Set Point Acupuncture for Migraines Using a Digital Assistant (SPAMDA)

Memorial Medical Center

Status and phase

Completed

Phase 1

Conditions

Migraine Headaches

Treatments

Procedure: acupuncture

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00714727

MMC 07-12

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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