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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sphenopalatine block group | Experimental | Patients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril. |
|
| BOTOX group | Experimental | Patients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphenopalatine block | Drug | Patients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree 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. | 12 weeks post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks post-procedure |
| Headache relief rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed E Abdel Fattah, MD | Contact | 00201284475792 | mohamed-elsaid@cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 12613 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D059387 | Sphenopalatine Ganglion Block |
| D008012 | Lidocaine |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001340 | Autonomic Nerve Block |
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
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| Botulinum Toxin Type A | Drug | Patients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm. |
|
Headache relief rate (percentage of patients with 50% or more reduction in headache intensity at four-week and 12-weeks period).
| 12 weeks post-procedure |
| D000760 |
| Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |