Migraine Without AuraNCT04766762
A Randomized Controlled Trial of Acupuncture in Treating Migraine
A study of Migraine Without Aura, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Migraine Without Aura
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients meet the diagnostic criteria of migraine without aura;
- 25 ≤ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Chuanlong Zhou, MM, 15868486255 ext. 86, 471388079@qq.com
About this study
Official title: A Randomized Controlled Trial of Acupuncture in Treating Migraine Without Aura by the Method of Regulating Ying and Wei
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.
Read the 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.
- Conditions
- Migraine Without Aura
- Being tested
- Acupuncture combined with placebo, Sham acupuncture combined with flunarizine hydrochloride
- Keywords
- migraine, acupuncture, randomized controlled trial
- Medical subject headings
- Migraine without Aura, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture combined with placeboProcedure or surgery
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 flunarizine hydrochlorideProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture combined with placebo group | Experimental | Patients in this group will receive acupuncture combined with placebo. Receives: Procedure: Acupuncture combined with placebo |
| Sham acupuncture combined with medication group | Other | Participants in this group will receive sham acupuncture plus flunarizine hydrochloride. Receives: Procedure: Sham acupuncture combined with flunarizine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start21 Apr 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine Without AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanlong Zhou, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Chuanlong Zhou, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766762
- Sponsor's protocol ID
- 2020ZB125
- Status last verified
- Jul 2022
- First submitted
- 17 Feb 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35957963
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Acupuncture in Treating Migraine Without Aura by the Method of Regulating Ying and Wei
- ClinicalTrials.gov ID
- NCT04766762
- Acronym / sponsor ID
- 2020ZB125
- Conditions
- Migraine Without Aura
- Keywords
- migraine, acupuncture, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture combined with placebo group | Experimental | Procedure: Acupuncture combined with placeboPatients in this group will receive acupuncture combined with placebo. |
| Sham acupuncture combined with medication group | Other | Procedure: Sham acupuncture combined with flunarizine hydrochlorideParticipants in this group will receive sham acupuncture plus flunarizine hydrochloride. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients meet the diagnostic criteria of migraine without aura;
- 25 ≤ 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture combined with placeboThis 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. | Procedure or surgery | Acupuncture combined with placebo group |
| Sham acupuncture combined with flunarizine hydrochlorideThis 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. | Procedure or surgery | Sham acupuncture combined with medication group |
Primary outcome
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.
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Derived from this study: PubMed 35957963Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuanlong Zhou principal investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Migraine Without Aura, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuanlong Zhou (15868486255, 471388079@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.