Status:
NOT_YET_RECRUITING
Pulsed Radiofrequency Combined With Platelet-Rich Plasma Applied to the Sphenopalatine Ganglion in Treating Episodic Cluster Headache
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
People's Hospital of Zhengzhou University
Huadong Hospital
Conditions:
Cluster Headache
Pain Management
Eligibility:
All Genders
18-70 years
Brief Summary
Cluster headache (CH) is one of the most severe pain accompanied by ipsilateral autonomic symptoms such as lacrimation and conjunctival injection. CH can be categorized into episodic cluster headache ...
Eligibility Criteria
Inclusion
- 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；
- The patient's age is between 18 and 70 years;
- Patients have had ≥2 bouts previously, ≥4 typical (treated or untreated) attacks per week and usual bouts should last 4 weeks;
- 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
- Have atypical features: absence of cranial autonomic symptoms, post-traumatic onset, cluster-tic syndrome;
- 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;
- Previous history of invasive treatments such as pterygopalatine ganglion radiofrequency thermocoagulation and chemical destruction;
- Current pregnancy or breast feeding.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT06882278
Start Date
May 1 2025
End Date
May 1 2029
Last Update
March 24 2025
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070