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

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.

Study Overview

• Status: Completed
• Conditions: Migraine Headaches
• Intervention / Treatment: Procedure: acupuncture

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Migraines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Medical Center
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Sharon Plank, MD, LAc, John P. Murtha Neuroscience and Pain Institute

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: July 10, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 14, 2008

Study Record Updates

• Last Update Posted (Estimate): July 12, 2013
• Last Update Submitted That Met QC Criteria: July 11, 2013
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: acupuncture; headache; migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: MMC 07-12