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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02765581 on ClinicalTrials.gov