Clinical trial NCT06121102: Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve in Oropharyngeal Cancer Pain
Official title: Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve Therapy in Management of Oropharyngeal Cancer Pain: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulsed Radiofrequency
Super Voltage Pulsed Radiofrequency
Glossopharyngeal Nerve
Oropharyngeal Cancer
Pain
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤ 70 Years.
* Both sexes
* American Society of Anesthesiologists (ASA) class II and III.
* Patients under pain management for oropharyngeal cancer (failed medical treatment or intolerance to the side effects of the drug).
* Visual analog scale (VAS) equal to or more than 6 cm in spite medical treatment.

Exclusion Criteria:

* Patient refusal.
* Patients with local or systemic sepsis.
* Uncorrectable coagulopathy.
* Unstable cardiovascular disease.
* History of psychiatric and cognitive disorders.
* Patients allergic to medication used.7
* Unable to lie supine.
* Local anatomical distortion (either congenital, post-surgical or post-radiotherapy) making intervention difficult and hazardous.
* Elongated styloid process \> 25 mm.
* Age less than 18 year and more than 70 year.

Primary outcomes:
measure: The degree of pain
timeFrame: 3 months after the procedure
Secondary outcomes:
measure: Morphine consumption
timeFrame: 3 months after the procedure
measure: Gabapentin consumption
timeFrame: 3 months after the procedure
measure: Patient satisfaction score
timeFrame: 1 month after the block
measure: Percentage of functional improvement
timeFrame: 1 month after the procedure
measure: Quality of life score
timeFrame: 12 weeks after the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: