CTRI/2023/04/051913Not yet recruitingPhase 3
GREATER OCCIPITAL NERVE BLOCK WITH AND WITHOUT STEROIDS FOR CHRONIC MIGRAINE (GONBLOCK-FOR-CM): A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY - GONBLOCK-FOR-CM
GB Pant Institute of Post Graduate Medical Education and Research0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
Similar Trials
Not yet recruiting
Not Applicable
A study of Greater Occipital Nerve Blockade for the preventive treatment of Chronic MigraineCTRI/2020/07/026709GB Pant hospital
Not yet recruiting
Unknown
To compare the effect of blocking the nerve present in the back of head and nerve present in nose for treatment of headache after spinal anaesthesiaCTRI/2023/12/060809R Hravei
Not yet recruiting
Not Applicable
Comparison of nerve block Vs injection into shoulder joint for pain relief in patients with frozen shoulderCTRI/2020/04/024421Medical college thiruvananthapuram
Not yet recruiting
Not Applicable
Comparison of pericapsular nerve group block with fascia iliaca block in adult patients undergoing hip surgeriesCTRI/2020/07/026782S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL AND RESEARCH CENTER
Completed
Phase 3
Efficacy of greater occipital nerve block in postdural puncture headacheHeadache.Other headache syndromesIRCT20200621047860N1Tehran University of Medical Sciences28