A Prospective, Multicentre, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache

Beijing Tiantan Hospital3 sites in 1 country80 target enrollmentJuly 5, 2018

ConditionsCluster Headache

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cluster Headache
Sponsor: Beijing Tiantan Hospital
Enrollment: 80
Locations: 3
Primary Endpoint: Duration of the cluster period
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

July 5, 2018

End Date

January 5, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Tiantan Hospital

Responsible Party

Principal Investigator

Fang Luo

Director of Department of Pain Management

Beijing Tiantan Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Duration of the cluster period

Time Frame: Within 1 year (the cluster period is not over 3 months generally)

The duration of the cluster period is defined as the total duration of the headache, including the pain attack time before and after treatment.

Secondary Outcomes

The degree of pain during headache attacks after treatment(1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery)
Headache attack frequency(1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery)
Duration of each headache attack(1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery)
Dose of auxiliary analgesic drugs(1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery)
Duration of remission period(1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery)
Patient satisfaction(1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery)
Effective rate(1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery)