rating scale (NRS)
Time Frame: Change from baseline to 1st and 6th month after treatment
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
Change from baseline to 1st and 6th month after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Medication Quantification Scale III (MQS III)
Time Frame: Change from baseline 6th month after treatment
The MQS III is a validated tool in medical research that quantifies medication regimens by assigning a numerical value to each medication based on its class, dosage, and associated risks. This scale aids clinicians and researchers in tracking changes in pain levels throughout a treatment course or study, providing an objective measure of medication consumption and its potential negative impact.
Change from baseline 6th month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Investigators

  • Study Chair: Gevher Rabia Genc Perdecioğlu, Diskapi TRH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2023

Primary Completion (Actual)

February 4, 2024

Study Completion (Actual)

March 7, 2024

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Estimated)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trigeminal RFT vs max/mand PRF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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