Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sphenopalatine block, Botulinum Toxin Type A.
- Who it may be relevant to
- Registry conditions: Sphenopalatine Block, BOTOX, Chronic Migraine. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine: A Randomized Clinical Trial
Overview
This trial compares the efficacy and safety of sphenopalatine ganglion block (SPGB) and intramuscular BOTOX injection in chronic migraine.
Detailed description
The International Headache Society's Headache Classification Committee recognizes three broad categories of headaches: primary headaches, secondary headaches, and a third catchall category called "painful cranial neuropathies, other facial pain, and other headaches." Migraines fall into the primary headache category.
Sphenopalatine ganglion (SPG), or the pterygopalatine ganglion (PPG), is a large extracranial parasympathetic ganglion with multiple neural connections, including autonomic and motor.
The botulinum toxin (BOTOX®), which can exert a paralytic effect by binding to presynaptic cholinergic nerve terminals at the neuromuscular junction, is produced by the Gram-positive, rod-shaped, spore-forming, anaerobic bacterium Clostridium botulinum. It internalizes and inhibits the exocytosis of the neurotransmitter acetylcholine by decreasing the frequency of acetylcholine release
Interventions
- Drug Sphenopalatine block
Patients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril. - Drug Botulinum Toxin Type A
Patients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm.
Primary outcome measures
- Degree of pain [Time frame: 12 weeks post-procedure]
Secondary outcome measures (2)
- Percentage of patients free of headache [Time frame: 12 weeks post-procedure]
- Headache relief rate [Time frame: 12 weeks post-procedure]
Eligibility criteria
Inclusion criteria
- Age 18 and 65 years.
- Both sexes.
- Chronic migraine. Chronic migraine, defined as headaches on ≥15 days per month for ≥3 months, of which ≥8 days meet criteria for migraine without aura or respond to migraine-specific treatment according to International Classification of Headache Disorders-3 Beta.
Exclusion criteria
- Patients with medication over use headache.
- Bleeding disorders.
- Abnormal neurological examination.
- History of allergy to local anesthetics or BOTOX.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT06974617 · AP2411-501-101-193