Migraine HeadacheNCT01481103
Integrating Acupuncture Into the Management of Migraines
A study testing Acupuncture in people with Migraine Headache, run by National University of Health Sciences at 1 site in United States.
Trial summary
This research is being done to study the effect of incorporating acupuncture into the management of migraines. The primary aim is to determine in a randomized, controlled study whether individuals experiencing migraines have fewer occurrences and less intense migraines when acupuncture is integrated with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Migraine with or without aura according to the International Headache Society classification and diagnosed by a Medical Doctor.
- Subjects are required to have between 2 and 12 migraines but no more than 15 headache days (migraine or nonmigraine) per 28 days during the prospective baseline phase. A headache day is defined as a calendar day during which the patient experienced headache for at least 30 minutes.
- Taking a nonprescription medication for the migraine pain. More specifically Aspirin, Ibuprofen, Naproxen, and/or Acetaminophen (with or without caffeine).
- Age between 18 and 65 years.
- A history of migraine for at least 12 months.
- Completed at least 75% of the baseline headache diary.
- Completion of written informed consent.
Who cannot join
- Onset of headache disorder less than 12 months prior to age 50.
- Pregnancy or planning to get pregnant while participating in the study.
- Malignancy; cluster headache (IHS code 3); sinus headaches.
- Suspicion that headache disorder has specific etiology (IHS code 5-11); cranial neuralgias (IHS code12)
- Acupuncture treatment in the previous 12 months.
- Taking a prescription medication for the migraine pain.
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- Subject plans to receive acupuncture for another medical condition while participating in the study.
- Systemic disorder or illness, including serious psychiatric illness.
- Failure to fulfill baseline information.
- Failure to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Serenity Acupuncture and Oriental Medicine
Oak Park, Illinois, 60302
About this study
Official title: Integrating Acupuncture Into the Management of Migraines: A Randomized, Comparative Trial
This research is being done to study the effect of incorporating acupuncture into the management of migraines. The primary aim is to determine in a randomized, controlled study whether individuals experiencing migraines have fewer occurrences and less intense migraines when acupuncture is integrated with nonprescription pharmacological treatment. Nonprescription pharmacological treatment in this study refers to the use of the following over the counter medications: Aspirin, Ibuprofen, Naproxen, Acetaminophen (with or without caffeine). Aspirin, Ibuprofen, and Naproxen are members of a class of drugs known as non-steroidal anti-inflammatory drugs or NSAIDs.
Read the detailed description
70 men and women between the ages of 18-65 diagnosed with migraines by a medical doctor. Participants must be using only nonprescription medication to treat their head pain.
Once initial eligibility has been determined and informed consent obtained, a Traditional Chinese Medicine (TCM) differential diagnosis will be carried out to determine the underlying cause of the migraines experienced by the participant. If the migraines are due to Liver Qi stagnation with Liver Yang rising they will be eligible for participation in the study. Eligible participants will be randomly assigned to one of two groups: Group 1 will continue taking their current nonprescription migraine medication as needed and will receive acupuncture once a week for 8 weeks. Group 2 will continue with their current nonprescription migraine medication as needed but will not receive acupuncture. The same set of predetermined acupuncture points will be used at each session.
All participants will complete a daily headache and medication use diary for four weeks on two separate occasions. In addition all participants will complete the Headache Impact Test (HIT-6) survey on three separate occasions.
- Conditions
- Migraine Headache
- Being tested
- Acupuncture
- Keywords
- Over the counter medication, Acupuncture
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
participants will receive 8 weekly acupuncture sessions. Acupuncture will be performed by a licensed acupuncturist. Each session will last approximately 25 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Active comparator | Participants will keep a headache diary for 4weeks and then attend eight weekly acupuncture sessions. Acupuncture will be done by a licensed acupuncturist and will last approximately 25 minutes. Following the acupuncture sessions, participants will keep a headache diary for an additional 4 weeks Receives: Procedure: Acupuncture |
| Control group | No intervention | participants will be asked to maintain a daily diary of headache occurrences and OTC medication use for 16 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and intensity of migraine headaches
Participants will be asked to maintain a daily diary of headache occurrences and medication use for 4 weeks prior to intervention and 4 weeks after intervention
Measured: 16 weeks
Secondary outcomes (1)
Medication consumed
Participants will be asked to maintain a daily diary of headache occurrences and medication use for 4 weeks prior to intervention and 4 weeks after intervention
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: PI cited personal reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Miller, LAc, PT, Principal investigator, National University of Health SciencesHui Yan Cai, LAc, PhD, Study director, National University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481103
- Sponsor's protocol ID
- NUHS H1009
- Status last verified
- Apr 2013
- First submitted
- 22 Nov 2011
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Acupuncture Into the Management of Migraines: A Randomized, Comparative Trial
- ClinicalTrials.gov ID
- NCT01481103
- Acronym / sponsor ID
- NUHS H1009
- Conditions
- Migraine Headache
- Keywords
- Over the counter medication, Acupuncture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI cited personal reasons
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National University of Health SciencesUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Nov 2011 (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.
This research is being done to study the effect of incorporating acupuncture into the management of migraines. The primary aim is to determine in a randomized, controlled study whether individuals experiencing migraines have fewer occurrences and less intense migraines when acupuncture is integrated with nonprescription pharmacological treatment. Nonprescription pharmacological treatment in this study refers to the use of the following over the counter medications: Aspirin, Ibuprofen, Naproxen, Acetaminophen (with or without caffeine). Aspirin, Ibuprofen, and Naproxen are members of a class of drugs known as non-steroidal anti-inflammatory drugs or NSAIDs.
Detailed description
70 men and women between the ages of 18-65 diagnosed with migraines by a medical doctor. Participants must be using only nonprescription medication to treat their head pain.
Once initial eligibility has been determined and informed consent obtained, a Traditional Chinese Medicine (TCM) differential diagnosis will be carried out to determine the underlying cause of the migraines experienced by the participant. If the migraines are due to Liver Qi stagnation with Liver Yang rising they will be eligible for participation in the study. Eligible participants will be randomly assigned to one of two groups: Group 1 will continue taking their current nonprescription migraine medication as needed and will receive acupuncture once a week for 8 weeks. Group 2 will continue with their current nonprescription migraine medication as needed but will not receive acupuncture. The same set of predetermined acupuncture points will be used at each session.
All participants will complete a daily headache and medication use diary for four weeks on two separate occasions. In addition all participants will complete the Headache Impact Test (HIT-6) survey on three separate occasions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Active comparator | Procedure: AcupunctureParticipants will keep a headache diary for 4weeks and then attend eight weekly acupuncture sessions. Acupuncture will be done by a licensed acupuncturist and will last approximately 25 minutes. Following the acupuncture sessions, participants will keep a headache diary for an additional 4 weeks |
| Control group | No intervention | –participants will be asked to maintain a daily diary of headache occurrences and OTC medication use for 16 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Migraine with or without aura according to the International Headache Society classification and diagnosed by a Medical Doctor.
- Subjects are required to have between 2 and 12 migraines but no more than 15 headache days (migraine or nonmigraine) per 28 days during the prospective baseline phase. A headache day is defined as a calendar day during which the patient experienced headache for at least 30 minutes.
- Taking a nonprescription medication for the migraine pain. More specifically Aspirin, Ibuprofen, Naproxen, and/or Acetaminophen (with or without caffeine).
- Age between 18 and 65 years.
- A history of migraine for at least 12 months.
Key exclusion criteria (10 listed)
- Onset of headache disorder less than 12 months prior to age 50.
- Pregnancy or planning to get pregnant while participating in the study.
- Malignancy; cluster headache (IHS code 3); sinus headaches.
- Suspicion that headache disorder has specific etiology (IHS code 5-11); cranial neuralgias (IHS code12)
- Acupuncture treatment in the previous 12 months.
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 |
|---|---|---|
| Acupunctureparticipants will receive 8 weekly acupuncture sessions. Acupuncture will be performed by a licensed acupuncturist. Each session will last approximately 25 minutes. | Procedure or surgery | Acupuncture group |
Primary outcome
Number and intensity of migraine headaches
Time frame: 16 weeks
Participants will be asked to maintain a daily diary of headache occurrences and medication use for 4 weeks prior to intervention and 4 weeks after intervention
1 secondary outcome
Medication consumed
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: PI cited personal reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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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.
Patricia Miller, LAc, PT principal investigator
National University of Health Sciences
Hui Yan Cai, LAc, PhD study director
National University of Health Sciences
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 Headache, run by National University of Health Sciences at 1 site in United States.
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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 4 Apr 2013. 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 United States. 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 was stopped early (reason given: PI cited personal reasons). Results are not available in the source record.
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 and intensity of migraine headaches (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2013.