Cluster headache
Conditions
Interventions
experimental group:The experimental group was injected on the surface of the carotid artery on the same side as the headache under ultrasound guidance
control group:The control group was injected on the greater occipital nerve
Sponsors
Chinese PLA General Hosptial
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Agree to sign the informed consent form; 2) Age between 18 and 60 years old; 3) Meet the diagnostic criteria for episodic cluster headache in ICHD-3; 4) Have a headache frequency of at least once a day before enrollment; 5) The current cluster period has lasted for more than one week; 6) The expected duration of the cluster period after randomization is at least two weeks; 7) Have experienced at least two cluster periods, and the duration of previous cluster periods was more than two weeks; 8) The location of headache does not change during previous and current cluster periods; 9) Patients who have prospectively recorded headache diaries for more than seven days, or those who agree to record headache diaries for another seven days starting from this visit, are eligible for randomization treatment. The inclusion and exclusion criteria for supplementation during the acute phase 1) At the time of this injection, I was in the period of headache attack, and the degree of headache at the time of injection was moderate or above. 2) It is expected that if left untreated, the headache will last for at least another hour. 3) Agree to record the case record form for acute phase treatment and agree to stay in the hospital for observation for 1 hour after injection before leaving the hospital.
Exclusion criteria
Exclusion criteria: 2.1 Exclusion criteria related to target disease 1) Other types of headache that affect the judgment of cluster headache; 2.2 Medical history and comorbidities 1) Currently existing evidence of poorly controlled, unstable or recently diagnosed cardiovascular and cerebrovascular diseases, such as ischemic heart disease, coronary artery vasospasm and cerebral ischemia, severe left ventricular dysfunction, etc. 2) Poorly controlled hypertension or poorly controlled diabetes; 3) Hypotension (systolic blood pressure less than 90 mmHg) or cardiogenic shock; 4) Sick sinus syndrome; 5) Second or third degree atrioventricular block; 6) Atrial flutter or atrial fibrillation with atrioventricular bypass tract; 7) Currently diagnosed with severe depression, other pain syndromes, mental disorders (such as schizophrenia), dementia or other important neurological diseases that the researcher believes may interfere with the study assessment (except for migraine); 8) Gastric and duodenal ulcers; 9) History of visceral surgery within the past six months; 10) Glaucoma; 11) History or evidence of alcohol or drug abuse within the past 12 months; 12) Diagnosis of hematological or solid malignant tumors within the past five years before screening. 2.3 Allergy and adverse drug reactions 1) History of allergy to lidocaine, dexamethasone, verapamil; 2) Drug history or other allergy history that the principal investigator believes would make the subject unsuitable for participation in the study; 2.4 Gender and reproductive status 1) Pregnant or lactating women; 2.5 Related to local treatment 1) Use of anticoagulants; 2) Known bleeding disorders; 3) Cervical vascular disease; 4) Soft tissue diseases at the injection site and nearby; 2.6 Other exclusion criteria 1) Botulinum toxin or CGRP monoclonal antibody injection during this cluster period; 2) Use of steroid hormones and/or local anesthetics for occipital nerve block or oral steroid hormone treatment within the past month. 3) Use of transitional or preventive treatment drugs that may be effective for cluster headache during this cluster period, such as oral glucocorticoids, verapamil, lithium carbonate, etc. Exclusion criteria for the acute phase: 1) Other acute-phase medications (such as oxygen inhalation, painkillers, triptan drugs, etc.) have been applied; 2) It is not agreed that acute-phase remedial drugs should not be used within half an hour after injection. (The guide recommends no less than 15 minutes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in the frequency of headaches from D1-D7 and D8-D14 compared to the baseline; | — |
Countries
China
Contacts
Public ContactShengyuan Yu
the PLA General Hospital
Outcome results
None listed