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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (supervoltage pulsed radiofrequency glossopharyngeal nerve block) | Experimental | Patients will receive supervoltage pulsed radiofrequency glossopharyngeal nerve block. |
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| Group B (standard voltage pulsed radiofrequency glossopharyngeal nerve block) | Active Comparator | Patients will receive standard voltage pulsed radiofrequency glossopharyngeal nerve block. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervoltage pulsed radiofrequency glossopharyngeal nerve block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The degree of pain | Each patient will be instructed about pain assessment with the visual analog scale (VAS) score. VAS(0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS score will be measured at the following times: pre-procedure, day 1 after the procedure, 1,2,3,4 Weeks after the procedure, 2,3 Months after the procedure. | 3 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption | Morphine sulphate tablets drugs consumption will be recorded pre-procedure, day 1 after the procedure, 1,2,3,4 weeks after the procedure, 2,3 Months after the procedure. | 3 months after the procedure |
| Gabapentin consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hany M Benyameen, Master | Contact | 00201066972626 | hanydanial2008@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 11796 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| Standard voltage pulsed radiofrequency glossopharyngeal nerve block | Procedure | 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. |
|
Gabapentin capsules drugs consumption will be recorded before the block and 1 week, 2 weeks, 3 weeks, 4weeks, 2 months and 3 months afterwards.
| 3 months after the procedure |
| Patient satisfaction score | Patient satisfaction score will be assessed as the following, how satisfied are the patient with the results of the procedure ? very satisfied = 5, somewhat satisfied = 4, neither satisfied nor dissatisfied = 3, somewhat dissatisfied = 2, very dissatisfied =1 It will be assessed at the following times: 24 hours after the block, 1,2 weeks after the block, 1month after the block | 1 month after the block |
| Percentage of functional improvement | This is a self-reported analysis for the primary outcome after performing pain interventions. It is divided into 4 categories (0-25%)= no or minimal functional improvement, (more than 25-50%)= mild improvement, (more than 50-75%)= moderate improvement, and (more than 75-100%)= marked improvement. | 1 month after the procedure |
| Quality of life score | Quality of life score improvement using the Flanagan quality of life scale (QOLS) ,which is a 16 -item (domain) questionnaire with each item scored from 1 to 7 points. The scale will be explained to the patient by the pain physician, and the total score will be calculated and recorded at the preoperative10 assessment (base line) and at postoperative weeks 2,3,4, 8 and 12. | 12 weeks after the procedure |
| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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