MigraineNCT01152632
Acupuncture for Migraine: a Functional Magnetic Resonance Imaging (fMRI) Study
A study testing manual acupuncture in people with Migraine, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Selecting acupoints along meridians is the predominant principle in acupuncture treatment, and it is also considered to ensure acupuncture efficacy. This experiment is to investigate whether specific brain networks gradually come in formation in accordance with this kind of acupoint selection methods. Read more about this study
- Who is it for?
- Ages 17 to 45 years
- Conditions the study is for
- Migraine
- What is being tested?
- manual acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Dec 2013
- 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 17 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinical diagnosis of non-aura Migraine formulated by the international headache society in 2004
Who cannot join
- people with other types of headache
- people with organic cerebral disorders
- people with primary disorders
- people in moderate or severe anxiety or depression
- people in pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610075
About this study
Official title: Acupuncture Treatment for Migraine: a Functional Magnetic Resonance Imaging Study
Selecting acupoints along meridians is the predominant principle in acupuncture treatment, and it is also considered to ensure acupuncture efficacy. This experiment is to investigate whether specific brain networks gradually come in formation in accordance with this kind of acupoint selection methods.
Read the detailed description
Every participants in the four intervention groups will go through functional magnetic imaging (fMRI) scan four times: the 1st scan will be performed at their baselines; the 2nd scan will be done after 2 courses (10 times) acupuncture treatment; the 3rd scan will be performed when the 4 courses end; the 4th scan will be operated after three-month enrollment.
Volunteers in waiting list group will undergo the above scans at the same time points in exception of acupuncture treatment.
- Conditions
- Migraine
- Being tested
- manual acupuncture
- Keywords
- acupuncture, migraine, specific acupoints, brain network
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual acupunctureOther
Also called acupuncture
thirty minutes duration every time, five times per week for one course, a total four courses
| Study group | Role | What they receive |
|---|---|---|
| specific points of Bladder meridian and Shanjiao meridian | Experimental | In traditional Chinese acupuncture theory, Bladder meridian and Shanjiao meridian have been considered as the main pathological meridian location of migraine. Meanwhile, specific points on both meridians have been used widely in its treatment for a long time. Receives: Other: manual acupuncture |
| non-specific points of Bladder meridian and Shanjiao meridian | Experimental | Non-specific points of Shaoyang meridians are also used in cure of migraine. It is conventionally thought to be less effective using non-specific points than specific ones. Receives: Other: manual acupuncture |
| specific points of Stomach meridian | Active comparator | Specific points of Stomache meridian for migraine were searched in Chinese ancient data. And this group is set to compare with specific points of Shaoyang meridians for their possible different brain networks. Receives: Other: manual acupuncture |
| non-acupoints | Placebo comparator | Three non-acupoints were chosen,two of which were located on the arm and one one the leg. Receives: Other: manual acupuncture |
| waiting list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of headache frequency
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2013
- Study completionDec 2013
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 MigraineStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanrong Liang, Master, Study chair, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152632
- Sponsor's protocol ID
- 30930112/C190301
- Status last verified
- Aug 2012
- First submitted
- 27 Jun 2010
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li Z, Zhou J, Lan L, Cheng S, Sun R, Gong Q, Wintermark M, Zeng F, Liang F. Concurrent brain structural and functional alterations in patients with migraine without aura: an fMRI study. J Headache Pain. 2020 Dec 7;21(1):141. doi: 10.1186/s10194-020-01203-5.
PubMed 33287704
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Treatment for Migraine: a Functional Magnetic Resonance Imaging Study
- ClinicalTrials.gov ID
- NCT01152632
- Acronym / sponsor ID
- 30930112/C190301
- Conditions
- Migraine
- Keywords
- acupuncture, migraine, specific acupoints, brain network
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jun 2010 (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.
Selecting acupoints along meridians is the predominant principle in acupuncture treatment, and it is also considered to ensure acupuncture efficacy. This experiment is to investigate whether specific brain networks gradually come in formation in accordance with this kind of acupoint selection methods.
Detailed description
Every participants in the four intervention groups will go through functional magnetic imaging (fMRI) scan four times: the 1st scan will be performed at their baselines; the 2nd scan will be done after 2 courses (10 times) acupuncture treatment; the 3rd scan will be performed when the 4 courses end; the 4th scan will be operated after three-month enrollment.
Volunteers in waiting list group will undergo the above scans at the same time points in exception of acupuncture treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| specific points of Bladder meridian and Shanjiao meridian | Experimental | Other: manual acupunctureIn traditional Chinese acupuncture theory, Bladder meridian and Shanjiao meridian have been considered as the main pathological meridian location of migraine. Meanwhile, specific points on both meridians have been used widely in its treatment for a long time. |
| non-specific points of Bladder meridian and Shanjiao meridian | Experimental | Other: manual acupunctureNon-specific points of Shaoyang meridians are also used in cure of migraine. It is conventionally thought to be less effective using non-specific points than specific ones. |
| specific points of Stomach meridian | Active comparator | Other: manual acupunctureSpecific points of Stomache meridian for migraine were searched in Chinese ancient data. And this group is set to compare with specific points of Shaoyang meridians for their possible different brain networks. |
| non-acupoints | Placebo comparator | Other: manual acupunctureThree non-acupoints were chosen,two of which were located on the arm and one one the leg. |
| waiting list | No intervention | – |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- clinical diagnosis of non-aura Migraine formulated by the international headache society in 2004
Key exclusion criteria (5 listed)
- people with other types of headache
- people with organic cerebral disorders
- people with primary disorders
- people in moderate or severe anxiety or depression
- people in pregnancy
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 |
|---|---|---|
| manual acupunctureAlso: acupuncturethirty minutes duration every time, five times per week for one course, a total four courses | Other | non-acupoints, non-specific points of Bladder meridian and Shanjiao meridian, specific points of Bladder meridian and Shanjiao meridian, specific points of Stomach meridian |
Primary outcome
improvement of headache frequency
Time frame: 4 weeks
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 2 Dec 2014.
- Derived from this study: PubMed 33287704Li Z, Zhou J, Lan L, Cheng S, Sun R, Gong Q, Wintermark M, Zeng F, Liang F. Concurrent brain structural and functional alterations in patients with migraine without aura: an fMRI study. J Headache Pain. 2020 Dec 7;21(1):141. doi: 10.1186/s10194-020-01203-5.
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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, Master study chair
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 manual acupuncture in people with Migraine, run by Chengdu University of Traditional Chinese Medicine 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 1 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: finished, as of the sponsor's last update on 2 Dec 2014. 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. Some participants in this study may receive a placebo. 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?
improvement of headache frequency (time frame: 4 weeks). 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 NCT01152632, 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 2 Dec 2014.