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

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.

Study Overview

• Status: Recruiting
• Conditions: Glossopharyngeal Neuralgia; Platelet Rich Plasma; Pulsed Radiofrequency

• Study Type: Observational
• Enrollment (Estimated): 121

Contacts and Locations

• Study Contact: Name: Fang Luo, M.D.; Phone Number: +86 13611326978; Email: 13611326978@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Suitable participants will be screened at the pain management center of each hospital to participate in the study.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1day, 3days, 1week, 2weeks, 1month, 3months, 6months, and 1year following the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barrow Neurological Institute pain scale(BNI score)	BNI score during resting was used to evaluate pain relief	1day, 3days, 1week, 2weeks, 1month, 3months, 6months, and 1year following the procedure

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: The Second Hospital of Hebei Medical University; China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Neuralgia; Glossopharyngeal Nerve Diseases
• Other Study ID Numbers: KY 2023-263-03-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No