Chronic Migraine
Conditions
Keywords
onabotulinumtoxinA, chronic migraine, myofascial pain
Brief summary
This study was an observational, open-label, cohort-study conducted in accordance with the principles of the Helsinki Declaration. We prospectively and systematically recorded data from the patients and analyzed them retrospectively. During a first phase, called adaptation period, the injector (DR) used a follow-the-pain approach in order to determine the optimal injection scheme for each individual. The possible injection sites were the corrugator, temporalis, and trapezius muscles. Patients were systematically asked about the usual topography and time course of migraine attacks, and the existence of pain or stiffness of the cervical muscles. If the pain was predominantly located in the frontotemporal area, the corrugator and temporalis muscles were injected bilaterally. When the patients had predominant pain in the back of the head, or when their headache pain frequently started and/or ended in the trapezius muscles, both trapezius muscles were injected. These muscle groups were injected together if pain was both frontotemporal and cervico-occipital. When this first set of injections was efficacious, patients were re-injected in the same manner at the time when the frequency of headache days definitely increased. In the absence of efficacy, the paradigm was modified using the same follow-the-pain approach. Once the best procedure was determined for each patient, it was reproduced at each subsequent injection session. This adaptation phase could necessitate up to three sessions. The observation period started 8 weeks before the first efficacious injection and ended 2 months after the second consecutive efficacious injection, or in case of inefficacy. Throughout the adaptation and the observation phases, patients kept a headache diary where they were asked to note the days with headache and the use of rescue medication.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients refractory to conventional treatments
Exclusion criteria
* Contra-indication to botulinum toxin treatment Inability to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| frequency of headache days | Week 8 | change from baseline in frequency of headache days (as recorded in the patient diary) for the 2 months-period ending with week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the proportion of patients with a ≥ 70% decrease in headache day frequency | Week 8 | the proportion of patients with a ≥ 70% decrease in headache day frequency |
| the decrease in triptan consumption | Week 8 | the decrease in triptan consumption |
| the assessment of patient satisfaction | Week 8 | the assessment of patient satisfaction on a 0 to10 numerical scale (0=no improvement, and 10=maximum possible improvement). |