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.
RCT Entities:
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.
Authors: Klaus Linde; Gianni Allais; Benno Brinkhaus; Yutong Fei; Michael Mehring; Emily A Vertosick; Andrew Vickers; Adrian R White Journal: Cochrane Database Syst Rev Date: 2016-06-28
Authors: Klaus Linde; Gianni Allais; Benno Brinkhaus; Yutong Fei; Michael Mehring; Byung-Cheul Shin; Andrew Vickers; Adrian R White Journal: Cochrane Database Syst Rev Date: 2016-04-19
Authors: Andrew J Vickers; Rebecca W Rees; Catherine E Zollman; Rob McCarney; Claire M Smith; Nadia Ellis; Peter Fisher; Robbert Van Haselen Journal: BMJ Date: 2004-03-15
Authors: Klaus Linde; Gianni Allais; Benno Brinkhaus; Eric Manheimer; Andrew Vickers; Adrian R White Journal: Cochrane Database Syst Rev Date: 2009-01-21
Authors: Klaus Linde; Gianni Allais; Benno Brinkhaus; Eric Manheimer; Andrew Vickers; Adrian R White Journal: Cochrane Database Syst Rev Date: 2009-01-21
Authors: K Linde; A Vickers; M Hondras; G ter Riet; J Thormählen; B Berman; D Melchart Journal: BMC Complement Altern Med Date: 2001-07-16 Impact factor: 3.659