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

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06240494
• Other study ID #: Maxillary and mandibular RF
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: December 2, 2023

Study information

• Verified date: March 2024
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Procedure:
• Maxillary nerve and mandibular nerve pulsed radiofrequency
For maxillary nerve pulsed radiofrequency, the lineer transducer is placed distal and parallel to the zygomatic arch, bridging the coronoid and condylar processes and a 22 gauge 6 mm RF cannula was inserted into the target area. With sensory stimulation, patients experienced a distinct sensation in upper jaw, teeth, and palate. Then, PRF treatment was performed at 42 °C for 240 seconds. For mandibular nerve pulsed radiofrequency, the transducer was placed distally and parallel to the zygomatic arch, bridging the coronoid and condylar processes. The pterygopalatine fossa was visualized and the needle was inserted to target area. With sensory stimulation, patients experienced a distinct sensation in the lower jaw and teeth. With motor stimulation, a throwing movement of the jaw was observed with contraction of the masseter and temporal muscles. PRF treatment was performed at 42 °C for 240 s.

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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