We aim to conduct a 12-week double-blind placebo-controlled study for the efficacy of Greater occipital nerve blockade (GONB) using lidocaine alone and with steroid (methylprednisolone) in chronic migraine.
- Conditions
- Health Condition 1: G437- Chronic migraine without aura
- Registration Number
- CTRI/2023/04/051913
- Lead Sponsor
- GB Pant Institute of Post Graduate Medical Education and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Adults 18 to 65 years of age who had have a history of migraine with or without aura (as defined by ICHD-3) for at least 12 months before screening.
2.Patients should be experiencing >=15 days/month of headache for more than 3 months, having features of migraine headache on at least 8 days/month (as obtained by history from the patient).
3.Patients should be experiencing headache >=15 days/4 weeks, having features of migraine headache on at least 8 days/4 weeks during the baseline the phase (as recorded by headache diary)
4.Patients must demonstrate at least 80% adherence to reporting with the headache diary during the baseline phase.
5.Patients with medication overuse [overuse of triptans, ergot derivatives, analgesics, and combination drugs (any combination of those above or simple analgesics with opiates or butalbital)] will be permitted to participate in this study.
1.Patients older than 50 years at migraine onset
2.Patients will be excluded if they had no therapeutic response in migraine prevention after an adequate therapeutic trial of >=3 of the following medication categories: Category 1: Divalproex sodium, sodium valproate; Category 2: Topiramate; Category 3: Beta blockers; Category 4: Tricyclic antidepressants; Category 5: Serotonin-norepinephrine reuptake inhibitors; Category 6: Flunarizine, verapamil; Category 7: Lisinopril, candesartan; 8 Botulinum toxin; 9 GONB. (No therapeutic response will be defined as no reduction in headache frequency, duration, or severity after administration of the medication for >=6 weeks at the generally accepted therapeutic dose(s) based on the investigatorâ??s assessment. Lack of sustained response to a medication and failure to tolerate a therapeutic dose will not considered to be â??no therapeutic response.â??)
3.Patients who received Botulinum toxin (in the head and/or neck region) is excluded within 4 months before the start of the baseline phase and throughout the study.
4.Devices and procedures such as GONB used for migraine prophylaxis are excluded within 4 months before the start of the baseline phase and throughout the study.
5.Investigational medications and devices are excluded throughout the study.
6.Patients also must not have used investigational medications or devices for at least 90 days prior to baseline phase.
7.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.
8.Pregnant women, patient with known allergies against lidocaine or methylprednisolone, patients with history of moderate to severe anxiety or depression, psychosis and chronic liver, kidney and heart diseases shall be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in mean migraine headache days (MHD) per 28 days compared with baseline at the end of week 12 (migraine day is defined as a calendar day when the patient reported â?¥4 continuous hours of headache meeting ICHD 3 criteria for migraine; additionally, any calendar day on which acute migraineâ??specific medication (ergot or triptan) is used shall be counted as a migraine day. A qualified migraine headache is defined as a migraine with or without aura, lasting for â?¥30 minutes, and meeting at least one of the following criteria (a and/or b): a) â?¥2 of the following pain features: unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity and b) â?¥1 of the following associated symptoms: nausea and/or vomiting, photophobia, and phonophobia)Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method