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Integrating Acupuncture Into the Management of Migraines

This study has been terminated.
(PI cited personal reasons)
Sponsor:
Information provided by (Responsible Party):
National University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01481103
First received: November 22, 2011
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Migraine Headache
 Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Integrating Acupuncture Into the Management of Migraines: A Randomized, Comparative Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National University of Health Sciences:

Primary Outcome Measures:
  • Number and intensity of migraine headaches [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 9
Study Start Date: July 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acupuncture group
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
 Procedure: Acupuncture
participants will receive 8 weekly acupuncture sessions. Acupuncture will be performed by a licensed acupuncturist. Each session will last approximately 25 minutes.
No Intervention: Control group
participants will be asked to maintain a daily diary of headache occurrences and OTC medication use for 16 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481103

Locations
United States, Illinois
Serenity Acupuncture and Oriental Medicine
Oak Park, Illinois, United States, 60302
Sponsors and Collaborators
National University of Health Sciences
Investigators
Principal Investigator: Patricia Miller, LAc, PT National University of Health Sciences
Study Director: Hui Yan Cai, LAc, PhD National University of Health Sciences
  More Information

No publications provided

Responsible Party: National University of Health Sciences
ClinicalTrials.gov Identifier: NCT01481103     History of Changes
Other Study ID Numbers: NUHS H1009
Study First Received: November 22, 2011
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by National University of Health Sciences:
Over the counter medication
Acupuncture

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013