The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache
- Conditions
- Cluster Headache
- Interventions
- Procedure: Nerve Block treatmentProcedure: Pulsed Radiofrequency treatment
- Registration Number
- NCT03567590
- Lead Sponsor
- Beijing Tiantan Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nerve Block Group Nerve Block treatment This group will undergo nerve block treatment. Pulsed Radiofrequency Group Pulsed Radiofrequency treatment This group will undergo pulsed radiofrequency treatment.
- Primary Outcome Measures
Name Time Method Duration of the cluster period 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 Outcome Measures
Name Time Method 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 Evaluated by numeric rating scale (NRS, 0 points for no pain and 10 points for the most severe pain)
Headache attack frequency 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery The number of attacks per day
Duration of each headache attack 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery Duration of each headache attack after treatment
Dose of auxiliary analgesic drugs 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery Dose of auxiliary analgesic drugs per day
Duration of remission period 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery From the end of this cluster period to the beginning of the next cluster period
Patient satisfaction 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery Patient satisfactory scale (PSS) evaluation (0 for unsatisfactory, and 10 for very satisfied).
Effective rate 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery The effectiveness rate is calculated as follows: effectiveness rate = the number of effective patients / total number of patients in this group × 100%.
Trial Locations
- Locations (3)
Beijing Sanbo Brain Hospital
🇨🇳Beijing, Beijing, China
Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
Beijing Tiantan Hospital
🇨🇳Beijing, Beijing, China