Predictive Factors in Maxillary and Mandibular Nerve Radiofrequency Treatment for Trigeminal Neuralgia

Predictive Factors Associated With Successful Response to Ultrasound-guided Maxillary and Mandibular Nerve Radiofrequency Treatment for Trigeminal Neuralgia

Trigeminal neuralgia is one of the most common craniofacial neuralgias and one of the most severe types of facial pain, typically limited to the distribution of the trigeminal nerve. The first-line treatment for trigeminal neuralgia is medical therapy and primarily antiepileptic drugs. Various interventional and surgical methods can be used in patients who do not respond to medical treatment or who cannot tolerate side effects. Pulsed radiofrequency treatment of maxillary and mandibular nerves may provide longer-lasting pain relief in trigeminal neuralgia.This study aimed to investigate the clinical and demographic characteristics affecting treatment success in patients who underwent ultrasound-guided pulsed radiofrequency of the maxillary and/or mandibular nerves for trigeminal neuralgia.

Study Overview

• Status: Completed
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Procedure: Maxillary nerve and mandibular nerve pulsed radiofrequency

Detailed Description

Pulsed radiofrequency treatment applied to the maxillary and mandibular nerves, which are the peripheral branches of the trigeminal nerve, is frequently used in patients with trigeminal neuralgia who do not adequately respond to medical treatment.

Pain intensity was evaluated at baseline and 3 months after US-guided maxillary and/or mandibular nerve PRF treatment using NRS (numerical rating scale). The primary outcome measure was percent reduction in pain, with 50% pain relief lasting at least 3 months was defined as a positive categorical outcome.

In addition, demographic data such as age (years), gender, duration of pain (months), etiology (idiopathic or secondary), MRI findings (normal findings or abnormal findings due to conditions such as vascular compression and demyelinating plaque), pain side (unilateral or bilateral), and history of Gasser ganglion RF ablation were obtained from patient data. NRS scores before and 3 months after PRF were collected from the patient data and recorded. Pre-procedural cranial MRI and MR cisternography reports were accessed from patient records, and any abnormalities were recorded. We retrospectively analyzed the patient's electronic medical history records and the archive system containing the imaging results to obtain the variables.

The main aim of this study was to determine the clinical and demographic variables associated with treatment outcomes in patients with TN who underwent PRF of the maxillary and mandibular nerves. The secondary aim of this study was to determine the incidence of procedure-related adverse events.

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients who underwent maxillary and/or mandibular nerve pulsed radiofrequency for trigeminal neuralgia

Description

Inclusion Criteria:

• Diagnosis of trigeminal neuralgia according to the IHS 3-beta criteria
• No response to conservative treatment for > 3 months
• Magnetic resonance imaging within 1 year prior to injection
• Access to clinical data

Exclusion Criteria:

• Inadequate medical records with missing numerical rating scale (NRS) scores and MRI images
• Patients lost to follow-up within three months after the procedure
• History of surgery or gamma-knife radiosurgery for trigeminal neuralgia
• History of malignancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.	Change from Baseline NRS at 3 months

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Principal Investigator: Ömer Taylan Akkaya, MD, Diskapi Teaching and Research Hospital; Study Director: Ezgi Can, MD, Diskapi Teaching and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 2, 2023

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; analgesia; pulsed radiofrequency; mandibular nerve; maxillary nerve
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: Maxillary and mandibular RF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No