Clinical trial NCT03175263: OnabotulinumtoxinA Injections in Chronic Migraine, Targeted to Sites of Pericranial Myofascial Pain
Official title: OnabotulinumtoxinA Injections in Chronic Migraine, Targeted to Sites of Pericranial Myofascial Pain : an Observational, Open Label, Real-life Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Migraine
Keywords: onabotulinumtoxinA, chronic migraine, myofascial pain
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic migraine

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.


Eligibility criteria: Inclusion Criteria:

* Patients refractory to conventional treatments

Exclusion Criteria:

* Contra-indication to botulinum toxin treatment Inability to sign informed consent

Primary outcomes:
measure: frequency of headache days
timeFrame: Week 8
Secondary outcomes:
measure: the proportion of patients with a ≥ 70% decrease in headache day frequency
timeFrame: Week 8
measure: the decrease in triptan consumption
timeFrame: Week 8
measure: the assessment of patient satisfaction
timeFrame: Week 8
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Limoges
name: Daniele RANOUX, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ranoux D, Martine G, Espagne-Dubreuilh G, Amilhaud-Bordier M, Caire F, Magy L. OnabotulinumtoxinA injections in chronic migraine, targeted to sites of pericranial myofascial pain: an observational, open label, real-life cohort study. J Headache Pain. 2017 Dec;18(1):75. doi: 10.1186/s10194-017-0781-7. Epub 2017 Jul 21.