Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura

NCT ID: NCT02765581

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2018-11-20

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.

Conditions

Migraine Without Aura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Verum acupuncture

Intervention Type: DEVICE

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.

Usual care

Intervention Type: BEHAVIORAL

Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.

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.

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: DEVICE

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.

Usual care

Intervention Type: BEHAVIORAL

Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.

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.

Group Type: PLACEBO_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Usual care

Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hubei College of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Hubei Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Wuhan Integrated Traditional Chinese and Western Medicine Hospital

OTHER

Sponsor Role: collaborator

University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

The Second Hospital of Huangshi

UNKNOWN

Sponsor Role: collaborator

Xiangyang No.1 People's Hospital, Hubei University of Medicine

UNKNOWN

Sponsor Role: collaborator

Wei Wang

OTHER

Sponsor Role: lead

Responsible Party

Wei Wang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wei Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32213509 (View on PubMed)

Other Identifiers

201403RCTMWA

Identifier Type: -

Identifier Source: org_study_id