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Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura

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ClinicalTrials.gov Identifier: NCT02765581
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : June 1, 2018
Sponsor:
Collaborators:
Hubei College of Traditional Chinese Medicine
Hubei Hospital of Traditional Chinese Medicine
Wuhan Integrated Traditional Chinese and Western Medicine Hospital
University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine
The Second Hospital of Huangshi
Tongren Hospital of Wuhan University
Xiangyang No.1 People's Hospital, Hubei University of Medicine
Information provided by (Responsible Party):
Wei Wang, Huazhong University of Science and Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Without Aura Device: Verum acupuncture Device: Sham acupuncture Behavioral: Usual care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluating the Prophylactic Efficacy of Acupuncture for Migraine Without Aura (MWoA) : A Randomized Controlled Trial
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Migraine

Arm Intervention/treatment
Experimental: Verum acupuncture (VA)
Participants will be treated by verum acupuncture and usual care. They will be treated every other day to fulfill a 10-session treatment course, and another course will begin after resting 9 days. Each acupuncture treatment session for patients will be 30 minutes in duration.
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.

Behavioral: Usual care
Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.

Sham Comparator: Sham acupuncture (SA)
Participants will be treated by sham acupuncture and usual care. They will be treated every other day to fulfill a 10-session treatment course, and another course will begin after resting 9 days. Each acupuncture treatment session for patients will be 30 minutes in duration.
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.

Placebo Comparator: Usual care (UA)
Participants will undergo a clinical interview once a month, complete the headache diary assessment, have counseling and health education, and rescue medication if necessary. In addition, they will be scheduled to receive 20 sessions of verum acupuncture treatments for free after a waiting period of 24 weeks.
Behavioral: Usual care
Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.




Primary Outcome Measures :
  1. Change in the number of migraine days [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
    The changes in the mean number of migraine days per 4-week cycle

  2. Change in the frequency of migraine attacks [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
    The changes in the mean number of migraine attacks per 4-week cycle


Secondary Outcome Measures :
  1. The proportion of responders [ Time Frame: At weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
    The proportion of patients with at least a 50% reduction of the number of migraine days

  2. Change in visual analogue scale [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
    The changes in the mean visual analogue scale scores per 4-week cycle

  3. Change in Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2). [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
    The changes in the scores of Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2) per 4-week cycle

  4. Change in Migraine Disability Assessment questionnaire(MIDAS). [ Time Frame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. ]
    The changes in the scores of Migraine Disability Assessment questionnaire(MIDAS)

  5. Change in Migraine-Specific Quality of Life Questionnaire(MSQ) Version 2.1. [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
    The changes in the scores of Migraine-Specific Quality of Life Questionnaire(MSQ) per 4-week cycle

  6. Change in 36-Item Short-Form Health Survey(SF-36). [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
    The changes in the scores of 36-Item Short-Form Health Survey(SF-36) per 4-week cycle

  7. Change in Pittsburgh Sleep Quality Index(PSQI). [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
    The changes in the scores of Pittsburgh Sleep Quality Index(PSQI) per 4-week cycle

  8. Change in the dose of intake of acute medication. [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
    The changes in the dose of intake of acute medication per 4-week cycle


Other Outcome Measures:
  1. The Chinese Version of the Massachusetts General Hospital Acupuncture Sensation Scale [ Time Frame: Immediately following each session of acupuncture treatment. ]
    Acupuncture sensations will be measured by the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS)

  2. Change in Beck Anxiety Inventory(BAI). [ Time Frame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. ]
  3. Change in Beck Depression Inventory II(BDI- II). [ Time Frame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. ]
  4. 60-item NEO Personality Inventory-Short Form (NEO-FFI) [ Time Frame: At baseline (four weeks before randomization) only once. ]
  5. Chinese medicine constitution classification [ Time Frame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. ]
    Patients' Chinese medicine constitution classification will be measured by the score obtained from Constitution in Chinese Medicine Questionnaire (CCMQ)

  6. Acupuncture Expectancy Scale [ Time Frame: Before treatment, after the third session of treatment, and after the twentieth session of treatment. ]
  7. Change in Patient-Doctor Relationship Questionnaire(PDRQ-9) . [ Time Frame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. ]
  8. Change in Difficult Doctor-Patient Relationship Questionnaire(DDPRQ-10). [ Time Frame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. ]


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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed as migraine without aura according to the International Classification of Headache Disorders,3rd edition beta version (ICHD-3β);
  2. Aged between 15 and 65 years old, with initial onset of migraines before the age of 50 years; and
  3. Experienced migraine attacks for at least 1 year; and
  4. Experienced migraine attacks with 2-8 times per month during the last 3 months and baseline period, and the duration of migraine attacks lasting 4-72h without intake of acute drugs or at least 2h with intake of acute drugs; and
  5. the mean headache Visual Analogue Scale (VAS) scores 4-8 at baseline; and
  6. Had not taken any acupuncture treatment before study entry; and
  7. Able to complete the baseline headache diary; and
  8. Able to signing a informed consent.

Exclusion Criteria:

  1. Tension-type headache, cluster headache, and other primary headache disorders, secondary headache disorders, neuralgia of the face or head; and
  2. Combined with cardiovascular, liver, kidney, gastrointestinal tract, blood system and other serious primary diseases affecting the implementation of treatment programs, or combined with epilepsy, Parkinson or other nervous system diseases; and
  3. Patients with severe mental illness, such as severe anxiety and depression; and
  4. Pregnant women, women in lactation, and those planning to become pregnant; and
  5. Participation in other clinical trials; and
  6. Illiterate, or patients unable to read and understand scales;
  7. Have experience of acupuncture.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765581


Contacts
Contact: Shabei Xu, Doctor 86-13554178768 xushabei@126.com
Contact: Lingling Yu, Doctor 86-13545862185 527679774@qq.com

Locations
China, Hubei
Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China
Contact: Wei Wang, Doctor    86-027-8366-3648    tianyalinghu@126.com   
Sub-Investigator: Sha-Bei Xu, Doctor         
Sponsors and Collaborators
Wei Wang
Hubei College of Traditional Chinese Medicine
Hubei Hospital of Traditional Chinese Medicine
Wuhan Integrated Traditional Chinese and Western Medicine Hospital
University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine
The Second Hospital of Huangshi
Tongren Hospital of Wuhan University
Xiangyang No.1 People's Hospital, Hubei University of Medicine
Investigators
Principal Investigator: Wei Wang, Doctor Tongji Hospital

Responsible Party: Wei Wang, Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02765581     History of Changes
Other Study ID Numbers: 201403RCTMWA
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wei Wang, Huazhong University of Science and Technology:
Acupuncture
Migraine without aura
Efficacy
Randomized controlled trial
Non-penetrating sham acupuncture

Additional relevant MeSH terms:
Migraine Disorders
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases