This trial compares the efficacy and safety of sphenopalatine ganglion block (SPGB) and intramuscular BOTOX injection in chronic migraine.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Patients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril.
Patients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm.
Cairo University
Cairo, Egypt
RECRUITINGDegree of pain
The patients will be shown how to use the Visual Analogue Scale (VAS); 0-10 point where 0 = no pain and 10 = worst imaginable pain. VAS will be noted as well as after procedure, four-week, and 12-weeks period.
Time frame: 12 weeks post-procedure
Percentage of patients free of headache
The percentage of patients free of headache at baseline (just before the procedure), after procedure, four-week, and 12-weeks period.
Time frame: 12 weeks post-procedure
Headache relief rate
Headache relief rate (percentage of patients with 50% or more reduction in headache intensity at four-week and 12-weeks period).
Time frame: 12 weeks post-procedure
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