Sphenopalatine Block, BOTOX, Chronic Migraine
Conditions
Brief summary
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
Patients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril.
DRUGBotulinum Toxin Type A
Patients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 12 weeks post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients free of headache | 12 weeks post-procedure | The percentage of patients free of headache at baseline (just before the procedure), after procedure, four-week, and 12-weeks period. |
| Headache relief rate | 12 weeks post-procedure | Headache relief rate (percentage of patients with 50% or more reduction in headache intensity at four-week and 12-weeks period). |
Countries
Egypt
Contacts
Primary ContactMohamed E Abdel Fattah, MD
Outcome results
None listed