NCT06121102

Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve in Oropharyngeal Cancer Pain

Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve Therapy in Management of Oropharyngeal Cancer Pain: Randomized Clinical Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the safety and efficacy of supervoltage pulsed radiofrequency glossopharyngeal nerve therapy versus standard pulsed radiofrequency in reduction of oropharyngeal cancer pain, through Visual analog scale score reduction.

Detailed description

The glossopharyngeal nerve is the 9th cranial nerve. It has motor, sensory and parasympathetic function like trigeminal and facial nerves. It has its origin in the medulla oblongata and exits the skull via the jugular foramen, close to vagus and accessory nerves, together with the internal carotid artery and sympathetic nerves and terminates in the pharynx between the superior and middle pharyngeal constrictors, splitting into its terminal branches - lingual, pharyngeal, and tonsillar. Glossopharyngeal neuralgia is an extremely uncommon occurrence and accounts for only 0.2%-1.3% of the cases with facial pain. It usually affects the male individuals above 50-year age, and the reported incidence of glossopharyngeal neuralgia is roughly 0.8 per 100,000 persons per year. As per ICHD-3 (International Classification of Headache Disease- 3) classification, glossopharyngeal neuralgia is a disease characterized by an episodic unilateral pain, with sharp and stabbing in character, with sudden onset and cessation, in the glossopharyngeal nerve distribution (jaw angle, ear, tonsillar fossa and the base of the tongue). It also affect the pharyngeal and auricular branches of the vagus nerve. Pain is commonly aggravated by coughing, talking, and swallowing. Pain in glossopharyngeal neuralgia has a relapsing and remitting pattern. Vaso glossopharyngeal neuralgia may be associated with life-threatening cardiovascular features- syncope, hypotension, cardiac arrhythmias, in contrast to trigeminal neuralgia

Conditions

• Pulsed Radiofrequency
• Super Voltage Pulsed Radiofrequency
• Glossopharyngeal Nerve
• Oropharyngeal Cancer
• Pain

Interventions

Type	Name	Description
PROCEDURE	Supervoltage pulsed radiofrequency glossopharyngeal nerve block	Stimulation will be done using baylis generator both sensory at 50 HZ and 0.5-1.0 V (patient felt tingling at base of tongue, throat, ear and side of upper neck) and motor at 2 HZ and 1-2 V (contraction of stylopharyngeus muscle will be felt). After injecting 1 ml lidocaine 2% plus 1 ml (4 mg) Betamethasone (Diprofos) to augment analgesia and to lower impedance (usually it was 200-300 ohm due to bony proximity).Super voltage pulsed RF(60-75 volt according to patient tolerability will be done for 8 minutes with pulse width = 5 millisecond and pulse frequency of 2 HZ.
PROCEDURE	Standard voltage pulsed radiofrequency glossopharyngeal nerve block	Stimulation will be done using baylis generator both sensory at 50 HZ and 0.5-1.0 V (patient felt tingling at base of tongue, throat, ear and side of upper neck) and motor at 2 HZ and 1-2 V (contraction of stylopharyngeus muscle will be felt). After injecting 1 ml lidocaine 2% plus 1 ml (4 mg) Betamethasone (Diprofos) to augment analgesia and to lower impedance (usually it was 200-300 ohm due to bony proximity).Super voltage8 pulsed RF will be done for 8 minutes with pulse width = 5 millisecond and pulse frequency of 2 HZ.

Timeline

• Start date: 2023-11-08
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2023-11-07
• Last updated: 2023-11-13

Locations

1 site across 1 country: Egypt