Migraine Without AuraAMPNCT01687660
Acupuncture for Migraine Prophylaxis
A study testing acupuncture in people with Migraine Without Aura and Unilateral Headache, run by Li ying at 1 site in China.
Trial summary
Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A open-label randomized controlled trial. 249 participants will be included. Three arms: acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Without Aura, Unilateral Headache
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Sep 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of a subject is between 18 and 65 years old(initially occured beneath the age of 50), male or female;
- in accordance with diagnosis of migraine without aura in International Classification of Headache Disorders, ICHD-2, by IHS;
- 2 to 8 times attack per month in recent 3 months, with each period beyond 15 days;
- with migraine history for over 1 year;
- be able and willing to finish the headache diary in baseline ;
- informed consent form must be signed by patient or lineal relative;
Who cannot join
- Patients who are unconscious, psychotic.
- Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
- With serious primary illness or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
- Pregnant women or women in lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment
Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A open-label randomized controlled trial. 249 participants will be included. Three arms: acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.
Read the detailed description
Aim: to attest the abiding efficacy and safety of acupuncture for migraine prophylaxis Design: A open-label randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred and forty-three participants will be randomly assign to acupoint-meridian group, non-acupoint-meridian group, and wait-and-see group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. After all the treatments was accomplished, there will be 5 times follow-ups in the impending every 4 weeks. The primary outcome is frequency of migraine attacks 16 weeks after inclusion. Secondary outcomes include frequency of migraine attacks at the 4th and 24th week, headache severity, MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1), etc.
- Conditions
- Migraine Without Aura, Unilateral Headache
- Being tested
- acupuncture
- Keywords
- acupuncture, migraine prophylaxis
- Medical subject headings
- Migraine without Aura, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
apply acupuncture to prevent the migraine attack
| Study group | Role | What they receive |
|---|---|---|
| acupoint-meridian group | Experimental | Apply traditional acupuncture to prevent the migraine attack according to TCM theory Receives: Other: acupuncture |
| sham-acupoint group | Other | sham-acupoint will be penetrated for migraine prophylaxis. Receives: Other: acupuncture |
| waiting list | No intervention | No acupuncture nor other methods will be conducted in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of migraine attacks
to assess the frequency of migraine attacks at the 16th week after inclusion
Measured: 16th week after inclusion
Secondary outcomes (2)
frequency of migraine attacks
to assess the frequency of migraine attacks at the 4th and 24th week respectively
Measured: 4th and 24th week after inclusion
headache severity
to evaluate the change of severity of headache
Measured: 0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Li ying
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan University of Traditional Chinese Medicine, Chongqing Medical University
- Responsible party
- Sponsor-investigator, Li ying, Chengdu University of Traditional Chinese Medicine
- Investigators
- Fanrong Liang, Professor, Principal investigator, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687660
- Sponsor's protocol ID
- 2012CB518501-2
- Acronym
- AMP
- Status last verified
- Feb 2020
- First submitted
- 31 Aug 2012
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhao L, Chen J, Li Y, Sun X, Chang X, Zheng H, Gong B, Huang Y, Yang M, Wu X, Li X, Liang F. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial. JAMA Intern Med. 2017 Apr 1;177(4):508-515. doi: 10.1001/jamainternmed.2016.9378.
PubMed 28241154Chen J, Zhao L, Zheng H, Li Y, Yang M, Chang X, Gong B, Huang Y, Liu Y, Liang F. Evaluating the prophylaxis and long-term effectiveness of acupuncture for migraine without aura: study protocol for a randomized controlled trial. Trials. 2013 Oct 30;14:361. doi: 10.1186/1745-6215-14-361.
PubMed 24171782
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment
- ClinicalTrials.gov ID
- NCT01687660
- Acronym / sponsor ID
- AMP / 2012CB518501-2
- Conditions
- Migraine Without Aura, Unilateral Headache
- Keywords
- acupuncture, migraine prophylaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Li yingUniversity, hospital or other
- Collaborators
- Hunan University of Traditional Chinese Medicine, Chongqing Medical University
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Sep 2012 (estimated)
- 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.
Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A open-label randomized controlled trial. 249 participants will be included. Three arms: acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.
Detailed description
Aim: to attest the abiding efficacy and safety of acupuncture for migraine prophylaxis Design: A open-label randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred and forty-three participants will be randomly assign to acupoint-meridian group, non-acupoint-meridian group, and wait-and-see group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. After all the treatments was accomplished, there will be 5 times follow-ups in the impending every 4 weeks. The primary outcome is frequency of migraine attacks 16 weeks after inclusion. Secondary outcomes include frequency of migraine attacks at the 4th and 24th week, headache severity, MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1), etc.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acupoint-meridian group | Experimental | Other: acupunctureApply traditional acupuncture to prevent the migraine attack according to TCM theory |
| sham-acupoint group | Other | Other: acupuncturesham-acupoint will be penetrated for migraine prophylaxis. |
| waiting list | No intervention | –No acupuncture nor other methods will be conducted in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of a subject is between 18 and 65 years old(initially occured beneath the age of 50), male or female;
- in accordance with diagnosis of migraine without aura in International Classification of Headache Disorders, ICHD-2, by IHS;
- 2 to 8 times attack per month in recent 3 months, with each period beyond 15 days;
- with migraine history for over 1 year;
- be able and willing to finish the headache diary in baseline ;
Key exclusion criteria (4 listed)
- Patients who are unconscious, psychotic.
- Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
- With serious primary illness or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
- Pregnant women or women in lactation.
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 |
|---|---|---|
| acupunctureapply acupuncture to prevent the migraine attack | Other | acupoint-meridian group, sham-acupoint group |
Primary outcome
frequency of migraine attacks
Time frame: 16th week after inclusion
to assess the frequency of migraine attacks at the 16th week after inclusion
2 secondary outcomes
frequency of migraine attacks
Time frame: 4th and 24th week after inclusion
headache severity
Time frame: 0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Derived from this study: PubMed 28241154Zhao L, Chen J, Li Y, Sun X, Chang X, Zheng H, Gong B, Huang Y, Yang M, Wu X, Li X, Liang F. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial. JAMA Intern Med. 2017 Apr 1;177(4):508-515. doi: 10.1001/jamainternmed.2016.9378.
- Derived from this study: PubMed 24171782Chen J, Zhao L, Zheng H, Li Y, Yang M, Chang X, Gong B, Huang Y, Liu Y, Liang F. Evaluating the prophylaxis and long-term effectiveness of acupuncture for migraine without aura: study protocol for a randomized controlled trial. Trials. 2013 Oct 30;14:361. doi: 10.1186/1745-6215-14-361.
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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.
Fanrong Liang, Professor principal investigator
Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Migraine Without Aura and Unilateral Headache, run by Li ying 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 17 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of migraine attacks (time frame: 16th week after inclusion). 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 NCT01687660, which also lists 2 linked publications.
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 17 Feb 2020.