Evaluating the prophylaxis and long-term effectiveness of acupuncture for migraine without aura: study protocol for a randomized controlled trial

Abstract

Background: The instant-treatment effect of acupuncture for patients with migraines has been corroborated in numerous studies. However, most diseases are chronic and tend to recur, so the long-term effect of acupuncture can verify the existence of sustained efficacy or the placebo effect. Evaluating the efficacy of acupuncture in the prophylaxis of migraine without aura (MWoA) in China is also important because such studies are lacking.

Methods: This trial is a multicenter, prospective, pragmatic randomized controlled clinical trial. We will randomly allocate 249 participants to three groups of 83. Patients in the individualized acupoint group will be treated with individualized acupuncture point prescriptions. The non-acupoint control group will undergo insertion of acupuncture needles at four bilateral non-points in locations not corresponding to acupuncture points. The waiting-list control group will not undergo treatment but instead will receive 20 acupuncture treatments for free after a waiting period of 24 weeks. Participants in the individualized acupoint group and non-acupoint control group will receive 20 sessions over four weeks and then all participants will receive 20 weeks of follow-up.

Discussion: The results of our trial will help to supply evidence for the long-term acupuncture effect for MWoA in a long follow-up period, and special attention will be paid to comparison with the placebo effect.

Trial registration: The trial was registered at ClinicalTrials.gov (NCT01687660) on 18 September 2012.

Figure 1

Trial profile. Participants with a diagnosis of migraine without aura will be recruited at three centers (enrollment areas of Chengdu, Hunan and Chongqing) taking part in the study. All participants should endure a baseline period of four weeks and inappropriate participants will be excluded. A total of 249 participants will be randomized to three groups: individualized acupoint, non-acupoint control, and waiting-list control. Each patient will receive four weeks of treatment and 20 weeks of follow-up. Outcome will be measured before randomization, the week of the last acupuncture session, and 8, 12, 16, 20 and 24 weeks after randomization, except that the acupuncture expectation value will be assessed before randomization, and MSQ, SAS and SDS will be assessed only at four weeks after treatment.