Health Condition 1: G440- Cluster headaches and other trigeminal autonomic cephalgias (TAC)
Conditions
Interventions
Intervention1: Greater Occipital Nerve(2ml methylprednisolone (80mg) and 2ml lignocaine (2%): Patients will be assigned to receive GONB (2ml methylprednisolone (80mg) and 2ml lignocaine (2%)
plus pla
Sponsors
GB Pant Institute of Post Graduate Medical Education and Research New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18–65 years who meet the international classification of headache disorders-3 (ICHD-3) diagnostic criteria for episodic (3.1.1) cluster headache. 2. ECH patients must have had at least 1 CP prior to the current bout. 3. The mean duration of previous untreated CP in ECH patients must be at least of 15 days. 4. The previous cluster episode should have ended at least 30 days before inclusion in the study. 10 5. ECH patients should have 1 or more attacks per 24 h in the 3 days preceding the day of inclusion. 6. ECH patients in their present cluster period for no more than 2 weeks. 7. ECH patients who are not on preventive medications.
Exclusion criteria
Exclusion criteria: 1. All patients who have clinical phenotypes fulfilling the diagnostic criteria of ECH but on further investigation were found to have a secondary cause for their headaches will be excluded. 2. Patients with ECH phenotype who have consistent headache attacks of less than 30 min duration which occur more than five times daily (as they are likely to be cases of paroxysmal hemicrania and therefore an indomethacin trial should be given). 3. ECH patients who had a GONB or received oral steroids in the last 1 month. 4. Patients who have a contraindication to oral prednisolone, methylprednisolone or lignocaine. 5. Patients who are on anticoagulants or have a known bleeding disorder. 6. Pregnant and nursing women. 7. Fertile women who are not willing to use adequate contraception during the study duration. 8. Patients who are using steroids for any other systemic or skin diseases. 9. Intolerance or contraindications against verapamil, prednisone, pantoprazole, or potassium. 10. Systemic diseases like diabetes; cardiac arrhythmia; arterial hypotension or hypertension; gastrointestinal ulceration; severe osteoporosis; glaucoma; tuberculosis; current infection 11. Ongoing substance or alcohol abuse or dependence, psychiatric disease with risk of suicide, severe chronic or terminal illness, or HIV infection 12. Chronic liver and kidney disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving complete cessation of cluster headache attacks at the end of week 1Timepoint: 1 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Headache Impact Test-6 (HIT-6) and Headache Disability Inventory (HDI) scores from baseline to the end of 4 weeksTimepoint: 4 week;Changes in the Cluster headache quality of life scale (CHQOL) scores from baseline to the end of 4 weeks.Timepoint: 4 week;Changes in the rates of cranial autonomic symptoms and restlessness from baseline to end of 2 weeksTimepoint: 2 week;Mean change in attack duration and attack intensity between baseline and end of week 1 and 2.Timepoint: 1 week, 2 week;Mean change in weekly attack frequency from baseline to end of week 1 and 2Timepoint: 1 week, 2 week;Mean change in weekly attack severity and duration from baseline to end of 1and 2 weeks.Timepoint: 1 Week , 2 week;Mean number of times the specific acute treatment use during the first 4 weeks.Timepoint: 4 week;Patient satisfaction at the end of 2 weeksTimepoint: 2 week;The proportion of patients achieving 50% decrease in the weekly attack frequency at the end of week 1and 2Timepoint: 1 week, 2 week;The proportion of patients achieving complete cessation of cluster headache attacks at the end of week 2,3 and 4Timepoint: 2 week, 3 week, 4 week;Total number and type of adverse events and serious adverse eventsTimepoint: 4 week | — |
Countries
India
Contacts
Public ContactDr Arunav Garg
GB Pant Institute of Post Graduate Medical Education and Research, New Delhi
Outcome results
None listed