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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Migraine Headaches	Procedure: acupuncture	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Set Point Acupuncture for Migraines Using a Digital Assistant
Study Start Date :	July 2008
Actual Primary Completion Date :	January 2011
Actual Study Completion Date :	January 2011

Arms and Interventions

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Arm	Intervention/treatment
1	Procedure: 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.; Other Name: Migraines

Outcome Measures

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Primary Outcome Measures :

1. If a standard set of acupuncture points delivered over a set time frame, reduces the frequency and intensity of headaches in a population of migraine sufferers. [ Time Frame: 32 weeks ]

Secondary Outcome Measures :

1. Measurements of the impact of acupuncture intervention will be detected when baseline measurements of frequency and severity of headaches is compared to measurements taken 12 weeks after the last acupuncture session. MIDAS, HIT-6, BDI-II and SF-12 scores [ Time Frame: 32 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Pennsylvania
John P Murtha Neuroscience and Pain Institute
Johnstown, Pennsylvania, United States, 15904

Sponsors and Collaborators

Memorial Medical Center

United States Department of Defense

Investigators

Principal Investigator:	Sharon Plank, MD, LAc	John P. Murtha Neuroscience and Pain Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Memorial Medical Center
ClinicalTrials.gov Identifier:	NCT00714727 History of Changes
Other Study ID Numbers:	MMC 07-12
First Posted:	July 14, 2008
Last Update Posted:	July 12, 2013
Last Verified:	September 2009

Keywords provided by Memorial Medical Center:

migraine; headache; acupuncture

Additional relevant MeSH terms:

Migraine Disorders; Headache; Headache Disorders, Primary; Headache Disorders; Brain Diseases	Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms