Glossopharyngeal NeuralgiaNCT06931457
Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet Rich Plasma to Treat Idiopathic Glossopharyngeal Neuralgia (GPN)
An observational study of Glossopharyngeal Neuralgia and Pulsed Radiofrequency, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To investigate the efficacy and safety of the application of PRF combined PRP to the for the treatment of GPN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glossopharyngeal Neuralgia, Pulsed Radiofrequency, Platelet Rich Plasma
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Suitable participants will be screened at the pain management center of each hospital to participate in the study.
Who may be able to join
- age >18 years;
- diagnosed with idiopathic GPN according to the third International Classification of Headache Disorders (ICHD) classification;
- patients who failed pharmacotherapy or intolerable side effects of medication;
- undergoing PRF for GPN;
- at least 1 month of follow-up recordings.
Who cannot join
- Patients with bilateral GPN;
- Abnormalities in blood measurements, liver and kidney function, blood glucose, coagulation, electrocardiography or chest radiography;
- Infection at the puncture site;
- Previous mental illness;
- Previous history of narcotic drug abuse;
- Prior anticoagulant or antiplatelet therapy;
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- An implantable pulse generator;
- Current pregnancy or breast feeding.
- Patients with incomplete medical records (lack of baseline data or postoperative follow-up data).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
About this study
Official title: Efficacy and Safety of the Application of Pulsed Radiofrequency, Combined With Platelet Rich Plasma, to the Treatment of Idiopathic Glossopharyngeal Neuralgia (GPN): A Study Protocol for a Multi-Center, Prospective, Open-Label, Propensity Score Match Cohort Study
To investigate the efficacy and safety of the application of PRF combined PRP to the for the treatment of GPN.
- Medical subject headings
- Glossopharyngeal Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PRF group | Motor stimulation at 2 Hz, 1.0V will be performed and the negative results indicated that no muscle contraction will be generated. Afterwards, PRF treatment will be performed for 360 seconds. The parameters of PRF application were initiated at the voltage of 45 V, the temperature of 42°C, the pulse rate of 2Hz at the rate of 20 milliseconds. The pulse treatment generator will be set to the automatic pulsed radiofrequency mode, with a temperature of 42°C, pulse frequency of 2Hz, pulse width of 20ms and treatment duration of 360s. | |
| PRF+PRP group | Motor stimulation at 2 Hz, 1.0V will be performed and the negative results indicated that no muscle contraction will be generated. Afterwards, PRF treatment will be performed for 360 seconds. The parameters of PRF application were initiated at the voltage of 45 V, the temperature of 42°C, the pulse rate of 2Hz at the rate of 20 milliseconds. The pulse treatment generator will be set to the automatic pulsed radiofrequency mode, with a temperature of 42°C, pulse frequency of 2Hz, pulse width of 20ms and treatment duration of 360s. PRF group will only receive PRF treatment, PRF combined with PRP group, after removing the radiofrequency electrode, 2 ml of LP-PRP mixture will be injected slowly. Additional analgesics will be administered for participants' comfort during and after the procedure. If the patients were not satisfied with the outcome after one month, other treatment options will be available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS) score
Numeric rating scale (NRS) score during resting was used to evaluate pain intensity before and after PRF treatment (0=no pain, 10=intolerable pain)
Measured: 1day, 3days, 1week, 2weeks, 1month, 3months, 6months, and 1year following the procedure
Secondary outcomes (1)
Barrow Neurological Institute pain scale(BNI score)
BNI score during resting was used to evaluate pain relief
Measured: 1day, 3days, 1week, 2weeks, 1month, 3months, 6months, and 1year following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glossopharyngeal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, The Second Hospital of Hebei Medical University
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931457
- Sponsor's protocol ID
- KY 2023-263-03-07
- Status last verified
- Jul 2025
- First submitted
- 15 Apr 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Application of Pulsed Radiofrequency, Combined With Platelet Rich Plasma, to the Treatment of Idiopathic Glossopharyngeal Neuralgia (GPN): A Study Protocol for a Multi-Center, Prospective, Open-Label, Propensity Score Match Cohort Study
- ClinicalTrials.gov ID
- NCT06931457
- Acronym / sponsor ID
- KY 2023-263-03-07
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, The Second Hospital of Hebei Medical University
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 17 Apr 2025 (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.
To investigate the efficacy and safety of the application of PRF combined PRP to the for the treatment of GPN.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF group | – | –Motor stimulation at 2 Hz, 1.0V will be performed and the negative results indicated that no muscle contraction will be generated. Afterwards, PRF treatment will be performed for 360 seconds. The parameters of PRF application were initiated at the voltage of 45 V, the temperature of 42°C, the pulse rate of 2Hz at the rate of 20 milliseconds. The pulse treatment generator will be set to the automatic pulsed radiofrequency mode, with a temperature of 42°C, pulse frequency of 2Hz, pulse width of 20ms and treatment duration of 360s. |
| PRF+PRP group | – | –Motor stimulation at 2 Hz, 1.0V will be performed and the negative results indicated that no muscle contraction will be generated. Afterwards, PRF treatment will be performed for 360 seconds. The parameters of PRF application were initiated at the voltage of 45 V, the temperature of 42°C, the pulse rate of 2Hz at the rate of 20 milliseconds. The pulse treatment generator will be set to the automatic pulsed radiofrequency mode, with a temperature of 42°C, pulse frequency of 2Hz, pulse width of 20ms and treatment duration of 360s. PRF group will only receive PRF treatment, PRF combined with PRP group, after removing the radiofrequency electrode, 2 ml of LP-PRP mixture will be injected slowly. Additional analgesics will be administered for participants' comfort during and after the procedure. If the patients were not satisfied with the outcome after one month, other treatment options will be available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suitable participants will be screened at the pain management center of each hospital to participate in the study.
Key inclusion criteria (5 listed)
- age >18 years;
- diagnosed with idiopathic GPN according to the third International Classification of Headache Disorders (ICHD) classification;
- patients who failed pharmacotherapy or intolerable side effects of medication;
- undergoing PRF for GPN;
- at least 1 month of follow-up recordings.
Key exclusion criteria (9 listed)
- Patients with bilateral GPN;
- Abnormalities in blood measurements, liver and kidney function, blood glucose, coagulation, electrocardiography or chest radiography;
- Infection at the puncture site;
- Previous mental illness;
- Previous history of narcotic drug abuse;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numeric rating scale (NRS) score
Time frame: 1day, 3days, 1week, 2weeks, 1month, 3months, 6months, and 1year following the procedure
Numeric rating scale (NRS) score during resting was used to evaluate pain intensity before and after PRF treatment (0=no pain, 10=intolerable pain)
1 secondary outcome
Barrow Neurological Institute pain scale(BNI score)
Time frame: 1day, 3days, 1week, 2weeks, 1month, 3months, 6months, and 1year following the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No. Not yet decided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glossopharyngeal Neuralgia and Pulsed Radiofrequency, run by Beijing Tiantan Hospital at 1 site in China.
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 9 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: looking for participants now, as of the sponsor's last update on 3 Jul 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo, M.D. (+86 13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (NRS) score (time frame: 1day, 3days, 1week, 2weeks, 1month, 3months, 6months, and 1year following 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 3 Jul 2025.