Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet Rich Plasma to Treat Idiopathic Glossopharyngeal Neuralgia (GPN)
NCT ID: NCT06931457
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
121 participants
OBSERVATIONAL
2025-05-01
2027-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. diagnosed with idiopathic GPN according to the third International Classification of Headache Disorders (ICHD) classification;
3. patients who failed pharmacotherapy or intolerable side effects of medication;
4. undergoing PRF for GPN;
5. at least 1 month of follow-up recordings.
Exclusion Criteria
2. Abnormalities in blood measurements, liver and kidney function, blood glucose, coagulation, electrocardiography or chest radiography;
3. Infection at the puncture site;
4. Previous mental illness;
5. Previous history of narcotic drug abuse;
6. Prior anticoagulant or antiplatelet therapy;
7. An implantable pulse generator;
8. Current pregnancy or breast feeding.
9. Patients with incomplete medical records (lack of baseline data or postoperative follow-up data).
18 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
The Second Hospital of Hebei Medical University
OTHER
Beijing Tiantan Hospital
OTHER
Responsible Party
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Fang Luo
Director of Department of Pain Management
Locations
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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KY 2023-263-03-07
Identifier Type: -
Identifier Source: org_study_id
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