Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet Rich Plasma to Treat Idiopathic Glossopharyngeal Neuralgia (GPN)

Capital Medical University

Status: Enrolling

Conditions: Platelet Rich Plasma; Pulsed Radiofrequency; Glossopharyngeal Neuralgia

Study type: Observational

Funder types: Other

Identifiers

NCT06931457

KY 2023-263-03-07

Details and patient eligibility

About

To investigate the efficacy and safety of the application of PRF combined PRP to the for the treatment of GPN.

Enrollment: 121 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age >18 years;
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

1. Patients with bilateral GPN;
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).

Trial design

121 participants in 2 patient groups

PRF group

Description:

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

Description:

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.