To compare the efficacy and safety of oral prednisolone (oral drug) versus Greater occipital nerve block (injection) as a transitional preventive treatment for Cluster headache by performing a trial.
- Conditions
- Health Condition 1: G440- Cluster headaches and other trigeminal autonomic cephalgias (TAC)
- Registration Number
- CTRI/2023/11/059586
- Lead Sponsor
- GB Pant Institute of Post Graduate Medical Education and Research New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients achieving complete cessation of cluster headache attacks at the end of week 1Timepoint: 1 week
- Secondary Outcome Measures
Name Time Method