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

NCT06931457 | Recruiting

• 1 other identifier: KY 2023-263-03-07
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glossopharyngeal Neuralgia; Pulsed Radiofrequency; Platelet Rich Plasma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Barrow Neurological Institute pain scale(BNI score)

  1day, 3days, 1week, 2weeks, 1month, 3months, 6months, and 1year following the procedure

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• An implantable pulse generator;
• Current pregnancy or breast feeding.
• Patients with incomplete medical records (lack of baseline data or postoperative follow-up data).

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• China-Japan Friendship Hospital: collaborator
• The Second Hospital of Hebei Medical University: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Glossopharyngeal Nerve Diseases

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases

Central Study Contacts

Fang Luo, M.D.

CONTACT

+86 13611326978; 13611326978@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 17, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)