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

NCT06366139 | Completed

• 1 other identifier: Trigeminal RFT vs max/mand PRF
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trigeminal Neuralgia; Headache Disorders

Keywords

Pulsed Radiofrequency Treatment; Radiofrequency Ablation; Maxillary Nerve; Mandibular Nerve

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale (NRS)

  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 Outcomes (1)

• The Medication Quantification Scale III (MQS III)

  Change from baseline 6th month after treatment

Study Arms (2)

radiofrequency thermocoagulation group

ACTIVE COMPARATOR

Trigeminal ganglion radiofrequency thermocoagulation for trigeminal neuralgia

Procedure: Radiofrequency thermocoagulation of the trigeminal ganglion

pulsed radiofrequency group

ACTIVE COMPARATOR

Maxillary mandibular nerve pulsed radiofrequency for trigeminal neuralgia

Procedure: Maxillary/Mandibular nerve pulsed radiofrequency

Interventions

Radiofrequency thermocoagulation of the trigeminal ganglion PROCEDURE

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.

radiofrequency thermocoagulation group

Maxillary/Mandibular nerve pulsed radiofrequency PROCEDURE

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.

pulsed radiofrequency group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Diskapi Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Trigeminal Neuralgia; Headache Disorders

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Study Officials

• Gevher Rabia Genc Perdecioğlu

  Diskapi TRH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor Investigator

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: January 11, 2023
• Primary Completion: February 4, 2024
• Study Completion: March 7, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

TU (1)