Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura

Not Applicable

Completed

• Conditions: Migraine Without Aura
• Interventions: Device: Verum acupuncture; Device: Sham acupuncture; Behavioral: Usual care

• Registration Number: NCT02765581
• Lead Sponsor: Wei Wang

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.

Study Timeline

• Study First Submitted: 2016-04-10
• Study Start: 2016-05-01
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-06
• Primary Completion: 2018-11-20
• Study Completion: 2018-11-20
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham acupuncture (SA)	Usual care	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.
Verum acupuncture (VA)	Verum acupuncture	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.
Verum acupuncture (VA)	Usual care	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.
Sham acupuncture (SA)	Sham acupuncture	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.
Usual care (UA)	Usual care	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.

Primary Outcome Measures

Name	Time	Method
Change in the number of migraine days	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
Change in the frequency of migraine attacks	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

Name	Time	Method
Change in 36-Item Short-Form Health Survey(SF-36).	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
The proportion of responders	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
Change in visual analogue scale	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
Change in the dose of intake of acute medication.	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
Change in Migraine Disability Assessment questionnaire(MIDAS).	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)
Change in Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2).	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
Change in Migraine-Specific Quality of Life Questionnaire(MSQ) Version 2.1.	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
Change in Pittsburgh Sleep Quality Index(PSQI).	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

Trial Locations

Locations (1)

Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China