Clinical trial NCT02765581: Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura
Official title: Evaluating the Prophylactic Efficacy of Acupuncture for Migraine Without Aura (MWoA) : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Without Aura
Keywords: Acupuncture
Migraine without aura
Efficacy
Randomized controlled trial
Non-penetrating sham acupuncture
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Hubei College of Traditional Chinese Medicine
name: Hubei Hospital of Traditional Chinese Medicine
name: Wuhan Integrated Traditional Chinese and Western Medicine Hospital
name: University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine
name: The Second Hospital of Huangshi
name: Xiangyang No.1 People's Hospital, Hubei University of Medicine
First posted: 2016-05-06
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in the number of migraine days
timeFrame: 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.
measure: Change in the frequency of migraine attacks
timeFrame: 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 outcomes:
measure: The proportion of responders
timeFrame: 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.
measure: Change in visual analogue scale
timeFrame: 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.
measure: Change in Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2).
timeFrame: 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.
measure: Change in Migraine Disability Assessment questionnaire(MIDAS).
timeFrame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.
measure: Change in Migraine-Specific Quality of Life Questionnaire(MSQ) Version 2.1.
timeFrame: 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.
measure: Change in 36-Item Short-Form Health Survey(SF-36).
timeFrame: 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.
measure: Change in Pittsburgh Sleep Quality Index(PSQI).
timeFrame: 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.
measure: Change in the dose of intake of acute medication.
timeFrame: 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 outcomes:
measure: The Chinese Version of the Massachusetts General Hospital Acupuncture Sensation Scale
timeFrame: Immediately following each session of acupuncture treatment.
measure: Change in Beck Anxiety Inventory(BAI).
timeFrame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.
measure: Change in Beck Depression Inventory II(BDI- II).
timeFrame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.
measure: 60-item NEO Personality Inventory-Short Form (NEO-FFI)
timeFrame: At baseline (four weeks before randomization) only once.
measure: Chinese medicine constitution classification
timeFrame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.
measure: Acupuncture Expectancy Scale
timeFrame: Before treatment, after the third session of treatment, and after the twentieth session of treatment.
measure: Change in Patient-Doctor Relationship Questionnaire(PDRQ-9) .
timeFrame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.
measure: Change in Difficult Doctor-Patient Relationship Questionnaire(DDPRQ-10).
timeFrame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.
Locations:
city: Wuhan
country: China
facility: Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wei Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.