Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura

Evaluating the Prophylactic Efficacy of Acupuncture for Migraine Without Aura (MWoA) : A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Migraine Without Aura
• Intervention / Treatment: Device: Verum acupuncture; Behavioral: Usual care; Device: Sham 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of migraine days	The changes in the mean number of migraine days per 4-week cycle	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	The changes in the mean number of migraine attacks per 4-week cycle	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

Outcome Measure	Measure Description	Time Frame
The proportion of responders	The proportion of patients with at least a 50% reduction of the number of migraine days	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	The changes in the mean visual analogue scale scores per 4-week cycle	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).	The changes in the scores of Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2) per 4-week cycle	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).	The changes in the scores of Migraine Disability Assessment questionnaire(MIDAS)	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.	The changes in the scores of Migraine-Specific Quality of Life Questionnaire(MSQ) per 4-week cycle	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).	The changes in the scores of 36-Item Short-Form Health Survey(SF-36) per 4-week cycle	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).	The changes in the scores of Pittsburgh Sleep Quality Index(PSQI) per 4-week cycle	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.	The changes in the dose of intake of acute medication per 4-week cycle	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

Outcome Measure	Measure Description	Time Frame
The Chinese Version of the Massachusetts General Hospital Acupuncture Sensation Scale	Acupuncture sensations will be measured by the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS)	Immediately following each session of acupuncture treatment.
Change in Beck Anxiety Inventory(BAI).		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).		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)		At baseline (four weeks before randomization) only once.
Chinese medicine constitution classification	Patients' Chinese medicine constitution classification will be measured by the score obtained from Constitution in Chinese Medicine Questionnaire (CCMQ)	At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.
Acupuncture Expectancy Scale		Before treatment, after the third session of treatment, and after the twentieth session of treatment.
Change in Patient-Doctor Relationship Questionnaire(PDRQ-9) .		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).		At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.

Collaborators and Investigators

• Sponsor: Wei Wang
• Collaborators: Hubei Hospital of Traditional Chinese Medicine; Wuhan Integrated Traditional Chinese and Western Medicine Hospital; Hubei College of Traditional Chinese Medicine; University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine; The Second Hospital of Huangshi; Xiangyang No.1 People's Hospital, Hubei University of Medicine

Publications and helpful links

General Publications

• Xu S, Yu L, Luo X, Wang M, Chen G, Zhang Q, Liu W, Zhou Z, Song J, Jing H, Huang G, Liang F, Wang H, Wang W. Manual acupuncture versus sham acupuncture and usual care for prophylaxis of episodic migraine without aura: multicentre, randomised clinical trial. BMJ. 2020 Mar 25;368:m697. doi: 10.1136/bmj.m697.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): November 20, 2018
• Study Completion (ACTUAL): November 20, 2018

Study Registration Dates

• First Submitted: April 10, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (ESTIMATE): May 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Acupuncture; Efficacy; Randomized controlled trial; Migraine without aura; Non-penetrating sham acupuncture
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Migraine without Aura
• Other Study ID Numbers: 201403RCTMWA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No