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

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

Detailed Description
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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.

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

Conditions
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Cluster Headache

Intervention / Treatment
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* Procedure: Pulsed Radiofrequency treatment
* Procedure: Nerve Block treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed Radiofrequency Group<br>This group will undergo pulsed radiofrequency treatment. | Procedure: Pulsed Radiofrequency treatment<br>* The pulse treatment generator (PMF-21-100-5, Baylis Medical Inc., Montreal, Canada) with a length of 10 cm, 21-gauge, and an active tip length of 5 mm is inserted vertically into the puncture point. The pulse treatment generator is set to the pulsed radiofrequency automatic mode, with a temperature of 42 °C, pulse frequency of 2 Hz, pulse width of 20 ms, and treatment duration of 360s.<br>|
| Active Comparator: Nerve Block Group<br>This group will undergo nerve block treatment. | Procedure: Nerve Block treatment<br>* A mixture of 40 mg Triamcinolone + 2 ml of 1% Bupivacaine + 2 ml of 2% mepivacaine + 1:100000 epinephrine is injected for nerve block treatment using a puncture needle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the cluster period | The duration of the cluster period is defined as the total duration of the headache, including the pain attack time before and after treatment. | Within 1 year (the cluster period is not over 3 months generally) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of pain during headache attacks after treatment | Evaluated by numeric rating scale (NRS, 0 points for no pain and 10 points for the most severe pain) | 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery | 
| Headache attack frequency | The number of attacks per day | 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery | 
| Duration of each headache attack | Duration of each headache attack after treatment | 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery | 
| Dose of auxiliary analgesic drugs | Dose of auxiliary analgesic drugs per day | 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery | 
| Duration of remission period | From the end of this cluster period to the beginning of the next cluster period | 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery | 
| Patient satisfaction | Patient satisfactory scale (PSS) evaluation (0 for unsatisfactory, and 10 for very satisfied). | 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery | 
| Effective rate | The effectiveness rate is calculated as follows: effectiveness rate = the number of effective patients / total number of patients in this group × 100%. | 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cluster Headache, pulsed radiofrequency