Back to resultsIntegrating Acupuncture Into the Management of Migraines
Primary Purpose
Migraine Headache
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional prevention trial for Migraine Headache focused on measuring Over the counter medication, Acupuncture
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Serenity Acupuncture and Oriental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Acupuncture group
Control group
Arm Description
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
participants will be asked to maintain a daily diary of headache occurrences and OTC medication use for 16 weeks.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01481103
First Posted
November 22, 2011
Last Updated
April 2, 2013
Sponsor
National University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01481103
Brief Title
Integrating Acupuncture Into the Management of Migraines
Official Title
Integrating Acupuncture Into the Management of Migraines: A Randomized, Comparative Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
PI cited personal reasons
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University of Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
Over the counter medication, Acupuncture
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
participants will be asked to maintain a daily diary of headache occurrences and OTC medication use for 16 weeks.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
participants will receive 8 weekly acupuncture sessions. Acupuncture will be performed by a licensed acupuncturist. Each session will last approximately 25 minutes.
Primary Outcome Measure Information:
Title
Number and intensity of migraine headaches
Description
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
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Medication consumed
Description
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
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Miller, LAc, PT
Organizational Affiliation
National University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hui Yan Cai, LAc, PhD
Organizational Affiliation
National University of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Serenity Acupuncture and Oriental Medicine
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60302
Country
United States
12. IPD Sharing Statement
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Integrating Acupuncture Into the Management of Migraines
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