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Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine

ConditionsSphenopalatine BlockBOTOXChronic Migraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University

About this trial

This trial compares the efficacy and safety of sphenopalatine ganglion block (SPGB) and intramuscular BOTOX injection in chronic migraine.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with medication over use headache.

Bleeding disorders.

Abnormal neurological examination.

History of allergy to local anesthetics or BOTOX.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sphenopalatine block

    Drug

    Patients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril.

  • Botulinum Toxin Type A

    Drug

    Patients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Sphenopalatine block groupExperimental treatment 1 intervention
Group B: BOTOX groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks post-procedure

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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