Health Condition 1: G440- Cluster headaches and other trigeminal autonomic cephalgias (TAC)
Conditions
Interventions
Intervention1: Greater occipital nerve block using methyl-prednisolone and lignocaine: The site of injection shall be marked i.e. approximately two thirds of the distance on a line drawn from the cent
Sponsors
GB Pant Institute of Post Graduate Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.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(ECH). 2.ECH patients must have had atleast 1 cluster period (CP) prior to the current bout. 3.ECH patients should have 1 or more attacks per 24 h in the 7 days preceding the day of inclusion. 4.ECH patients also need to be in their present CP for no more than 2 weeks. 5.ECH patients who are not on preventive medications or who are on stable doses (without any dose change) of preventive medications for more than past 3 months shall be included.
Exclusion criteria
Exclusion criteria: 1.All patients who have clinical phenotype fulfilling the diagnostic criteria of ECH but on further investigation were found to have a secondary cause for their headaches will be excluded. 2.ECH patients who have always have CP less than 2 weeks. 3.Patients with ECH phenotype who have consistently 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). 4.ECH patients who have been recently started on preventive treatment in the last 3 months. 5.ECH patients who had a GONB in the last 3 months. 6.Patients who have a contraindication to methylprednisolone or lignocaine. 7.Patients who are on anticoagulants, or have a known bleeding disorder. 8.Pregnant females. 9.Patients who are using steroids for any other systemic or skin diseases.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of patients achieving complete remission of pain (disappearance of attacks) within 4days to 1st week (‘sustained attack- free day 4-1 week’), within 4days to 2nd week (‘sustained attack- free day 4-2 week’) and within 4days to 3rd week (‘sustained attack- free day 4-3 week’), within 4days for the entire 4-week follow-up period (‘sustained attack-free day 4- 4 weeks’).Timepoint: 1) 4 days to 1st week 2) 4 days to 2nd week 3) 4 days to 3rd week 4) 4 days to 4th week;Changes in Headache Impact Test-6 (HIT-6) and Headache Disability Inventory (HDI) scores from baseline (at the time of randomization) to 4 weeks.Timepoint: Baseline to 4 weeks;Changes in the Cluster headache quality of life scale scores from baseline (at the time of randomization) to 4 weeks.Timepoint: Baseline to 4 weeks;Changes in the rates of cranial autonomic symptoms and restlessness from baseline to 4 weeks.Timepoint: Baseline to 4 weeks;Mean change in weekly attack frequency from baseline to end of 1, 2 and 3 weeks.Timepoint: Baseline to end of 1,2 and 3 weeks.;Mean change in weekly attack severity and duration from baseline to end of 1, 2, 3 and 4 weeks.Timepoint: Baseline to end of 1,2,3 and 4 weeks.;Mean total number of attacks between day 1 and day 28 and their mean duration and severity.Timepoint: Day 1 to Day 2. ;Mean total number of attacks between day 1 and day 3 and their mean duration and severity.Timepoint: Day 1 to Day 3;Mean verapamil dose at 4 weeks.Timepoint: 4 weeks;Patient’s satisfaction at the end of 4 weeks.Timepoint: 4 weeks;Proportion of patients requiring additional preventive treatment (verapamil, lithium or topiramate) from 1 to 4 weeks.Timepoint: 1 to 4 weeks;Proportions of patients needing repeat GONB at 4 weeks.Timepoint: 4 weeks;Total number and type of adverse events and serious adverse events.Timepoint: 4 weeks;Total number of times the specific acute treatment used during first 4 weeks.Timepoint: 4 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| 1.Mean change in weekly attack frequency from baseline to end of 4 weeks.Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr Sanjay Rao Kordcal
GB Pant Institute of Post Graduate Medical Education and Research
Outcome results
None listed