Page 94 - The clinical aspects and management of chronic migraine Judith Anne Pijpers

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Chapter 5
Methods
Study design and patients
This was a concealed randomized, double-blind controlled clinical trial conducted at the Leiden University Medical Center, as part of the Chronification and Reversibility of Migraine study15 (CHARM study15; www.trialregister.nl, NTR3440). Patients aged 18-65 years, diagnosed with MOH and CM according to the International Classification of Headache Disorders (ICHD-3) criteria6 were enrolled between December 2012 and February 2015. Main exclusion criteria were: (i) other neurological disorders; (ii) other major comorbidity (chronic pain, psychiatric disorders, apart from depression and/or anxiety, cognitive, behavioral or oncologic disorders); (iii) regular use of ergots, opioids or barbiturates; (iv) abuse of illicit drugs in the past 12 months. 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.
Procedures and intervention
Patients started with a 4-week baseline assessment period, followed by the 12- week withdrawal period. Medication withdrawal was implemented according to the national guidelines and other withdrawal studies,13,16–19 comprising abrupt cessation of any acute headache medication and no allowance for escape medication. In case of use of prophylactic drugs, these were tapered off. During this withdrawal period, patients were randomized to receive either maximal or minimal intervention by a headache nurse. A headache nurse is specifically educated for headache care with additional training on cognitive behavioral therapy and motivational interviewing, with at least some years of experience. Maximal intervention by a headache nurse consisted of a 30 minutes consult immediately after the neurologist’s interview, examination and advice to withdraw, with at least three follow-up telephonic contacts (every 2-4 weeks) during withdrawal. These consults were used to reiterate the withdrawal advice, educate patients on the risks of medication overuse and expected course of the withdrawal period, and increase intrinsic motivation to initiate medication withdrawal using motivational interviewing techniques. Furthermore, an individualized plan of approach was developed, acknowledging the influence of chronic migraine and withdrawal on professional and social life and enhancing acceptance. Alternative behavioral strategies to cope with the untreated pain were discussed, and a value-based approach was used to establish activities