Set Point Acupuncture for Migraines Using a Digital Assistant

NCT ID: NCT00714727

Last Updated: 2013-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-01-31

Brief Summary

The object of this research study is to test a standardized set of acupuncture points on migraine patients to reduce frequency and intensity of headaches. Acupuncture has been studied in prior research but the treatment points have varied between subjects, making it difficult to replicate studies.

Detailed Description

Subjects will be recording daily headache activity on personal digital assistants (PDA's) for 12 weeks before and 12 weeks after 8 weeks of acupuncture intervention. MIDAS, HIT-6 and BDI-II measurements will be done at the beginning of the study (12 weeks pre-intervention), directly before the intervention, directly after, and 12 weeks post-intervention. Measurements will be compared before and after intervention. This is a follow-up to a successful earlier study when these same acupuncture points were used on subjects with chronic daily headache, the majority being migraine.

Conditions

Migraine Headaches

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: OTHER

acupuncture

Intervention Type: PROCEDURE

8 weeks of acupuncture, starting with twice a week for 4 weeks, followed by once a week for 4 weeks, using 8 standardized, bilateral acupuncture points.

Interventions

acupuncture

8 weeks of acupuncture, starting with twice a week for 4 weeks, followed by once a week for 4 weeks, using 8 standardized, bilateral acupuncture points.

Intervention Type: PROCEDURE

Other Intervention Names

Migraines

Eligibility Criteria

Inclusion Criteria

• Male and female subjects between the ages of 21 years and 65 years of age
• Subjects with a history of migraine headaches for at least 12 months
• Subjects who have not received acupuncture for any medical condition in the past 6 months.
• A negative pregnancy test for childbearing females since some acupuncture points may be contraindicated in pregnancy. Pregnancy tests will be conducted at MMC.
• Subjects willing and able to use a PDA daily for data collection

Exclusion Criteria

• Subjects who plan to receive acupuncture treatment for any other type of medical condition while enrolled in this protocol
• Subjects with the presence of organic pathology (i.e., brain tumor)
• Subjects who have the presence of a systemic disorder or illness, including serious psychiatric illness
• Subjects who began a new headache treatment less than two weeks before proposed enrollment date
• Subjects who are pregnant, lactating, or planning to become pregnant within 6 months
• Subjects that use alcohol on a regular basis
• Subjects that use recreational drugs
• Subjects that have a cardiac pacemaker
• Subjects that use analgesics on more than 10 days per month
• Subjects that exercise prophylactic headache treatment with drugs during the past 4 weeks

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Memorial Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Plank, MD, LAc

Role: PRINCIPAL_INVESTIGATOR

John P. Murtha Neuroscience and Pain Institute

Locations

John P Murtha Neuroscience and Pain Institute

Johnstown, Pennsylvania, United States

Countries

United States

Other Identifiers

MMC 07-12

Identifier Type: -

Identifier Source: org_study_id