Pulsed RadiofrequencyNCT06121102
Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve in Oropharyngeal Cancer Pain
A study testing Supervoltage pulsed radiofrequency glossopharyngeal nerve block and Standard voltage pulsed radiofrequency glossopharyngeal nerve block in people with Pulsed Radiofrequency and Super Voltage Pulsed Radiofrequency, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulsed Radiofrequency, Super Voltage Pulsed Radiofrequency, Glossopharyngeal Nerve
- What is being tested?
- Supervoltage pulsed radiofrequency glossopharyngeal nerve block and Standard voltage pulsed radiofrequency glossopharyngeal nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Nov 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 11796
Hany M Benyameen, Master, 00201066972626, hanydanial2008@gmail.com
Emad G Saleh, MD
About this study
Official title: Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve Therapy in Management of Oropharyngeal Cancer Pain: Randomized Clinical Trial.
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.
Read the 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
- Being tested
- Supervoltage pulsed radiofrequency glossopharyngeal nerve block, Standard voltage pulsed radiofrequency glossopharyngeal nerve block
- Medical subject headings
- Oropharyngeal Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervoltage pulsed radiofrequency glossopharyngeal nerve blockProcedure or surgery
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.
Standard voltage pulsed radiofrequency glossopharyngeal nerve blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (supervoltage pulsed radiofrequency glossopharyngeal nerve block) | Experimental | Patients will receive supervoltage pulsed radiofrequency glossopharyngeal nerve block. Receives: Procedure: Supervoltage pulsed radiofrequency glossopharyngeal nerve block |
| Group B (standard voltage pulsed radiofrequency glossopharyngeal nerve block) | Active comparator | Patients will receive standard voltage pulsed radiofrequency glossopharyngeal nerve block. Receives: Procedure: Standard voltage pulsed radiofrequency glossopharyngeal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after the procedure
Secondary outcomes (5)
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.
Measured: 3 months after the procedure
Gabapentin consumption
Gabapentin capsules drugs consumption will be recorded before the block and 1 week, 2 weeks, 3 weeks, 4weeks, 2 months and 3 months afterwards.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 12 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start8 Nov 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulsed RadiofrequencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Magdy Danial, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121102
- Sponsor's protocol ID
- 2203-301-013
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve Therapy in Management of Oropharyngeal Cancer Pain: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06121102
- Acronym / sponsor ID
- 2203-301-013
- Conditions
- Pulsed Radiofrequency, Super Voltage Pulsed Radiofrequency, Glossopharyngeal Nerve, Oropharyngeal Cancer, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (supervoltage pulsed radiofrequency glossopharyngeal nerve block) | Experimental | Procedure: Supervoltage pulsed radiofrequency glossopharyngeal nerve blockPatients will receive supervoltage pulsed radiofrequency glossopharyngeal nerve block. |
| Group B (standard voltage pulsed radiofrequency glossopharyngeal nerve block) | Active comparator | Procedure: Standard voltage pulsed radiofrequency glossopharyngeal nerve blockPatients will receive standard voltage pulsed radiofrequency glossopharyngeal nerve block. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Patient refusal.
- Patients with local or systemic sepsis.
- Uncorrectable coagulopathy.
- Unstable cardiovascular disease.
- History of psychiatric and cognitive disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervoltage pulsed radiofrequency glossopharyngeal nerve blockStimulation 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 or surgery | Group A (supervoltage pulsed radiofrequency glossopharyngeal nerve block) |
| Standard voltage pulsed radiofrequency glossopharyngeal nerve blockStimulation 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. | Procedure or surgery | Group B (standard voltage pulsed radiofrequency glossopharyngeal nerve block) |
Primary outcome
The degree of pain
Time frame: 3 months after the procedure
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.
5 secondary outcomes
Morphine consumption
Time frame: 3 months after the procedure
Gabapentin consumption
Time frame: 3 months after the procedure
Patient satisfaction score
Time frame: 1 month after the block
Percentage of functional improvement
Time frame: 1 month after the procedure
Quality of life score
Time frame: 12 weeks after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervoltage pulsed radiofrequency glossopharyngeal nerve block and Standard voltage pulsed radiofrequency glossopharyngeal nerve block in people with Pulsed Radiofrequency and Super Voltage Pulsed Radiofrequency, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hany M Benyameen, Master (00201066972626, hanydanial2008@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of pain (time frame: 3 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.