Pulsed Radiofrequency Combined With Platelet-Rich Plasma Applied to the Sphenopalatine Ganglion in Treating Episodic Cluster Headache

Launched by BEIJING TIANTAN HOSPITAL · Mar 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people who suffer from episodic cluster headaches (ECH), which are extremely painful headaches that can cause symptoms like tearing and redness in one eye. The researchers want to see if combining two treatments—pulsed radiofrequency (PRF) therapy and platelet-rich plasma (PRP)—can work better than PRF alone for relieving these headaches. PRF is a minimally invasive procedure that targets a specific nerve area to help reduce pain, while PRP is derived from the patient's own blood and contains healing factors that might promote recovery.

To participate in the trial, individuals must be between 18 and 70 years old and have been diagnosed with ECH. They should have experienced multiple headache attacks per week, and previous medications have not significantly reduced their pain. Participants will receive either the combined treatment or just PRF, based on their preference. Throughout the trial, people can expect to receive careful monitoring and support as researchers evaluate the safety and effectiveness of these treatments. It's important to note that those with certain medical conditions or prior treatments may not be eligible to join the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The diagnosis of ECH is confirmed according to the diagnostic criteria of the International Classification of Headache Disorders third edition 3 (Table 2), and the patient is within five days of the current cluster period；
• • 2. The patient's age is between 18 and 70 years;
• • 3. Patients have had ≥2 bouts previously, ≥4 typical (treated or untreated) attacks per week and usual bouts should last 4 weeks;
• • 4. The patient's pain condition remains the same after preventive therapy with drugs available in our hospital such as verapamil, topiramate, lithium or steroids, or there is a reduction of less than 50% in the intensity and frequency of headache attacks, the duration of each attack and the dosage of auxiliary analgesic drugs used.
• Exclusion Criteria:
• • 1. Have atypical features: absence of cranial autonomic symptoms, post-traumatic onset, cluster-tic syndrome;
• • 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. Previous history of invasive treatments such as pterygopalatine ganglion radiofrequency thermocoagulation and chemical destruction;
• • 9. Current pregnancy or breast feeding.