Acupuncture for migraine and headache in primary care: a protocol for a pragmatic, randomized trial.

Overview

UNLABELLED: This paper presents the protocol for a randomized trial of acupuncture for migraine and headache. SUBJECTS: Four hundred patients with migraine or headache will be recruited from GP practices. INCLUSION CRITERIA: Eighteen to 65 years old, contractable by telephone, onset at least 1 year prior at age less than 50, two headaches per month in the previous 6 months, adequate data completion and headache severity during pre-randomization baseline. EXCLUSION CRITERIA: Pregnancy or malignancy, cluster headache, serious pathological aetiology, cranial neuralgia, acupuncture treatment in the past year. DESIGN: Following a 4-week baseline, patients will be allocated to acupuncture or control by minimized randomization. Up to 12 acupuncture treatments will be provided by advanced members of the Acupuncture Association of Chartered Physiotherapists. The type of acupuncture given will be recorded. STUDY MEASURES: Outcome will be assessed by headache diary, medication diary and SF36 at 3 months and 1 year. Resource use and days off sick will be assessed by quarterly questionnaire. Adverse events will be monitored by self-report. The primary outcome measure will be the change in mean daily headache score between baseline and the 1 year follow-up. An economic evaluation will also be undertaken.