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Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura

Primary Purpose

Migraine Without Aura

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Verum acupuncture

Sham acupuncture

Usual care

About this trial

This is an interventional treatment trial for Migraine Without Aura focused on measuring Acupuncture, Migraine without aura, Efficacy, Randomized controlled trial, Non-penetrating sham acupuncture

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Placebo Comparator

Arm Label

Verum acupuncture (VA)

Sham acupuncture (SA)

Usual care (UA)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in the number of migraine days

The changes in the mean number of migraine days per 4-week cycle

Change in the frequency of migraine attacks

The changes in the mean number of migraine attacks per 4-week cycle

Secondary Outcome Measures

The proportion of responders

The proportion of patients with at least a 50% reduction of the number of migraine days

Change in visual analogue scale

The changes in the mean visual analogue scale scores per 4-week cycle

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

Change in Migraine Disability Assessment questionnaire(MIDAS).

The changes in the scores of Migraine Disability Assessment questionnaire(MIDAS)

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

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

Change in Pittsburgh Sleep Quality Index(PSQI).

The changes in the scores of Pittsburgh Sleep Quality Index(PSQI) per 4-week cycle

Change in the dose of intake of acute medication.

The changes in the dose of intake of acute medication per 4-week cycle

Full Information

NCT ID

NCT02765581

First Posted

April 10, 2016

Last Updated

September 5, 2019

Sponsor

Wei Wang

Collaborators

Hubei College of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Wuhan Integrated Traditional Chinese and Western Medicine Hospital, 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

1. Study Identification

Unique Protocol Identification Number

NCT02765581

Brief Title

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

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

May 1, 2016 (Actual)

Primary Completion Date

November 20, 2018 (Actual)

Study Completion Date

November 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Wei Wang

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine Without Aura

Keywords

Acupuncture, Migraine without aura, Efficacy, Randomized controlled trial, Non-penetrating sham acupuncture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Verum acupuncture (VA)

Arm Type

Experimental

Arm Description

Arm Title

Sham acupuncture (SA)

Arm Type

Sham Comparator

Arm Description

Arm Title

Usual care (UA)

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Verum acupuncture

Intervention Description

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

Intervention Name(s)

Sham acupuncture

Intervention Description

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

Behavioral

Intervention Name(s)

Usual care

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in the number of migraine days

Description

The changes in the mean number of migraine days per 4-week cycle

Time Frame

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.

Title

Change in the frequency of migraine attacks

Description

The changes in the mean number of migraine attacks per 4-week cycle

Time Frame

Secondary Outcome Measure Information:

Title

The proportion of responders

Description

The proportion of patients with at least a 50% reduction of the number of migraine days

Time Frame

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.

Title

Change in visual analogue scale

Description

The changes in the mean visual analogue scale scores per 4-week cycle

Time Frame

Title

Change in Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2).

Description

The changes in the scores of Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2) per 4-week cycle

Time Frame

Title

Change in Migraine Disability Assessment questionnaire(MIDAS).

Description

The changes in the scores of Migraine Disability Assessment questionnaire(MIDAS)

Time Frame

At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.

Title

Change in Migraine-Specific Quality of Life Questionnaire(MSQ) Version 2.1.

Description

The changes in the scores of Migraine-Specific Quality of Life Questionnaire(MSQ) per 4-week cycle

Time Frame

Title

Change in 36-Item Short-Form Health Survey(SF-36).

Description

The changes in the scores of 36-Item Short-Form Health Survey(SF-36) per 4-week cycle

Time Frame

Title

Change in Pittsburgh Sleep Quality Index(PSQI).

Description

The changes in the scores of Pittsburgh Sleep Quality Index(PSQI) per 4-week cycle

Time Frame

Title

Change in the dose of intake of acute medication.

Description

The changes in the dose of intake of acute medication per 4-week cycle

Time Frame

Other Pre-specified Outcome Measures:

Title

The Chinese Version of the Massachusetts General Hospital Acupuncture Sensation Scale

Description

Acupuncture sensations will be measured by the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS)

Time Frame

Immediately following each session of acupuncture treatment.

Title

Change in Beck Anxiety Inventory(BAI).

Time Frame

At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.

Title

Change in Beck Depression Inventory II(BDI- II).

Time Frame

At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.

Title

60-item NEO Personality Inventory-Short Form (NEO-FFI)

Time Frame

At baseline (four weeks before randomization) only once.

Title

Chinese medicine constitution classification

Description

Patients' Chinese medicine constitution classification will be measured by the score obtained from Constitution in Chinese Medicine Questionnaire (CCMQ)

Time Frame

At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.

Title

Acupuncture Expectancy Scale

Time Frame

Before treatment, after the third session of treatment, and after the twentieth session of treatment.

Title

Change in Patient-Doctor Relationship Questionnaire(PDRQ-9) .

Time Frame

At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.

Title

Change in Difficult Doctor-Patient Relationship Questionnaire(DDPRQ-10).

Time Frame

At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Wang, Doctor

Organizational Affiliation

Tongji Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Wuhan

State/Province

Hubei

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32213509

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.

Results Reference

derived

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Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura

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