A Randomized Controlled Trial of Acupuncture in Treating Migraine

• ClinicalTrials.gov Identifier: NCT04766762
• Recruitment Status: Not yet recruiting
• First Posted: February 23, 2021
• Last Update Posted: February 23, 2021
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Information provided by (Responsible Party): Chuanlong Zhou, The Third Affiliated hospital of Zhejiang Chinese Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Migraine Without Aura	Procedure: Acupuncture combined with placebo; Procedure: Sham acupuncture combined with flunarizine hydrochloride	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Acupuncture in Treating Migraine Without Aura by the Method of Regulating Ying and Wei
• Estimated Study Start Date: March 1, 2021
• Estimated Primary Completion Date: August 31, 2022
• Estimated Study Completion Date: February 28, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Acupuncture combined with placebo group; Patients in this group will receive acupuncture combined with placebo.	Procedure: Acupuncture combined with placebo; 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.
Sham acupuncture combined with medication group; Participants in this group will receive sham acupuncture plus flunarizine hydrochloride.	Procedure: Sham acupuncture combined with flunarizine hydrochloride; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in pain intensity [ Time Frame: 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 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.
2. Change in number of migraine attacks per 4 weeks [ Time Frame: 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 is assessed by patients' pain diary

Secondary Outcome Measures :

1. Migraine-specific Quality of life [ Time Frame: 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 ]
   Quality of life will be measure by migraine-specific quality of life (MSQOL) scale.This questionnaire consists of 25 items, with 4 answers for each question. The overall format and scores are as follows: 1.Very much; 2. Many; 3. Some; 4. Not at all. The overall scale ranges from 25 to 100, with higher scores indicating the better quality of life.
2. Headache Needs Assessment Survey (HANA) Questionnaire Scale [ Time Frame: 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 ]
   Evaluate the frequency and severity of the migraine effect.The overall score ranges from 14 to 70, with higher scores indicating the greater impact of migraine on life.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Chuanlong Zhou; 15868486255; 471388079@qq.com

Sponsors and Collaborators

The Third Affiliated hospital of Zhejiang Chinese Medical University

Investigators

• Principal Investigator: Chuanlong Zhou; The Third Affiliated hospital of Zhejiang Chinese Medical University

More Information

• Responsible Party: Chuanlong Zhou, Deputy chief physician of TCM, The Third Affiliated hospital of Zhejiang Chinese Medical University
• ClinicalTrials.gov Identifier: NCT04766762
• Other Study ID Numbers: 2020ZB125
• First Posted: February 23, 2021
• Last Update Posted: February 23, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chuanlong Zhou, The Third Affiliated hospital of Zhejiang Chinese Medical University:

migraine, acupuncture, randomized controlled trial

Additional relevant MeSH terms:

Migraine Disorders; Migraine without Aura; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Flunarizine; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Vasodilator Agents