The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache

Capital Medical University

Status: Completed

Conditions: Cluster Headache

Treatments: Procedure: Nerve Block treatment; Procedure: Pulsed Radiofrequency treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03567590

KY 2018-027-02

Details and patient eligibility

About

The investigators aim to investigate the effectiveness and safety of sphenopalatine ganglion pulsed radiofrequency on cluster headache.

Full description

The investigators aim to investigate whether the sphenopalatine ganglion pulsed radiofrequency treatment is better than traditional sphenopalatine ganglion nerve block technology and provides medical evidence for the clinical application and promotion of sphenopalatine ganglion pulsed radiofrequency treatment to provide a minimally invasive, safe, and effective treatment for patients with cluster headache who do not respond to drug treatment.

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of cluster headache is confirmed according to the diagnostic criteria of the 2018 International Classification of Headache Disorders 3rd edition (ICHD-3);
• patient's age is between 18 and 60 years;
• patients seek treatment in the pain clinics of hospitals participating in the study within 5 days of the onset of the cluster period; pain conditions of patients remain the same after conservative treatment of conventional oral medication, or the reduction rates are less than 50% in pain degree during headache attacks, headache attack frequency, duration of each headache attack, and auxiliary analgesic drug dosage; and
• patients signed the informed consent.

Exclusion criteria

• abnormalities in blood measurements, liver and kidney function, blood glucose, coagulation, electrocardiogram, and chest radiograph;
• infection at the puncture site;
• previous mental illness;
• previous history of narcotic drug abuse;
• history of anticoagulant and antiplatelet aggregation drugs;
• implantable pulse generator;
• previous history of invasive treatments such as sphenopalatine ganglion radiofrequency thermocoagulation and chemical destruction;
• pregnant or breastfeeding patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Pulsed Radiofrequency Group

Experimental group

Description:

This group will undergo pulsed radiofrequency treatment.

Treatment:

Procedure: Pulsed Radiofrequency treatment

Nerve Block Group

Active Comparator group

Description:

This group will undergo nerve block treatment.

Treatment:

Procedure: Nerve Block treatment