NCT01481103

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

1.8 years

First QC Date

November 22, 2011

Last Update Submit

April 2, 2013

Conditions

Migraine Headache

Keywords

Over the counter medicationAcupuncture

Outcome Measures

Primary Outcomes (1)

  • 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

    16 weeks

Secondary Outcomes (1)

  • Medication consumed

    16 weeks

Study Arms (2)

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

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.

Interventions

AcupuncturePROCEDURE

participants will receive 8 weekly acupuncture sessions. Acupuncture will be performed by a licensed acupuncturist. Each session will last approximately 25 minutes.

Acupuncture group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Serenity Acupuncture and Oriental Medicine

Oak Park, Illinois, 60302, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Patricia Miller, LAc, PT

    National University of Health Sciences

    PRINCIPAL INVESTIGATOR

  • Hui Yan Cai, LAc, PhD

    National University of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2011

First Posted

November 29, 2011

Study Start

July 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

US(1)