A Randomized Controlled Trial of Acupuncture in Treating Migraine
1 other identifier
interventional
96
1 country
1
Brief Summary
Migraine without aura is a common kind of nervous system diseases that can easily cause recurrent headache, leading to severe impacts on quality of life and health care costs. Current therapeutic options for migraine without aura mainly include flunarizine hydrochloride that can relieve vasospasm. Nevertheless, the efficacy of flunarizine hydrochloride is always limited by inevitable side effects, which result in poor compliance of patients. Moreover, for some most suffering patients, the control of pain is often unsatisfactory despite of the administration of complex treatment combinations. As a non-pharmaceutical therapy, acupuncture is widely used for a wide range of pain conditions. Thus, it might be an alternative treatment for migraine without aura. The aim of this randomized controlled trial is to investigate the efficacy and safety of acupuncture therapy in patients with migraine without aura from the perspective of Regulating Ying and Wei.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2021
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedStudy Start
First participant enrolled
April 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedJuly 11, 2022
July 1, 2022
1.7 years
February 17, 2021
July 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in pain intensity
Change in Pain intensity will be measured by visual analog scale (VAS)，he VAS divides the pain from 0 to 10 into 11 grades. 0: No pain; 10: the worst pain; ≤3: mild pain; 4-6: moderate pain which is tolerable; 7-10: severe pain which is unbearable.
Baseline，4 weeks after treatment，8 weeks after treatment，4 weeks after follow-up visiting，12 weeks after follow-up visiting，and 24 weeks after follow-up visiting
Change in number of migraine attacks per 4 weeks
Change in Number of migraine attacks is assessed by patients' pain diary
Baseline，4 weeks after treatment，8 weeks after treatment，4 weeks after follow-up visiting，12 weeks after follow-up visiting，and 24 weeks after follow-up visiting
Secondary Outcomes (2)
Migraine-specific Quality of life
Baseline，4 weeks after treatment，8 weeks after treatment，4 weeks after follow-up visiting，12 weeks after follow-up visiting，and 24 weeks after follow-up visiting
Headache Needs Assessment Survey (HANA) Questionnaire Scale
Baseline，4 weeks after treatment，8 weeks after treatment，4 weeks after follow-up visiting，12 weeks after follow-up visiting，and 24 weeks after follow-up visiting
Study Arms (2)
Acupuncture combined with placebo group
EXPERIMENTALPatients in this group will receive acupuncture combined with placebo.
Sham acupuncture combined with medication group
OTHERParticipants in this group will receive sham acupuncture plus flunarizine hydrochloride.
Interventions
This group will include 48 patients. Patients in this group will receive acupuncture combined with placebo. Participants are in the supine position. The bilateral Tianrong (SI 17) acupoints are needled for 1-1.5 inch with the direction tilted back 45±5 degrees. The bilateral Fengchi (GB 20) acupoints are needled for 0.5-1 inch with the direction tilted to nose. The bilateral Neiguan (PC 6) acupoints are also needled for 0.5-1 inch with the straight direction. In addition, 4-6 additional acupoints can be identified according to different syndrome types of patients. The needles are kept for 30 min, the treatment frequency is 3 times per week, and the treatment duration lasts 8 weeks. Meanwhile, the dosage of placebo is 1 capsule twice a day and the treatment duration also lasts 8 weeks.
This group will include 48 patients. Participants in this group will receive sham acupuncture plus flunarizine hydrochloride. Participants are in the supine position and sham acupuncture is conducted. The bilateral Tianrong (SI 17) acupoints, Fengchi (GB 20) acupoints and Neiguan (PC 6) acupoints are selected, and 4-6 additional acupoints can be identified according to the syndrome type of the participants. The needles are kept for 30 min, the treatment frequency is 3 times per week, and the treatment duration lasts 8 weeks. Moreover, the dosage of flunarizine hydrochloride is 5mg twice a day and the treatment duration also lasts 8 weeks.
Eligibility Criteria
You may qualify if:
- Patients meet the diagnostic criteria of migraine without aura;
- ≤ age ≤50 years, male or female;
- The efficacy of drugs and other therapeutic methods is not obvious; the frequency of migraine attacks in the past 3 months is more than twice a month;
- Drug treatment for migraine without aura is stopped for at least one week;
- Participants can understand the study protocol and written informed consent is signed.
You may not qualify if:
- Patients have severe complications in cardiovascular, liver, kidney, hematopoietic and other systems;
- Pregnant or lactating women;
- Patients have spontaneous bleeding tendency so it is not suitable for them to receive acupuncture;
- Patients have an allergic history of flunarizine hydrochloride or a history of depression;
- Patients are diagnosed as psychosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000, China
Related Publications (1)
Zhou C, Bao J, Hu H, Ye S, Shao X, Liang Y, Fang J. Acupuncture Based on Regulating Autonomic Nerves for the Prevention of Migraine Without Aura: A Prospective, Double-Dummy, Randomized Controlled Clinical Trial. J Pain Res. 2022 Aug 4;15:2211-2221. doi: 10.2147/JPR.S372311. eCollection 2022.
PMID: 35957963DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chuanlong Zhou
The Third Affiliated hospital of Zhejiang Chinese Medical University
Central Study Contacts
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy chief physician of TCM
Study Record Dates
First Submitted
February 17, 2021
First Posted
February 23, 2021
Study Start
April 21, 2021
Primary Completion
January 1, 2023
Study Completion
February 28, 2023
Last Updated
July 11, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share