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
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
To investigate the efficacy and safety of the application of PRF combined PRP to the for the treatment of GPN.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
Contact Information
Primary
Fang Luo, M.D.
13611326978@163.com
+86 13611326978
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 121
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: The Second Hospital of Hebei Medical University, China-Japan Friendship Hospital
Leads: Beijing Tiantan Hospital