Randomized controlled trial to treat migraine with acupuncture: design and protocol
We report the design and the protocol of a randomized controlled trial to treat Migraine with acupuncture aimed to testify whether acupuncture is effective for treating migraine, and its effectiveness maybe is different duo to using acupoints of different meridians or different acupoints of one meridian.Methods and Design: A multi-center randomized controlled trial with three acupoints treatment groups and one non-acupoints control group. Acupuncture treatment consists of 20 sessions per patient during observation period of 20 weeks.
480 patients with Migraine are enrolled in this study within 8 hospitals in China from March 2008 to June 2009. All patients are randomly assigned to receive either one of acupoints treatment groups (1)specific acupoints of Shaoyang meridians (120 patients), (2)non-specific acupoints of Shaoyang meridians (120 patients), (3)acupoints of other meridians (120 patients); or non-acupoints control group (120 patients).The Main outcome measures in the trial are the differences between the number of days with migraine and frequency of migraine attacks during 4 weeks before randomization (baseline phase) and 4, 8 and 16 weeks after randomization.
And intensity of headache which includes Headache intensity grade (0-3) and visual analogue scale (VAS) score will also be used. Moreover, the differences of Migraine-Specific Quality-of-Life Questionnaire (MSQ) and Transcranial Doppler Sonography (TCD) before and after randomization are the secondary outcomes measurement.DiscussionThe result of this trial (available in 2009) will certify the efficacy of acupuncture treating migraine, and whether the specific effect of acupoints is existed, and whether this specific effect of acupoints is related to meridian and gathering of meridian Qi.Trials registration: Clinical Trials.gov NCT00599586
Author: Ying Li, FanRong Liang, ShuGuang Yu, XuGuang Liu, Yong Tang, XuGuang Yang, XiaoPing Tian, Jie Yan, GuoJie Sun, XiaoRong Chang, Hui Zheng, HongXing Zhang and Tingting Ma
Credits/Source: Trials 2008, 9:57
Published on: 2008-10-20
Copyright by the authors listed above - made available via BioMedCentral (Open Access). Please
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