An observational study in Chronic Migraine, sponsored by University Hospital, Limoges. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-05.
Sponsored by University Hospital, Limoges · Observational
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 57 is below the median of 130 across 299 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University Hospital, Limoges is the lead sponsor of 255 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with chronic migraine
Exclusion Criteria:
Patients with chronic migraine refractory to conventional treatments
frequency of headache days
change from baseline in frequency of headache days (as recorded in the patient diary) for the 2 months-period ending with week 8
Time frame: Week 8
the proportion of patients with a ≥ 70% decrease in headache day frequency
the proportion of patients with a ≥ 70% decrease in headache day frequency
Time frame: Week 8
the decrease in triptan consumption
the decrease in triptan consumption
Time frame: Week 8
the assessment of patient satisfaction
the assessment of patient satisfaction on a 0 to10 numerical scale (0=no improvement, and 10=maximum possible improvement).
Time frame: Week 8
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Limoges