Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura
Study type: Interventional

Summary: 
      Acupuncture is commonly used for the prevention of migraine, while the evidence for its
      efficacy is still uncertain. Current studies have not been able to determine whether the
      efficacy of acupuncture is due to the actual therapeutic effect of acupuncture, or a result
      of psychological benefits. To address this issue, we designed a clinical trial to evaluate
      the prophylactic efficacy of acupuncture for migraine without aura (MWoA). Furthermore, we
      will evaluate the impact of Chinese medicine factors and psychological factors on the
      efficacy of acupuncture.
    

Detailed description: 
      This is a multicentre, stratified, randomized, sham-controlled clinical trial. 150 eligible
      participants will be randomly allocated into verum acupuncture, sham acupuncture, or usual
      care groups, in a 2:2:1 ratio. The verum acupuncture group will receive twenty verum
      acupuncture treatments over an eight-week period, while the sham acupuncture group will
      receive sham acupuncture treatments with non-penetrating needling. Participants assigned to
      the usual care group are scheduled to receive twenty verum acupuncture treatments for free
      after waiting 24 weeks. Health education will be provided to participants in the three
      groups. The primary outcomes will be the changes in the mean number of migraine days and
      migraine attacks per four-week cycle. The secondary outcomes will be as follows: the
      proportion of responders, migraine intensity, migraine disability assessment questionnaire,
      health-related and sleep-related quality of life, the dose of intake of acute medication.
      Chinese medicine factors will include de qi sensations and Traditional Chinese Medicine (TCM)
      constitution. Psychological outcomes will include anxiety, depression, personality,
      expectancy about acupuncture, and doctor-patient relationship. The central randomization and
      data collection will be conducted by an electronic data management system.
    

Intervention name(s): Verum acupuncture; Sham acupuncture; Usual care
Intervention type(s): Device; Device; Behavioral
Intervention description(s): The main acupuncture points are bilateral "Hegu" (L14) and "Taichong" (LR3), unilateral "Taiyang"(EX-HN5), "Fengchi" (GB20) and "Shuaigu" (GB8). Additional points can be chosen according to individual syndrome differentiation of meridians: (1) Yangming headache: Touwei (ST8); (2) Taiyang headache: Tianzhu (BL10); (3) Jueying: Baihui" (GV20). The NO.16 special type of acupuncture (0.30 x 30 mm) produced by German asia-med company will be applied.The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi.; We use a non-insertive sham control produced by Asia-med Company in Germany-the streitberger placebo-needle. Sham points are described as follows: 1) Bilateral of midpoint between acupoint "Jianjin"(GB21) and "Jugu"(LI16); 2) 5 cun lateral to the seventh thoracic spine; 3) 5 cun lateral to the eighth thoracic spine; 4) 5 cun lateral to the ninth thoracic spine. Cun is a distance measure unit used in locating acupoints in traditional Chinese medicine (TCM) acupuncture, and the width of patient's thumb interphalangeal joint is regarded as one cun.; Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Migraine without aura; Efficacy; Randomized controlled trial; Non-penetrating sham acupuncture