Clinical trial NCT06240494: Predictive Factors in Maxillary and Mandibular Nerve Radiofrequency Treatment for Trigeminal Neuralgia
Official title: Predictive Factors Associated With Successful Response to Ultrasound-guided Maxillary and Mandibular Nerve Radiofrequency Treatment for Trigeminal Neuralgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigeminal Neuralgia
Keywords: mandibular nerve
maxillary nerve
pulsed radiofrequency
ultrasound
analgesia
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients who underwent maxillary and/or mandibular nerve pulsed radiofrequency for trigeminal neuralgia

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS
timeFrame: Change from Baseline NRS at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: Diskapi Teaching and Research Hospital
name: Ömer Taylan Akkaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diskapi Teaching and Research Hospital
name: Ezgi Can, MD
role: STUDY_DIRECTOR
References: