Cluster Headache
Conditions
Keywords
Cluster Headache, pulsed radiofrequency
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.
Interventions
PROCEDUREPulsed Radiofrequency treatment
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.
PROCEDURENerve Block treatment
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.
Sponsors
Beijing Sanbo Brain Hospital
Jilin Province People's Hospital
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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%. |
| 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 |
Countries
China
Outcome results
None listed