Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura

NCT02765581 | Completed DMC

• 1 other identifier: 201403RCTMWA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Without Aura

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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.

• 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.

• 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.

• Change in 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.

  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 (8)

• The Chinese Version of the Massachusetts General Hospital Acupuncture Sensation Scale

  Immediately following each session of acupuncture treatment.

• Change in Beck Anxiety Inventory(BAI).

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

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

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

Study Arms (3)

Verum acupuncture (VA)

EXPERIMENTAL

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; Behavioral: Usual care

Sham acupuncture (SA)

SHAM COMPARATOR

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; Behavioral: Usual care

Usual care (UA)

PLACEBO COMPARATOR

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

Interventions

Verum acupuncture 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.

Verum acupuncture (VA)

Sham acupuncture 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.

Sham acupuncture (SA)

Usual care BEHAVIORAL

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

Sham acupuncture (SA); Usual care (UA); Verum acupuncture (VA)

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wei Wang: lead
• Hubei College of Traditional Chinese Medicine: collaborator
• Hubei Hospital of Traditional Chinese Medicine: collaborator
• Wuhan Integrated Traditional Chinese and Western Medicine Hospital: collaborator
• University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine: collaborator
• The Second Hospital of Huangshi: collaborator
• Xiangyang No.1 People's Hospital, Hubei University of Medicine: collaborator

Study Sites (1)

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

Wuhan, Hubei, China

Location

Related Publications (1)

• 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.

  PMID: 32213509 DERIVED

MeSH Terms

Conditions

Migraine without Aura

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Wei Wang, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2016
• First Posted: May 6, 2016
• Study Start: May 1, 2016
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: September 9, 2019

Record last verified: 2019-09

Locations

CN (1)