MigraineNCT00599586
Randomized Controlled Trial of Treating Migraine With Acupuncture
A study testing acupuncture in people with Migraine, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of the study is to testify whether acupuncture is effective for migraine, and provide evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point." Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Nov 2007to Sep 2009
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of a subject is older than 18 and is younger than 65.(The subject is younger than 50 when he was ill for the first time.)
- Consistent with the diagnostic criteria of Premonitory Migraine and Non- Premonitory Migraine.
- Attacks of migraine are equal to or more than 2 times in the last three months.
- With more than one year history of migraine
- Informed consent is signed by a subject or his lineal relation.
Who cannot join
- With serious protopathy or disease of cardiovascular, liver, renal,gastrointestinal, hematological systems and so on.
- Psychotic，patients with allergic constitution or easily getting infected or bleeding.
- Patients have used drugs for preventing migraine in the last four weeks.
- Pregnant women or women in lactation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to testify whether acupuncture is effective for migraine, and provide evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."
Read the detailed description
The purpose of the study is to testify whether acupuncture is effective for migraine, through treating migraine patients for a month, using different acupoints according to literatures of treating migraine with acupuncture, and try to provide clinical evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."
- Conditions
- Migraine
- Being tested
- acupuncture
- Keywords
- migraine, acupuncture, efficacy, safety, meridian, acupoint
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Also called electro-acupuncture
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | specific acupoints of Shaoyang meridians Receives: Other: acupuncture |
| Group 2 | Experimental | Non-specific acupoints of Shaoyang meridians Receives: Other: acupuncture |
| group 3 | Experimental | Acupoints of other meridians Receives: Other: acupuncture |
| group 4 | Sham comparator | Non-acupoints Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days with migraine
Measured: 4 weeks
frequency of migraine attacks
Measured: 4 weeks
Secondary outcomes (2)
Migraine-Specific Quality-of-Life Questionnaire
Measured: a month
Transcranial Doppler Sonography
Measured: a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Fan-rong Liang, master, Study chair, Chengdu University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599586
- Sponsor's protocol ID
- 2006CB5045011
- Other IDs
- 2006CB5045011
- Status last verified
- Jun 2010
- First submitted
- 3 Jan 2008
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Linde K, Streng A, Jurgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005 May 4;293(17):2118-25. doi: 10.1001/jama.293.17.2118.
PubMed 15870415Zheng H, Huang W, Li J, Zheng Q, Li Y, Chang X, Sun G, Liang F. Association of pre- and post-treatment expectations with improvements after acupuncture in patients with migraine. Acupunct Med. 2015 Apr;33(2):121-8. doi: 10.1136/acupmed-2014-010679. Epub 2014 Dec 30.
PubMed 25549933Deng ZQ, Zheng H, Zhao L, Zhou SY, Li Y, Liang FR. Health economic evaluation of acupuncture along meridians for treating migraine in China: results from a randomized controlled trial. BMC Complement Altern Med. 2012 Jun 14;12:75. doi: 10.1186/1472-6882-12-75.
PubMed 22697367Li Y, Zheng H, Witt CM, Roll S, Yu SG, Yan J, Sun GJ, Zhao L, Huang WJ, Chang XR, Zhang HX, Wang DJ, Lan L, Zou R, Liang FR. Acupuncture for migraine prophylaxis: a randomized controlled trial. CMAJ. 2012 Mar 6;184(4):401-10. doi: 10.1503/cmaj.110551. Epub 2012 Jan 9.
PubMed 22231691Zhao L, Zhang FW, Li Y, Wu X, Zheng H, Cheng LH, Liang FR. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011 Mar 24;12:87. doi: 10.1186/1745-6215-12-87.
PubMed 21435214Li Y, Liang F, Yu S, Liu X, Tang Y, Yang X, Tian X, Yan J, Sun G, Chang X, Zheng H, Zhang H, Ma T. Randomized controlled trial to treat migraine with acupuncture: design and protocol. Trials. 2008 Oct 20;9:57. doi: 10.1186/1745-6215-9-57.
PubMed 18928574
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Treating Migraine With Acupuncture
- ClinicalTrials.gov ID
- NCT00599586
- Acronym / sponsor ID
- 2006CB5045011
- Conditions
- Migraine
- Keywords
- migraine, acupuncture, efficacy, safety, meridian, acupoint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 24 Jan 2008 (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.
The purpose of the study is to testify whether acupuncture is effective for migraine, and provide evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."
Detailed description
The purpose of the study is to testify whether acupuncture is effective for migraine, through treating migraine patients for a month, using different acupoints according to literatures of treating migraine with acupuncture, and try to provide clinical evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Other: acupuncturespecific acupoints of Shaoyang meridians |
| Group 2 | Experimental | Other: acupunctureNon-specific acupoints of Shaoyang meridians |
| group 3 | Experimental | Other: acupunctureAcupoints of other meridians |
| group 4 | Sham comparator | Other: acupunctureNon-acupoints |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of a subject is older than 18 and is younger than 65.(The subject is younger than 50 when he was ill for the first time.)
- Consistent with the diagnostic criteria of Premonitory Migraine and Non- Premonitory Migraine.
- Attacks of migraine are equal to or more than 2 times in the last three months.
- With more than one year history of migraine
- Informed consent is signed by a subject or his lineal relation.
Key exclusion criteria (4 listed)
- With serious protopathy or disease of cardiovascular, liver, renal,gastrointestinal, hematological systems and so on.
- Psychotic，patients with allergic constitution or easily getting infected or bleeding.
- Patients have used drugs for preventing migraine in the last four weeks.
- 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 |
|---|---|---|
| acupunctureAlso: electro-acupunctureSubjects are treated five days a week continuously, and for four weeks.They are treated 30min every time. | Other | Group 2, group 1, group 3, group 4 |
Primary outcome
number of days with migraine
Time frame: 4 weeks
frequency of migraine attacks
Time frame: 4 weeks
2 secondary outcomes
Migraine-Specific Quality-of-Life Questionnaire
Time frame: a month
Transcranial Doppler Sonography
Time frame: a month
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 29 Jun 2010.
- Results publication: PubMed 15870415Linde K, Streng A, Jurgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005 May 4;293(17):2118-25. doi: 10.1001/jama.293.17.2118.
- Derived from this study: PubMed 25549933Zheng H, Huang W, Li J, Zheng Q, Li Y, Chang X, Sun G, Liang F. Association of pre- and post-treatment expectations with improvements after acupuncture in patients with migraine. Acupunct Med. 2015 Apr;33(2):121-8. doi: 10.1136/acupmed-2014-010679. Epub 2014 Dec 30.
- Derived from this study: PubMed 22697367Deng ZQ, Zheng H, Zhao L, Zhou SY, Li Y, Liang FR. Health economic evaluation of acupuncture along meridians for treating migraine in China: results from a randomized controlled trial. BMC Complement Altern Med. 2012 Jun 14;12:75. doi: 10.1186/1472-6882-12-75.
- Derived from this study: PubMed 22231691Li Y, Zheng H, Witt CM, Roll S, Yu SG, Yan J, Sun GJ, Zhao L, Huang WJ, Chang XR, Zhang HX, Wang DJ, Lan L, Zou R, Liang FR. Acupuncture for migraine prophylaxis: a randomized controlled trial. CMAJ. 2012 Mar 6;184(4):401-10. doi: 10.1503/cmaj.110551. Epub 2012 Jan 9.
- Derived from this study: PubMed 21435214Zhao L, Zhang FW, Li Y, Wu X, Zheng H, Cheng LH, Liang FR. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011 Mar 24;12:87. doi: 10.1186/1745-6215-12-87.
- Derived from this study: PubMed 18928574Li Y, Liang F, Yu S, Liu X, Tang Y, Yang X, Tian X, Yan J, Sun G, Chang X, Zheng H, Zhang H, Ma T. Randomized controlled trial to treat migraine with acupuncture: design and protocol. Trials. 2008 Oct 20;9:57. doi: 10.1186/1745-6215-9-57.
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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.
Fan-rong Liang, master study chair
Chengdu University of TCM
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, 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 5 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 29 Jun 2010. 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?
number of days with migraine (time frame: 4 weeks). 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 NCT00599586, which also lists 6 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 29 Jun 2010.