Page 110 - The clinical aspects and management of chronic migraine Judith Anne Pijpers
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Chapter 6
in medication overuse 4,15,16. However, cutaneous allodynia as predictor for treatment response in chronic migraine patients has not been studied. Moreover, spatial distribution of cutaneous allodynia has never been studied in the light of migraine chronification and its reversibility or as predictor of response. Therefore, the aim of this study was to investigate the association between cutaneous allodynia and its subtypes (based on spatial distribution and type of stimulus) to response to treatment in patients with chronic migraine with medication overuse.
Material and methods
Study design and population
This study was conducted as part of the Chronification and reversibility of migraine (CHARM) study at the outpatient headache clinic of Leiden University Medical Centre, the Netherlands, which is described in detail elsewhere 17. Briefly, consecutive patients aged 18-65 years, diagnosed with chronic migraine and medication overuse according to the formerly International Classification of Headache Disorders (ICHD) 3-beta criteria, but also fulfilling ICHD 3 criteria 2, who provided written informed consent, were enrolled. Exclusion criteria were: (i) other primary headache or neurological disorders; (ii) other chronic pain disorders with medium to high pain intensity or requiring pain medication; (iii) major psychiatric disorders, other than depression; (iv) major cognitive, behavioural or oncologic disorders; (v) contraindications for treatment, or inability to adhere to the study protocol (vi) (planned) pregnancy or breastfeeding (vii) use of ergots, opioids or barbiturates; (viii) abuse of drugs in the past 12 months.
All participants started with a 4-week baseline-assessment period, followed by a 12-week withdrawal period, consisting of instruction to withdraw abruptly from all acute anti-headache medications and caffeine (‘advice-only’). Prophylactic treatment was tapered off and rescue medication was not allowed. Immediately prior to withdrawal, botulinum toxin A or placebo injections were administered in a 1:1 randomised, double-blind manner 17 .
The study was performed in accordance with the declaration of Helsinki Ethical Principles and Good Clinical Practices and was approved by the local and national ethics committees.



























































































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