Health Condition 1: G437- Chronic migraine without aura
Conditions
Interventions
Intervention1: GONB WITH 2% LIDOCAINE INJECTION: Greater Occipital Nerve Blockade involving 2ml of 2% Lidocaine injection which shall be injected on each side subcutaneouly in patients of group A at 0
Sponsors
GB Pant hospital
Eligibility
Inclusion criteria
Inclusion criteria: Any patient above 18 years and less than 65 years of age who fulfills the diagnostic criteria laid down by ICHD 3 for Chronic Migraine( with or without aura) and willing to give consent will be included.
Exclusion criteria
Exclusion criteria: All patients with a clinical phenotype of chronic migraine but on further investigation, found to have a secondary cause for their headaches will be excluded. Pregnant women, patient with known allergies against topiramate or lidocaine, patients with history of glaucoma, renal stones, dementia, psychosis and severe depression shall be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in headache days per 28 days (Headache day is defined as a calendar day [00:00 to 23:59] when the patient reported â?¥4 continuous hours of headache episode in the diary)Timepoint: for double blind phase primary and secondary outcome will be assessed at the end of 4 weeks after first GONB injection. Final assessment of efficacy including primary and secondary outcomes shall be carried out at end of 12 weeks and results shall be compared with the baseline. For open label phase primary and secondary outcomes shall be assessed at the end of 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in mean Visual analogue scale (VAS) score per 28 days.Timepoint: for double blind phase primary and secondary outcome will be assessed at the end of 4 weeks after first GONB injection. Final assessment of efficacy including primary and secondary outcomes shall be carried out at end of 12 weeks and results shall be compared with the baseline. For open label phase primary and secondary outcomes shall be assessed at the end of 24 weeks.;1.Change in migraine days per 28 days. 2.More than 50% reduction in headache days compared to baseline per 28 days. 3.Change in number of days drug taken to abort the acute attacks per 28 days 4.Change in duration of total headache ( in hours) and migraine headache (in hours) per 28 days Timepoint: for double blind phase primary and secondary outcome will be assessed at the end of 4 weeks after first GONB injection. Final assessment of efficacy including primary and secondary outcomes shall be carried out at end of 12 weeks and results shall be compared with the baseline. For open label phase primary and secondary outcomes shall be assessed at the end of 24 weeks.;ADVERSE EVENTSTimepoint: for double blind phase primary and secondary outcome will be assessed at the end of 4 weeks after first GONB injection. Final assessment of efficacy including primary and secondary outcomes shall be carried out at end of 12 weeks and results shall be compared with the baseline. For open label phase primary and secondary outcomes shall be assessed at the end of 24 weeks.;Impact on headache disorder and associated disability 1.Change in mean HIT-6 (Headache Impact Test) score per 28 days 2.Change in mean MIDAS (Migraine Disability Assessment) score per 28 days 3.Change in migraine specific quality of life score per 28 days 4.Global impression of change score per 28 daysTimepoint: for double blind phase primary and secondary outcome will be assessed at the end of 4 weeks after first GONB injection. Final assessment of efficacy includi | — |
Countries
India
Contacts
Public ContactApoorva Tomar
GB PANT HOSPITAL
Outcome results
None listed