Set Point Acupuncture for Migraines Using a Digital Assistant

Migraine Headaches Clinical Trial

— SPAMDA  

Official title:

Set Point Acupuncture for Migraines Using a Digital Assistant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714727
• Other study ID #: MMC 07-12
• Status: Completed
• Phase: Phase 1
• First received: July 10, 2008
• Last updated: July 11, 2013
• Start date: July 2008
• Est. completion date: January 2011

Study information

• Verified date: September 2009
• Source: Memorial Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine Headaches

Intervention

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.

Locations

Country	Name	City	State
United States	John P Murtha Neuroscience and Pain Institute	Johnstown	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		32 weeks	No
Secondary	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		32 weeks	No