refractory migrane. Migraine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients experiencing migraine attacks for more than six months, with a frequency of 1 to 6 attacks per month of severe intensity. 2. Patients with migraine resistant to beta-blockers and tricyclic antidepressants. 3. Age 18 to 50 years.
Exclusion criteria
Exclusion criteria: 1. Non-migraine headaches (e.g., tension-type or sinus headaches). 2. Familial hemiplegic migraine. 3. Migraine with brainstem aura (previously known as basilar migraine) or migrainous infarction. 4. History of alcohol or illicit drug abuse. 5. History of seizure, favism (G6PD deficiency), severe hemoglobinopathies, or uncontrolled coagulation disorders. 6. Known hypersensitivity or allergy to ozone gas.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale : VAS. Timepoint: Pain intensity will be measured at the beginning of the study and upon completion of the 12 treatment sessions. Method of measurement: Pain intensity will be measured using the Visual Analogue Scale (VAS), which yields a score between 0 and 10, where 0 = no pain and 10 = the worst possible pain. The mean scores before and after the intervention will be compared. | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of headaches (number of headache days). Timepoint: will be measured at the beginning of the study and upon completion of the 12 treatment sessions. Method of measurement: The frequency of headaches (number of headache days) will be recorded based on the headache diary or clinical interview.;Drug consumption will be extracted in terms of total analgesic dose (milligrams per month). Timepoint: will be measured at the beginning of the study and upon completion of the 12 treatment sessions. Method of measurement: Drug consumption will be extracted in terms of total analgesic dose (milligrams per month) from medical records or patient reports. A significant reduction in dosage compared to pre-intervention levels will be considered an improvement. | — |
Countries
Iran (Islamic Republic of)
Contacts
Bagheiat-allah University of Medical Sciences