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

NCT06240494 | Completed

• 1 other identifier: Maxillary and mandibular RF
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigeminal Neuralgia

Keywords

mandibular nerve; maxillary nerve; pulsed radiofrequency; ultrasound; analgesia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Maxillary nerve and mandibular nerve pulsed radiofrequency PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Trigeminal Neuralgia; Agnosia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ömer Taylan Akkaya, MD

  Diskapi Teaching and Research Hospital

  PRINCIPAL INVESTIGATOR

• Ezgi Can, MD

  Diskapi Teaching and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 2, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

TU (1)