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Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura

This study is not yet open for participant recruitment.
Verified May 2016 by Wei Wang, Huazhong University of Science and Technology
Sponsor:
ClinicalTrials.gov Identifier:
NCT02765581
First Posted: May 6, 2016
Last Update Posted: June 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Hubei College of Traditional Chinese Medicine
Hubei Hospital of Traditional Chinese Medicine
Wuhan Hospital of Intergreted Chinese and Western Medicine
University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine
Information provided by (Responsible Party):
Wei Wang, Huazhong University of Science and Technology
  Purpose
The purpose of this study is to evaluate the efficacy of verum acupuncture (VA) for the prevention of migraine without aura compared to non-penetrating sham acupuncture (SA) and usual care alone (UC). This study also aims to determine whether the intensity of deqi sensations and psychosocial factors (including patient expectations, patient personality traits, patient-doctor relationship, traditional Chinese medicine constitution, depression, anxiety, sleep quality, etc.) are associated with clinical outcomes.

Condition Intervention
Migraine Without Aura Device: Verum acupuncture Device: Sham acupuncture Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Efficacy of Acupuncture in the Prevention of Migraine Without Aura: a Randomized Sham-controlled Trial

Resource links provided by NLM:


Further study details as provided by Wei Wang, Huazhong University of Science and Technology:

Primary Outcome Measures:
  • 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. ]
  • 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. ]

Secondary Outcome Measures:
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Other Outcome Measures:
  • The Chinese Version of the Massachusetts General Hospital Acupuncture Sensation Scale [ Time Frame: Immediately following each session of acupuncture treatment. ]
  • 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. ]
  • 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. ]
  • 60-item NEO Personality Inventory-Short Form (NEO-FFI) [ Time Frame: At baseline (four weeks before randomization) only once. ]
  • Chinese medicine constitution classification [ Time Frame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. ]
  • Acupuncture Expectancy Scale [ Time Frame: Before treatment, after the third session of treatment, and after the twentieth session of treatment. ]
  • 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. ]
  • 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. ]

Estimated Enrollment: 150
Study Start Date: May 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum acupuncture (VA)
Participants will receive verum acupuncture plus usual care. Participants will receive acupuncture treatment every other day to fulfill a 10-session treatment course, and another 10-session course will begin after a nine-day break, totally be treated with 20 sessions. Verum needles will be inserted into the skin and manipulated manually until deqi occurs. The needles are retained for 30 min in each session. During the treatment, the acupuncturist inquires the patient about deqi sensations every 10 min and manipulates the needles to maintain the intensity of deqi. Participants will receive the same usual care as those in the usual care group.
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 receive sham acupuncture plus usual care. The Streitberger placebo needle will be placed at non-acupuncture points which are distant from the meridian parts and not located on the same neuromuscular segments as the prescribed points used in the VA group, so as to minimize any therapeutic and segmental effects. The same acupuncture schedule as that in the verum acupuncture group will be applied. The needles are retained for 30 min in each session. During the treatment, the acupuncturist inquires the patient about deqi sensations every 10 min and pretends to manipulate the needles but deqi is not sought. Participants will receive the same usual care as those in the usual care group.
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 not receive acupuncture treatment besides health education as a control group.
Behavioral: Usual care
Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.

Detailed Description:
The trail consists of three periods: baseline period before treatment and randomization (week-4 to week 0), treatment period (week 1 to week 8), and follow-up period (week 9 to week 20).A total of 150 participants will be randomly assigned to verum acupuncture(VA)group, sham acupuncture(SA)group, and usual care(UC) group in a ratio of 2:2:1. The primary outcome measures are the change of migraine days and migraine attacks in a cycle of 4 weeks compared to baseline. The secondary outcome measures are the proportion of responders, headache intensity, intake of acute medication, and the change of life quality and sleep quality. Deqi sensations will be measured by the Chinese version of the Massachusetts General Hospital Acupuncture Sensation Scale. Psychological outcome measures are Beck Depression Rating Scale, Beck Anxiety Inventory, NEO Five-Factor Inventory, Doctor-Patient Relationship Scale, and Difficult Doctor-Patients Relationship Scale. Participants will be asked to complete headache diaries from the baseline to follow-up period. The central randomization and data collection will be conducted by an electronic data management system.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, 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.
  Contacts and Locations
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 Not yet 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 Hospital of Intergreted Chinese and Western Medicine
University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine
Investigators
Principal Investigator: Wei Wang, Doctor Tongji Hospital
  More Information

Responsible Party: Wei Wang, Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02765581     History of Changes
Other Study ID Numbers: 201403RCTMWA
First Submitted: April 10, 2016
First Posted: May 6, 2016
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Wei Wang, Huazhong University of Science and Technology:
Acupuncture
Migraine
Randomized Controlled Trial
Placebo Effect

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