Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura
NCT02765581 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2019-09-09
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.
Conditions
- Migraine Without Aura
Interventions
- DEVICE
-
Verum acupuncture
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.
- DEVICE
-
Sham acupuncture
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.
- BEHAVIORAL
-
Usual care
Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.
Sponsors & Collaborators
-
Hubei College of Traditional Chinese Medicine
collaborator OTHER -
Hubei Hospital of Traditional Chinese Medicine
collaborator OTHER -
Wuhan Integrated Traditional Chinese and Western Medicine Hospital
collaborator OTHER -
University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine
collaborator UNKNOWN -
The Second Hospital of Huangshi
collaborator UNKNOWN -
Xiangyang No.1 People's Hospital, Hubei University of Medicine
collaborator UNKNOWN -
Wei Wang
lead OTHER
Principal Investigators
-
Wei Wang, Doctor · Tongji Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-01
- Primary Completion
- 2018-11-20
- Completion
- 2018-11-20
Countries
- China
Study Locations
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