Page 68 - The clinical aspects and management of chronic migraine Judith Anne Pijpers
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Chapter 4
patients with chronic migraine and medication overuse. To minimise risk of unblinding, injections in the forehead of participants allocated to placebo contained low masking doses of BTA, sufficient to remove forehead wrinkling, but unlikely to reduce headache frequency.
Methods
Study design and participants
This was a randomised, double-blind, placebo-controlled, clinical trial done at Leiden University Medical Centre Headache Clinic: the Chronification and reversibility of migraine study (CHARM; www.trialregister.nl #3440). We enrolled consecutive patients with chronic migraine and medication overuse.3 Diagnoses were established in consultation with headache experts and confirmed by a 4-week baseline headache diary. Patients aged 18-65, who were able to comply with the study protocol, and provided written informed consent, were eligible. Exclusion criteria included: contraindications for BTA;18 other primary or secondary headaches or neurological disorders; moderate/severe chronic pain disorders; psychiatric disorders other than depression; cognitive, behavioural, or oncologic disorders; use of ergots, opioids or barbiturates; and abuse of recreational soft or hard drugs.
The study was performed in accordance with the declaration of Helsinki and Good Clinical Practices and approved by the local ethics committee.
Randomization
Upon inclusion, patients were randomly assigned to receive BTA or placebo injections (1:1), according to a centralised randomisation schedule using blocks of four to eight patients, stratified for gender. The randomization schedule was prepared and kept concealed in the data management system by an independent trial statistician. An independent pharmacist and research nurse prepared the appropriate treatments. The study investigators who enrolled participants and administered treatment were not involved in these procedures.


























































































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