Clinical trial NCT04766762: A Randomized Controlled Trial of Acupuncture in Treating Migraine
Official title: A Randomized Controlled Trial of Acupuncture in Treating Migraine Without Aura by the Method of Regulating Ying and Wei
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine Without Aura
Keywords: migraine, acupuncture, randomized controlled trial
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 96
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This randomized controlled trial will enroll 96 migraine patients without aura from the Third Affiliated Hospital of Zhejiang Chinese Medical University. All patients will be randomly assigned to either the acupuncture combined with placebo group or sham acupuncture combined with medication group through a randomization system. Primary outcome will be pain intensity assessed by visual analogue scale (VAS) scale. Secondary outcomes will include migraine-specific quality of life (MSQOL) scale and headache needs assessment survey (HANA) questionnaire scale.

Eligibility criteria: Inclusion Criteria:

1. Patients meet the diagnostic criteria of migraine without aura;
2. 25 ≤ age ≤50 years, male or female;
3. 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;
4. Drug treatment for migraine without aura is stopped for at least one week;
5. Participants can understand the study protocol and written informed consent is signed.

Exclusion Criteria:

1. Patients have severe complications in cardiovascular, liver, kidney, hematopoietic and other systems;
2. Pregnant or lactating women;
3. Patients have spontaneous bleeding tendency so it is not suitable for them to receive acupuncture;
4. Patients have an allergic history of flunarizine hydrochloride or a history of depression;
5. Patients are diagnosed as psychosis.

Primary outcomes:
measure: Change in pain intensity
timeFrame: 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
measure: Change in number of migraine attacks per 4 weeks
timeFrame: 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:
measure: Migraine-specific Quality of life
timeFrame: 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
measure: Headache Needs Assessment Survey (HANA) Questionnaire Scale
timeFrame: 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
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Chuanlong Zhou
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.