Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura

Study Overview
=================
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.

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.

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

Conditions
-----------------
Migraine Without Aura

Intervention / Treatment
-----------------
* Device: Verum acupuncture
* Device: Sham acupuncture
* Behavioral: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as migraine without aura according to the International Classification of Headache Disorders,3rd edition beta version (ICHD-3β); Aged between 15 and 65 years old, with initial onset of migraines before the age of 50 years; and Experienced migraine attacks for at least 1 year; and 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 the mean headache Visual Analogue Scale (VAS) scores 4-8 at baseline; and Had not taken any acupuncture treatment before study entry; and Able to complete the baseline headache diary; and Able to signing a informed consent. Exclusion Criteria: Tension-type headache, cluster headache, and other primary headache disorders, secondary headache disorders, neuralgia of the face or head; and 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 Patients with severe mental illness, such as severe anxiety and depression; and Pregnant women, women in lactation, and those planning to become pregnant; and Participation in other clinical trials; and Illiterate, or patients unable to read and understand scales; Have experience of acupuncture.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum acupuncture (VA)<br>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<br>* 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.<br>Behavioral: Usual care<br>* Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.<br>|
| Sham Comparator: Sham acupuncture (SA)<br>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<br>* 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.<br>Behavioral: Usual care<br>* Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.<br>|
| Placebo Comparator: Usual care (UA)<br>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<br>* Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.<br>|

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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture, Migraine without aura, Efficacy, Randomized controlled trial, Non-penetrating sham acupuncture